This report is based on research conducted by the Tufts Evidence-based Practice Center (EPC) 

under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD 

(Contract No. HHSA 290-2007-10055-I). The findings and conclusions in this document are 

those of the author(s), who are responsible for its content, and do not necessarily represent the 

views of AHRQ. No statement in this report should be construed as an official position of AHRQ 

or of the U.S. Department of Health and Human Services. 

The information in this report is intended to help clinicians, employers, policymakers, and others 

make informed decisions about the provision of health care services. This report is intended as a 

reference and not as a substitute for clinical judgment. 

This report may be used, in whole or in part, as the basis for the development of clinical practice 

guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage 

policies. AHRQ or U.S. Department of Health and Human Services endorsement of such 

derivative products may not be stated or implied. 

 
Evidence Report/Technology Assessment 

Number 183 

Vitamin D and Calcium: A Systematic Review of 

Health Outcomes 

Prepared for: 

Agency for Healthcare Research and Quality 

U.S. Department of Health and Human Services 

540 Gaither Road 

Rockville, MD 20850 

www.ahrq.gov 

Contract No. HHSA 290-2007-10055-I 

Task Order No. 4 

Prepared by: 

Tufts Evidence-based Practice Center, Boston, MA 

Investigators: 

Mei Chung, M.P.H. 

Ethan M Balk, M.D., M.P.H. 

Michael Brendel, B.A. 

Stanley Ip, M.D. 

Joseph Lau, M.D. 

Jounghee Lee, Ph.D. 

Alice Lichtenstein, D.Sc. 

Kamal Patel, M.B.A., M.P.H. 

Gowri Raman, M.D. 

Athina Tatsioni, M.D., Ph.D. 

Teruhiko Terasawa, M.D. 

Thomas A Trikalinos, M.D., Ph.D. 

AHRQ Publication No. 09-E015 

August 2009

ii
This document is in the public domain and may be used and reprinted without permission except 

those copyrighted materials noted for which further reproduction is prohibited without the 

specific permission of copyright holders. 

Suggested Citation: 

Chung M, Balk EM, Brendel M, Ip S, Lau J, Lee J, Lichtenstein A, Patel K, Raman G, Tatsioni 

A, Terasawa T, Trikalinos TA. Vitamin D and Calcium: A Systematic Review of Health 

Outcomes. Evidence Report No. 183. (Prepared by the Tufts Evidence-based Practice Center 

under Contract No. HHSA 290-2007-10055-I.) AHRQ Publication No. 09-E015. Rockville, MD: 

Agency for Healthcare Research and Quality. August, 2009.

No investigators have any affiliations or financial involvement (e.g., 

employment, consultancies, honoraria, stock options, expert testimony, 

grants or patents received or pending, or royalties) that conflict with 

iii
Preface 

 The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based 

Practice Centers (EPCs), sponsors the development of evidence reports and technology 

assessments to assist public- and private-sector organizations in their efforts to improve the 

quality of health care in the United States. The Office of Dietary Supplements/National Institutes 

of Health, the Public Health Agency of Canada, Health Canada, and Food and Drug 

Administration requested and provided funding for this report. The reports and assessments 

provide organizations with comprehensive, science-based information on common, costly 

medical conditions and new health care technologies. The EPCs systematically review the 

relevant scientific literature on topics assigned to them by AHRQ and conduct additional 

analyses when appropriate prior to developing their reports and assessments. 

 To bring the broadest range of experts into the development of evidence reports and health 

technology assessments, AHRQ encourages the EPCs to form partnerships and enter into 

collaborations with other medical and research organizations. The EPCs work with these partner 

organizations to ensure that the evidence reports and technology assessments they produce will 

become building blocks for health care quality improvement projects throughout the Nation. The 

reports undergo peer review prior to their release. 

 AHRQ expects that the EPC evidence reports and technology assessments will inform 

individual health plans, providers, and purchasers as well as the health care system as a whole by 

providing important information to help improve health care quality. 

 We welcome comments on this evidence report. They may be sent by mail to the Task Order 

Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, 

Rockville, MD 20850, or by email to epc@ahrq.gov. 

Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H. 

Director Director, Center for Outcomes and Evidence 

Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality 

Beth A. Collins Sharp, R.N., Ph.D. Stephanie Chang, M.D., M.P.H. 

Director, EPC Program EPC Program Task Order Officer 

Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality 

Paul M. Coates, Ph.D. Elizabeth A. Yetley, Ph.D. 

Director, Office of Dietary Supplements Senior Nutrition Research Scientist, Retired 

National Institutes of Health Office of Dietary Supplements 

 National Institutes of Health 

iv
v

Mary Frances Picciano, Ph.D. Kimberly D. Elmslie, M.Sc. 

Senior Nutrition Research Scientist Director General 

Office of Dietary Supplements Centre for Chronic Disease Prevention and 

National Institutes of Health Control 

 Public Health Agency of Canada 

Margaret de Groh, Ph.D. Hasan Hutchinson, Ph.D., N.D. 

Manager, Risk Factors Unit Director General 

Centre for Chronic Disease Prevention and Control Office of Nutrition Policy and Promotion 

Health Canada Public Health Agency of Canada 

Linda Greene-Finestone, Ph.D., R.D. Paula R. Trumbo, Ph.D. 

Nutrition Advisor Supervisor, Nutrition Science Evaluation 

Centre for Chronic Disease Prevention and Control Office of Nutrition, Labeling and Dietary 

Public Health Agency of Canada Supplements 

 Center for Food Safety and Applied 

 Nutrition 

 Food and Drug Administration 
Acknowledgments 

 We would like to acknowledge with appreciation the following members of the Technical 

Expert Panel for their advice and consultation to the Tufts Evidence-based Practice Center 

during the preparation for this report: 

Steven Abrams, M.D. 

Professor of Pediatrics 

Baylor College of Medicine 

Section of Neonatology 

Texas Children's Hospital 

Houston, Texas 

Stephanie Atkinson, Ph.D. 

Professor and Associate Chair 

Department of Pediatrics 

Biochemistry and Biomedical Sciences 

Health Sciences 

McMaster University 

Hamilton, Canada 

Patsy M. Brannon, Ph.D. 

Professor 

Division of Nutritional Sciences 

Cornell University 

Ithaca, New York 

Rebecca D. Jackson, M.D. 

Associate Professor 

Department of Internal Medicine 

Division of Endocrinology, Diabetes, and 

Metabolism 

The Ohio State University 

Columbus, Ohio 

Glenville Jones, Ph.D. 

Professor and Head 

Department of Biochemistry 

Queen's University 

Ontario, Canada 

Susan Taylor Mayne, Ph.D., F.A.C.E. 

Professor 

Division of Chronic Disease Epidemiology 

Yale School of Public Health 

New Haven, Connecticut 

Clifford J. Rosen, M.D. 

Senior Scientist 

Maine Medical Center Research Institute 

Scarborough, Maine 

vi
Structured Abstract 

Background: Since the 1997 Dietary Reference Intake (DRI) values for vitamin D and calcium 

were established new data have become available on their relationship, both individually and 

combined, to a wide range of health outcomes. The Institute of Medicine/Food and Nutrition 

Board has constituted a DRI committee to undertake a review of the evidence and potential 

revision of the current DRI values for these nutrients. To support this review, several US and 

Canadian federal government agencies commissioned a systematic review of the scientific 

literature for use during the deliberations by the committee. The intent of providing a systematic 

review to the committee is to support transparency of the literature review process and provide a 

foundation for subsequent reviews of the nutrients. 

Purpose: To systematically summarize the evidence on the relationship between vitamin D, 

calcium, and a combination of both nutrients on a wide range of health outcomes as identified by 

the IOM, AHRQ and technical expert panel convened to support the project. 

Data sources: MEDLINE; Cochrane Central; Cochrane Database of Systematic Reviews; and 

the Health Technology Assessments; search limited to English-language articles in humans. 

Study selection: Primary interventional or observational studies that reported outcomes of 

interest in human subjects in relation to vitamin D and/or calcium, as well as systematic reviews 

that met the inclusion and exclusion criteria. Cross sectional and retrospective case-control 

studies were excluded. 

Data extraction: A standardized protocol with predefined criteria was used to extract details on 

study design, interventions, outcomes, and study quality. 

Data synthesis: We summarized 165 primary articles and 11 systematic reviews that 

incorporated over 200 additional primary articles. Available evidence focused mainly on bone 

health, cardiovascular diseases or cancer outcomes. For many outcomes, it was difficult to draw 

firm conclusions on the basis of the available literature concerning the association of either 

serum 25(OH)D concentration or calcium intake, or the combination of both nutrients. Findings 

were inconsistent across studies for colorectal and prostate cancer, and pregnancy-related 

outcomes including preeclampsia. There were few studies for pancreatic cancer and immune 

function. Among trials of hypertensive adults, calcium supplementation lowered systolic, but not 

diastolic, blood pressure by 2-4 mm Hg. For body weight, the trials were consistent in finding no 

significant effect of increased calcium intake on weight. For growth rates, a meta-analysis did 

not find a significant effect on weight or height gain attributable to calcium supplement in 

children. For bone health, one systematic review found that vitamin D plus calcium 

supplementation resulted in small increases in BMD of the spine and other areas in 

postmenopausal women. For breast cancer, calcium intakes in premenopausal women were 

associated with a decreased risk. For prostate cancer, some studies reported that high calcium 

intakes were associated with an increased risk. 

Limitations: Studies on vitamin D and calcium were not specifically targeted at life stages 

(except for pregnant and postmenopausal women) specified for the determination of DRI. There 

vii
viii

is large variation on the methodological quality of studies examined. Use of existing systematic 

reviews limits analyses that could be performed on this source of information. 

Conclusions: The majority of the findings concerning vitamin D, calcium, or a combination of 

both nutrients on the different health outcomes were inconsistent. Synthesizing a dose-response 

relation between intake of either vitamin D, calcium, or both nutrients and health outcomes in 

this heterogeneous body of literature prove challenging. 
Contents 

Executive Summary

Evidence Report.......................................................................................................................... 15 

Chapter 1. Introduction

Background

Sources, metabolism and functions of vitamin D

Sources, metabolism and functions of calcium

Challenges for the DRI committees

Key Questions addressed in this report

Chapter 2. Methods

Overview

Sponsoring Federal agencies

AHRQ Task Order Officer (TOO)

Technical Expert Panel (TEP)

EPC methodologists

Development of the analytic framework and refinement of key questions

Definitions

Vitamin D and calcium exposures

Clinical outcomes

Indicators of exposure (nutrient intake)

Surrogate outcomes

Intermediate outcomes

Life stages

Key questions

Literature search strategy

Study selection

Abstract screening

Full text article eligibility criteria

Primary studies

Systematic reviews

Other specific eligibility criteria

Data extraction

Data analysis

Meta-analysis

Grading of studies analyzed in this evidence report

Critical appraisal and grading of primary studies

Additional considerations of methodological quality of primary studies for the 

purpose of DRI decision making

Critical appraisal of systematic reviews

Reporting of the evidence

Evidence tables

Summary tables

ix
Graphical presentation of dose-response relationship

Grand summary tables (evidence map)

Units of measurement

Assay method

Sunlight exposure

Primary and secondary outcomes

Study quality

Organization of the Results Section

Chapter 3. Results

Literature search results

Vitamin D and health outcomes

Vitamin D and growth

Vitamin D and cardiovascular disease

Vitamin D and body weight

Vitamin D and cancer

Cancer from all causes and total cancer mortality

Prostate cancer

Colorectal cancer

Colorectal adenoma

Breast cancer

Pancreatic cancer

Vitamin D and immunologic outcomes

Vitamin D and pregnancy-related outcomes

Preeclampsia

Other outcomes

Vitamin D and clinical outcomes of bone health

Rickets

Fractures, falls, or performance measures

Vitamin D and all-cause mortality

Vitamin D and hypertension and blood pressure

Hypertension

Vitamin D and blood pressure

Vitamin D and bone mineral density or bone mineral content

Calcium and health outcomes

Calcium and growth

Calcium and cardiovascular disease

Calcium and body weight

Calcium and cancer

Cancer from all cause and total cancer mortality

Prostate cancer

Colorectal cancer

Colorectal adenoma

Breast cancer incidence

Breast Mammographic Density

Pancreatic cancer

x
Calcium and pregnancy-related outcomes

Preeclampsia

High blood pressure with or without proteinuria during pregnancy

Preterm birth

Small for gestational age infant

Calcium and all-cause mortality

Calcium and hypertension and blood pressure

Calcium and hypertension

Calcium and blood pressure

Combined vitamin D and calcium and health outcomes

Combined vitamin D calcium and growth

Combined vitamin D and calcium and cardiovascular disease

Combined vitamin D and calcium and body weight

Combined vitamin D and calcium and cancer

Cancer from all causes and total cancer mortality

Colorectal cancer

Colorectal adenoma

Breast cancer

Combined vitamin D and calcium and pregnancy-related outcomes

Preeclampsia

Other pregnancy-related outcomes

Combined vitamin D and calcium and clinical outcomes of bone health

Rickets, fractures, falls, or performance measures

Combined vitamin D and calcium and all-cause mortality

Combined vitamin D and calcium and hypertension and blood pressure

Combined vitamin D and calcium and hypertension

Combined vitamin D and calcium and blood pressure

Combined vitamin D and calcium and bone mineral density or bone mineral content

How does dietary intake of vitamin D from fortified foods and vitamin D 

supplementation affect serum 25(OH)D concentrations (arrow 4)?

RCTs on dietary intakes of vitamin D from fortified foods and serum 25(OH)D 

concentrations

RCTs on vitamin D supplementation and serum 25(OH)D concentrations

Outcomes for Tolerable Upper Intake Levels

Renal outcomes

Adverse events reported in RCTs

Chapter 4. Discussion

Strengths of this report

DRI and the literature on vitamin D and calcium

Limitations of our methodological approach

Comments on the observational studies

Sources of heterogeneity and potential biases

Vitamin D intake and response in serum 25(OH)D concentration

Considerations for future DRI committees

xi
Abbreviations

Latitudes of selected cities

xii
Tables 

Table 1. Number of primary studies on vitamin D intake or concentration and specific 

health outcomes that could be applicable to certain life stages

Table 2. Number of primary studies on calcium intake and specific health outcomes that 

could be applicable to certain life stages

Table 3. Number of primary studies on combined vitamin D and calcium intake and 

specific health outcomes that are relevant to certain life stages

Table 4. Vitamin D on growth outcome: Characteristics of interventional studies

Table 5. Vitamin D and growth outcomes: Characteristics of cohort studies

Table 6. Vitamin D and growth outcomes: Results of RCTs

Table 7. Vitamin D and growth outcomes: Results of cohort studies

Table 8. Vitamin D and cardiovascular outcomes: Characteristics of RCTs

Table 9. Vitamin D and cardiovascular outcomes: Results of RCTs

Table 10. Vitamin D and cardiovascular outcomes: Characteristics of cohort studies

Table 11. Vitamin D and cardiovascular outcomes: Results of cohort studies

Table 12. Vitamin D and weight: Characteristics of RCTs

Table 13. Vitamin D and weight: Results of RCTs

Table 14. Vitamin D and total cancer: Characteristics of RCTs

Table 15. Vitamin D and total cancer: Characteristics of cohort studies

Table 16. Vitamin D and total cancer: Results of RCTs

Table 17. Vitamin D and total cancer: Results of cohort studies

Table 18. Vitamin D and prostate cancer: Characteristics of nested case-control studies

Table 19. Vitamin D and prostate cancer: Results of nested case-control studies

Table 20. Vitamin D and colorectal cancer: Characteristics of RCTs

Table 21. Vitamin D and colorectal cancer: Results of RCTs

Table 22. Vitamin D and colorectal cancer: Characteristics of observational studiesA

Table 23. Vitamin D and colorectal cancer: Results of observational studies

Table 24. Vitamin D and colorectal adenoma: Characteristics of observational studies

Table 25. Vitamin D and colorectal adenoma: Results of observational studies

Table 26. Vitamin D and breast cancer: Characteristics of observational studies

Table 27. Vitamin D and breast cancer: Results of observational studies

Table 28. Vitamin D and pancreatic cancer: Characteristics of observational studies

Table 29. Vitamin D and pancreatic cancer: Results of observational studies

Table 30. Vitamin D (mother) and immunologic outcomes (offspring): Characteristics of 

cohort studies

Table 31. Vitamin D (mother) and immunologic outcomes (offspring): Results of cohort 

studies

Table 32. Vitamin D and preeclampsia: Characteristics of nested case-control studies

Table 33. Vitamin D and preeclampsia: Results of nested case-control studies

Table 34. Summary of systematic review of the effect of vitamin D on bone health

Table 35. Vitamin D and bone health: Characteristics of RCTs published after the Ottawa 

EPC report

Table 36. Vitamin D and bone health: Results of RCTs published after the Ottawa EPC 

report

xiii
Table 37. Summary of systematic review on vitamin D supplementation and all-cause 

mortality

Table 38. Vitamin D and all-cause mortality: Characteristics of cohort studies

Table 39. Vitamin D and all-cause mortality: Results of cohort studies

Table 40. Vitamin D and hypertension: Characteristics of cohort studies

Table 41. Vitamin D and hypertension: Results of cohort and nested case control studies

Table 42. Vitamin D and blood pressure: Characteristics of RCTs

Table 43. Vitamin D and blood pressure: Results of RCTs

Table 44. Vitamin D and bone mineral density: Characteristics of RCTs published after 

the Ottawa EPC report

Table 45. Vitamin D and bone mineral density or bone mineral contents: Results of RCTs 

published after the Ottawa EPC report

Table 46. Summary of systematic review of calcium on growth in children

Table 47. Calcium and growth: Characteristics of primary studies

Table 48. Calcium and growth: Results of primary studies

Table 49. Calcium and cardiovascular outcomes: Characteristics of cohort studiesB

Table 50. Calcium and cardiovascular outcomes: Results of cohort studies

Table 51. Systematic reviews of calcium supplementation and weight

Table 52. Calcium and weight: Characteristics of RCTs

Table 53. Calcium and weight: Results of RCTs

Table 54. Calcium and total cancer mortality: Characteristics of RCTs

Table 55. Calcium and total cancer incidence or mortality: Characteristics of cohort 

studies

Table 56. Calcium and total cancer mortality: Results of RCTs

Table 57. Calcium and total cancer incidence or mortality: Results of cohort studies

50-71, males

Table 58. Calcium and prostate cancer: Characteristics of observational studies

Table 59. Calcium and prostate cancer: Results of observational studies

Table 60. Systematic review of calcium supplementation and colorectal cancer incidence 

or adenoma recurrence

Table 61. Calcium and colorectal cancer: Characteristics of observational studies

Table 62. Calcium and colorectal cancer: Results of cohort studies

Table 63. Calcium and colorectal cancer: Results of nested case-control studies

Table 64. Calcium and colorectal adenoma: Characteristics of interventional studies

Table 65. Calcium and colorectal adenoma: Characteristics of cohort studies

Table 66. Calcium and colorectal adenoma recurrence: Results of RCTs

Table 67. Calcium and colorectal adenoma recurrence: Results of nonrandomized 

comparative study

Table 68. Calcium and colorectal adenoma: Results of cohort studies

Table 69. Calcium and breast cancer: Characteristics of cohort studies

Table 70. Calcium and breast cancer: Results of cohort studies

Table 71. Calcium and breast mammography density: Characteristics of cohort studies

Table 72. Calcium and breast cancer: Results of cohort studies

Table 73. Calcium and pancreatic cancer: Characteristics of cohort studies

Table 74. Calcium and pancreatic cancer: Results of cohort studies

xiv
Table 75. Summary table of systematic review on calcium supplementation and 

preeclampsia, small for gestational age, preterm birth

Table 76. Calcium and preeclampsia and other pregnancy outcomes: Characteristics of 

cohort studies

Table 77. Calcium and preeclampsia and other pregnancy outcomes: Results of cohort 

studies

Table 78. Calcium intake and all-cause mortality: Characteristics of cohort studies

Table 79. Calcium intake and all-cause mortality: Results of cohort studies

Table 80. Calcium and hypertension incidence: Characteristics of cohort studies

Table 81. Calcium and hypertension incidence: Results of cohort studies

Table 82. Summary of systematic reviews of calcium and blood pressure

Table 83. Calcium and blood pressure: Characteristics of RCTs

Table 84. Calcium and blood pressure: Results of RCTs

Table 85. Combined vitamin D and calcium and cardiovascular outcomes: 

Characteristics of RCTs

Table 86. Combined vitamin D and calcium and cardiovascular outcomes: Results of 

RCTs

Table 87. Combined vitamin D and calcium and weight: Characteristics of RCTs

Table 88. Combined vitamin D and calcium and weight: Results of RCTs

Table 89. Combined vitamin D and calcium and total cancer incidence: Characteristics of 

RCTs

Table 90. Combined vitamin D and calcium and total cancer incidence: Results of RCTs

Table 91. Combined vitamin D with calcium and colorectal cancer: Characteristics of 

RCTs

Table 92. Combined vitamin D with calcium and colorectal cancer: Results of RCTs

Table 93. Combined vitamin D and calcium and breast cancer outcomes: Characteristics 

of RCTs

Table 94. Combined vitamin D and calcium and breast cancer outcomes: Results of 

RCTs

Table 95. Combined vitamin D and calcium and preeclampsia: Characteristics of RCTs

Table 96. Combined vitamin D and calcium and preeclampsia: Results of RCTs

Table 97. Combined vitamin D and calcium and bone health: Characteristics of RCTs 

published after the Ottawa EPC report

Table 98. Combined vitamin D and calcium and bone health: Results of RCTs published 

after the Ottawa EPC report (stress fracture)

Table 99. Combined vitamin D and calcium and bone health: Results of RCTs published 

after the Ottawa EPC report (performance measures)

Table 100. Combined vitamin D and calcium and incident hypertension: Characteristics 

of RCTs

Table 101. Combined vitamin D and calcium and incident hypertension: Results of 

RCTs

Table 102. Combined vitamin D and calcium and blood pressure: Characteristics of 

RCTs

Table 103. Combined vitamin D and calcium and blood pressure: Results of RCTs

Table 104. Combined vitamin D and calcium and bone mineral density/content: 

Characteristics of RCTs published after the Ottawa EPC report

xv
Table 105. Combined vitamin D and calcium and bone mineral density/content: Results 

of RCTs published after the Ottawa EPC report

Table 106. The relationship between vitamin D3 daily doses and changes in 25(OH)D 

concentrations in RCTs

Table 107. Adverse events reported in RCTs

Figures 

Figure 1. Summary of the vitamin D endocrine system

Figure 2. Generic analytic framework to assist formulation of key questions for the 

development of DRIs

Figure 3. Analytic framework for vitamin D and/or calcium EARs

Figure 4. Analytic framework for vitamin D and/or calcium ULs

Figure 5. Literature flow in this report

Figure 6. Cardiovascular outcomes risk stratified by vitamin D concentration

Figure 7. Prostate cancer risk stratified by vitamin D concentration

Figure 8. Colorectal cancer risk stratified by vitamin D concentration

Figure 9. Colon cancer risk stratified by vitamin D concentration

Figure 10. Rectal cancer risk stratified by vitamin D concentration

Figure 11. Cardiovascular outcomes risk stratified by calcium intake

Figure 12. Stroke risk stratified by calcium intake

Figure 13. Prostate cancer risk stratified by calcium intake

Figure 14 Colorectal cancer risk in both sexes stratified by calcium intake

Figure 15 Colorectal cancer risk in men stratified by calcium intake

Figure 16 Colorectal cancer risk in women stratified by calcium intake

Figure 17 Colon cancer risk stratified by calcium intake

Figure 18. Rectal cancer risk stratified by calcium intake

Figure 19. Colorectal adenomatous polyp risk stratified by calcium intake

Figure 20. Breast cancer risk stratified by calcium intake

Figure 21. Hypertension risk stratified by calcium intake

Figure 22. Forest plot of trials of combined vitamin D and calcium supplementation and 

effects on all-cause mortality

Figure 23. Relationship between doses of Vitamin D3 supplementation and net changes 

in serum 25(OH)D concentrations in RCTs

Figure 24. Relationship between doses of Vitamin D3 supplementation and net changes in 

serum 25(OH)D concentrations in RCTs by baseline vitamin D status among adults

Figure 25. Relationship between doses of Vitamin D3 supplementation and net changes in 

serum 25(OH)D concentrations in RCTs by duration of supplementation among 

adults

Appendixes 

Appendix A. Search Strategy for Primary Studies 

Appendix B. Search Strategy for Systematic Reviews 

Appendix C. Evidence Tables 

Appendix D. Existing Systematic Reviews 

xvi
xvii

Appendix E. Blank Data Extraction Form and Quality Assessment Checklists 

Appendix F. Excluded Studies With Reasons 

Appendixes and Evidence Tables for this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/vitadcal/vitadcal.pdf.
Evidence Report

15
16
Chapter 1. Introduction 

Background 

The Food and Nutrition Board of the Institute of Medicine (IOM), with funding from 

agencies and departments of the US and Canadian governments, recently completed their 10-

year development of nutrient reference values entitled Dietary Reference Intakes (DRI).1 In 

September, 2007, the IOM held a conference to examine the lessons learned and future 

challenges from the process used to develop the DRI values.2

 One improvement identified at that 

meeting for DRI updating was the use of systematic reviews to enhance the transparency and 

rigor of the literature review process that is a necessary component in the deliberations of DRI 

committees. To assess the feasibility of implementing this approach in the DRI updating process, 

the Office of Dietary Supplements (ODS) of the National Institutes of Health (NIH) through the 

Agency for Healthcare Research and Quality (AHRQ) requested the Tufts Medical Center 

Evidence-based Practice Center (Tufts-EPC) perform an exercise to identify the issues and 

challenges of conducing systematic reviews as a component of the process used to support the 

development and updating of DRI values. The Tufts-EPC assembled a group of nutrition experts 

from academic institutions and federal government agencies, led participants in teleconferences 

and meetings, and conducted exercises in formulating questions that would be amenable to a 

systematic review of the scientific literature and abstract screening.3

 One of the intents of this 

exercise was to identify limitations, challenges, and unanticipated issues that IOM committees 

may face prior to actually initiating the use systematic reviews as a routine part of the DRI 

process. 

Following these activities, a working group of US and Canadian government scientists 

convened to determine whether the scientific literature was sufficient to justify a new review of 

the vitamin D DRI. To address this issue in May and September of 2007, two conferences were 

held on the topic of vitamin D and health.4 As a result of these conferences in March of 2008 the 

IOM convened a working group of US and Canadian government scientists to determine whether 

significant new and relevant scientific evidence had become available since the 1997 IOM 

publication of vitamin D DRI to justify initiating a formal review and potential revision of the 

values.5

 The working group reviewed the proceedings of the two conferences and the results 

from a systematic review commissioned by the ODS on the effectiveness and safety of vitamin D 

in relation to bone health conducted by the University of Ottawa EPC (Ottawa-EPC).6

 They 

concluded that there was sufficient new data on bone health for several of the lifestage groups, 

on potential adverse effects, and on dose-response relationships between intakes and circulating 

25-hydroxyvitamin D [25(OH)D] concentrations, and between 25(OH)D concentrations and 

several health outcomes to warrant a formal review and potential revision of the values.5

 As a 

result, the NIH/ODS, Public Health Agency of Canada, Health Canada and FDA commissioned 

the Tufts-EPC to update the Ottawa-EPC report, and systematically review the data related to 

vitamin D and calcium with respect to a broader spectrum of health outcomes. 

Sources, Metabolism and Functions of Vitamin D 

Vitamin D was classified as a vitamin in the early 20th century and in the second half of the 

20th century as a prohormone (“conditional” vitamin).7,8 There are two forms of vitamin D, 

vitamin D3 (cholecalciferol), which is produced from the conversion of 7-dehydrocholesterol in 

17
the epidermis and dermis in humans, and vitamin D2 (ergocalciferol) which is produced in 

mushrooms and yeast. The chemical difference between vitamin D2 and D3 is in the side chain; 

in contrast to vitamin D3, vitamin D2 has a double bond between carbons 22 and 23 and a methyl 

group on carbon 24. 

The major source of vitamin D for humans is exposure to sunlight. The efficiency of the 

conversion of 7-dehydrocholesterol to vitamin D3 is dependent on time of day, season of the 

year, latitude, skin color and age. There is little vitamin D that occurs naturally in the food 

supply. The major naturally occurring food sources include fatty fish, beef liver and egg yolk. In 

the U.S. and Canada, the major dietary source of dietary vitamin D is fortified foods, including 

cow’s milk and, depending on country, other fortified foods and dietary supplements. These 

sources cannot be relied on in countries other than the U.S. and Canada. Dietary vitamin D is 

absorbed from the intestine and circulates in plasma bound to a vitamin D binding protein. 

In its native form vitamin D is not biologically active, the active form is 1,25(OH)2D. The 

conversion of vitamin D to 1,25(OH)2D requires two hydroxylation in tandem. Vitamin D is 

first hydroxylated by the liver to form 25(OH)D, which is then hydroxylated by the kidney to 

form 1,25(OH)2D. 25(OH)D has low biological activity, but it is the major form of vitamin D 

that circulates in the blood stream. Serum 25(OH)D concentrations are generally thought to 

reflect nutritional status.7,8 When adequate amounts of vitamin D are available, the kidney, the 

major site of 1,25(OH)2D production converts some of the 25(OH)D to alternate hydroxylated 

metabolites, which have low biological activity (e.g., 24,25(OH)2D or 1,24,25(OH)3D). Renal 

synthesis of 1,25(OH)2D is tightly regulated by plasma parathyroid hormone, together with 

serum calcium and phosphorus concentrations. Additional tissues that express the enzyme that 

catalyses the conversion of 25(OH)D to 1,25(OH)2D, 25-hydroxyvitamin D3-1-α-hydroxylase, 

include colon, prostate, mammary gland, macrophages, antigen-presenting cells, osteoblasts and 

keratinocytes.9

 

Vitamin D has both genomic and nongenomic functions. For the genomic functions, 

1,25(OH)2D interacts with nuclear vitamin D receptors to influence gene transcription. Nuclear 

receptors for 1,25(OH)2D have been identified in over 30 cell types, including bone, intestine, 

kidney, lung, muscle and skin. For the nongenomic functions, 1,25(OH)2D acts like a steroid 

hormone, working through activation of signal transduction pathways linked to vitamin D 

receptors on cell membranes. Major sites of action include intestine, bone, parathyroid, liver and 

pancreatic beta cells. Biological actions include increases in intestinal calcium absorption, 

transcellular calcium flux and opening gated calcium channels allowing calcium uptake into cells 

such as osteoblasts and skeletal muscle. 

One of the major biological functions of vitamin D is to maintain calcium homeostasis which 

impacts on cellular metabolic processes and neuromuscular functions. Vitamin D affects 

intestinal calcium absorption by increasing the expression of the epithelial calcium channel 

protein, which in turn enhances the transport of calcium through the cytosol and across the 

basolateral membrane of the enterocyte. Vitamin D also facilitates the absorption of intestinal 

phosphate. 1,25(OH)2D indirectly affects bone mineralization by maintaining plasma calcium 

and phosphorus concentrations, and subsequently extracellular calcium and phosphorus 

concentrations at the supersaturating range necessary for mineralization. 1,25(OH)2D, in concert 

with parathyroid hormone, also causes demineralization of bone when calcium concentrations 

fall to maintain plasma concentrations within a narrow range. It has yet to be determined whether 

1,25(OH)2D directly influences bone mineralization. 

18
In addition to intestine and bone, a wide range of other tissues and cells that are influenced 

by vitamin D. Five biological systems have vitamin D receptors and are responsive to 

1,25(OH)2D, as summarized in Figure 1.10 These systems include immune, pancreas, 

cardiovascular, muscle and brain; and control of cell cycle. The biological effects of 1,25(OH)2D 

are diverse. For example, as recently noted, 1,25(OH)2D inhibits PTH secretion and promotes 

insulin secretion, inhibits adaptive immunity and promotes innate immunity, and inhibits cell 

proliferation and stimulates their differentiation.11 A number of recent reviews have appeared on 

these topics.10-17

Figure 1. Summary of the vitamin D endocrine system 

From Norman AW. A vitamin D nutritional cornucopia: new insights concerning the serum 25-

hydroxyvitamin D status of the US population.10

Sources, Metabolism, and Functions of Calcium 

The major source of dietary calcium in the North American diet, but not necessarily other 

counties, is dairy products (about 70 percent). Additional sources include commercial white 

bread made with calcium sulfate, foods made with milk products, leafy greens, canned fish and 

calcium fortified foods. Oxalic acid impedes the absorption of calcium from many plant foods. 

Intestinal calcium absorption is regulated by two processes. One route of intestinal calcium 

19
absorption is dependent on 1,25(OH)2D. This process occurs primarily in the duodenum and 

proximal jejunum, is saturable, is energy dependent, and involves a calcium binding protein. The 

1,25(OH)2D-dependent absorption of calcium is stimulated by low dietary calcium intakes. The 

other route of intestinal calcium absorption is independent of 1,25(OH)2D and is termed 

paracellular. This process is passive (does not depend on carrier proteins or energy) and occurs 

primarily in the jejunum and ileum. Calcium is absorbed between cells, rather than through cells, 

and down the concentration gradient. Calcium can be transported in blood bound to albumin and 

prealbumin, complexed with sulfate, phosphate or citrate, or in a free (ionized) state. 

Calcium is transported in blood bound to proteins (~40 percent), primarily albumin and 

prealbumin, complexed with sulfate, phosphate or citrate (~10 percent), and in the ionized form 

(~50 percent). Blood calcium concentrations are controlled extracellularly by parathyroid 

hormone, calcitriol and calcitonin. Intracellular calcium concentrations are maintained at 

relatively low levels. Increased intracellular calcium concentrations occur in response to second 

messengers by stimulating release from intracellular sites (endoplasmic reticulum, mitochondria) 

and hormones by facilitating influx from extracellular sites by transmembrane diffusion or 

channels. 

Calcium balance measures provide information on calcium absorption relative to calcium 

loss in urine, sweat and endogenous intestinal secretions. During periods of growth, positive 

calcium balance implies bone mineralization but does not provide an indication of whether the 

rate of bone mineralization is optimal. During adulthood negative calcium balance implies 

calcium lost from bone but does not provide an indication of which site(s). Calcium balances 

measures provide an indication of current but not prior calcium balance. An alternate approach to 

assessing bone mineralization is by measuring bone mineral density. 

Approximately 99 percent of the calcium in the human body is in bone and teeth. In addition 

to structural roles, calcium has other critical functions. These include serving as a second 

messenger (e.g., cytosolic calcium, calcium-dependent trigger proteins, removal of calcium 

stimulus) and protein activator (e.g. phospholipase A2, calpains [calcium dependent proteins that 

contain calmodulin-like domains], blood clotting enzymes, annexins [calcium and phospholipid 

binding proteins]). 1,25(OH)2D plays a critical role in regulating plasma calcium concentrations 

through its role in intestinal calcium absorption, bone resorption and renal calcium resorption. 

These functions of calcium are frequently classified into the following general categories; bone 

development and maintenance, blood clotting, transmission of nerve impulses to target cells, 

muscle contraction and cell metabolism. In addition, calcium may play a role in colon cancer, 

kidney stones, blood pressure, body weight and lead absorption. 

Challenges for the DRI Committees 

The following generic challenges must be addressed, preferably in a standardized way, 

before additional systematic reviews are conducted for use by upcoming DRI committees to 

ensure the resulting product will yield a maximally useful document.3

 Because the potential 

volume of peer reviewed literature on the biological effects of most essential nutrients is large 

and continues to grow, rational and well defined eligibility criteria will need to be identified by 

the committee to manage the workload. Appropriate questions must be formulated so that the 

answers to those questions can be used to inform the DRI development process, ensure 

transparency and reproducibility, and serve as the foundation for future updates as new data 

emerge. Experience has shown that in the absence of unlimited resources, only a limited set of 

20
questions can be addressed. Hence, it is critical that the committee prioritize the topics and refine 

the questions in a way that will address critical issues for development and revision of DRI 

values. 

Age specific intermediate or surrogate outcomes will need to be identified by the committee 

when few or no studies directly link specific nutrient intakes with clinical outcomes. Preferably, 

these would include only validated surrogates of the clinical outcome, that is outcomes that are 

strongly correlated with the clinical outcome (e.g., bone mineral density as a surrogate for 

fractures in postmenopausal women), and changes in their status reflect corresponding changes 

in the risk of the clinical outcome (e.g., changes in bone mineral density reflect changes in 

fracture risk in postmenopausal women).18 In the absence of validated surrogate outcomes, 

intermediate outcomes must be identified and considered (e.g., absence of anemia as an 

intermediate outcome for the absence of disease or serum osteocalcin [bone turnover index] as an 

intermediate marker for fractures). When a nonvalidated intermediate outcome must be 

considered, the implicit assumption is that they would have the properties of a validated 

surrogate outcome. Not only should this assumption be made explicit, but the uncertainties 

involved in applying this assumption should be identified, documented, and discussed by the 

committee. 

Reliable indicators of exposure (or biomarkers) need to be identified by the panel. A reliable 

biomarker should accurately reflect the degree of biological exposure to the nutrient of interest 

and fulfill the classic risk assessment model (e.g., exhibit a dose-response relationship). To that 

extent, the measurement of biological exposure should be independent and free from any 

interaction with the self-estimated intake of the nutrient of interest. It is important for the DRI 

committee to recognize that use of a biomarker to evaluate the strength of downstream 

associations requires that the biomarker concentrations be back translated into levels of nutrient 

intake and that if an association is found between a given biomarker concentration and risk of a 

clinical outcome, an estimate of the nutrient intake that corresponds to the clinical outcome will 

likewise be necessary. 

Additional challenges for the DRI committees with respect to the conduct of systematic 

review include defining relevance of studied populations with respect to nutrient distributions 

and health risks to those for which reference values are being established, generalizability of 

well-controlled experiments with few subjects, generalizability of studies of subjects having 

narrow eligibility criteria, applicability for findings of animal studies to humans when data in 

humans are nonexistent, generalizability of early studies that used methodologies not considered 

state of the art or directly comparable with contemporary methods (e.g., change in analytical 

techniques or standardization), appropriate approaches to evaluating, interpreting and integrating 

data from observational studies with interventional data, and approaches to factor contemporary 

issues into the process, such as the role of genomics and nutrient fortification into the systematic 

review. 

21
Key Questions Addressed in this Report 

The aim of this report is to answer specific questions formulated to support the review and 

updating of DRI values by the DRI committee. The primary purpose of this report is to 

summarize all existing literature of vitamin D and calcium, and clinical outcomes in a way that 

will facilitate the deliberations of the IOM committee commissioned to review and potentially 

revise the DRI values for these nutrients. Specific clinical, surrogate and intermediate outcomes 

that are relating to vitamin D or calcium functions were selected by a technical expert panel. 

Detailed methods and analytic frameworks are described in Chapter 2. The intent of this report is 

not to make recommendations on specific outcomes nor specific values for DRI to be based 

upon, the intent of this report is to provide information for use during the deliberations of the 

IOM committee. The federal agencies of the US and Canadian governments involved in the DRI 

process formulated the key questions listed below based on the generic analytic framework as 

recently described (Figure 2).3

 The key questions are: 

• What is the effect of exposures on functional or clinical outcomes? (Arrow 1) 

• What is the effect of exposures on indicators of functional or clinical outcomes? (Arrow 2) 

• What is the effect of indicators of exposure or body stores on functional or clinical 

outcomes? (Arrow 3) 

• What is the effect of exposures on indicators of exposure? (Arrow 4) 

• What is the effect of indicators of exposure or body stores and intermediate indicators of 

outcomes? (Arrow 5) 

• What is the effect of intermediate indicators of outcomes and functional or clinical 

outcomes? (Arrow 6) 

For each of these questions, the mandate was to also address factors that affect these 

relationships. 

22
Figure 2. Generic analytic framework to assist formulation of key questions for the development 

of DRIs. 

Exposure Arrow 4

Arrow 2

Arrow 1

(Valid) Surrogate

Outcomes

(Predictors of

clinical outcomes) Indicators

of

Exposure

Clinical

Outcomes

Arrow 6

(Non-validated)

Intermediate

Outcomes

(Possible predictors of

clinical outcomes)

Arrow 6

Arrow 5

Arrow 3

Arrow 2

Arrow 1: Association of exposure with clinical outcomes of interest. 

Arrow 2: Association of exposure with surrogate or intermediate outcomes (with good or possible 

evidence for linkage with clinical outcomes). 

Arrow 3: Association of indicators of exposure to clinical outcomes. 

Arrow 4: Association between exposure and indicators of exposure. 

Arrow 5: Association of indicators of exposure to surrogate or intermediate outcomes (with good or 

possible evidence for linkage with clinical outcomes). 

Arrow 6: Association between surrogate outcomes (with good or possible evidence for linkage) and 

clinical outcomes. 

The focus of this evidence report is on the relationship of vitamin D only, calcium only, and 

combinations of vitamin D and calcium to relevant health outcomes. Serum 25(OH)D 

concentration was used as an indicator of vitamin D status and calcium intake (dietary and 

supplement) as an indicator of calcium status. Evidence was sought for the life stages as defined 

in the DRI process. For the above questions, information relevant to benefit (efficacy) and safety 

(adverse effects) were considered. The questions were refined with input from a committee of 

vitamin D and calcium experts, discussed in the Methods chapter.

23


Chapter 2. Methods 

Overview 

This report is based on a systematic review of key questions on the relationships between 

vitamin D [either 25(OH)D concentrations or supplements] or dietary calcium intake, and health 

outcomes. The methodologies employed in this evidence report generally follow the methods 

outlined in the AHRQ Methods Reference Guide for Effectiveness and Comparative 

Effectiveness Reviews 

(http://effectivehealthcare.ahrq.gov/repFiles/2007_10DraftMethodsGuide.pdf). The initial 

questions identified by the federal sponsors of this report were refined with input from a 

Technical Expert Panel (TEP). This report does not make clinical or policy recommendations. 

The report is being provided to an IOM committee charged with updating vitamin D and calcium 

DRIs. 

A description of roles and responsibilities of sponsoring federal agencies, AHRQ, the TEP 

and the EPC is included to clarify the relationships that support the process and ensure 

transparency and that the approach adhered to the highest standards of scientific integrity. 

Because of the large number of abbreviations for unfamiliar terms are used, their 

explanations have been repeated whenever deemed necessary. A table of Abbreviations can be 

found after the references in page 316. We also provide a table with the latitudes of several major 

cities in Central and North America, right after the Abbreviations table, on page 320. 

Sponsoring Federal agencies. 

The sponsoring agencies were responsible for specifying the topic-specific task order 

requirements. They participated in a Kick-Off meeting with the EPC and the Task Order Officer 

(TOO) to facilitate a common understanding of the topic-specific work requirements, and 

responded to inquiries from the TOO if modifications to the work order were requested by the 

EPC. Any communication between the sponsoring agencies and the EPC occurred with oversight 

from the TOO. 

Review by Federal sponsors was limited to comments on factual errors, requests for 

clarification, and consistency with the original contract task order. Comments on the scientific 

content of the report were not provided. In all cases, reviewer comments are advisory only and 

are not binding on the scientific authors of the final report. 

AHRQ Task Order Officer (TOO). 

The TOO was responsible for overseeing all aspects of this Task Order. The TOO served as 

the point person for all communication required between the sponsoring agencies, the EPC, and 

other AHRQ officials. The purpose of this communication was to facilitate a common 

understanding of the task order requirements among the sponsors, the TOO, and the EPC, 

resolve ambiguities and to allow the EPC to focus on the scientific issues and activities. 

Technical Expert Panel (TEP). 

The TEP is comprised of qualified experts including, but not limited to, individuals with 

knowledge of DRI decision making processes, vitamin D and calcium nutrition and biology 

across the life cycle, health outcomes of interest, and the methodology of conducting systematic 

reviews. The EPC worked closely with the TEP in the formative stages of the project on question 

25
refinement and throughout the evidence review process to address questions that occurred. The 

EPC conducted the actual systematic review of the questions independent of the TEP and other 

stakeholders. It was specified, a priori, that a TEP member who served as a peer reviewer for the 

final report could not also serve as a member of the subsequent calcium and vitamin D DRI 

Committee. 

Those serving on the TEP provided input on such factors as reviewing search terms to ensure 

they were adequately inclusive, assessing search strategies to ensure they comprehensively 

covered the questions of interest, and answering questions about technical details (e.g., nuances 

of laboratory methods of performing an assay). Members of the TEP did not participate in EPC 

research meetings or in reviewing and synthesizing evidence. Their function was limited to 

providing domain-specific knowledge and advising the proper context that is relevant to the 

process of evaluating DRI. They did not have any decision making role and did not participate in 

writing any part of the evidence report. 

EPC methodologists. 

This evidence report was carried out under the AHRQ EPC program, which has a 12-year 

history of producing over 175 evidence reports and numerous technology assessments for 

various users including many federal agencies. EPCs are staffed by experienced methodologists 

who continually refine approaches to conducting evidence reviews and develop new methods on 

the basis of accumulated experience encompassing a wide range of topics. The Tufts EPC has 

produced many evidence reports on nutrition topics19-24 (http://www.ahrq.gov/clinic/epcix.htm). 

We have also conducted methodological research to identify the issues and challenges of 

including evidence-based methods as a component of the process used to develop nutrient 

reference values, such as the DRI, using vitamin A as an example.3

Development of the Analytic Framework and Refinement of 

Key Questions 

The focus of this report is on the relationship of vitamin D only, calcium only, and 

combinations of vitamin D and calcium with specific health outcomes. Key questions and 

analytic frameworks were developed by defining each box in the generic analytic framework 

described in Chapter 1 with specific reference to vitamin D and calcium. 

A one-day meeting of the federal sponsors, TEP and Tufts EPC staff was held in Boston on 

September 20, 2008. At this meeting, the analytic framework was discussed, the key questions 

refined, and study eligibility criteria established. Two analytic frameworks were developed: one 

for vitamin D and/or calcium Estimated Average Requirements (EARs) and one for Tolerable 

Upper Intake Levels (ULs) (Figures 3 & 4). We used the PI(E)CO method to establish study 

eligibility criteria. This method defines the Population, Intervention (or Exposure in the case of 

observational studies), Comparator, and Outcomes of interest. Details are described in the 

sections that follow. 

26
Figure 3. Analytic framework for vitamin D and/or calcium EARs 

Hypertension

BMD, BMC 25(OH)D; 

1,25(OH)D

Calcium 

balance

Bone health

CVD

Cancer

Muscle 

Function

Cancer markers

Blood Pressure

UV 

exposure

Calcium

Foods & 

supplements

Arrow 1

Arrow 2

Arrow 2

Arrow 3

Arrow 4 Arrow 5

Arrow 5

Arrow 6

Arrow 6

Immune 

Outcomes

Breast milk or infant 

circulating levels

Vitamin 

D2,D3,

25(OH)D 

Pregnancy 

Outcomes

All cause 

mortality

Body weight, 

BMI; Growth

Arrow 1: Association of exposure with clinical outcomes of interest. 

Arrow 2: Association of exposure with surrogate or intermediate outcomes (that have good or possible 

evidence for linkage with clinical outcomes, respectively). (Surrogate outcomes are depicted in boxes 

with a solid outline, and intermediate outcomes are depicted in boxes with dashed outline.) 

Arrow 3: Association of indicators of exposure to clinical outcomes. 

Arrow 4: Association between exposure and indicators of exposure. 

Arrow 5: Association of indicators of exposure to surrogate or intermediate outcomes. 

Arrow 6: Association between surrogate or intermediate outcomes and clinical outcomes. 

27
Figure 4. Analytic framework for vitamin D and/or calcium ULs 

Arrow 1: Association of exposure with clinical outcomes of interest. 

Arrow 3: Association of indicators of exposure to clinical outcomes. 

Arrow 4: Association between exposure and indicators of exposure. 

Definitions

Vitamin D and Calcium Exposures 

Vitamin D exposure included intake of vitamin D2 or vitamin D3 from foods and 

supplements, including human milk and commercial infant formulas. Because the primary source 

of vitamin D in the human body is produced in skin exposed to sunlight, background information 

on ultraviolet B (UVB) exposure was captured to the extent possible. However, we did not 

include studies that evaluated the effect of or association between exposure to sunlight (or UVB) 

and clinical outcomes or serum 25(OH)D concentrations. In other words, we did not investigate 

sunlight exposure as a proxy for or a source of vitamin D intake. Sunlight exposure was 

considered only as a potential confounder or effect modifier of associations between vitamin D 

or calcium and clinical outcomes. 

Calcium exposure included intake of calcium from foods and supplements, including 

calcium-containing antacids, mineral-supplemented water, human milk and commercial infant 

formulas. 

Combined vitamin D and calcium exposure included any relevant combinations of the above. 

Clinical Outcomes 

Clinical outcomes are measures of how a person (e.g., a study participant) feels, functions or 

survives, or a clinical measurement of the incidence or severity of a disease (e.g., diagnosis of 

disease or change from one disease state to another). Examples of clinical outcomes used in this 

report are incidence of cancer, vascular events, and preeclampsia. The clinical outcomes of 

interest in this report are described in the “Specific Outcomes of Interest” section. 

28
Indicators of Exposure (Nutrient Intake) 

Indicators of exposure are measures that correlate with dietary intake of a nutrient, such as 

nutrient biomarkers, nutritional status, or markers of nutritional status. 

Indicators of vitamin D exposure (i.e., vitamin D intake and sun exposure) included serum 

25(OH)D and 1,25(OH)2D concentrations. 

Indicators of dietary calcium intakes included calcium balance (i.e., calcium accretion, 

retention, and loss). 

Surrogate Outcomes 

Surrogate outcomes are biomarkers or physical measures that are generally accepted as 

substitutes for or predictors of specific clinical outcomes.18 Changes induced by the exposure or 

intervention on a surrogate outcome marker are expected to reflect changes in a clinical outcome. 

Examples of surrogate outcomes used in this report are bone mineral density (as a surrogate 

marker of fracture risk) and breast mammographic density (as a surrogate marker of breast 

cancer risk). The surrogate outcomes of interest in this report are described in “Specific 

Outcomes of Interest” section. 

Intermediate Outcomes 

Intermediate outcomes are possible predictors of clinical outcomes that are not generally 

accepted to fulfill the criteria for a surrogate outcome. However, in the absence of data for surrogate 

outcomes, intermediate markers are often used. Examples of intermediate markers used in this 

report are prostate cancer antigen (as a marker of prostate cancer risk) and blood pressure (as a 

marker of stroke risk). All intermediate markers of interest in this report are described in 

“Specific Outcomes of Interest” section. 

Life Stages 

In consultation with the TEP, the 22 life stages defined by the FNB/IOM for the development 

of DRI were consolidated to 9 categories to facilitate the reporting of results. Within each life 

stages, men and women (or boys and girls) were considered separately when possible. There are 

also some inevitable overlaps between these categories. For example, most women in 51-70 

years life stage are postmenopausal women. The 9 categories created for this report are: 

o 0 – 6 months 

o 7 months – 2 years 

o 3 – 8 years 

o 9 – 18 years 

o 19 – 50 years 

o 51 – 70 years 

o ≥71 years 

o Pregnant and lactating women 

o Postmenopausal women 

In summarizing studies for each given outcome, we used our best judgment to describe the 

study results for each applicable life stage. 

29
Key Questions 

In agreement with the TEP, the following key questions were addressed in this evidence 

report. It was decided that arrow 6 in the analytic framework (What is the relationships between 

intermediate or surrogate outcomes and clinical outcomes?) is outside the scope of the DRI 

literature review in this report. All outcomes of interest in this report are described in “Eligibility 

Criteria” section. 

Key Question 1. What is the effect of vitamin D, calcium, or combined vitamin D and calcium 

intakes on clinical outcomes, including growth, cardiovascular diseases, weight outcomes, 

cancer, immune function, pregnancy or birth outcomes, mortality, fracture, renal outcomes, and 

soft tissue calcification? (Arrow 1) 

Key Question 2. What is the effect of vitamin D, calcium or combined vitamin D and calcium 

intakes on surrogate or intermediate outcomes, such as hypertension, blood pressure, and bone 

mineral density? (Arrow 2) 

Key Question 3. What is the association between serum 25(OH)D concentrations or calcium 

balance and clinical outcomes? (Arrow 3) 

Key Question 4. What is the effect of vitamin D or combined vitamin D and calcium intakes on 

serum 25(OH)D concentrations? (Arrow 4) 

Key Question 5. What is the association between serum 25(OH)D concentrations and surrogate 

or intermediate outcomes? (Arrow 5) 

Literature Search Strategy 

We conducted a comprehensive literature search to address the key questions. For primary 

studies, the EPC used the Ovid search engine to conduct searches in the MEDLINE® and 

Cochrane Central database. A wide variety of search terms were used to capture the many 

potential sources of information related to the various outcomes (see Appendix A). Search terms 

that were used to identify outcomes of interest, for both EARs and ULs, can be categorized into 

the following groups: 1) body weight or body mass index; 2) growth (height and weight); 3) 

fracture or bone mineral density; 4) falls or muscle strength; 5) cardiovascular diseases; 6) 

hypertension or blood pressure; 7) cancer or neoplasms, including adenomas, colon polyps, and 

mammography; 8) autoimmune diseases (e.g., type 1 diabetes, psoriasis, rheumatoid arthritis, 

multiple sclerosis, inflammatory bowel disease, ulcerative colitis, and Crohn's disease); 9) 

preeclampsia, eclampsia and pregnancy-related hypertension; 10) preterm or low birth weight; 

11) breast milk or lactation; 12) death; 13) infectious diseases; 14) soft tissue calcification (for 

ULs only); and 15) kidney disease or hypercalcemia (for ULs only). The different outcomes 

were crossed with terms to identify vitamin D and calcium exposure: “vitamin D”, “plasma 

vitamin D”, “25-hydroxyvitamin D” and its abbreviations, “25-hydroxycholecalciferol”, “25-

hydroxyergocalciferol”, “calcidiol”, “calcifediol”, “ergocalciferol”, “cholecalciferol”, 

“calciferol”, “calcium”, “calcium carbonate”, “calcium citrate”, “calcium phosphates” and 

30
“calcium malate”. Literature searches of the outcomes alone without references to vitamin D or 

calcium were not conducted. 

The searches were limited to human studies, English language publications, and citations 

from 1969 to September 2008 for all but bone outcomes. For outcomes related to bone health 

(i.e., bone mineral density, fracture, fall or muscle strength), we relied on a recent comprehensive 

systematic review performed by the Ottawa EPC.6

 The Ottawa EPC report was updated from 

January 2006 to September 2008. The electronic search was supplemented by bibliographies of 

relevant review articles. Unpublished data, including abstracts and conference proceedings, were 

not included. An updated literature search was performed in April 2009 for all the topics to 

include relevant primary studies published since September 2008 for the final report. 

For potentially relevant systematic reviews, we also searched MEDLINE®, the Cochrane 

Database of Systemic Reviews, and the Health Technology Assessments database up to 

December 2008. We searched for systematic reviews of the relationships between vitamin D or 

calcium and the prespecified outcomes. In this search, terms for identifying vitamin D or calcium 

exposures were crossed with terms for identifying systematic reviews, such as “systematic,” 

“evidence,” “evidence-based,” “meta-analysis,” or “pooled analysis”; specific terms for the 

outcomes were not included (Appendix B). 

Study Selection 

Abstract Screening 

All abstracts identified through the literature search were screened. Eligible studies included 

all English language primary interventional or observational studies that reported any outcome of 

interest in human subjects in relation to vitamin D and/or calcium. 

Full Text Article Eligibility Criteria 

Articles that potentially met eligibility criteria at the abstract screening stage were retrieved 

and the full text articles were reviewed for eligibility. Rejected full text articles were examined 

only once, unless the articles were equivocal for inclusion or exclusion. In that event, the article 

in question was examined again by a different reviewer and a consensus was reached after 

discussion with the first reviewer. We recorded the reason for rejection of all full text articles. 

Primary studies. 

 Because the outcomes of interest ranged from very broad topics with common occurrences 

(e.g., cardiovascular disease) to narrowly focused topics with relatively few occurrences (e.g., 

preeclampsia), the number and types of studies available for each outcome varied widely in the 

distribution of study designs and sample sizes. It was neither possible nor desirable to use a 

uniform, strict set of inclusion and exclusion criteria applicable to all outcomes. Therefore, 

additional eligibility criteria germane to the specific outcome were applied to all accepted full 

text articles. Details are described in the “Eligibility criteria” section. 

General eligibility criteria for the full text articles were: 

Population of interest: 

• Primary population of interest is generally healthy people with no known disorders 

31
• Studies that include a broad population that might have included some people with 

diseases. For example, some hypertensive and diabetic patients were included. 

• People with prior cancers (or cancer survivors), prior fractures, and precancer conditions 

(e.g., colon polyps) were included 

• Studies that enrolled more than 20 percent subjects with any diseases at baseline were 

excluded. An exception was made for older adults (mean age ≥65 years old) due to high 

prevalence of diseases in this population. For studies of older adults, only studies that 

exclusively enrolled subjects with particular disease (e.g., 100 percent type 2 diabetes) 

were excluded. In addition, for studies of blood pressure, studies of people exclusively 

with hypertension were included. 

• For UL outcomes, we included any adverse effects of high intake in any population. 

Intervention/exposure of interest. 

• For observational studies: 

o Serum 25(OH)D or 1,25(OH)2D concentration 

o Dietary intake level of vitamin D were not included due to inadequacy of nutrient 

composition tables for vitamin D.25

o Dietary intake level of calcium from food and/or supplements 

o Calcium balance (i.e., calcium accretion, retention, and loss) 

• For interventional studies: 

o Vitamin D supplements (but not analogues) with known doses 

o Calcium supplements with known doses 

o The only combination of dietary supplements of interest was the combination of 

vitamin D and calcium. Any other combinations of supplements and/or drug 

treatments were excluded unless the independent effects of vitamin D and/or 

calcium can be separated. Thus studies of multivitamins were excluded. 

o Trials in which participants in both study groups took the same calcium (or 

vitamin D) supplement were evaluated as vitamin D (or calcium) versus control 

trials. In other words, the intervention common to both study groups was ignored 

(though it was noted). 

o Food based interventions were included if the doses of vitamin D and/or calcium 

were quantified and there were differences in the doses between the comparison 

groups. For example, a trial of dairy supplementation (with 500 mg/d calcium) 

versus no supplementation was qualified to be included. However, a trial of 

calcium fortified orange juice (with 1200 mg/d calcium) versus milk (with 1200 

mg/d calcium) was not qualified to be included because there are no differences in 

the calcium doses. 

o Non-oral routes of nutrient delivery were excluded 

Specific outcomes of interest. 

• Growth outcomes 

o In infants and premenarchal children: weight and height gain 

• Cardiovascular disease clinical outcomes 

o Cardiac events or symptoms (e.g., myocardial infarction, angina) 

o Cerebrovascular events (stroke, transient ischemic attacks) 

o Peripheral vascular events or symptoms (diagnosis, claudication) 

32
o Cardiovascular death 

o Study-specific combinations of cardiovascular events 

• CVD intermediate outcomes 

o Diagnosis of hypertension 

o Blood pressure 

• Weight outcomes 

o In adults only: incident overweight or obesity, body mass index, or weight (kg) 

• Cancer (incident or mortality) 

o Cancer from all cause (or total cancer) 

o Prostate 

o Colorectal cancer 

o Breast cancer 

o Pancreatic cancer 

o Cancer-specific mortality 

• Cancer intermediate outcomes 

o Colorectal adenoma 

o Aberrant cryptic 

o Breast mammographic density (quantitative whole breast density) 

• Immune function clinical outcomes 

o Infectious diseases 

o Autoimmune diseases 

o Infectious disease-specific mortality 

• Pregnancy-related outcomes 

o Preeclampsia 

o High blood pressure with or without proteinuria 

o Preterm birth or low birth weight 

o Infant mortality 

• Mortality, all cause 

• Bone health clinical outcomes 

o Rickets 

o Fracture 

o Fall or muscle strength 

• Bone health intermediate outcomes 

o Bone mineral density or bone mineral content 

• Dose-response relationship between intake levels and indicators of exposure (arrow 4 of 

Figures 2 and 3) 

o Serum 25(OH)D concentration 

o Breast milk or circulating concentrations of 25(OH)D in infants 

• Outcomes of tolerable upper intake levels (ULs) 

o All-cause mortality 

o Cancer and cancer-specific mortality 

o Renal outcomes 

o Soft tissue calcification 

o Adverse events from vitamin D and/or calcium supplements 

33
Study design. 

• Randomized controlled trials (RCTs) 

• Nonrandomized, prospective comparative studies of interventions 

• Prospective, longitudinal, observational studies (where the measure of exposure occurred 

before the outcome) 

• Prospective nested case-control studies (case-control study nested in a cohort so the 

measure of exposure occurred before the outcome) 

• We excluded cross-sectional studies and traditional, retrospective case-control studies 

(where the measure of exposure occurred after or concurrent with the outcome) 

Systematic reviews. 

We included relevant systematic reviews that addressed the key questions. Systematic review 

is defined as a study that has at a minimum the following three components: a statement of the 

research questions (aims or objectives); a description of the literature search; and a listing of the 

study eligibility criteria. We did not attempt to contact authors for clarifications of outstanding 

questions. In addition, the following types of reviews were excluded: reviews of foods or diets 

that did not quantify vitamin D or calcium intake; reviews that included non-oral routes of 

nutrient delivery; reviews that did not evaluate the association between vitamin D or calcium 

intake to health outcomes; reviews of nonhuman data; and pooled analyses of primary databases 

(i.e., secondary database analyses of multiple cohorts) that did not include a systematic review 

(except possibly as a replacement for data from the original cohorts). 

To determine the relevance of a systematic review to this report, the following inclusion 

criteria were applied: 

• Address key question(s) of interest (i.e., similar PI(E)CO criteria used): 

a. Systematic review must include only healthy population at baseline or have 

separate analyses for population with diseases and without diseases. 

b. Systematic reviews of interventional studies had to include only vitamin D or 

calcium interventions. Cointerventions with other nutrients had to be disallowed 

or separate analyses were needed for studies of vitamin D or calcium 

interventions alone. 

c. Systematic review of observational studies had to report the baseline 

concentrations of serum 25(OH)D and the assay methods used or the dietary 

assessment methods used to measure dietary calcium intake (e.g. food frequency 

questionnaire, 24 hour recall). 

d. Exposure levels (e.g., level of 25(OH)D or calcium intake) or doses of 

interventions had to be reported 

e. Outcome definitions had to be reported 

f. Designs of primary studies had to be reported. If cross-sectional or case-control 

studies were included, the systematic review must provide sufficient information 

or separate analyses to separate them from RCTs or cohort studies. 

• We include only the most recent update if there were multiple systematic reviews from 

the same group of investigators using the same review process. 

• Where there were several systematic reviews on the same topic with similar conclusions 

and the same set of primary studies, we selected the systematic review with either the 

latest cutoff date for the end of the literature search or the most included primary studies. 

34
Other Specific Eligibility Criteria 

• Growth outcomes (weight and height gain) 

o Only infants (<1 year old) and children (age <18 years old) were included 

o For infants, we include all eligible study designs. The vitamin D and/or calcium 

intervention or exposure can be administered to the mothers or to the infants in 

the study. 

o For infants, premenarchal girls, and boys of similar age, only RCTs that reported 

weight as a primary or secondary outcome were included. RCTs of weight loss 

were excluded. 

• Cardiovascular disease clinical outcomes 

o Only adults (aged ≥18 years old) were included. 

• Blood pressure and body weight 

o Only adults (aged ≥18 years old) were included. 

o Only RCTs of calcium or vitamin D interventions were included. We did not 

include observational studies of associations between calcium or vitamin D intake 

or serum vitamin D concentrations and blood pressure or weight measurements 

(as continuous outcomes). This decision was made in agreement with the TEP in 

part because it was agreed that any conclusions based on observational studies 

(e.g., associations between baseline calcium intake and change in systolic blood 

pressure) would be weak and difficult to interpret. 

• Bone health clinical outcomes 

o The Ottawa EPC report6

 was updated with literature published between January 

2006 and September 2008. Only RCTs qualified for inclusion. 

o Studies of calcium and bone health clinical outcomes were excluded. 

• Bone health intermediate outcomes 

o The Ottawa EPC report6 was updated with literature published between January 

2006 and September 2008. For adults, we included only BMD indices. For 

children, we included only BMC indices. Only RCTs with duration of more than 

1 year were qualified for inclusion. 

o Studies of calcium and bone health clinical outcomes were excluded. 

• Dose-response relationship between intake levels and indicators of exposure (arrow 4 of 

Figures 2 and 3) 

o Studies for this question were identified in our literature search that crossed 

vitamin D terms with various outcomes terms. Some studies that addressed this 

question but do not report any of the outcomes of interest would not have been 

identified in this manner. Because the availability of serum 25(OH)D 

concentration is unlikely to be adequately indexed in the Medline citation, it 

would be difficult to comprehensively search the literature for this question. To 

do so would require retrieving all full text articles mentioning vitamin D 

supplements (in excess of 10,000) to look for data on serum 25(OH)D 

concentration. 

35
o Only RCTs were included for this question. However, RCTs of different regimens 

but with the same dose of vitamin D supplementation were excluded (e.g., 

comparison of daily, weekly versus monthly dose). 

Data Extraction 

For outcomes that had not been subjected to a prior systematic review, we extracted and 

summarized the relevant data from the primary studies. Where previous systematic reviews were 

available, we summarized their results into our report. In addition, we updated the previous 

systematic reviews (with our eligibility criteria) and extracted and summarized the additional 

primary studies. 

Data extraction forms (evidence tables) were developed separately for extraction of 

systematic reviews and primary studies. For primary studies, the items extracted were: study 

characteristics, baseline population characteristics, background diet data, dietary assessment 

methods for calcium intake, 25(OH)D assay methods, interventions (for interventional studies 

only), confounders and effect modifiers that were adjusted for in statistical analysis, results, and 

quality assessments. Whenever the type of vitamin D supplement (D2 or D3) was clearly 

reported, we extracted and reported this information. Otherwise, we used the general term 

“vitamin D”. Evidence tables for all eligible studies are available in Appendix C. For systematic 

reviews, items extracted were: design, population, intervention (exposure) and comparator, 

results, and AMSTAR26 checklist criteria (a measurement tool created to assess the 

methodological quality of systematic reviews). A table with a list of all systematic reviews with 

the evaluation of their relevance to this report, and evidence tables of the qualified systematic 

reviews are available in Appendix D. 

Data Analysis 

We explored the dose-response relationship between the level of intake of vitamin D (with or 

without calcium) and serum 25(OH)D concentrations graphically, using a scatter (“bubble”) plot. 

We plotted the observed net changes in 25(OH)D concentration, against the doses of vitamin D 

supplementation. In these plots studies were represented by empty circles (bubbles) with area 

proportional to the inverse of the within-study variances. Typically, the larger the bubble, the 

larger the sample size and the smaller the standard error of the changes in 25(OH)D. 

Studies were included only if they reported sufficient data to estimate both mean net change 

and SE of the net change. We required data on both the mean net change in outcome level and 

the SE of the change. However, many studies provided only the SEs for the baseline and final 

outcome levels. In order to include these studies in the analyses we had to make several 

assumptions to estimate the SE of the change. To do this we used the equation: 

SE12 = √ (SE1

2

 + SE2

2

 - 2ρSE1SE2) 

where SE1, SE2, and SE12 are the SEs for baseline, final and change, respectively, and ρ is the 

correlation between the baseline and final measurements.27 We arbitrarily chose the correlation, 

ρ, to be 0.50, the midpoint value. In our experience, using different values for ρ generally does 

not greatly affect the meta-analysis results of quantitative analyses or conclusions. 

For each RCT, the SE of the net change was then calculated using the standard calculation 

for determining the SE of 2 independent cohorts. Namely, in the above equation where the 

correlation factor ρ becomes 0, and thus the final term drops out. Where studies reported either 

within-cohort SEs or net change SEs, these numbers were used. Some RCTs may have more than 

36
two arms (e.g., two different doses of vitamin D supplement compared to the placebo), and in 

this case, the same control arm was used to calculate the net change and the SE of the net change 

as for two independent comparisons. 

Meta-analysis 

Overall, we did not perform new meta-analyses in this report because of large degree of 

clinical and methodological heterogeneity across studies. However, we reanalyzed an existing 

meta-analysis using available data in the all-cause mortality section. We performed random 

effects model meta-analyses of risk ratios using the DerSimonian and Laird model.28 The random 

effects model assigns a weight to each study that is based both on the individual study variance 

and the between-study heterogeneity. Compared with the fixed effect model, the random effects 

model is more conservative in that it results in broader confidence intervals when between-study 

heterogeneity is present. We tested for heterogeneity using Cochran’s Q (considered significant 

for P <0.10) and quantified its extent with I2 29,30. I2 ranges between 0 and 100 percent and 

quantifies the proportion of between-study variability that is attributed to heterogeneity rather 

than chance. 

Intercooled Stata SE version 9.2 and Meta-Analyst version 3.2 (developed by Tufts EPC) 

were used for analyses. All P values are two tailed and considered significant when less than 

0.05, unless otherwise indicated. 

Grading of Studies Analyzed in This Evidence Report 

Studies included as part of accepted in this report have been designed, conducted, analyzed, 

and reported with various degrees of methodological rigor and completeness. Deficiencies in any 

of these items may lead to biased reporting or interpretation of the results. While it is desirable to 

have a simple evidence grading system using a single quantity, the quality of evidence is 

multidimensional. A single metric cannot adequately capture information needed to interpret a 

study. Not withstanding these limitations, providing an indication of study quality adds an 

important dimension to the summary of published data. 

Critical Appraisal and Grading of Primary Studies 

Critical appraisal of the evidence is an important aspect of conducting a systematic review. 

For the assessment of interventional studies, the criteria were based on the CONSORT31

statement for reporting RCTs (a checklist with specifications for reporting important aspects of a 

trial). We primarily considered the methods used for randomization, allocation concealment, and 

blinding as well as the use of intention-to-treat analysis, the report of well-described valid 

primary outcomes, and the dropout rate. 

For interventional studies with nonrandomized design, we used the report of eligibility 

criteria and assessed the adequacy of controlling for differences between compared groups in 

terms of baseline characteristics and prognostic factors. We also considered the reporting of 

intention-to-treat analyses and crossovers when so designed, as well as important differential loss 

to followup between the compared groups or overall high loss to followup. The validity and the 

adequate description of outcomes and results were also assessed. 

37
For the assessment of prospective cohorts and nested case-control studies (cross-sectional 

and retrospective case-control studies were excluded from this review), we developed a rating 

checklist specifically designed for nutritional epidemiology study based on some of the reporting 

items for cohort study in STROBE (STrengthening the Reporting of OBservational studies in 

Epidemiology) checklist32 and the nutrition-specific items in our previous publication.33 Items 

assessed include: eligibility criteria and sampling of study population, blinding of exposure and 

outcome assessors, dietary assessment methodology (when applicable), assay methodology of 

biomarkers of intake (when applicable), clear reporting of comparisons in the study, statistical 

analyses, adequacy of controlling for baseline characteristics and prognostic factors (including 

confounders), clear reporting of outcome definitions, and prospective study design with 

preplanned hypotheses. 

 The quality assessment checklists for intervention or observational studies can be found in 

Appendix E. Additional considerations that were not included in the checklists are described 

later in this section. 

 In this report we adapted a three-category grading system of the AHRQ Methods Reference 

Guide for Effectiveness and Comparative Effectiveness Reviews. This system defines a generic 

grading system that is applicable to each type of study design including interventional and 

observational studies: 

A 

Studies have the least bias and results are considered valid. These studies adhere mostly to 

the commonly held concepts of high quality including the following: a formal study design; 

clear description of the population, setting, interventions, and comparison groups; 

appropriate measurement of outcomes; appropriate statistical and analytic methods and 

reporting; no reporting errors; less than 20 percent dropout; clear reporting of dropouts; and 

no obvious bias. Studies must provide valid estimation of nutrient exposure, from dietary 

assessments and/or biomarkers with reasonable ranges of measurement errors, and 

justifications for approaches to control for confounding in their design and analyses. 

B 

Studies are susceptible to some bias, but not sufficient to invalidate the results. They do not 

meet all the criteria in category “A”, they have some deficiencies but none likely to cause 

major bias. The study may be missing information, making it difficult to assess limitations 

and potential problems. 

C 

Studies have significant bias that may invalidate the results. These studies have serious errors 

in design, analysis, or reporting; there are large amounts of missing information, or 

discrepancies in reporting. 

If the initial assigned grade was equivocal, then the study received a second round of review 

by an independent reviewer, and the final grade was reached via consensus. Lastly, it should be 

noted that the quality grading system evaluates and grades the studies within their own design 

strata (i.e., RCTs, cohorts, nested case-control). It does not attempt to assess the comparative 

validity of studies across different design strata. Thus, it is important to be cognizant of the study 

design when interpreting the methodological quality grade of a study. 

38
Additional Considerations of Methodological Quality of Primary 

Studies for the Purpose of DRI Decision Making 

Randomized controlled trials of all outcomes. 

The Tufts EPC debated about the quality assessment of RCTs. A consensus was reached to 

include additional considerations for RCTs to receive grade A. The general quality assessment of 

interventional studies as described earlier has been widely adopted for the purpose of grading 

high quality effectiveness trials (in contrast with a more standardized efficacy trial) which are 

most relevant to the actual use of supplements. Thus the crossover of interventions (i.e., 

contamination between supplementation and placebo groups) affects the applicability more than 

the methodological quality. However, it was the consensus among the Tufts EPC methodologists 

that the RCTs with contamination between supplementation and placebo groups cannot receive 

grade A because this issue affects the actual differences in the doses given to the subjects. 

Therefore it is particularly important when the trial results are used to guide decisions about DRI, 

as opposed to decisions about whether to actively recommend supplementation for an individual. 

Observational studies of cancer outcomes. 

When cancer cases were identified based on cancer registries or questionnaire-based data, we 

perused whether the investigators verify the diagnoses independently (e.g., by medical records or 

pathological reports). An observational study of cancer outcomes cannot receive grade A if the 

cancer diagnoses were not verify independently. We also examined if the study adequately 

control for other risk factors for specific cancer. We used the suggested risk factors by National 

Cancer Institute (www.cancer.org). An observational study of cancer outcomes cannot receive 

grade A if important risk factors for the specific cancer were not fully controlled for in their 

analyses. 

Critical Appraisal of Systematic Reviews 

We also critically appraised systematic reviews utilized in this report. However, a summary 

quality grade for systematic review is difficult to interpret. While it may be straightforward to 

assign a high quality grade to a rigorously carried out systematic review of high quality primary 

studies, a rigorously conducted systematic review finding only poor quality primary studies to 

summarize has uncertain value. Similarly, a poorly conducted systematic review of high quality 

studies may also result in be misleading conclusions. Therefore, to appreciate its validity, the 

various dimensions and nuances of the systematic review must be understood. 

To help readers appreciate the methodological quality of a systematic review, we applied the 

AMSTAR checklist,26 a tool that was created for this purpose. This tool does not assign a 

composite grade. Instead, the items evaluated are made explicit for the reader. Another 

challenge in evaluating systematic reviews is that none of the existing systematic reviews were 

specifically conducted to be used for DRI development; therefore their “quality”, for the purpose 

of DRI development, is impossible to reliably define. 

In addition to using AMSTAR, we made comments on special considerations, issues or 

limitations concerning design, conduct and analyses of the systematic review, and interpretability 

of the results for the purpose of DRI development. 

39
Reporting of the Evidence 

Evidence tables. 

Evidence tables offer a detailed description of the primary studies we identified that address 

each of the key questions. These tables provide detailed information about the study design, 

patient characteristics, background diet, inclusion and exclusion criteria, interventions (or 

exposures), comparators used, and outcomes assessed in the study. A study, regardless of how 

many interventions (or exposures) or outcomes were reported, appears once in the evidence 

tables. Evidence tables are ordered alphabetically by the first author’s last name to allow for easy 

searching within the tables. Evidence tables are available electronically in Appendix C. 

Summary tables. 

Summary tables were created to assist (qualitative) synthesis of primary studies of the same 

outcomes and life stage. If feasible, data were also grouped by sex. Typically, in each outcome 

section, we presented one summary table for the study characteristics of all included studies, 

followed by another summary table for study findings. 

We created different summary tables for different exposures (i.e., vitamin D or calcium) and 

for different study designs (i.e., interventional or observational studies). Key study 

characteristics, such as population characteristics (i.e., health status, age and sex), vitamin D 

assay method and season in which blood was drawn, dietary assessment methods and whether 

the instrument was internally validated, patient or participant adherence, and study comparisons, 

were presented in the summary table for study characteristics. We reported daily vitamin D doses 

(IU/d) and/or elemental calcium doses (mg/d) in all summary tables. 

For observational studies, we also list the confounders adjusted in either design (e.g., 

matching factors) or analyses. If any confounders or effect modifiers in each prespecified 

category (i.e., nutrients, demographics, anthropometry, medical conditions, ultraviolet exposure, 

and life styles) were controlled for, we marked “X” in the category. Otherwise, the category was 

left blank. 

Graphical presentation of dose-response relationship. 

We present graphically the results of studies associating outcomes with categorical 

exposures (e.g., percentiles or other arbitrary categories of 25(OH)D concentration or of total 

calcium intake). The graphs complement the information mentioned in the tables and allow the 

reader to appreciate the direction of the estimated effects, even when the choice of the reference 

category is inconsistent across studies. The graphs do not readily convey the slope (strength) of 

the dose-response relationship between exposure and outcome, because the exposure categories 

are simply ranked and their spacing does not necessarily correspond to the actual values that they 

represent within study or across studies. 

Grand summary tables (evidence map). 

In the beginning of the Results section, we created a grand overview table. The table details 

how many studies reported an outcome of interest (either as a primary or non-primary outcome) 

and also listed the total number of unique studies (including systematic reviews) as each study 

may have provided data on more than one outcome. The number of primary studies included in 

each existing systematic review is also reported. 

40
Units of measurement. 

In this report, we converted serum 25(OH)D concentrations as reported by various studies as 

different units (i.e., ng/mL, μg/dL, μg/L and ng/dL) to nmol/L. The conversion formula is 1 

ng/mL = 2.5 nmol/L. To limit the variation in the reporting of vitamin D unit (e.g., nmol, IU, μg 

and mg), IU was chosen as the standard unit and all other units were converted using a standard 

formula. The conversion formula for micrograms is 1 μg = 40 IU. 

Assay method. 

For 25(OH)D measurements, we present information on the assay used in our evidence 

tables, and summary tables describing individual studies. When reported, we also recorded 

details on the methodology or kit used (e.g., RIA–radioimmunoassay, RIA “DiaSorin”) used. 

Often, additional information was lacking. We did not perform any subgroup analyses based on 

the type of 25(OH)D assay used. 

Sunlight exposure. 

We report information on country where the study took place and its latitude (when this was 

meaningful), and when available, the season when serum 25(OH)D concentrations were 

measured. A substantial amount of vitamin D is formed in the skin in humans. The amount of 

vitamin D synthesized in the skin depends on a person’s exposure to UV irradiation. Therefore, 

information on country’s latitude (and season of serum 25(OH)D measurements) informs on 

whether different populations are likely to have similar or different amount of endogenous 

vitamin D production. Latitudes were extracted directly from the published reports, or 

extrapolated from the city or country where the study took place (by searching Google for 

“<county/city> latitude”). For national or international studies that spanned a wide range of 

latitudes (e.g., NHANES), the latitude information was summarized simply as "various." To 

facilitate the reader, we also provide a Table with the latitudes of major cities in Central and 

North America (this table is found right after the Abbreviations table on page 316. 

Primary and secondary outcomes. 

For intervention studies, we distinguished primary from secondary (or nonspecified) 

outcomes. Outcomes were considered primary only when they were clearly reported as such or 

when the outcome was used in an ad hoc sample size calculation. For observational studies we 

did not separate primary from secondary outcomes. For example, many observational studies are 

analyses of the same well known cohorts for several different outcomes. Each of these studies 

may have a different “primary” outcome. 

Study quality. 

We summarize methodological and reporting quality of individual studies and meta-analyses. 

More details on the reporting characteristics of individual studies and systematic reviews are 

found in the evidence tables (Appendix C). 

41
42

Organization of the results section. 

The Results section is organized in the following way: 

• Nutrient (vitamin D | calcium | combined calcium and vitamin D) 

o Outcome (e.g., growth, cardiovascular diseases) 

 Synopsis 

 Detailed presentation (depending on availability of data) 

• Findings per calcium intake level / vitamin D concentration 

• Findings per age and sex 

 Findings by life stage 
43
Chapter 3. Results 

Literature Search Results 

 The original MEDLINE® and Cochrane Central database search for primary studies yielded 

15,621 citations of EAR outcomes and 194 citations of UL outcomes. The update search for 

primary studies published between September, 2008 and April, 2009 yielded 918 citations We 

identified 654 of these as potentially relevant and retrieved the full-text articles for further 

evaluation. Of these, 478 did not meet eligibility criteria (Appendix E); thus, a total of 165 

primary study articles met the inclusion criteria and were included in this report (Figure 5). Of 

the 165 primary study articles, 60 were randomized controlled trials (RCTs), 3 were 

nonrandomized comparative studies, and 102 were observational studies (either cohort or nested 

case-control studies). The publication dates of the 165 primary study articles ranged from 1980 

to 2009. 

 The MEDLINE®, Cochrane Database of Systemic Reviews, and the Health Technology 

Assessments database search for systematic reviews yielded 1746 citations. We identified 68 of 

these as potentially relevant and retrieved the full-text articles for further evaluation. Of these, 46 

did not meet eligibility criteria. After examining the 22 qualifying systematic reviews, 11 were 

excluded for various reasons (Appendix D; Figure 5). 

The grand overview tables (Tables 1, 2, and 3) detailed how many studies reported an 

outcome (either as a primary or secondary outcome) that is of interest and also listed the total 

number of unique studies (including those from systematic reviews) as each study may have 

provided data for more than one outcome. 

35
Figure 5. Literature flow in this report 

Citations identified in MEDLINE and Cochrane

Central database search for primary studies,

published between 1969 and Arpil 2009

(n=16,733)

Citations identified in MEDLINE, Cochrane

Database of Systemic Reviews, and the Health

Technology Assessments database search for

systematic review articles published before

December, 2008 (n=1,746)

Primary study articles retreived for full-text review

(n=584)

Systematic review articles retreived for full-text

review (n=68)

Abstracts failed to meet

criteria (n=17,825)

Primary study articles reviewed (n=165)

- 60 randomized, controlled trials

- 3 nonrandomized comparative studies

- 102 observational studies (either cohort or

nested case-control studies)

Systematic reviews included (n=11)

Articles failed to meet

criteria (n= 476)

 

36
Table 1. Number of primary studies on vitamin D intake or concentration and specific health outcomes that could 

certain life stages 

Growth 

CVD clinical 

Body weight (adults) 

Total cancer 

Prostate cancer 

Colorectal cancer 

Colorectal adenoma 

Breast cancer 

Breast mammographic density 

Pancreatic cancer 

Immune function clinical outcomes 

Preeclampsia & pregnancy outcomes 

All-cause mortality 

0 – 6 mo 8 7 mo – 2 y 1 1B

3 - 8 y 9 – 18 y 2 19 – 50 y 1 1 1 2 1 1 1 

51 – 70 y 3 2 1 10 6 1 2 2 1 8 ≥71 y 2 1 1 1 8 Pregnant & lactating women 7 1 1 

Postmenopause 1 1 1 1 1B 

Total unique studies per outcome [Total number of RCTs per outcome] 

9 

[6] 

5 

[1] 

3 

[3A] 

3 

[2] 

12 

[0] 

9 

[1] 

1 

[0] 

3 

[0] 

0 2 

[0] 

2 

[0] 

1 

[0] 

8 

[8] 

Systematic reviews (unique studies) per outcome 0 0 0 0 0 0 0 0 0 0 0 0 

1 

(4) 

Shaded cells indicate that either the eligibility criteria excluded outcomes in those life stages or the outcomes are not applicable to those life stages. Blank primary studies were identified in this report in those life stages. A Only RCTs were eligible for this outcome B Relationship between maternal 25(OH)D concentration and atopic eczema in infants C 1 study was a combined analysis of Nurses Health Study and Health Professionals Follow-up Study 

37
Table 2. Number of primary studies on calcium intake and specific health outcomes that could be applicable to ce

Growth 

CVD clinical 

Body weight (adults) 

Total cancer 

Prostate cancer 

Colorectal cancer 

Colorectal adenoma 

Breast cancer 

Breast mammographic density 

Pancreatic cancer 

Immune function clinical outcomes 

Preeclampsia & pregnancy outcomes 

All-cause mortality 

0 – 6 mo 1 7 mo – 2 y 

3 - 8 y 1 1B9 – 18 y 3 19 – 50 y 2 3 1 3 1 1 1 1 

51 – 70 y 9 5 1 12 17 6 5 2 1 ≥71 y 1 1 1 1B 1 

Pregnant & lactating women 1 14 

Postmenopause 1 4 1 4 

Total unique studies per outcome [Total number of RCTs per outcome] 

3 

[1] 

11 

[0] 

8 

[8A] 

3 

[2] 

12 

[0] 

21 

[0] 

6 

[1] 

6 

[0] 

1 

[0] 

2C

[0] 

0 14 1 

Systematic reviews (unique studies) per outcome 

1 

(17) 

0 

3 

(41) 

0 0 

1 

(2) 

1 

(2) 

0 0 0 0 

1 

(12) 

0 

Shaded cells indicate that either the eligibility criteria excluded outcomes in those life stages or the outcomes are not applicable to those life stages. Blank primary studies were identified in this report in those life stages. A Only RCTs were eligible for this outcome B Association between total calcium intake in childhood and colorectal cancer after 65 years of followup C 1 study was a combined analysis of Nurses Health Study and Health Professionals Follow-up Study D 6 analyses, including 2 separate analyses of NHANES I 

38
39

Table 3. Number of primary studies on combined vitamin D and calcium intake and specific health outcomes that a

life stages 

Growth 

CVD clinical 

Body weight (adults) 

Total cancer 

Prostate cancer 

Colorectal cancer 

Colorectal adenoma 

Breast cancer 

Breast mammographic density 

Pancreatic cancer 

Immune function clinical outcomes 

Preeclampsia & pregnancy outcomes 

All-cause mortality 

0 – 6 mo 1 7 mo – 2 y 

3 - 8 y 9 – 18 y 19 – 50 y 1 

51 – 70 y 1 1 1 3 

≥71 y 1 8 

Pregnant & lactating women 1 1 

Postmenopause 1 1 2 1 1 1 8 

Total unique studies per outcome [Total number of RCTs per outcome] 

1 1B

[1] 

2B

[2A] 

2B

[2] 

0 1B

[1] 

2B

[1] 

1B

[1] 

0 0 0 1 

11B

[11

Systematic reviews (unique studies) per outcome 0 0 0 0 0 0 0 0 0 0 0 0 

1 

(10B

Shaded cells indicate that either the eligibility criteria excluded outcomes in those life stages or the outcomes are not applicable to those life stages. Blank primary studies were identified in this report in those life stages. A Only RCTs were eligible for this outcome B Including the Women’s Health Initiative (WHI) trial C A de novo reanalysis of the 10 RCTs in a previous systematic review and one newly added trial 
Vitamin D and Health Outcomes 

Vitamin D and Growth 

 We reviewed primary studies that evaluated relationships between vitamin D and growth 

parameters in infants and children. 

Synopsis. 

 Seven intervention studies and two observational studies evaluated intake of or exposure to 

vitamin D and growth parameters in infants and children. Two intervention studies from the 

same center found a significant association of maternal vitamin D intakes with infant birth 

weights. Study methodologies were incompletely reported in these two studies. The rest of the 

studies did not find a significant association between either maternal or offspring vitamin D 

intake and offspring’s weight or height. No overall conclusions could be drawn as the studies 

reviewed had diverse populations and methodological approaches. 

Detailed presentation (Tables 4, 5, 6 & 7). 

 Six RCTs34-40 and one nonrandomized comparative study41 in eight publications reported on 

the effect of vitamin D supplementation on growth parameters in infants and children. Two 

cohort studies reported on the association between maternal serum 25(OH)D concentration and 

her offspring’s growth parameters.42,43 The number of subjects in the RCTs ranged from 19 to 

200. The two cohort studies had 374 and 466 subjects, respectively. The latitudes of the studies 

ranged from 38o to 51o. Four studies administered vitamin D exclusively to expectant mothers 

during the third trimester of pregnancy. One study administered vitamin D to both the lactating 

mothers and her offspring. Two studies administered vitamin D only to the infants or children. 

Followup ranged from delivery until 9 years. Methodological quality of two studies were rated B 

and seven studies were rated C. The studies were limited by such factors as incomplete reporting 

and small sample sizes. 

Infant 0 - 6 months; 7 months - 2 years; pregnant or lactating women. 

 One RCT from UK administered vitamin D 1000 IU/d or placebo to 126 expectant mothers 

(first generation Asian immigrants) during the third trimester and found no significant difference 

between the infants’ birth weights or birth lengths and those of the control population.34,38 There 

were twice as many low birth weight infants (<2500 g) in the control group compared to the 

supplemented group (21.7 percent vs. 11.9 percent); however, this difference was not significant. 

A study from US supplemented 10 lactating mothers with vitamin D 400 IU/d and their infants 

with 300 IU/d for 6 months. Compared to the group where nine mothers received 6400 IU/d and 

their infants none, there was no significant difference in the infants’ weight or length at 1 month, 

4 months, and 7 months of age.39 A study from China randomly assigned 255 newborn infants to 

100, 200, or 400 IU/d of vitamin D for 6 months and reported no significant difference in weight 

or length among the three groups at 6 months of age.36 One study from India randomly selected 

100 expectant mothers to receive a total of 1.2 million IU of vitamin D (600,000 IU of vitamin 

D2 in 7th and 8th month) during the third trimester. The newborns’ birth weight was significantly 

increased compared to those from 100 unsupplemented expectant mothers (difference 190 g).37

Important elements of the study methodology like randomization technique and any blinding of 

outcome assessors were not reported. An earlier nonrandomized comparison from the same study 

center involving smaller samples reported similar findings.41 The estimated baseline mean 

40
dietary vitamin D intake in the expectant mothers from these two studies was less than 30 to 35 

IU/d (the validity of these measures is unclear). An RCT from France supplemented 48 expectant 

mothers with either vitamin D 1000 IU/d in the third trimester or 200,000 IU one time dose at 7 

month pregnancy and found no significant difference in the infants’ birth weights between the 

two methods.40 A cohort study from Australia analyzed the maternal serum 25(OH)D 

concentration in 374 women at 28-32 week gestation (geometric mean in winter 48 nmol/L; 

summer 69 nmol/L) and found no association with infant birth weight or length.43 One cohort 

study from UK analyzed the serum 25(OH)D concentration in 466 white women in late 

pregnancy (~33 wk) and found the concentrations (from <30 to >75 nmol/L) were not related to 

their offspring’s weight or height at birth, 9 months, and 9 years.42

9 - 18 years. 

 One RCT of vitamin D3 (placebo, 200, or 2000 IU/d for 1 year) on girls in Lebanon aged 10-

17 years found no significant difference at 1 year followup in weight or height among the 34 

girls who were premenarchal at time of enrollment.35

Findings by life stage. 

• 0 – 6 mo One RCT found that supplementing expectant mothers with vitamin D 

1000 IU/d during the 3rd trimester has no effect on infant birth weight or length. Another 

RCT found that supplementing expectant mothers with a total of 1.2 million IU of 

vitamin D during the 3rd trimester effected a significant increase in birth weight (+190 g). 

Background diet is low in vitamin D in this study. A study compared supplementing 

lactating mothers with vitamin D 400 IU/d and their infants 300 IU/d for 6 months with 

mothers supplemented with 6400 IU/d and their infants none, there was no significant 

difference in the infants’ weight or length at 1 month, 4 months, and 7 months of age. 

Another study compared supplementing newborn infants with 100, 200, or 400 IU/d of 

vitamin D for 6 months and reported no significant difference in weight or length at 6 

months of age. An RCT supplemented expectant mothers with either vitamin D 1000 

IU/d during the third trimester or 200,000 IU one time dose at 7 month pregnancy and 

found no significant difference in the infants’ birth weights between the two methods. A 

cohort study analyzed the maternal serum 25(OH)D concentration at 28-32 week 

gestation (geometric mean in winter 48 nmol/L; summer 69 nmol/L) and found no 

association with infant birth weight or length. Another cohort study found that serum 

25(OH)D concentration (ranged from <30 to >75 nmol/L) in late pregnancy (~33 wk) 

was not related to the newborn’s weight or height at birth, 9 months, and 9 years. 

• 7 mo – 2 y A cohort study found that serum 25(OH)D concentration (ranged from 

<30 to >75 nmol/L) in late pregnancy (~33 wk) was not related to the newborn’s weight 

or height at birth, 9 months, and 9 years. 

• 3 – 8 y No study covered this life stage.

• 9 – 18 y A cohort study found that serum 25(OH)D concentration (ranged from 

<30 to >75 nmol/L) in late pregnancy (~33 wk) was not related to the newborn’s weight 

or height at birth, 9 months, and 9 years. One RCT of vitamin D3 (placebo, 200, or 2000 

IU/d for 1 year) on girls 10-17 years old found no significant difference at 1 year 

followup in weight or height among the girls who were premenarchal at time of 

enrollment. 

• 19 – 50 y Not reviewed

• 51 – 70 y Not reviewed

41
42

• ≥71 y Not reviewed

• Postmenopause Not reviewed

• Pregnant & lactating women One RCT found that supplementing expectant mothers 

with vitamin D 1000 IU/d during the 3rd trimester has no effect on infant birth weight or 

length. Another RCT found that supplementing expectant mothers with a total of 1.2 

million IU of vitamin D during the 3rd trimester effected a significant increase in birth 

weight (+190 g). Background diet is low in vitamin D in this study. A study compared 

supplementing lactating mothers with vitamin D 400 IU/d and their infants 300 IU/d for 6 

months with mothers supplemented with 6400 IU/d and their infants none, there was no 

significant difference in the infants’ weight or length at 1 month, 4 months, and 7 months 

of age. An RCT supplemented expectant mothers with either vitamin D 1000 IU/d during 

the third trimester or 200,000 IU one time dose at 7 month pregnancy and found no 

significant difference in the infants’ birth weights between the two methods.
Table 4. Vitamin D on growth outcome: Characteristics of interventional studies 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake & 

Vitamin D Data 

Comparisons Compliance Comments 

RCTs 

• Health 

status 

pregnancy 

• Mean age 

(range/SD), y 

25(OH)D at 28-32 

wk: 20.1 nmol/L 

Vit D 1000 

IU/d 3rd

trimester only 

nd First generation

Asian 

immigrants only 

Maxwell 

198138

Brooke 

198034

UK (51oN) 

[6793058] 

[6989438] 

• Male (%) 

nd 

0 

• Health 

status 

healthy term 

• Mean age 

(range/SD), y 

86% infant breastfed 

until 5-6 mo 

Vit D 100 IU/d 

vs. 200 IU/d 

vs. 400 IU/d 

Feliciano nd 

199436

China (22oN 

to 47oN) 

[8078115] • Male (%) 

newborn 

nd 

• Health 

status 

healthy 

• Mean age 

(range/SD), y 

El-Hajj 200635

Lebanon 

(33oN) 

[16278262] 

• Male (%) 

25(OH)D 35 nmol/L; 

dietary Ca 677 mg/d 

Vit D3 200 

IU/d vs. 2000 

IU/d vs. 

placebo x 1 y 

98% in placebo; 

98% in low dose; 

97% in high dose 

7.4 h sun 

exposure/wk 

13.2 (10-17) 

0 

• Health 

status 

Fully lactating; 

<1 mo 

postpartum 

• Mean age 

(range/SD), y 

Lactating mother’s 

dietary Vit D 273 

IU/d; dietary calcium 

intake: 1125 mg/d; 

Mother Vit D3

400 IU/d + 

infant 300 

IU/d vs. 

mother 6400 

IU/d + infant 0 

IU/d 

≥80% in mothers; 

as low as 61% for 

infants 

78% white; 

11% black; 

11% Hispanic 

Wagner 

200639

Charleston, 

US (32oN) 

[17661565] 

• Male (%) 

29 

0 

• Health 

status 

no pregnancyrelated 

complications 

• Mean age 

(range/SD), y 

Marya 198837

India 

(28oN) 

[3243609] 

• Male (%) 

Expectant mother’s 

dietary Vit D 35 IU/d; 

calcium 429 mg/d 

Mother Vit D 

1.2 mil IU 

(total; 600,000 

IU vit D2 in 7th

& 8th mo) vs. 

no 

supplement 

nd 

24 

0 

• Health 

status 

pregnancy 

• Mean age 

(range/SD), y 

Mallet 198640

France (48o 

N) 

[3755517] 

• Male (%) 

Ca intake 550 to 

1000 mg/d in 55% of 

the subjects 

Vit D 1000 

IU/d vs. 

200,000 IU 1x 

dose 

nd 

newborn 

nd 

Nonrandomized comparative study 

• Health 

status 

no pregnancyrelated 

complications 

• Mean age 

(range/SD), y 

Marya 198141

India 

(28oN) 

[7239350] 

• Male (%) 

Expectant mother’s 

daily milk intake 

<500 mL; dietary Vit 

D <30 IU/d 

Vit D 1200 

IU/d + Ca 375 

mg/d (3rd

trimester) or 

Vit D 1.2 mil 

IU (total; 

600,000 IU in 

7th & 8th mo) 

or no 

supplement 

nd 

nd 

0 

43
Table 5. Vitamin D and growth outcomes: Characteristics of cohort studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Vitamin D 

Concentration Comparisons 

Nutrients Demograph Anthrop Medical UV exposure 

Comments 

Lifestyle 

• Health 

status 

singleton 

pregnancy; 

no disease 

Length and 

weight in 

offspring 

stratified by 

mother’s 

25(OH)D 

X X X X 99% 

white; 

excluded 

dark skin 

or women 

with 

concealing 

clothing 

• Mean age 29 

(range/SD), 

y 

• Assay 

method 

Morley RIA 

200643

Australia 

(38oS) 

[16352684] 

• Male (%) 0 winter & 

summer 

• Season 

blood 

drawn 

• Health 

status 

singleton 

pregnancy 

<17 wk 

• Mean age 

(range/SD), 

y 

26.3 

• Assay 

method 

Gale 2008 RIA 42

PAHSG 

UK (50oN) 

[17311057] 

• Male (%) 0 

Length and 

weight in 

offspring 

stratified by 

mother’s 

25(OH)D 

X X 

• Season nd 

blood 

drawn 

White only 

44
Table 6. Vitamin D and growth outcomes: Results of RCTs 

Author Year Study Name [PMID] 

Life Stage Outcome 1°/2° Mean Followup Interventions, Daily Dose No. Analyzed Unit Baseline Change (SD) Change 95% CI Net Diff 

Vit D 1000 IU 59 g NA Final 3157 3037, 3277 Diff +123 

Infant birth weight 

2° until 

delivery 

Control 67 NA 3034 2909, 3159 

Vit D 1000 IU 59 cm NA Final 49.7 49.6, 49.8 Diff +0.2 

Maxwell 198138

Brooke 198034[6793058] [6989438] 

Pregnant women & infant 0-6 mo (Asians) Infant 

birth length 

2° until 

delivery 

Control 67 NA 49.5 49.4, 49.6 

Vit D 400 IU 12 g nd 3745 2613, 4877 -463 Vit D 200 IU 13 nd 5296 4718, 5874 1088 

Weight gain born in spring, N. ChinaA

1° 6 mo 

Vit D 100 IU 17 nd 4208 3402, 5013 

Vit D 400 IU 12 cm nd 18.8 17.4, 20.2 -0.5 

Vit D 200 IU 13 nd 19.0 18.1, 19.9 -0.3 

Feliciano 199436

[8078115] 

0-6 mo 

Length gain born in spring, N. China 

1° 6 mo 

Vit D 100 IU 15 nd 19.3 17.6, 21.0 

Vit D3 2000 IU % nd 5.6% ~4.8, 6.4C ~1.8% 

Vit D3 200 IU nd 5.0% ~4.2, 5.8C ~1.2% 

Height 2° 1 y 

Placebo 

nd, ≤34 

total nd 3.8% ~0.9, 6.7C 

Vit D3 2000 IU % nd 18.4% ~14.7, 22.1C ~3.5% Vit D3 200 IU nd 15.3% ~12.5, 18.1C ~0.4 

El-Hajj 200635

[16278262] 

9-18 y female, premenarche 

Weight 2° 1 y 

Placebo 

nd, ≤34 

total nd 14.9% ~11.8, 18.0C 

Mother (400) +infant (300) 10 g NA Final 7600 7100, 8100 Diff -800 

Infant weightB 1° 7 mo 

Mother (6400)+infant (0) 9 NA 8400 7700, 9100 

Mother (400) +infant (300) 10 cm NA Final 65.5 64.4, 66.6 Diff -3.8 

Wagner 200639

[17661565] 

Lactating mothers & infant 0 - 6 mo; 7 mo - 2 y Infant 

length 

1° 7 mo 

Mother (6400)+infant (0) 9 NA 69.3 67.4, 71.2 

Vit D 1.2 mil IU total 100 g NA Final 2990 2920, 3060 Diff +190 

Birth weight 1o Delivery 

No supplement 100 NA 2800 2730, 2870 

Vit D 1.2 mil IU total 100 cm NA Final 50.06 49.7, 50.4 Diff +1.6 

Marya 198837

India [3243609] 

Pregnant women & infant 0-6 mo 

Birth length 

2o 

No supplement 100 NA 48.45 48.1, 48.8 

Vit D 1.2 mil IU total 20 g NA Final 3140 2940, 3340 Diff +410 

Vit D 1200 IU + 375 mg Ca (3rd trimester) 

25 g NA Final 2890 2760, 3020 Diff +160 

Marya 198141

[7239350]E

Pregnant women & infant 0-6 mo 

Birth weight 

2o Delivery 

No supplement 75 NA 2730 2650, 2810 

Continued 

45
Author Year 

Study Name [PMID] 

Life Stage Outcome 1°/2° Mean Followup Interventions, Daily Dose No. Analyzed Unit Baseline Change (SD) Change 95% CI Net Diff 

Birth weight 

2° delivery 

Vit D 1000 IU 21D g NA 

Final 

3370 

(80) 

Diff 

+160 

Mallet 198640

France (48o N) [3755517] 

Pregnant women & infant 0-6 mo 

Vit D 200,000 IU 1x dose 27D NA 3210 (90) 

A See Table 1 in original paper for complete results stratified by North vs. South China and birth in spring vs. fall B See Table 3 in original paper for results on 1 mo and 4 mo C Estimated from available dataD Estimated from number of mothers; number of infants not reported E This is not an RCT; the supplemented groups were randomized, but not the control (non-supplemented group); data from comparisons between the su

reported.

46
47

Table 7. Vitamin D and growth outcomes: Results of cohort studies Author Year Study Name PMID 

Life Stage Outcome (n/N; Incidence) Followup Duration Maternal 25(OH)D concentration, nmol/L No. in Category Final value Fin

S

Pregnant 

women; 

infant 0-6 mo 

Birth weight 

(N=374) Delivery <28 at 28-32 wk 27 3397 g 5

≥28 at 28-32 wk 347 3555 5

Birth length 

(N=374) Delivery <28 at 28-32 wk 27 49.8 cm 2

Morley 200643

Australia [16352684] 

≥28 at 28-32 wk 347 50.4 2

Pregnant 

women; 

infant 0-6 mo 

Birth weight 

(N=466) Delivery <30 (Quartile) nd 3.38 kg 0.

30-50 nd 3.40 0.50-75 nd 3.49 1.

>75 nd 3.43 0.

Weight at 9 mo 

(N=440) 9 mo <30 nd 15.9 1.

30-50 nd 15.8 1.50-75 nd 16.1 1.

>75 nd 15.9 1.

Weight at 9 y 

(N=178) 9 y <30 nd 27.4 kg 1.

30-50 nd 29.4 1.50-75 nd 30 1.

>75 nd 29.3 1.

Pregnant 

women; 

infant 0-6 mo 

Birth length (N=466) Delivery <30 nd 50 cm 1.

30-50 nd 50 2.50-75 nd 50.5 2.

>75 nd 50.1 2.

Length at 9 mo 

(N=440) 9 mo <30 nd 71.2 cm 2.

30-50 nd 71.4 2.50-75 nd 71.7 2.

>75 nd 71.1 2.

Height at 9 y 

(N=178) 9 y <30 nd 129.6 cm 5.

30-50 nd 131.5 6.50-75 nd 131.8 5.

Gale 200842

PAHSG, UK [17311057] 

>75 nd 130.6 6.

A Non-adjusted 
Vitamin D and Cardiovascular Disease 

Synopsis. 

 No qualified systematic reviews have evaluated the association between vitamin D intake or 

serum 25(OH)D concentrations and incidence of hypertension. One RCT of almost 2700 elderly 

British who received either vitamin D3 100,000 IU every 4 months or placebo for 5 years found 

no statistically significant difference in event rates for various cardiovascular outcomes, 

including total events and cardiovascular deaths. No effects were also found in subgroup 

analyses of men and women. Three cohort and one nested case-control studies have analyzed the 

association between serum 25(OH)D concentrations and cardiovascular outcomes 

(cardiovascular events, nonfatal myocardial infarction or fatal coronary heart disease, 

cardiovascular death, myocardial infarction, and stroke). Significant associations were found 

between progressively lower 25(OH)D concentration and progressively increased risk of 

cardiovascular events in two studies of people approximately 40 to 75 years old. No significant 

associations were found between serum 25(OH)D concentrations and cardiovascular death, 

myocardial infarction, or stroke in one study each. 

Detailed presentation (Tables 8, 9, 10 & 11; Figure 6). 

Total cardiovascular events. 

 Total cardiovascular events were evaluated by an RCT,44 the Framingham Offspring Study 

(FOS),45 and a nested case-control study derived from the Health Professionals Follow-up Study 

(HPFS).46 The RCT found no significant effect of vitamin D; both cohort studies found 

significant associations between lower serum 25(OH)D concentrations and increased rates of 

outcomes. 

 The RCT randomized almost 2700 elderly participants (65-85 years) from the general 

population in Ipswich, UK (52° N) to vitamin D3 100,000 IU every 4 months or placebo.44 After 

5 years, 36 percent of the participants had a cardiac or cerebrovascular event, but there was no 

statistically significant difference between those taking vitamin D or placebo. Similar results 

were found in subgroups of men and women. The RCT was rated quality B primarily due to 

inadequate verification of outcomes. 

 The FOS cohort evaluated 1739 men and women with no history of cardiovascular disease 

and a mean age of 59 years (based on the standard deviation, with an approximate rage of 41 to 

77 years).45 After 5.4 years, 6.9 percent had a cardiovascular event (including myocardial 

infarction, coronary insufficiency, angina, stroke, transient ischemic attack, claudication, and 

heart failure). Overall, the methodological quality of the study was A; though their secondary 

analysis of three categories of serum 25(OH)D concentrations (as opposed to two categories) 

was rated C due to incomplete reporting and lack of adjustment for important variables including 

season of blood draw. In their primary analysis, people with serum 25(OH)D concentrations less 

than 37.5 nmol/L were 70 percent more likely (P=0.02) to have a cardiovascular event. In their 

secondary analysis, those with 25(OH)D concentrations between 25 and 37.5 nmol/L were about 

50 percent more likely (P=0.01) to have an event than those with higher concentrations. 

Furthermore, a multivariable analysis of continuous 25(OH)D concentrations suggested 

increased likelihoods of cardiovascular events in those with 25(OH)D concentrations below 

approximately 50 to 55 nmol/L. 

48
 In a nested case-control study of the HPFS, 454 men 40 to 75 years old with no 

cardiovascular history who had a nonfatal myocardial infarction or coronary heart disease death 

over a 10 year period were matched with 1354 controls.46 The methodological quality of the 

analysis was A, although due to limitations on analyzable serum, the investigators had to use a 

case-control analysis instead of a complete analysis of all eligible men in the HPFS. Across four 

categories of men based on their serum 25(OH)D concentrations, lower concentrations were 

significantly associated with increased cardiovascular events (trend across categories P=0.02). 

Compared with men who had 25(OH)D concentrations above 75 nmol/L, those with 25(OH)D 

concentrations 56 to 75 nmol/L had an adjusted relative risk (RR) of 1.6 (95 percent CI 1.1, 2.3), 

those with 25(OH)D 37.5 to 56 nmol/L had an RR of 1.4 (95 percent CI 0.96, 2.1), and those 

with 25(OH)D below 37.5 nmol/L had an RR of 2.1 (95 percent CI 1.2, 3.5). 

Cardiovascular death. 

 The British RCT of vitamin D3100,000 IU every 4 months versus placebo analyzed 

cardiovascular death as a primary outcome; 8 percent of the participants had cardiovascular 

deaths within 5 years.44 Fewer people taking vitamin D3 supplements had cardiovascular deaths 

(RR = 0.84), but this finding was not statistically significant (95 percent CI 0.65, 1.10). Similar 

results were found in subgroups of men and women. 

 An analysis of NHANES III (methodological quality C) evaluated cardiovascular death (due 

to hypertensive disease, ischemic heart disease, arrhythmia, heart failure, cerebrovascular 

disease, atherosclerosis or other disease of the arteries) in over 13,000 men and women 

regardless of baseline medical history.47 During almost 9 years of followup, 5.8 percent had a 

cardiovascular death. The analysis compared four categories of serum 25(OH)D concentrations 

ranging from less than 44.5 nmol/L to more than 80 nmol/L. No significant association was 

found between serum 25(OH)D concentration and cardiovascular death. 

Ischemic heart disease. 

 The RCT evaluated total ischemic heart disease.44 In this elderly British population, 17 

percent had an ischemic heart disease event; no effect of vitamin D3 supplementation was found. 

Similar results were found in subgroups of men and women. 

Ischemic heart disease death. 

 The RCT evaluated total ischemic heart disease death as a primary outcome.44 In the trial, 3.4 

percent had an ischemic heart disease event; no effect of vitamin D3 supplementation was found 

(RR = 0.84 [95 percent CI 0.56, 1.27]). Similar results were found in subgroups of men and 

women. 

Myocardial infarction. 

 In one small analysis, 755 elderly (age 65 to 99 years) Finnish men and women, regardless of 

cardiovascular history, were evaluated on the basis of myocardial infarction (methodological 

quality C due to lack of reporting of relevant data including information on the serum 25(OH)D 

or 1,25(OH)2D concentrations within the tertiles).48

During 10 years of followup, 17 percent of the participants had a myocardial infarction. Both 

analyses of serum 25(OH)D and 1,25(OH)2D concentrations found no significant association 

with risk of myocardial infarction. 

49
Stroke. 

 The RCT evaluated total cerebrovascular disease.44 In this elderly British population, 7.7 

percent had a cerebrovascular event; no effect of vitamin D3 supplementation was found. Similar 

results were found in subgroups of men and women. 

 Stroke was evaluated in the same small Finnish study. During 10 years of followup, 9.3 

percent of the participants had a stroke. Both analyses of serum 25(OH)D and 1,25(OH)2D 

concentrations found no significant association with risk of stroke. 

Cerebrovascular death. 

 The RCT evaluated cerebrovascular disease death as a primary outcome.44 In the trial, 2.0 

percent had a fatal stroke; no effect of vitamin D3 supplementation was found. Similar results 

were found in subgroups of men and women. 

Findings per vitamin D concentration. 

 The RCT compared vitamin D3 supplementation 100,000 IU every 4 months with placebo, 

but found no effect on cardiovascular outcomes. Two cohort studies found a significant 

association between higher serum 25(OH)D concentrations and lower risk of combined 

cardiovascular events. Both found that those people in the highest 25(OH)D category analyzed 

within each study had the lowest risk. The FOS used a maximum threshold of 37.5 nmol/L; the 

HPFS used a maximum threshold of 75 nmol/L. The FOS provided a graphic representation of a 

multivariable regression of continuous 25(OH)D concentrations (Figure 2 in the study).45 The 

risk of cardiovascular events rose below 37 to 50 nmol/L serum 25(OH)D concentration. The 

Finnish cohort did not report the range of serum 25(OH)D and 1,25(OH)2D concentrations.48

Findings per age and sex. 

 The single RCT included elderly people from the general population. No effects on various 

cardiovascular events were found. Subgroup analyses of men and women yielded similar 

findings. The four cohort studies included adults across the full age range. Three of the cohorts 

included about half men and women; one included only men. None evaluated potential 

differences in associations based on age or sex, but no differences were evident across studies. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y For cardiovascular events, only a minority of evaluated participants were 

within this life stage (almost all above 40 years). The NHANES III study, which found 

no association between serum 25(OH)D concentration and cardiovascular death, included 

largely people within this life stage. 

• 51 – 70 y The majority of people investigated for the association between serum 

25(OH)D concentration and cardiovascular events were within this life stage. Significant 

associations were found between lower serum 25(OH)D concentrations and increased 

rates of cardiovascular events, across a range of 25(OH)D concentrations. The NHANES 

III study likely included many people within this life stage; no association was found 

with cardiovascular death. 

• ≥71 y The majority of participants in the British RCT included men and women 

within this age group. Vitamin D supplementation was not found to have an effect on 

50
51

• Postmenopause Only the RCT provided data on a subgroup that included only 

postmenopausal women. No effect of vitamin D3 supplementation was found. 

• Pregnant & lactating women Not reviewed 

Table 8. Vitamin D and cardiovascular outcomes: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake & 

Vitamin D Data 

Comparisons Compliance Comments 

• Health 

status 

General 

population 

• Mean 

age 

(range), y 

75 (65-85) 

Trivedi 20044

Ipswich, UK 

(52°N) 

[12609940] 

• Male (%) 76% 

742 mg/day (at 4 

years, no difference 

by treatment 

allocation) 

Vit D3 100,000 IU 

vs placebo every 4 

months 

76% with at least 80% 

compliance; 66% at last 

dose (80% if excluding 

deaths) 
Table 9. Vitamin D and cardiovascular outcomes: Results of RCTs 

Author Year Study Name [PMID] 

Age 

Range, 

Sex 

(Subgp) 

Outcome 1°/2° Mean Followup Interventions, Daily Dose n Event N Total Outcome Metric (Comparison) Result 95

Vit D3 100,000 IU 

every 4 mo 477 1345 Age adj RR (Vit D/Placebo) 0.90A 0.77

Trivedi 20044 [12609940] 65-85 y, Both CVD, total 2° 

Placebo 503 1341 

Vit D3 224 1345 Age adj RR (Vit D/Placebo) 0.94A 0.77

IHD, total 2° 

Placebo 233 1341 

Vit D3 105 1345 Age adj RR (Vit D/Placebo) 1.02A 0.77

CeVD, total 2° 

Placebo 101 1341 

Vit D3 101 1345 Age adj RR (Vit D/Placebo) 0.84A 0.65

CVD death 1° 

Placebo 117 1341 

Vit D3 42 1345 Age adj RR (Vit D/Placebo) 0.84A 0.56

IHD death 1° 

Placebo 49 1341 

Vit D3 28 1345 Age adj RR (Vit D/Placebo) 1.04 1° A

5 y 

Placebo 26 1341 

CeVD 

death 0.61

A Similar results for subgroups of men and women 

52
Table 10. Vitamin D and cardiovascular outcomes: Characteristics of cohort studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Vitamin D Concentration 

Demograph Medical UV exposure 

Specific 

CVD 

Outcomes 

Comparisons 

Nutrients Anthrop Lifestyle 

• Health 

status 

No 

CVD 

Wang 200845

Framingham 

Offspring 

Framingham, 

MA (mostly) 

(42°N) 

• Mean 

age 

(SD), y 

59 (9) 

• Assay 

method 

RIA 

(DiaSorin) 

[18180395] • Male 

(%) 

45 • Season 

blood drawn 

All 

Outcome 

stratified by 2 

or 3 

categories 

XA X X X XA X CVD event 

• Health 

status 

No 

CVD 

• Mean 

age 

(range), 

y 

64 

(40-75) 

• Dietary 

assessment 

method 

RIA (Hollis 

1993) 

Giovannucci 

200846

HPFS 

US 

(various) 

[18541825] 

• Male 

(%) 

100 • Internal 

validation? 

(y/n) 

All 

Outcome 

stratified by 4 

categoriesB

X X X X X X Nonfatal 

MI or fatal 

CHD 

• Health 

status 

Any 

• Mean 

age 

(range), 

y 

45 

(≥20) 

• Assay 

method 

RIA 

(DiaSorin) 

Melamed 

200847

NHANES III 

US 

(various) 

[18695076] 

• Male 

(%) 

46 • Season 

blood drawn 

All (even 

distribution) 

Outcome 

stratified by 4 

categories 

X X X X X X CVD death 

• Health 

status 

Any 

• Mean 

age 

(range), 

y 

79 

(65-99) 

• Assay 

method 

RIA 

(Incstar) 

• Season 

blood drawn 

All 

Outcome 

stratified by 

tertiles 

X X MI 

Stroke 

Marniemi 

200548

Turku, 

Finland 

(60°N) 

[15955467] 

• Male 48 

(%) A

 Not in 3-category analysis 

B

 Case-control study 

53
Table 11. Vitamin D and cardiovascular outcomes: Results of cohort studies 

Author Year Study Name [PMID] 

Age 

Range, 

Sex 

Outcome 

(n/N; Incidence) 

Followup 

Duration 

(Time to 

Dx) 

Vit D 

Measure 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 95

CVD Events 

Both Sexes 

Wang 200845

Framingham Offspring [18180395] 

Mean 

(SD) 

59 (9), 

Both 

CVD event (120/1739; 

0.069) 5.4 y 25(OH)D <37.5 50 481 1.70 1.08

≥37.5 70 1258 1 Refe

<25 nd nd 1.80 1.05

25-37.5 nd nd 1.53 1.00

≥37.5 70 1258 1 Refe

Men 

Giovannucci 200846

HPFS [18541825] 

40-75 y, 

Men 

Nonfatal MI or fatal 

CHD (454 cases; 

1354 controls) 

10 y 25(OH)D ≤37.5 63 150 2.09 1.24

37.5-56.25 156 463 1.43 0.96

56.25-75 165 464 1.60 1.10

>75 70 277 1 Refe

CVD Death 

Both Sexes 

Melamed 200847

NHANES III [18695076] 

≥20 y, 

Both 

CVD death 

(777/13,331; 0.058) 8.7 y 25(OH)D <44.5 nd nd 1.20 0.87

44.5-60.75 nd nd 0.88 0.69

60.75-80.25 nd nd 0.83 0.65

>80.25 nd nd 1 Refe

Myocardial Infarction 

Both Sexes 

Marniemi 200548

[15955467] 

65-99 y, 

Both 

MI 

(130/755; 0.172) 10 y 25(OH)D nd nd ~252 1 Refe

nd nd ~252 0.99 0.64nd nd ~252 0.77 0.47

1,25(OH)2D nd nd ~252 1 Refe

nd nd ~252 1.05 0.68nd nd ~252 0.82 0.52

Continued 

54
55

Author Year Study Name [PMID] 

Age 

Range, 

Sex 

Outcome 

(n/N; Incidence) 

Followup 

Duration 

(Time to 

Dx) 

Vit D 

Measure 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 95

Stroke 

Both Sexes 

Marniemi 200548

[15955467] 

65-99 y, 

Both 

Stroke 

(70/755; 0.093) 10 y 25(OH)D nd nd ~252 1 Refe

nd nd ~252 1.13 0.62nd nd ~252 1.00 0.5

1,25(OH)2D nd nd ~252 1 Refe

nd nd ~252 0.63 0.37nd nd ~252 0.41 0.22

* Statistically significant (P<0.05) A Multivariable Cox regression with continuous 25(OH)D and regression splines with nonlinear relationships suggests an increased hazard of CVD even

concentrations below approximately 50-55 nmol/L. See Figure 2 on page 508 of article. B Adjusted regression analyses found OR=0.98 (0.96, 0.998) per 2.5 nmol/L increase in 25(OH)D and risk reduction of -2.1% (-0.2%, -4.0%) per 2.5 nmo

25(OH)D concentration. C In a subgroup analysis of participants on no cholesterol lowering drugs at baseline, comparing the highest serum 25(OH)D concentration category (>7

nmol/L), adjusted RR=2.30 (1.33, 3.97).
Figure 6. Cardiovascular outcomes risk stratified by vitamin D concentration 

56
Vitamin D and Body Weight 

 We searched for systematic reviews and primary studies that evaluated associations between 

vitamin D intake or body stores and incidence of overweight or obesity; no such studies were 

found. For the outcome weight change (in kilograms or body mass index units), we included 

only randomized controlled trials. The EPC and the TEP agreed that the limited resources would 

not be expended on reviewing observational studies for the surrogate outcome body weight 

(where overweight or obesity are considered to be the clinical outcomes). We included only 

studies of adults. Studies of weight gain in children are included in the “Growth” section. 

Synopsis. 

 No qualified systematic reviews have evaluated the association between vitamin D intake or 

serum 25(OH)D concentrations and body weight in adults. Three RCTs from Finland, Norway, 

and India compared different doses of vitamin D (300 IU daily, 20,000 or 40,000 IU weekly, or 

120,000 IU every 2 weeks) to placebo, with or without supplemental calcium in both groups. The 

study participants also varied: they were postmenopausal women, obese men and women, or 

only obese men. In the Finnish and Norwegian studies, the participants on average, gained 

weight in all groups over 1 or 3 years; in the Indian study weight remained mostly stable over 6 

weeks. All studies found no difference in weight change with or without vitamin D 

supplementation. 

Detailed presentation (Tables 12 & 13). 

 Three RCTs of vitamin D reported body weight (or body mass index [BMI]) as an outcome. 

The Kuopio (Finland) Osteoporosis Risk Factor and Prevention Study (Kuopio ORFPS) included 

postmenopausal women in a four-arm study.49 Two of the study arms included hormone 

replacement treatment and are not further discussed here. The remaining two arms compared 

vitamin D3 300 IU (83 women) versus placebo (95 women), where all women were taking low 

dose calcium lactate 500 mg/d (equivalent to 93 mg Ca++/d). Women on cholesterol-lowering 

medication at any point during the trial were excluded. The primary outcome of the trial was the 

serum lipid profile. The women ranged in age from 47 to 56 years. After 3 years, women, on 

average, gained weight in both study arms (about 1-2 kg). Those in the placebo arm gained an 

absolute 1.5 percent more weight than those in the vitamin D arm, but the difference was not 

statistically significant. The study had a methodological quality of C due to an uneven 

distribution of body weights between study arms at baseline (means 71.5 and 67.6 kg) and an 

overall withdrawal rate of over 30 percent. 

 The second trial was conducted in Norway among healthy overweight and obese women and 

men.50 The participants’ mean baseline serum 25(OH)D concentration was 53 nmol/L. The trial 

compared vitamin D2 40,000 IU weekly (116 participants completed), 20,000 IU weekly (106 

participants), and placebo (112 participants). All study participants also took calcium carbonate 

500 mg daily. Almost all participants complied with the vitamin D (or placebo). Changes in 

weight and BMI were primary outcomes. The participants ranged in age from 21 to 70 years. 

After 1 year, changes in weight were small (increases of 0.1-0.5 kg) in each trial group. 

Compared to the placebo group, those taking the larger dose of vitamin D had less weight gain 

than those taking the smaller dose, but none of the differences among study groups were 

statistically significant. The study was rated methodological quality B, primarily due to the high 

dropout rate (25 percent), which was not explained. 

57
 The third trial was conducted in New Delhi, India among healthy obese men.51 The 

participants’ mean baseline serum 25(OH)D concentration was about 33 nmol/L. The trial 

compared vitamin D3 120,000 given under supervised conditions every 2 weeks and placebo in 

100 men, of whom 71 were analyzed; most dropouts occurred because of refusals for subsequent 

blood draws (to assess the primary outcome). After 6 weeks, weight in kg and BMI were 

essentially stable, with no difference in weight change between the interventions. The study was 

rated methodological quality B because of the high dropout rate; for weight (in kg), the study 

was of quality C because baseline weights were not reported. 

Findings per vitamin D dose. 

 There was a lack of effect found across a range of doses from 300 IU to 8570 IU (prorated) 

daily. 

Findings per age and sex. 

 There was a lack of effect found in studies both of men mostly in their 40s, somewhat older 

people of both sexes, and postmenopausal women. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y No effect was found in one trial of men mostly within this life stage after 6 

weeks. 

• 51 – 70 y The majority of people in the trials were within this life stage. No 

significant effect was found on weight from vitamin D supplementation for 1 or 3 years. 

• ≥71 y No data 

• Postmenopause All the women in the Finnish trial were postmenopausal. 

• Pregnant & lactating women Not reviewed 

58
59

Table 12. Vitamin D and weight: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake 

& Vitamin D 

Data 

Comparisons Compliance Comments 

• Health 

status 

All, postmenopause 

• Mean 

age 

(range), 

y 

53 (47-56) 

Heikkinen 

199749

Kuopio 

ORFPS 

Kuopio, 

Finland 

(63°N) 

[9405029] • Male 

(%) 

0 

nd Vit D3 & Ca 

lactate vs 

Placebo & Ca 

lactate 

nd 

• Health 

status 

Healthy 

overweight 

and obese 

• Mean 

age 

(range), 

y 

48 (21-70) 

Sneve 

200850

Tromsø, 

Norway 

(70°N) 

[19056900] 

• Male 

(%) 

36 

25(OH)D 

53.1±16.9 

nmol/L 

Ca intake 

940±398 mg/d 

Vit D3 40,000 IU 

per week vs 

Vit D3 20,000 IU 

per week vs 

Placebo 

All: Ca 

carbonate 500 

mg/d 

The compliance rate for 

cholecalciferol/placebo 

capsules were 95% in all 3 

groups, and for the calcium 

tablets 81-85% across all 3 

groups. 

• Health 

status 

Healthy, 

obese 

• Mean 

age 

(SD), y 

44 (8) 

Nagpal 

200951

New Delhi, 

India 

(28.5°N) 

[19125756] • Male 

(%) 

100% 

25(OH)D: 36.5 

nmol/L 

(treatment 

group), 30.0 

nmol/L (control 

group) 

Vit D3 120,000 

IU every 2 

weeks vs 

Placebo 

100% (implied); supervised 

home visits 

Excluded 

subjects who 

refused 

subsequent 

blood draws 
Table 13. Vitamin D and weight: Results of RCTs 

Author Year Study Name [PMID] 

Age 

Range, 

Sex 

(Subgp) 

Outcome 1°/2° Mean Followup Interventions, Daily Dose No. Analyzed Unit Baseline Change Change 95% CI 

Isocaloric Diet 

Vit D3 300 IU + Ca 

lactate 93 mg 83 kg 71.5 +1.84% +0.43%, +3.25% 

Heikkinen 199749

Kuopio ORFPS [9405029] 

47-56 y, 

Women Weight 2° 3 y 

Ca lactate 93 mg 95 67.6 +3.32% +1.73%, 4.91% 

Vit D3 40,000 IU weekly+ 

Ca carbonate 500 mg 116 kg 101.0 +0.1 -0.6, +0.8 

Vit D3 20,000 IU weekly + 

Ca carbonate 500 mg 106 98.6 +0.3 -0.3, +0.9 

Weight 1° 1 y 

Ca carbonate 500 mg 112 100.6 +0.5 -0.2, +1.2 

Vit D3 40,000 IU weekly + 

Ca carbonate 500 mg 116 BMI 35.0 0.0 -0.2, +0.2 

Vit D3 20,000 IU weekly + 

Ca carbonate 500 mg 106 34.4 +0.1 -0.1, +0.3 

Sneve 200850

[19056900] 

21-70 y, 

Both 

BMI 1° 1 y 

Ca carbonate 500 mg 112 35.1 +0.2 -0.1, +0.5 

Vit D3 120,000 IU every 

2 wk 35 kg nd +0.03 -0.6, +0.6 

Weight 2° 6 wk 

Placebo 36 nd -0.38 -0.9, +0.2 

Vit D3 120,000 IU every 

2 wk 35 BMI 26.7 -0.02 -0.2, +0.2 

Nagpal 200951

New Delhi, India [19125756] 

44 (8, 

SD) 

Men BMI 2° 6 wk 

Placebo 36 26.0 -0.04 -0.3, +0.2 

A Estimated from reported data B Per estimated 95% confidence interval, P=0.17

60
Vitamin D and Cancer 

Cancer from all causes and total cancer mortality. 

Synopsis. 

No qualified systematic reviews have evaluated relationships between vitamin D and total 

cancer incidence or mortality. One RCT showed no effect of combined vitamin D3 (1000 IU/d) 

and calcium (~1500 mg/d) supplementation versus calcium supplementation (~1500 mg/d) alone 

on the risk of total cancer in healthy postmenopausal women (>55 years old) living in Nebraska 

(latitude 41°N). Another RCT also found no difference in total cancer mortality or incidence 

between supplemental vitamin D3 (100,000 IU every 4 months) and placebo in elderly (71+ 

years old) men and women living in the United Kingdom (latitude 52° N). Both RCTs were rated 

B quality. 

Analyses using NHANES III data (general adult populations living in the US) showed no 

significant association between baseline 25(OH)D concentrations and total cancer mortality. 

Detailed presentation (Tables 14, 15, 16 & 17). 

A 4-year population-based RCT,52 sampled from a 9 county, largely rural area in eastern 

Nebraska (latitude 41°N), aimed to determine the efficacy of vitamin D3 (1000 IU/d) plus 

calcium (either calcium citrate 1400 mg/d or calcium carbonate 1500 mg/d) or calcium alone 

(either calcium citrate 1400 mg/d or calcium carbonate 1500 mg/d) compared to placebo in 

reducing fracture incident. Only the comparison between the combined vitamin D and calcium 

versus the calcium alone groups is discussed here. The other comparisons are described in the 

calcium and combined vitamin D and calcium sections. This study was rated methodological 

quality B. Incidence of cancer was a secondary outcome of this trial. A total of 1179 

postmenopausal women, aged more than 55 years old, were randomized. The mean 25(OH)D 

concentration at baseline was 72 nmol/L. The relative risk of developing cancer at the end of 

study was 0.76 (95 percent CI: 0.38, 1.55). On the hypothesis that cancers diagnosed early in the 

study would have been present, although unrecognized on entry, the analyses were restricted to 

women who were free of cancer at 1 year intervention. The relative risk of developing cancer at 

the end of study for the vitamin D3 plus calcium group changed to 0.55 (95 percentCI 0.24, 

1.28). 

Another 5-year RCT compared the effects of supplemental vitamin D3 (100,000 IU every 4 

months) with placebo on total cancer mortality and incidence in 2686 elderly participants with a 

mean age of 75 years in the United Kingdom (latitude 52° N).44 Total cancer mortality and 

incidence were evaluated as two of multiple secondary endpoints. The primary endpoint was the 

prevention of fracture. At 5 years vitamin D3 supplementation had no significant effect on the 

prevention of total cancer mortality (HR 0.86; 95 percent CI 0.61, 1.20) or incidence (HR 1.09; 

95 percent CI 0.86, 1.36). This trial was rated B because it did not report in sufficient detail the 

randomization method, and the outcome ascertainment was based on death certificates or selfreported data, not verified with another objective documents (e.g., medical records or pathology 

reports). 

Reported in two publications (one was rated B and one was rated C), there was no 

association between baseline 25(OH)D concentrations and total cancer mortality in the total 

NHANES III study population47,53 or in subgroup analyses by either season or latitude after a 

median 9 years of followup.53

61
Findings by age, sex and/or ethnicity. 

There were no differences in the total cancer mortality and incidence between men and 

women, reported in a 5-year RCT compared the effects of supplemental vitamin D3 (100,000 IU 

every 4 months) with placebo. In the NHANES III analysis, there was a suggestion of increased 

risk of total cancer mortality in men whose baseline 25(OH)D were in the two highest categories 

(80 to <100 nmol/L; ≥100 nmol/L) compared to the reference category (<50 nmol/L) [80 to <100 

nmol/L: RR = 1.21, 95 percent CI 0.83 to 1.78; ≥100 nmol/L: RR = 1.35; 95 percent CI 0.78 to 

2.31; P for trend=0.08]. However, this relationship was not seen in women (P for trend=0.12).53

When racial/ethnic groups were considered separately, there was also no association between 

baseline 25(OH)D concentrations and total cancer mortality in non-Hispanic whites (P for 

trend=0.80), non-Hispanic blacks (P for trend=0.14), or Mexican Americans (P for trend=0.37). 

Findings by life stage. 

• 0 – 6 mo No data 

• 7 mo – 2 y No data 

• 3 – 8 y No data 

• 9 – 18 y No data 

• 19 – 50 y Analyses using NAHANES III data showed no significant association 

between baseline 25(OH)D concentrations and total cancer mortality. NHANES III 

included participants mostly within this life stage. 

• 51 – 70 y A proportion of participants in NHANES III were in this life stage, but no 

unique conclusions are possible for this life stage separate from those for people 19 to 50 

years. 

• ≥71 y One RCT included elderly men and women mostly in this life stage. The 

trial found no difference in total cancer mortality or incidence between supplemental 

vitamin D3 (100,000 IU every 4 months) and placebo. 

• Postmenopause One RCT with healthy postmenopausal women showed no effect 

of vitamin D3 supplementation (1000 IU/d) on the risk of total cancer. 

• Pregnant & lactating women No Data 

62
63

Table 14. Vitamin D and total cancer: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake & 

Vitamin D Data 

Comparisons Compliance Comments 

• Health 

status 

Mentally and 

physically fit; 

postmenopause 

• Mean 

age (SD), 

y 

67 (7.3) 

Lappe 

200752

Nebraska, US 

(41o N) 

[17556697] 

• Male 

(%) 

0 

25(OH)D: 71.8 

nmol/L 

Vit D3 1000 IU/d + Ca 

(citrate 1400 mg/d or 

carbonate 1500 mg/d) 

vs. Ca (citrate 1400 

mg/d or carbonate 1500 

mg/d) vs. placebo 

nd 

• Health 

status 

General 

population 

• Mean 

age 

(range), y 

75 (65-85) 

Trivedi 200344

Oxford, UK 

(52°N) 

[12609940] 

• Male 

(%) 

76% 

25(OH)D: 53.4 

nmol/L 

Calcium intake= 

742 mg/d (at 4 

years, no 

difference by 

treatment 

allocation) 

Vit D3 100,000 IU vs 

placebo every 4 months 

Participants 

taking ≥80% of 

study 

medication: 

76%A

Previous CVD: 

28%, previous 

cancer: 6%, 

steroids user: 

5%, and HRT 

taker: 7% 

A

 No difference between the vitamin D and the placebo arm. 

Table 15. Vitamin D and total cancer: Characteristics of cohort studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Vitamin D 

Concentration Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Comments 

Cohort 

• Health 

status 

Any 

• Mean 

age 

(range), 

y 

44 

(≥17) 

• Assay 

method 

RIA 

(DiaSorin) 

Freedman 

200753

NHANES III 

US 

(various) 

[16481636] 

• Male 

(%) 

45 • Season 

blood 

drawn 

All 

Cancer 

mortality 

stratified by 

prespecified 

baseline 

25(OH)D cut 

points 

X X X X X X Final model 

includes sex, 

race/ethnicity, 

and smoking 

pattern. Other 

potential 

confounders 

were 

examined but 

not chosen. 

• Health 

status 

DM 

7.4%, 

history 

of 

CVD 

7.9%, 

HTN 

25% 

• Mean 

age 

(range), 

y 

45 

(≥20) 

• Assay 

method 

RIA 

(DiaSorin) 

Melamed 

200847

NHANES III 

US 

(various) 

[18695076] 

• Male 

(%) 

46 • Season 

blood 

drawn 

All 

Cancer 

mortality 

stratified by 

baseline 

25(OH)D 

quartiles 

X X X X X X 
Table 16. Vitamin D and total cancer: Results of RCTs 

Author Year Study Name Location (Latitude) [PMID] 

Life Stage Outcome 1°/2° Followup, y Interventions, Daily Dose n Event N Total Outcome Metric (Comparison) Result 

Vit D3 1000 IU + Ca 

(citrate 1400 mg or carbonate 1500 mg)

13 446 RR (Vit D+Ca 

vs Ca) 

0.76 

Lappe 200752

Nebraska, US (41o N) [17556697] 

Postmenopausal 

women 

Incident cancer (all 

causes) 

2° 4 

Ca (citrate 1400 mg or carbonate 1500 mg)

17 445 

Vit D3 1000 IU + Ca 

(citrate 1400 mg or carbonate 1500 mg)

8 403 RR (Vit D+Ca 

vs Ca) 

Post- 0.55 

menopausal 

women 

Incident cancer 

(restricted to subjects 

who were free of 

cancer at 1 y 

intervention) 

2° 4 

Ca (citrate 1400 mg or carbonate 1500 mg)

15 416 

Vit D3 100,000 IU 

every 4 mo (~833 IU/d) 

188 1345 HR (Vit D vs 

placebo) 

1.09 

Trivedi 2003 

44

[12609940] 

65-85 y, Both 

sexes 

Incident cancer (all 

causes) 

2° 5 

Placebo 173 1341 

Vit D3 100,000 IU 

every 4 mo (~833 IU/d) 

63 1345 HR (Vit D vs 

placebo) 

Total cancer mortality 2° 5 0.86 

Placebo 72 1341 

64
65

Table 17. Vitamin D and total cancer: Results of cohort studies Author Year Study Name [PMID] 

Life Stage Outcome (n/N; Incidence) Followup Duration (Time to Dx) 25(OH)D, nmol/L No. of Cases No. in Category Adjusted HR 95% 

Freedman 200753

NHANES III US [16481636] 

Adults, 

both sexes 

Cancer mortality 

(536/16818; 0.032) 105 mo <50 175 5744 1 Refer

50 to <62.5 103 3143 1.22 0.91, 62.5 to <80 117 3713 1.02 0.69, 

80 to <100 80 4218 (total, 

≥80 nmol/L) 

1.00 0.71, 

100 to <120 41 0.92 0.58, 

≥120 20 1.49 0.85, 

Adults, 

males 

Cancer mortality 

(318/7632; 0.042) 105 mo <50 88 1993 1 Refer

50 to <62.5 57 1461 1.03 0.73, 62.5 to <80 71 1845 0.99 0.57, 80 to <100 58 2333 (total, ≥80 nmol/L) 1.21 0.83, 

≥100 44 1.35 0.78, 

Adults, 

females 

Cancer mortality 

(218/9163; 0.024) 105 mo <50 87 3751 1 Refer

50 to <62.5 46 1682 1.40 0.94, 62.5 to <80 46 1845 1.02 0.62, 80 to <100 22 1885 (total, ≥80 nmol/L) 0.72 0.40, 

≥100 17 0.78 0.40, 

Melamed 200847

NHANES III US (various) [18695076] 

Adults, 

both sexes 

Cancer mortality 

(N=13331) 

Median 8.7 (IQR 

7.1-10.2) y >80 nd nd 1 Refer

61-80 nd nd 0.8 0.54, 44-60 nd nd 1.08 0.8, <44 nd nd 0.91 0.63, 

* Statistically significant (P<0.05) 
Prostate cancer. 

Synopsis. 

 No qualified systematic reviews have evaluated the association between serum vitamin D 

concentrations and incidence of prostate cancer. Eight nested case-control studies (2B, 6C) found 

no association between baseline serum 25(OH)D concentrations and the risk of prostate cancer. 

One study rated C found a significant association between lower baseline serum 25(OH)D 

concentrations (<30 compared to >55 nmol/L) and higher risk of prostate cancer (adjusted OR 

1.8, lowest compared to highest quartile). The same study found that the prostate cancer risk was 

increased in subjects less than 52 years at study entry and who had serum 25(OH)D 

concentration less than 40 nmol/L (adjusted OR 3.5). However, there was no difference in risk 

between low and high serum 25(OH)D concentration for those older than 51 years at study entry. 

A C study suggested an U-shaped association between baseline serum 25(OH)D concentrations 

and the risk of prostate cancer. 

Detailed presentation (Tables 18 & 19; Figure 7). 

 A total of 12 nested case-control studies in 14 publications reported on the association 

between baseline serum 25(OH)D concentrations and the risk of prostate cancer.53-66 The number 

of cases ranged from 61 to 749. The latitudes of the studies ranged from 21o N to 60o N. The 

mean age of the subjects ranged from 44 to 68 years. Baseline serum concentrations of 25(OH)D 

in these studies ranged from 12.8 to 194 nmol/L. The time between blood drawn and the 

diagnosis of prostate cancer varied from 2 to 16 years. The methodological quality of three 

studies was rated B and nine studies were rated C. 

19-50 years. 

 Two studies provided data on younger subjects. Ahonen et al. analyzed subjects from 40 to 

57 years of age.55 The study found that the prostate cancer risk was increased in subjects less 

than 52 years at study entry and had low serum 25(OH)D concentration (≤40 nmol/L) (adjusted 

OR 3.5, 95% CI 1.7, 7.0). The corresponding adjusted OR for those older than 51 years at study 

entry was 1.2 and was not significant. This study adjusted for factors related to insulin resistance 

syndrome but not those potentially related to prostate cancer. 

 Freedman et al. analyzed data from NHANES III and reported on subjects with a mean age 

of 44 years and found that the adjusted relative risk of mortality from prostate cancer was 0.91 

(95% CI 0.39, 2.14) in the group with baseline serum 25(OH)D concentration of at least 62.5 

nmol/L compared to the group with less than 62.5 nmol/L.53

51-70 years. 

 Ten studies reported data on subjects with a mean age ranged from 51 to 68 years. Eight 

studies did not find an association by trend analysis between baseline serum 25(OH)D 

concentrations and the risk of prostate cancer.54,56-63,66 One study found no association between 

baseline serum 25(OH)D concentrations and mortality from prostate cancer.58 One study found 

an association between lower baseline serum 25(OH)D concentrations (<30 compared to >55 

nmol/L) and the risk of prostate cancer (P for trend = 0.01).55 The adjusted OR of the lowest 

compared to highest quartile was 1.8. The study also found that the prostate cancer risk was 

increased in subjects less than 52 years at study entry and had low serum 25(OH)D concentration 

(≤40 nmol/L) (adjusted OR 3.5, 95 percent CI 1.7, 7.0). However, there was no difference in risk 

(adjusted OR 1.2, P=NS) between low (≤40 nmol/L) and high (>40 nmol/L) serum 25(OH)D 

66
concentration for those older than 51 years at study entry. This study did not adjust for factors 

potentially relevant to prostate cancer. One study reported an U-shaped association between 

baseline serum 25(OH)D concentrations and the risk of prostate cancer: the odds ratio in the 

group with 25(OH)D concentration of at least 80 nmol/L was 1.7 (95 percent CI 1.1, 2.4) 

compared to the group with a 25(OH)D concentration of 40-49 nmol/L; the odds ratio in the 

group with 25(OH)D concentration of no more than 19 nmol/L was 1.5 (95 percent CI 0.8, 2.7) 

compared to the group with a 25(OH)D concentration of 40 to 49 nmol/L.64 Even though this 

study used a conditional logistic regression in its analysis to maintain matching status, it was 

unclear if additional factors potentially relevant to prostate cancer were also entered into the 

regression analysis. 

1,25(OH)2D. 

 Five studies reported on the association between 1,25(OH)2D serum concentrations and the 

risk of prostate cancer. Four studies did not find an association.59,62,63,66 One study found that the 

risk of prostate cancer decreased with higher serum concentrations of 1,25(OH)2D in men with 

low serum concentrations of 25(OH)D (unadjusted OR 0.15, comparing 4th quartile of 

1,25(OH)2D (104-211 pmol/L) to 1st quartile (13-68 pmol/L) in men with serum 25(OH)D 

concentrations that ranged from 7.5-45 nmol/L).58 When stratified by age and race, this 

association was only found in men above the median age of 57 years at time of blood drawn but 

not in younger men; the association was similar in black and white men. 

Findings by life stage. 

• 0 – 6 mo not applicable 

• 7 mo – 2 y not applicable 

• 3 – 8 y not applicable

• 9 – 18 y not reviewed

• 19 – 50 y One study found that the prostate cancer risk was highest in subjects less 

than 52 years at study entry and had low serum 25(OH)D concentration (≤40 nmol/L) 

(adjusted OR 3.5, 95 percent CI 1.7, 7.0). Another study analyzed data from NHANES III 

and reported on subjects with a mean age of 44 years and found that the adjusted relative 

risk of mortality from prostate cancer was 0.91 (95 percent CI 0.39, 2.14) in the group 

with baseline serum 25(OH)D concentration of at least 62.5 nmol/L compared to the 

group with less than 62.5 nmol/L. 

• 51 – 70 y Eight studies did not find an association by P for trend analysis between 

baseline serum 25(OH)D concentrations and the risk of prostate cancer. One study found 

an inverse association of baseline serum 25(OH)D concentrations (<30 compared to >55 

nmol/L) and the risk of prostate cancer (adjusted OR 1.8, lowest compared to highest 

quartile, P for trend = 0.01). This study found that the prostate cancer risk was increased 

in subjects less than 52 years at study entry and had low serum 25(OH)D concentration 

(≤40 nmol/L) (adjusted OR 3.5, 95 percent CI 1.7, 7.0). However, there was no 

difference in risk (adjusted OR 1.2, P=NS) between low (≤40 nmol/L) and high (>40 

nmol/L) serum 25(OH)D concentration for those older than 51 years at study entry. One 

study reported an U-shaped association between baseline serum 25(OH)D concentrations 

and the risk of prostate cancer: the odds ratio in the group with 25(OH)D concentration of 

at least 80 nmol/L was 1.7 (95 percent CI 1.1, 2.4) compared to the group with a 

25(OH)D concentration of 40-49 nmol/L; the odds ratio in the group with 25(OH)D 

67
concentration of no more than 19 nmol/L was 1.5 (95 percent CI 0.8, 2.7) compared to 

the group with a 25(OH)D concentration of 40 to 49 nmol/L.

• ≥71 y No study specifically targeted men older than 70 years.

• Postmenopause Not applicable 

• Pregnant & lactating women Not applicable 

68
Table 18. Vitamin D and prostate cancer: Characteristics of nested case-control studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 25(OH)D Comparisons 

Nutrients Demographic Anthrop Medical UV exposure 

Comments 

Life styles 

Health 

status 

8% current 

smoker 

Mean age 

(range/SD), 

y 

67.8 (5.3) 

Assay RIA 

(Heartland) 

Ahn 

200854

PLCO 

US 

(21oN to 

44oN) 

[18505967] 

Male (%) 100 

Prostate 

cancer risk 

stratified by 

baseline 

25(OH)D 

quintiles 

X X X X 

Season 

blood 

drawn 

nd 

Health 

status 

Smoked 

18%; DM 

3.6% 

Mean age 

(range/SD), 

y 

66 (7) 

Platz 2004 Assay RIA 63

Mikhak 

200761

HPFS 

US 

(multiple 

latitudes) 

[15090720] 

[17440943] 

Male (%) 100 

Prostate 

cancer risk 

stratified by 

baseline 

25(OH)D 

quartiles 

X X X X X X 6% 

nonwhite 

Season 

blood 

drawn 

nd 

Health 

status 

28% 

current 

smoker 

Prostate 

cancer 

mortality 

stratified by 2 

baseline 

25(OH)D 

categories 

X X X X X X 71% white; 

14% black; 

6% 

Mean age Hispanics 

(range/SD), 

y 

44 

Freedman Assay RIA 

200753

NHANES III 

US (multiple 

latitudes) 

[17971526] 

Male (%) 100 Season 

blood 

drawn 

South: Nov 

to Mar; 

North: Apr 

to Oct 

Health 

status 

Gemfibrozil 

vs. placebo 

subjects 

Mean age 

(range/SD), 

y 

<40 to >60 

Assay RIA 

(Incstar) 

Tuohimaa 

200464

Helsinki 

Heart 

Vasterbotten; 

Janus 

Project; 

Finland 

(60°N) 

[14618623] 

Male (%) 100 

Prostate 

cancer risk 

stratified by 5 

baseline 

25(OH)D 

categories 

X X 

Season 

blood 

drawn 

nd 

Health 

status 

on ASA, βcarotene, 

placebo 

trial; 9% 

current 

smoker 

Mean age 

(range/SD), 

y 

58.9 (8.3) 

Assay RIA (Bruce 

Hollis) 

Li 200760

Gann 199666

PHS 

US 

(multiple 

latitudes) 

[17388667] 

[8850273] 

Male (%) 100 

Prostate 

cancer risk 

stratified by 

baseline 

25(OH)D 

quartiles 

X X 94% white 

Season 

blood 

drawn 

24% spring 

or winter 

Assay Competitive 

proteinbinding 

(Haddad, 

1971) 

Prostate 

cancer risk 

compared by 

baseline 

25(OH)D 

Health X X 

status 

Corder nd 

199358

San 

Francisco 

US 

Mean age 

(range/SD), 

y 

57 (38-81) 

50% black; 

50% white 

69
Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 25(OH)D Comparisons 

Nutrients Demographic UV exposure 

Comments 

Anthrop Medical Life styles 

(37oN) 

[8220092] 

Male (%) 100 Season 

blood 

drawn 

nd 

continued 

Health 

status 

Gemfibrozil 

vs. placebo 

subjects 

Mean age 

(range/SD), 

y 

40-57 

Assay RIA 

(Incstar) 

Ahonen 

200055

Helsinki 

Heart 

Finland 

(60°N) 

[11075874] Male (%) 100 

Prostate 

cancer risk 

stratified by 

baseline 

25(OH)D 

quartiles 

X X X X X 

Season 

blood 

drawn 

Jan-Feb; 

Mar-May; 

Sep 

Health 

status 

64% 

smoked 

Mean age 

(range/SD), 

y 

58 (49-70) 

Assay Proteinbinding Nomura 

199862

Honolulu 

Heart 

US 

(21oN) 

[9794175] 

Male (%) 100 

Prostate 

cancer risk 

stratified by 

baseline 

25(OH)D 

quartiles 

X X X 100% 

Japanese 

Americans 

Season 

blood 

drawn 

nd 

Health 

status 

Gemfibrozil 

vs. placebo 

subjects 

Prostate 

cancer risk 

stratified by 3 

baseline 

25(OH)D 

categories 

X X X 

Mean age 

(range/SD), 

y 

51 (3.7) 

Assay RIA 

(Incstar) 

Tuohimaa 

200765

Helsinki 

Heart 

Finland 

(60°N) 

17301263 Male (%) 100 Season 

blood 

drawn 

Most in 

winter 

Health 

status 

Selenium 

vs. placebo 

subjectsA

Prostate 

cancer risk 

stratified by 

baseline 

25(OH)D 

tertiles 

X X X X X 

Mean age 

(range/SD), 

y 

68 (nd) 

Jacobs Assay RIA 

200459

NPC 

Eastern US 

(25o46’N to 

41oN) 

[15225833] Male (%) 100 Season 

blood 

drawn 

nd 

Health 

status 

nd 

Mean age 

(range/SD), 

y 

<45-75+ 

Assay RIA (Bruce 

Hollis, 

1993) 

Braun 

199557

WCC, MD 

US 

(39°N) 

[7612803] Male (%) 100 

Prostate 

cancer risk 

stratified by 

baseline 

25(OH)D 

quintiles 

X 100% 

white 

Season 

blood 

drawn 

Aug 

through 

Nov 

Health 

status 

had >1 

colon 

adenoma 

removal 

Mean age 

(range/SD), 

y 

62 (8.7) 

Assay Competitive 

proteinbinding 

(Quest) 

Baron 

200556

CPP 

US 

(multiple 

latitudes) 

[15767334]B

Male (%) 100 

Prostate 

cancer risk 

stratified by 

baseline 

25(OH)D 

tertiles 

X X X 5% black 

Season 

blood 

drawn 

nd 

continued 

70
71

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 25(OH)D Comparisons 

Nutrients Demographic Anthrop Medical UV exposure 

Comments 

Life styles 

Health 

status 

nd 

Mean age 

(range/SD), 

y 

<45-75+ 

Assay RIA (Bruce 

Hollis, 

1993) 

Braun 

199557

WCC, MD 

US 

(39°N) 

[7612803] Male (%) 100 Season 

blood 

drawn 

Aug 

through 

Nov 

Prostate 

cancer risk 

stratified by 

baseline 

25(OH)D 

quintiles 

X 100% 

white 

Health 

status 

had >1 

colon 

adenoma 

removal 

Mean age 

(range/SD), 

y 

62 (8.7) 

Assay Competitive 

proteinbinding 

(Quest) 

Baron 

200556

CPP 

US 

(multiple 

latitudes) 

[15767334]B

Male (%) 100 Season 

blood 

drawn 

nd 

Prostate 

cancer risk 

stratified by 

baseline 

25(OH)D 

tertiles 

X X X 5% black 

A

 For prevention of recurrence of non-melanoma skin cancer B

 This is a cohort study, not a nested case-control study. 
Table 19. Vitamin D and prostate cancer: Results of nested case-control studies 

Author Year Study Name PMID 

Life Stage (male), y 

Outcome (no. of cases; no. of control) 

Time to diagnosis, y 

25(OH)D concentration, nmol/L 

No. of cases 

No. of control 

Adjusted OR 95% 

51-70 Prostate cancer (741; 781) 2-8 12.8-42.5 119 157 1 Refe

42.5-51. 125 156 1.10 0.7851.4-60.5 190 157 1.53 1.1060.6-71.7 167 156 1.33 0.95

Ahn 200854

PLCO [8505967] 

71.8-129.5 148 155 1.18 0.83

51-70 Prostate cancer (460; 460) 2.2 (mean) Quartile 1A 109 114 1 Refe

Quartile 2 115 113 1.00 0.67Quartile 3 94 120 0.77 0.51

Platz 200463

Mikhak 200761

HPFS [15090720] [17440943] Quartile 4 142 113 1.19 0.79

19-50 Mortality prostate 

cancer 

nd <62.5 22 nd 1 Refe

Freedman 200753

NHANES III [17971526] ≥62.5 25 nd 0.91 0.39

19-50 51-70 

Prostate cancer (622; 1451) ≤9 ->14 (range) ≤19 19 nd 1.5 0.8, 

20-39 169 nd 

Tuohimaa 200464

Helsinki Heart [14618623] 1.3 0.98

40-59 229 nd 1 Refe60-79 138 nd 1.2 0.9, 

≥80 67 nd 1.7 1.1, 

19-50 51-70 

Prostate cancer (492; 664) 11 (median) Quartile 1B nd nd 1.01 0.71

Quartile 2 nd nd 1.26 0.89Quartile 3 nd nd 1.00 0.71

Li 200760

PHS [17388667] 

Quartile 4 nd nd 

1 Refe

19-50 51-70 

Prostate cancer (232; 414) 6 (mean) 15.7-53.3 nd nd 1.00 nd 

53.4-70.9 nd nd 1.10 nd 71-93.5 nd nd 1.16 nd 93.6-194 nd nd 0.92 0.56

Prostate cancer; age ≤61 y 15.7-53.3 nd nd 1.00 nd 

53.4-70.9 nd nd 1.19 nd 71-93.5 nd nd 1.75 nd 93.6-194 nd nd 1.48 0.73

Prostate cancer; age >61 y 15.7-53.3 nd nd 1.00 nd 

53.4-70.9 nd nd 1.00 nd 71-93.5 nd nd 0.82 nd 

Gann 199666

PHS [8850273] 

93.6-194 nd nd 

0.76 0.39

continued 

72
Author Year 

Study Name PMID 

Life Stage (male), y 

Outcome (no. of cases; no. of control) 

Time to diagnosis, y 

25(OH)D concentration, nmol/L 

No. of cases 

No. of control 

Adjusted OR 95% 

19-50 51-70 

Prostate cancer (181; 181) >5 (mode) 60.0 (case) vs. 50.5 (control) (est.) 181 181 - - Corder 

199358

[8220092] Mortality prostate 

cancer 

nd 51 nd - - 

19-50 51-70

Prostate cancer (149; 566) 8-14 (mode) < 30C 48 131 1.8 1.0, 

31-40 41 143 1.4 0.8, 41-54 26 148 0.8 0.5, 

> 55 34 144 1 Refe

Prostate cancer in those <52 years old at entry 

≤40 nd nd 3.5 1.7, >40 nd nd 1 

Prostate cancer in those >51 years old at entry 

≤40 nd nd 1.2 0.7, 

Ahonen 200055

Helsinki Heart[11075874] 

>40 nd nd 1 

19-50 51-70 

Prostate cancer (136; 136) 16 (mean) <85D 38 34 1 Refe

85-101 35 36 0.8 0.4, 102-119 30 32 0.8 0.4, 

Nomura 199862

Honolulu Heart [9794175] 

≥120 33 34 

0.8 0.4, 

19-50 51-70 

Prostate cancer (132; 456) 10.8 (mean) <40 - - 1.88 1.15

40-59 - - 1 Refe

Tuohimaa 200765

Helsinki Heart [17301263] 

≥60 - - 1.25 0.64

51-70 Prostate cancer (83; 166) 5.1 (mean) 20-63.3 26 58 1 Refe

63.4-81.9 33 49 

1.71 0.68

Jacobs 200459

NPC [15225833] 82-149 24 59 0.75 0.29

19-50 51-70 

Prostate cancer (61; 122) 14 (mean) <60.1 7 24 1 Refe

60.1-73.8 17 25 2.3 0.7, 73.9-88.5 16 24 2.3 0.7, 88.6-103 4 25 0.6 0.1, 

Braun 199557

WCC [7612803] 

>103 17 24 

2.4E 0.8, 

19-50 51-70 

Prostate cancer (70 cases in a total of 672)F

<4 (34%) <62.9 nd NA 1 Refe

62.9-84.9 nd NA 1.22 0.66

Baron 200556

CPP [15767334]F

85 nd NA 

0.32 0.72

*Statistically significant (P<0.05) 

73
74

A Cut points separated by analytical run; season, distributions among control (see Table 3 in original study) B Cut points based on control standardized by season of collection C Cut points based on total original cohort D Cut points based on control frequency E Unadjusted F This is a cohort study, not a nested case-control study 
Figure 7. Prostate cancer risk stratified by vitamin D concentration 

75
Colorectal cancer. 

Synopsis. 

No qualified systematic reviews have evaluated the association between 25(OH)D 

concentrations and colorectal cancer mortality or incidence. One B quality RCT of elderly 

population reported no significant difference in colorectal cancer mortality or incidence between 

supplemental vitamin D3 and no supplements. One B quality cohort study found an inverse 

association between higher 25(OH)D concentrations and the risk of colorectal cancer mortality 

(HR 0.28, highest compared to lowest tertile). Two B quality nested case-control studies of 

women found a trend between higher 25(OH)D serum concentrations and lower risk of 

colorectal cancer incidence (trend analysis). Another two B quality nested case-control studies of 

men, and one B quality and two C quality nested case-control studies of both sexes reported no 

significant association between 25(OH)D concentrations and risk of colorectal cancer or colon 

cancer. 

Detailed presentation of supplemental vitamin D and colorectal caner (Tables 20 & 21). 

An RCT compared supplemental vitamin D3 (100,000 IU every 4 months) with placebo in 

2686 elderly participants with a mean age of 75 years in the United Kingdom (latitude 52° N). 44

Colorectal cancer mortality and incidence were evaluated as two of multiple secondary 

endpoints. The primary endpoint was the prevention of fracture. At 5 years vitamin D3

supplementation had no significant effect on the prevention of colorectal cancer mortality 

(P=0.33) or incidence (P=0.94). This trial was rated B because it did not report in sufficient 

detail the randomization method, and the outcome ascertainment was based on death certificates 

or self-reported data, not verified with another objective documents (e.g., medical records or 

pathology reports). 

Findings per age and sex. 

The same British trial reported no significant difference in colorectal cancer mortality or 

incidence between the vitamin D supplements group and the placebo at 5 years in men (P=0.96 

and 0.59, respectively). In women, the trial also found no significant difference in colorectal 

cancer incidence between the two groups (P=0.32), whereas the risk of colorectal cancer 

mortality in the supplements group was significantly decreased compared to the placebo (0/326 

deaths vs. 4/323 deaths; HR, not reported; P=0.04). 

Findings per special populations. 

No subgroup data were available regarding special populations (e.g., obese participants, 

smokers, ethnic groups, or users of contraceptives). 

76
77

Table 20. Vitamin D and colorectal cancer: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background Calcium 

Intake & Vitamin D 

Data 

Comparisons Compliance Comments 

• Health 

status 

General 

population 

• Mean 

age 

(range), y 

75 (65-85) 

Trivedi 

200344

Oxford, UK 

(52°N) 

[12609940] 

• Male 

(%) 

76% 

25(OH)D: 53.4 nmol/L 

Calcium intake= 742 

mg/day (at 4 years, no 

difference by 

treatment allocation) 

Vit D3 100,000 IU vs 

placebo every 4 

months 

Participants 

taking ≥80% 

of study 

medication: 

76%A

Previous CVD: 28%, 

previous cancer: 6%, 

steroids user: 5%, 

and HRT taker: 7% 

CVD = cardiovascular disease; HRT = hormone replacement therapy. 

A

 No difference between the vitamin D and the placebo arm. 
Table 21. Vitamin D and colorectal cancer: Results of RCTs 

Author Year Study Name [PMID] 

Age 

Range, 

Sex 

(Subgp) 

Outcome 1°/2° Mean Followup Interventions, Daily Dose n Event N Total Outcome Metric (Comparison) Result 95

Vit D3 100,000 IU 

every 4 mo 7 1345 Age adj HR (Vit D/Placebo) 0.62 0.24

65-85 y, Both sexes 

CRC, mortality 2° 

Placebo 11 1341 

Vit D3 28 1345 Age adj HR (Vit D/Placebo) 1.02 0.60

CRC, incidence 2° 

5 y 

Placebo 27 1341 

Vit D3 7 1019 Age adj HR (Vit D/Placebo) 0.97 65-85 y, Men 0.34

CRC, mortality 2° 

Placebo 7 1018 

Vit D3 25 1019 Age adj HR (Vit D/Placebo) 1.18 0.65

CRC, incidence 2° 

5 y 

Placebo 21 1018 

Vit D3 0 326 Age adj HR (Vit D/Placebo) NA 

Trivedi 200344

[12609940] 

65-85 y, 

Women 

CRC, 

mortality 

2° 

Placebo 4 323 

N

Vit D3 3 326 Age adj HR (Vit D/Placebo) 2° 0.49 0.12

5 y 

Placebo 6 323 

CRC, 

incidence 

78
Detailed presentation of 25(OH)D concentrations and colorectal cancer (Tables 22 & 23; 

Figures 8, 9, & 10). 

A total of seven nested case-control studies evaluated the associations between 25(OH)D 

concentrations and risk of colorectal cancer67-71 or colon cancer.72,73 The number of pairs of cases 

and controls in these studies ranged from 101 to 588. Another cohort study comprising 16,818 

adult community volunteers from the NHANES III53 assessed the association between 25(OH)D 

concentrations and colorectal cancer mortality. The mean age of the subjects ranged from 44 to 

66 years. Locations of the studies ranged from 20° N to 60° N. Baseline 25(OH)D concentrations 

ranged from 10 nmol/L to 227.5 nmol/L. No studies reported followup 25(OH)D concentrations. 

Time between blood drawn and the diagnosis of colorectal cancer incidence or mortality ranged 

from less than 1 year to 17 years. None of the studies reported power calculations. 

Methodological quality of five nested case-control studies67-71 were rated B and two were rated 

C.72,73 Common reasons for downgrading the quality ratings included exclusion of participants 

without available blood samples, no verification of cancer diagnosis, and lack of adequate 

statistical adjustments. The cohort study53 was rated B because it was unclear whether cases were 

verified and there was no statistical adjustment for family history. 

Findings per age and sex. 

The NHANES III53 analyzed data for both sexes combined. An adjusted analysis found an 

inverse association between 25(OH)D concentrations and the risk of colorectal cancer mortality 

(HR: 0.28, highest [≥80 nmol/L] compared to lowest tertile [<50 nmol/L]; P for trend = 0.02). 

Two studies from WCC reported colon cancer incidence for both sexes combined.72,73 One study 

reported a significantly lower 25(OH)D concentrations in colon cancer cases than controls (58.9 

nmol/L vs. 86.6 nmol/L; P<0.001).73 Both studies reported no significant association between 

25(OH)D concentrations and colon cancer risk by trend analysis. 

Three studies, from the Japan PHC, HPFS, and ATBC respectively, provided data on adult 

men.67-69 None of the studies found an association between 25(OH)D concentrations and 

colorectal cancer risk. Although all three studies provided data on colon cancer and rectal cancer 

as subgroup analysis, only HPFS reported a significant trend between higher 25(OH)D 

concentrations and lower risk of colon cancer (OR 0.46, highest [median 97.0 nmol/L] compared 

to lowest quartile [median 48.3 nmol/L]; P for trend = 0.005).69 The HPFS also reported a 

subgroup analysis on men aged 65 years or older.69 No significant association was reported 

between 25(OH)D concentrations and colorectal cancer risk by trend analysis. 

The Japan PHC and HPFS compared 25(OH)D concentrations between colorectal cancer 

cases and controls.68,69 Neither reported a significant difference. One study explored subgroup 

analyses. Only the rectal cancer cases had significantly lower 25(OH)D concentrations compared 

to the controls (55 nmol/L for cases vs. 110 nmol/L for controls; P = 0.005).68 

Two nested case-control studies from the NHS and Japan PHC provided data on adult 

women.68,70 The NHS reported a trend between higher 25(OH)D concentrations and lower 

colorectal cancer risk (OR 0.53, highest [median 99.1 nmol/L] compared to lowest quintile 

[median 40.2 nmol/L]; P for trend = 0.02).70 This trend remained significant in a subgroup 

analysis of women age 60 years or older (OR 0.35 between the highest quintiles [median 99.1 

nmol/L] and lowest [median 40.2 nmol/L]; P for trend = 0.006) or in rectal cancer alone (OR 

0.31, highest [median 92.4 nmol/L] compared to lowest tertile [median 44.4 nmol/L]; P for trend 

= 0.03).70 The WHI focused on postmenopausal women.71 A significant trend was reported 

79
between higher 25(OH)D concentrations and lower colorectal cancer risk (OR 2.53, between 

highest [≥58.4 nmol/L] and lowest quintiles [<31.0 nmol/L]; P for Trend = 0.02). 

The Japan PHC compared 25(OH)D concentrations between cases and controls; no 

significant difference was reported.68 

Findings per special populations. 

No subgroup data were available regarding the association between 25(OH)D concentrations 

and colorectal cancer risk in obese persons. One study exclusively included male smokers aged 

between 50 and 69 years,67 and reported no significant association between 25(OH)D 

concentrations and colorectal cancer risk by trend analysis. Another study that exclusively 

included white population also found no association.72 In addition, another study that focused on 

women who were taking hormone replacement therapy reported no significant association 

between 25(OH)D and colorectal cancer.70

Findings excluding early cases. 

Three studies performed sensitivity analyses on the association between 25(OH)D 

concentrations and colorectal cancer risk by excluding cases diagnosed within the first 1 to 2 

years after blood draw.67,69,70 One study found a significant association between higher 25(OH)D 

concentrations and lower colon cancer risk (OR 0.3, between highest [>48.2 nmol/L] and lowest 

quartiles [≤ 24.5 nmol/L]; P for Trend = 0.04), which was not significant in main analysis.67

Otherwise, the results were not materially different from the main analysis.

Findings on 1,25-Dihydroxyvitamin D. 

A total of three studies evaluated the associations between 1,25(OH)2D concentrations and 

colorectal cancer risk 67,70 or colon cancer.73 None of the studies found a significant association 

by trend analysis. One study reported no significant association between 1,25(OH)2D 

concentrations and rectal cancer risk.67 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y The analysis of the NHANES III with a mean age of 44 years included 

participants mostly within this life stage. The study found an inverse association between 

25(OH)D and colorectal cancer mortality. 

• 51 – 70 y The seven nested case-control studies included people with a mean age 

ranged from 55 to 66 years. A trend between higher 25(OH)D concentrations and lower 

colorectal cancer risk was found in two studies of women. Out of five studies that 

separately assessed the risk of colon cancer and rectal cancer, only one study of men and 

another study of women found trends between higher 25(OH)D concentrations and lower 

risks of colon cancer and rectal cancer, respectively. Otherwise, no association was found 

between 25(OH)D concentrations and cancer risk. 

• ≥71 y One RCT with a mean age of 75 included participants mostly within this 

life stage. The trial found no difference in colorectal cancer mortality or incidence 

between supplemental vitamin D and no supplements. 

80
• Postmenopause One study and a subgroup analysis in another study focused on 

postmenopausal women. A trend between higher 25(OH)D concentrations and lower 

colorectal cancer risk was found in these two studies. 

• Pregnant & lactating women Not reviewed 

81
Table 22. Vitamin D and colorectal cancer: Characteristics of observational studiesA

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Vitamin D 

Concentration Comparisons 

Nutrients Demograph Anthrop Medical UV exposure 

Comments 

Lifestyle 

Cohort 

• Health 

status 

Any Colorectal 

cancer 

mortality 

stratified by 

prespecified 

baseline 

25(OH)D cut 

points 

X X X X X X White: 71%; 

Black: 14%; 

Hispanic: 

6%; Others: 

9% 

• Mean 44 (≥17) 

age 

(range), 

y 

• Assay 

method 

RIA 

(DiaSorin) 

Freedman 

200753

NHANES III 

US 

(various) 

[16481636] 

• Male 

(%) 

45 • Season All 

blood 

drawn 

Nested 

casecontrol 

• Health 

status 

Any • 25(OH)D 

levels 

between 

cases and 

controls 

• Colon cancer 

risk stratified 

by baseline 

25(OH)D 

quintiles 

X X 

• Mean 55 (nd) 

age 

(range), 

y 

• Assay 

method 

RIA 

(Horris 

1993) 

Braun 

199573

WCC 

Maryland, 

US (38°N) 

[329893]

• Male 

(%) 

Nd • Season Fall 

blood 

drawn 

• Health 

status 

Any Colorectal 

cancer risk 

stratified by 

baseline 

25(OH)D 

quintiles 

X X X X X X Aspirin user 

(>10 y): 

10%; 

Hormone 

replacement 

therapy: 

34% 

• Mean 60 (43-70) 

age 

(range), 

y 

• Assay 

method 

RIA 

(Horris 

1997) 

Feskanich 

200470

NHS 

US 

(various) 

[15342452] 

• Male 

(%) 

0 • Season All 

blood 

drawn 

• Health 

status 

Any • 25(OH)D 

levels 

between 

cases and 

controls 

• Colon cancer 

risk stratified 

by baseline 

25(OH)D 

quintiles 

X X White: 

100% 

• Mean 63 (nd) 

age 

(range), 

y 

• Assay 

method 

HPLA 

(Clemens 

1982) 

Garland 

198972

WCC 

Maryland, 

US 

(38°N) 

[2572900] • Male 

(%) 

50 • Season Fall 

blood 

drawn 

• Health 

status 

Any 

• Mean 

age 

(range), 

y 

Men: 57 

(40-69); 

Women: 56 

(40-69) 

• Assay 

method 

CPBA 

(Haddad 

1971) 

Otani 200768

Japan PHC 

Japan 

(various) 

[17622244] 

• Male 

(%) 

• 25(OH)D 

levels 

between 

cases and 

controls 

• Colorectal 

cancer risk 

stratified by 

baseline 

25(OH)D 

quartiles 

X X X X X X 

• Season All 

blood 

drawn 

continued 

82
83

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Vitamin D 

Concentration Comparisons 

Nutrients Demograph Anthrop Medical UV exposure 

Comments 

Lifestyle 

• Health 

status 

SmokerB

• Mean 

age 

(range), 

y 

60 (50-69) 

• Assay 

method 

RIA 

(Horris 

1993) 

Tangrea 

199767 

ATBC 

Finland 

(~60°N) 

[9242478] 

• Male 

(%) 

100 • Season 

blood 

drawn 

All 

Colorectal 

cancer risk 

stratified by 

baseline 

25(OH)D 

quartiles 

X X X X X 

• Health 

status 

Postmenopausal 

womenC

• Mean 

age 

(range), 

y 

Nd (50-79) 

• Assay 

method 

RIA 

(DiaSorin) 

WactawskiWende 

200671

WHI 

US 

(various) 

[16481636] 

• Male 

(%) 

0 • Season 

blood 

drawn 

All 

Colorectal 

cancer risk 

stratified by 

baseline 

25(OH)D 

quartiles 

X X X X White: 83%; 

Black: 9%; 

Hispanic: 

4% Others: 

4% 

• Health 

status 

Smoker 5% 

• Mean 

age 

(range), 

y 

66 (nd) 

• Assay 

method 

RIA 

(Horris 

1997) 

Wu 200769 

HPFS 

US 

(various) 

[17623801] 

• Male 

(%) 

100 • Season 

blood 

drawn 

All 

• 25(OH)D 

levels 

between 

cases and 

controls 

• Colorectal 

cancer risk 

stratified by 

baseline 

25(OH)D 

quintiles 

X X X X X X Aspirin user 

in 1994: 

40%; 

Current 

smoker: 5% 

A

 This table is ordered alphabetically by study author. 

B

 Participants of a lung cancer prevention 2 by 2 RCT of alpha-tocopherol and beta-carotene. C

 Participants of a hip fracture prevention RCT of vitamin D3 and calcium 
Table 23. Vitamin D and colorectal cancer: Results of observational studies 

Author Year Study Name [PMID] 

Life Stage Outcome 

(n/N; Incidence) 

Followup 

Duration 

(Time to 

Dx) 

25(OH)D 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95

Cohort study Colorectal cancer mortality

Women 

Freedman 200753

[17971526] 

19-50A

51-70 

≥71 

Colorectal Cancer 

Mortality 

(66/16818; 0.004) 

nd <50 28 ~5606 1 Refe

50-80 24 ~5606 0.44 0.20

≥80 14 ~5606 0.28 0.11

Nested case-control studyColorectal cancer

Men 

Otani 200768

Japan PHC [17622244] 

19-50 

51-70A

Colorectal cancer 

(N=196 cases; 392 

controls) 

1-13 <57.2 43 74 1 Refe

57.2-69.0 40 85 0.76 0.469.0-80.2 36 85 0.76 0.3

≥80.2 44 80 0.73 0.3

Wu 200769

HPFS [17623801] 

19-50 

51-70A

≥71 

Colorectal cancer 

(179 cases; 356 

controls) 

1-9 46, median 45 71 1 Refe

62.5 44 71 0.97 0.5572.8 30 68 0.66 0.3583.3 23 74 0.51 0.2798.5 37 72 0.83 0.45

19-50 

51-70A

Colorectal cancer, 

age <65 

48.2, median 25 34 1 Refe

66.8 15 28 1.03 0.3680.0 9 30 0.38 0.1297.0 14 36 0.45 0.15

51-70A

≥71 

Colorectal cancer, 

age ≥65 

48.2, median 34 55 1 Refe

66.8 36 61 0.97 0.5080.0 19 58 0.56 0.2797.0 27 54 0.83 0.39

Tangrea 199767

ATBC [9242478] 

19-50 

51-70A

Colorectal cancer 

(146 cases; 292 

controls) 

1-8 ≤24.5 46 72 1 Refe

24.5-34.7 35 73 0.7 0.434.7-48.2 36 73 0.8 0.4

>48.2 29 72 0.6 0.3

continued 
Author Year 

Study Name [PMID] 

Life Stage Outcome 

(n/N; Incidence) 

Followup 

Duration 

(Time to 

Dx) 

25(OH)D 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95

Women 

Wactawski-Wende 200671

WHI [16481636] 

Postmenopausal 

women 

Colorectal cancer 

(306 cases; 306 

controls) 

1-12 <31.0 88 67 2.53 1.49

31.0-42.3 80 73 1.96 1.1842.4-58.3 78 73 1.95 1.18

≥58.4 60 93 1 Refe

Feskanich 200470

NHS [15342452] 

19-50 

51-70A

Colorectal cancer 

(192 cases; 384 

controls) 

1-11 40.2, median 53 77 1 Refe

55.1 47 79 0.93 0.5366.7 35 75 0.79 0.4477.5 29 77 0.58 0.3199.1 29 75 0.53 0.27

Otani 200768

Japan PHC [17622244] 

19-50 

51-70A

Colorectal cancer 

(179 cases; 358 

controls) 

1-13 <57.2 41 77 1 Refe

57.2-69.0 34 73 1.0 0.569.0-80.2 44 71 1.2 0.6

≥80.2 41 76 1.1 0.5

Colon cancer 

Both sexes 

Braun 199573

WCC [329893] 

19-50 

51-70A

≥71 

Colon cancer (57 

cases; 114 

controls) 

1-17 <43 nd nd 1 Refe

43.0-51.5 nd nd 0.3 0.151.5-61.8 nd nd 0.5 0.261.8-75.3 nd nd 0.7 0.2

≥75.3 nd nd 0.4 0.1

Garland 198972

WCC [2572900] 

19-50 

51-70A

≥71 

Colon cancer (34 

cases; 67 controls) 

1-9 10 to <50 9 8 1 Refe

50.0-67.5 7 13 0.48 0.1367.5-82.5 5 18 0.25 0.06

82.5-105 4 17 0.21 0.05

105-227.5 9 11 0.73 0.20

Men 

Otani 200768

Japan PHC [17622244] 

19-50 

51-70A Colon cancer (141 cases; 282 

controls) 

1-13 <57.2 25 54 1 Refe

57.2-69.0 27 55 0.98 0.469.0-80.2 29 66 1.0 0.4

≥80.2 38 62 1.2 0.5

continued 

85
Author Year 

Study Name [PMID] 

Life Stage Outcome 

(n/N; Incidence) 

Followup 

Duration 

25(OH)D 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95

(Time to 

Dx) 

Wu 200769

HPFS [17623801] 

19-50 

51-70A

≥71 

Colon cancer (139 

cases; 276 

controls) 

1-9 48.3, median 49 66 1 Refe

66.8 44 68 0.74 0.4280.0 17 68 0.29 0.1497.0 29 74 0.46 0.24

Tangrea 199767

ATBC [9242478] 

19-50 

51-70A

Colon cancer (91 

cases; 182 

controls) 

1-8 ≤24.5 30 47 1 Refe

24.5-34.7 18 47 0.6 0.334.7-48.2 22 45 0.8 0.4

>48.2 21 42 0.8 0.4

Women 

Feskanich 200470

NHS 

19-50 

[15342452] 

51-70A Colon cancer (148 cases; 296 

controls) 

1-11 41.2, median 41.2 75 1 Refe

59.7 59.7 71 1.03 0.56

73.3 73.3 77 0.54 0.28

98.1 98.1 72 0.70 0.35

Otani 200768

Japan PHC [17622244] 

19-50 

51-70A

Colon cancer (115 

cases; 230 

controls) 

1-13 <57.2 21 53 1 Refe

57.2-69.0 27 48 1.7 0.769.0-80.2 27 41 2.1 0.9

≥80.2 31 53 2.1 0.7

Rectal cancer 

Men 

Otani 200768

Japan PHC [17622244] 

19-50 

51-70A Rectal cancer (55 cases; 110 

controls) 

1-13 <57.2 18 20 1 Refe

57.2-69.0 13 30 0.17 0.069.0-80.2 7 19 0.25 0.0

≥80.2 6 18 0.075 0.00

Tangrea 199767

ATBC [9242478] 

19-50 

51-70A

Rectal cancer (55 

cases; 110 

controls) 

1-8 ≤24.5 16 25 1 Refe

24.5-34.7 17 26 0.9 0.4

34.7-48.2 14 28 0.8 0.3

>48.2 8 30 0.4 0.1

continued 

86
87

Author Year Study Name [PMID] 

Life Stage Outcome 

(n/N; Incidence) 

Followup 

Duration 

(Time to 

Dx) 

25(OH)D 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95

Wu 200769

HPFS [17623801] 

19-50 

51-70A

≥71 

Rectal cancer (40 

cases; 80 controls) 

1-9 53.0, median 11 30 1 Refe

73.3 15 28 1.74 0.6193.5 14 22 3.32 0.87

Women 

Otani 200768

Japan PHC [17622244] 

19-50 

51-70A

Rectal cancer (64 

cases; 128 

controls) 

1-13 <57.2 20 24 1 Refe

57.2-69.0 7 25 0.26 0.0

69.0-80.2 17 30 0.46 0.1

≥80.2 10 23 0.33 0.0

Feskanich 200470

NHS [15342452] 

19-50 

51-70A

Rectal cancer (44 

cases; 88 controls) 

1-11 44.4, median 24 31 1 Refe

66.2 10 26 0.52 0.1492.4 10 31 0.31 0.08

* Statistically significant (P<0.05) A Most representative life stage. B P for trend = 0.31 when cases diagnosed within 2 years of blood collection were excluded. C Results were not notably changed when cases diagnosed within the first year after blood collection were excluded (P for trend not reported). Subgroup 

reported as follows: Age ≥ 60, OR = 0.35 (95% CI 0.14, 0.87) between the lowest and highest quintiles; P for trend = 0.006. Age < 60, OR = 1.36 (95% 

lowest and highest quintiles; P for trend = 0.70. D P for trend = 0.008 when cases diagnosed within 2 years of blood collection were excluded. E P for trend = 0.58 when cases diagnosed within 2 years of blood collection were excluded. F P for trend = 0.04 when cases diagnosed within 2 years of blood collection were excluded. 
Figure 8. Colorectal cancer risk stratified by vitamin D concentration 
Figure 9. Colon cancer risk stratified by vitamin D concentration 

89
Figure 10. Rectal cancer risk stratified by vitamin D concentration 

 
Colorectal adenoma. 

Synopsis. 

 No systematic reviews have evaluated the association between 25(OH)D concentrations and 

the risk of colorectal adenoma. One B quality nested case-control study in women found no 

significant association between 25(OH)D concentrations and the risk of colorectal adenoma. 

Detailed presentation (Tables 24 & 25). 

 One nested case-control study within the NHS evaluated the relationship between 25(OH)D 

concentrations and the risk of colorectal adenoma in women.74 At 5 years, an adjusted analysis 

found no significant association between 25(OH)D concentrations and the incidence of 

colorectal adenoma by trend analysis. Subgroup analyses also found no significant association 

between 25(OH)D concentrations and the incidence of colon or rectal adenoma. No subgroup 

data were available regarding age or other special populations (e.g., obese, smokers, ethnic 

groups, or users of contraceptives). This study was rated B because it excluded more than 50 

percent of participants of the original cohort because their blood samples were not available. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y A proportion of participants in the NHS was in this life stage. No unique 

conclusions are possible for this life stage separate from those for people 51 to 70 years. 

• 51 – 70 y The analysis of the NHS included female participants mostly within this 

life stage. The study found no association between 25(OH)D and the incidence of 

colorectal adenoma. 

• ≥71 y A proportion of participants in the NHS was in this life stage. No unique 

conclusions are possible for this life stage separate from those for people 51 to 70 years. 

• Postmenopause The analysis of NHS partially included postmenopausal women. 

However, no unique conclusions are possible for this life stage separate from those for 

people 51 to 70 years. 

• Pregnant & lactating women Not reviewed 

91
92

Table 24. Vitamin D and colorectal adenoma: Characteristics of observational studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Vitamin D 

Concentration Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Comments 

Nested casecontrol 

• Health 

status 

Any 

• Mean 

age 

(SD), y 

59 

(7) 

• Assay 

method 

RIA 

(Horris 

1993) 

Platz 200074

NHS 

US 

(various) 

[11045788] 

• Male 

(%) 

0 • Season 

blood 

drawn 

All 

• Colorectal 

adenoma risk 

stratified by 

baseline 

25(OH)D 

quartiles 

X X X X X X Aspirin user: 

26%; 

Hormone 

replacement 

therapy: 36% 
Table 25. Vitamin D and colorectal adenoma: Results of observational studies 

Author Year Study Name [PMID] 

Life 

Stage 

Outcome 

(n/N; Incidence) 

Followup 

Duration 

(Time to Dx) 

25(OH)D 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95% 

Nested case-control studyColorectal adenoma 

Women 

Platz 200074

NHS [11045788] 

19-50 

51-70A

≥71 

Colorectal adenoma 

(326 cases; 326 

controls) 

5 16.3, median 103 82 1 Refer

22.6 62 80 0.64 0.41, 28.3 61 82 0.58 0.36, 38.0 100 82 1.04 0.66, 

Colon adenoma 

Women 

Platz 200074

NHS [11045788] 

19-50 

51-70A

≥71 

Colon adenoma (261 

cases; 261 controls) 

5 16.3, median 79 64 1 Refer

22.6 55 64 0.71 0.43, 28.3 51 69 0.60 0.35, 38.0 76 64 1.02 0.60, 

Rectal adenoma

Women 

Platz 200074

NHS [11045788] 

19-50 

51-70 A

≥71 

Rectal adenoma (65 

cases; 65 controls) 

5 16.3, median 24 18 1 Refer

22.6 7 16 0.38 0.12, 28.3 10 13 0.34 0.08, 38.0 24 18 1.59 0.50, 

* Statistically significant (P<0.05) A Most representative life stage 
Breast cancer. 

Synopsis. 

 No qualified systematic reviews evaluated the association between vitamin D and calcium 

intake or serum 25(OH)D concentration and risk of breast cancer. One cohort study compared 

serum 25(OH)D concentrations and the risk of breast cancer-specific mortality,53 and two nested 

case-control studies compared 25(OH)D concentrations and the risk of breast cancer.75,76 The 

cohort study utilizing NHANES III data found significant decrease in breast cancer-specific 

mortality during 9 years of followup in those with serum concentration of 25(OH)D greater than 

62 nmol/L. The Nurses’ Health Study and Prostate, Lung, Colorectal, and Ovarian (PLCO) 

Cancer Screening Trial, however, found no significant relationship between serum concentration 

of 25(OH) D and risk of breast cancer diagnosis in either pre- or postmenopausal women during 

7 to 12 years of followup.75,76 All three studies were rated B quality. 

Detailed presentation (Tables 26 & 27). 

 The NHANES III study followed 16,818 adults with a mean age of 44 years with a 

background calcium intake on average of about 812 mg/day (from diet and supplements). 53 The 

study included 71 percent non-Hispanic white, 14 percent non-Hispanic black, 6 percent 

Mexican American, and 9 percent from other races. During 9 years of followup, women with 

serum concentration of 25(OH) D greater than 62 nmol/L had a hazard ratio of 0.28 for breast 

cancer-specific mortality compared to those with 62 nmol/L or lower (95 percent CI 0.08-0.93). 

The breast cancer-specific mortality was one of many cancer-specific mortality outcomes 

reported in this study. 

 Two nested case-control studies of women with a mean age of 57 years and 67 years, 

respectively, found no relationship between serum 25(OH)D concentrations and risk of breast 

cancer.75,76 However, in the second study, when compared with the lowest quintile, quintiles 3 to 

5 were associated with nonsignificantly elevated risks. In multivariable adjusted analyses, the 

risk associated with 25(OH)D levels below 15 ng/mL compared with higher levels was 0.81 (95 

percent CI 0.59, 1.12).76

Findings by age and sex. 

 In the one nested case-control study (methodological quality B) including both 

premenopausal and postmenopausal women, no relationship was found between vitamin D levels 

and risk of breast cancer. However, in this study, there was a statistically significant trend 

towards decreased risk of breast cancer among women older than 60 years of age with serum 

concentration of 25(OH)D greater than 62 nmol/L. 

Findings by life stage. 

• 0 – 6 mo Not applicable 

• 7 mo – 2 y Not applicable 

• 3 – 8 y Not applicable 

• 9 – 18 y Not applicable 

• 19 – 50 y A followup study of NHANES III including women with a mean age of 44 

years found a decreased mortality (hazard ratio 0.28) due to breast cancer among those 

with serum concentration of 25(OH)D greater than 62 nmol/L. 
95

• 51 – 70 y Two nested case-control studies of women with a mean age of 57 years 

and 67 years, respectively, found no relationship between vitamin D levels and risk of 

breast cancer. However, in one of these studies, there was a statistically significant trend 

towards decreased risk of breast cancer among women older than 60 years of age with 

serum concentration of 25(OH)D greater than 62 nmol/L. 

• ≥71 y Not reviewed 

• Postmenopause Not reviewed 

• Pregnant & lactating women Not reviewed 

Table 26. Vitamin D and breast cancer: Characteristics of observational studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Vitamin D 

Concentration Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Comments 

Cohort 

• Health 

status 

Noninstitutionalized 

• Mean age 

(range/SD), 

y 

44 (ND) 

• Assay 

method 

Freedman RIA 

200753

NHANES III 

US 

(38o N) 

[17971526] • Season 

blood 

drawn 

All 

year 

Breast cancer 

risks: Quintile 

1 vs. Quintile 

2 

X X X X X 

Nested 

CaseControl 

• Health 

status 

No Cancer 

• Mean age 

(range/SD), 

y 

57 (7.0) 

• Assay 

method 

Bertone- RIA 

Johnson 

200575

NHS 

US 

(38o N) 

[16103450] • Season 

blood 

drawn 

All 

year 

Breast cancer 

risks: Quintile 

1 vs. Quintile 

2, 3, 4, 5 

X X X X X 

• Health 

status 

No Cancer 

• Mean age 

(range/SD), 

y 

67 (ND) 

• Assay 

method 

Freedman RIA 

200876

PLCO Trial 

US 

(38o N) 

[18381472] • Season 

blood 

drawn 

DecSep 

Breast cancer 

risks: Quintile 

1 vs. Quintile 

2, 3, 4, 5 

X X X X X 
Table 27. Vitamin D and breast cancer: Results of observational studies 

Author Year Study Name [PMID] 

Life Stage Outcome 

(n/N; 

Incidence) 

Followup 

Duration 

(Time to 

Dx) 

Vit D 

Measure 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

RR 

9

Cohort Freedman 200753

NHANES III [17971526] 

All Adults Breast cancer 

mortality 

(28/ND)A

105 mo 25(OH)D <63 20 ND 1 Ref

≥63 8 ND HR 0.28 0.0

Nested CaseControl Bertone-Johnson 200575

NHS [16103450] 

Pre- and Postmenopausal Breast cancer (701/1425) <1-82 mo 25(OH)D ≤50 (1st batch) 

≤70 (2nd batch) 

≤45 (3rd batch) 

159 297 1 Ref

51 - 70 

72 - 85 47 to 60 

149 278 0.95 0.6

72 - 82 

87 - 97 62 - 72 

125 266 0.74 0.5

85 - 97 

100 - 117 75 - 90 

144 296 0.80 0.5

≥100 ≥120 ≥92

124 265 0.73 0.4

Breast cancer 

<60 y 

(701/1425) 

97 191 1 Ref

84 170 0.96 0.677 164 0.80 0.5

90 192 0.85 0.570 146 0.92 0.5

Breast cancer 

≥60 y 

(701/1425) 

62 109 1 Ref65 114 1.07 0.648 105 0.64 0.354 99 0.68 0.354 125 0.57 0.3

continued 
97

Author Year Study Name [PMID] 

Life Stage Outcome 

(n/N; 

Incidence) 

Followup 

Duration 

(Time to 

Dx) 

Vit D 

Measure 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

RR 

9

Freedman 200876

PLCO Cancer Screening Trial [18381472] 

Pre- and Postmenopausal Breast cancer (1005/2010) 12 y 25(OH)D <46 172 2010 1 Ref

46-58 188 2010 1.02 0.759-71 244 2010 1.36 0.972-83 205 2010 1.13 0.8

≥84 196 2010 1.04 0.7

* Statistically significant (P<0.05) A Total number of women not reported 
Pancreatic cancer. 

Synopsis. 

 No qualified systematic reviews evaluated associations between serum vitamin D 

concentrations and the incidence of pancreatic cancer. Two nested case-control studies, rated A 

in methodological quality, evaluated the association between serum 25(OH) concentration and 

the risk of developing pancreatic cancer in two different populations. One study found that older 

adult male smokers living in Finland with higher baseline serum 25(OH)D concentration had an 

increased risk of exocrine pancreatic cancer compared with those with lower concentration 

(>65.5 vs. <32 nmol/L; OR=2.92; P for trend=0.001). The other study found that baseline 

25(OH)D concentrations were not associated with the risk of overall pancreatic cancer (>82.3 vs. 

<45.9 nmol/L; OR=1.45; P for trend=0.49) among older adults living in the United States. 

However, there was an increased risk of pancreatic cancer among the study participants with 

higher compared to lower 25(OH)D concentrations (>78.4 vs. <49.3 nmol/L; OR=4.03) only in 

those living in low residential UVB exposure areas but not among those living in moderate or 

high residential UVB exposure areas. 

Detailed presentation (Tables 28 & 29). 

51 - 74 years. 

 One nested case-control study based on the Alpha-Tocopherol, Beta-Carotene Cancer 

Prevention Study (ATBC) in older adult male smokers aged 54 to 62 years in Finland identified 

200 cases of incident exocrine pancreatic cancer.77 These cases were matched to 400 controls. 

Baseline serum 25(OH)D concentration was stratified into quintiles. The odds ratio for exocrine 

pancreatic cancer was 2.92 (95 percent CI 1.56, 5.48) comparing 5th quintile (>65.5 nmol/L) to 

1st quintile (<32 nmol/L). The result was adjusted for age, month of blood drawn, years smoked, 

number of cigarettes smoked per day, reporting to have quit smoking more than three 

consecutive visits (>1 y) during the trial (1985-1993), occupational physical activity, education, 

and serum retinol. The study authors excluded islet cell carcinomas from analysis because the 

etiology for their pathogenesis might be different from that of exocrine tumors. 

 Another nested case-control study based on the Prostate, Lung, Colorectal, and Ovarian 

Screening (PLCO) trial in older men and women aged 55 to 74 years in the United States 

identified 184 cases of incident pancreatic cancer.78 These cases were matched to 368 controls. 

Baseline serum 25(OH)D concentration was stratified into quintiles. The odds ratio for exocrine 

pancreatic cancer was 1.45 (95 percent CI 0.66, 3.15) comparing 5th quintile (>82.3 nmol/L) to 

1st quintile (<45.9 nmol/L). The result was adjusted for age, race, sex, date of blood draw based 

on 2-month blocks, BMI and smoking. The association was not significantly modified by season 

of blood collection (P for interaction > 0.14); but estimated residential annual solar UVB 

exposure significantly modified the 25(OH)D concentration and pancreatic cancer association (P 

for interaction = 0.015). In the joint effects models, among subjects with low estimated annual 

UVB residential exposure, higher compared with lower 25(OH)D concentrations were associated 

with increased risk of pancreatic cancer (compared with the lowest quartile, the ORs for each 

respective quartile were 2.52, 2.33, and 4.03; 95 percent CI 1.38, 11.79), whereas among 

subjects with moderate to high residential UVB exposure, 25(OH)D concentrations were not 

associated with pancreatic cancer. There was no significant interaction of 25(OH)D 
concentration and pancreatic cancer by smoker status, sex, physical activity, or total vitamin A 

intake. 

Findings by life stage. 

• 0 – 6 mo not reviewed 

• 7 mo – 2 y not reviewed 

• 3 – 8 y not reviewed

• 9 – 18 y not reviewed

• 19 – 50 y No study specifically targeted this age group.

• 51 – 70 y One nested case-control study found that male smokers living in Finland 

with higher baseline serum 25(OH)D concentration had an increased risk of pancreatic 

cancer compared with those with lower concentration (5th vs. 1st quintile, >65.5 vs. <32 

nmol/L: OR 2.92, 95 percent CI 1.56, 5.48, P for trend = 0.001). Another study found 

that baseline 25(OH)D concentrations were not associated with overall risk of pancreatic 

cancer among older adults living in the United States (5th vs. 1st quintile, >82.3 vs. <45.9 

nmol/L: OR 1.45, 95 percent CI 0.66, 3.15; P for trend=0.49). However, there was an 

increased risk of pancreatic cancer among the study participants living in low residential 

UVB exposure areas (4th vs. 1st quartile >78.4 vs. <49.3 nmol/L: OR=4.03; 95 percent CI 

1.38, 11.79). 

• ≥71 y No study specifically targeted this age group.

• Postmenopause not reviewed 

• Pregnant & lactating women not reviewed 

99
100

Table 28. Vitamin D and pancreatic cancer: Characteristics of observational studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Trial/Cohort 

Country 

(Latitude) 

[PMID] 

Population 25(OH)D Comparisons 

Nutrients Demographic Anthrop Medical UV exposure Life styles 

Comments 

Health 

status 

All 

smokers 

Mean age 

(range/SD), 

y 

58 

Assay RIA 

(DiaSorin) 

StolzenbergSolomon 

200677

ATBC 

Finland 

(60°N) 

[17047087] Male (%) 100 Season 

blood 

drawn 

nd; but 

result 

adjusted 

for this 

variable 

Exocrine 

pancreatic risk 

stratified by 

baseline 

25(OH)D 

quintiles 

X X X X 

Health 

status 

DM: 

10.5% 

Mean age 

(range), y 

66 (55-

74) 

Assay RIA 

(Heartland 

Assays 

lab) 

StolzenbergSolomon 

200978

PLCO 

US 

(various) 

[19208842] 

Male (%) 65.2 Season 

blood 

drawn 

All 

seasons 

Pancreatic risk 

stratified by 

baseline 

25(OH)D 

quintiles 

Pancreatic risk 

stratified by 

residential sun 

exposure 

levels and 

baseline 

25(OH)D 

quartiles 

X X X X 
Table 29. Vitamin D and pancreatic cancer: Results of observational studies 

Author Year Study Name PMID 

Life Stage, y 

Outcome (no. of cases; no. of control) 

Time to diagnosis, y 

25(OH)D concentration, nmol/L 

No. of cases 

No. of control 

Adjusted OR 95% CI 

51-70, male only 

Exocrine 

pancreatic cancer 

(200; 400) 

11.8 (median) 

<32 27 80 1 Reference 32-41.1 34 80 1.30 0.70, 2.40 41.1-51.1 47 80 2.12 1.15, 3.90* 51.1-65.5 35 81 1.50 0.81, 2.76 

Stolzenberg-Solomon 200677

ATBC Finland (60°N) [17047087] 

>65.5 57 79 2.92 1.56, 5.48* 

51-70, both sexes 

Pancreatic cancer 

(184; 368) 

5.4 (median), 

up to 11 y ≤45.9 44 74 1 Reference 

>45.9 to ≤60.3 40 74 0.97 0.47, 1.98 >60.3 to ≤69.5 27 73 0.86 0.40, 1.84 >69.5 to ≤82.3 31 74 0.84 0.39, 1.80 

Stolzenberg-Solomon 200978

PLCO US (various) [19208842] 

>82.3 42 73 1.45 0.66, 3.15 

Pancreatic 

cancer: Low 

residential sun 

exposure area 

(91; 167) 

nd 

<49.3 22 44 1 Reference >49.3 to <65.2 22 42 2.52 0.92, 6.90 >65.2 to <78.4 21 43 2.33 0.83, 6.48 

>78.4 26 38 4.03 1.38, 11.79* 

Pancreatic 

cancer: Moderate 

residential sun 

exposure area 

(91; 167) 

nd 

<49.3 33 48 1.97 0.80, 4.82 

>49.3 to <65.2 15 50 0.66 0.22, 2.01 

>65.2 to <78.4 18 49 0.91 0.31, 2.71 

>78.4 24 54 1.45 0.53, 3.96 

* Statistically significant (P<0.05) 
Vitamin D and Immunologic Outcomes 

We reviewed primary studies that evaluated relationships between vitamin D and any 

immune function related outcomes. 

Synopsis. 

Analyses using NHANES III data (general adult populations living in the US) showed no 

significant association between baseline 25(OH)D concentrations and infectious disease 

mortality. 

One cohort study from UK suggested a relationship between maternal 25(OH)D 

concentration and the risk of eczema in their children, but the analysis did not control for 

important potential confounders, and the 25(OH)D concentrations in children were not 

measured. 

Detailed presentation (Tables 30 & 31). 

One study analyzed NHANES III data and showed no association between baseline 25(OH)D 

concentrations and infectious disease.47 NHANES III cohort represents general adult populations 

living in the United States. This study was rated quality C. 

One cohort study from UK analyzed the serum 25(OH)D concentration in 440 white women 

in late pregnancy (~33 wk) and found their infants’ risk of eczema at age 9 months was higher in 

those mothers in the top quartile of the distribution of serum 25(OH)D (>50 nmol/L) compared 

with those at the bottom quartile (<30 nmol/L), although the results were not statistically 

significant.42 However, this analysis did not control for important potential confounders, and the 

25(OH)D concentrations in children were not measured. This study was rated quality C. 

Findings by life stage. 

• 0 – 6 mo No data 

• 7 mo – 2 y No data 

• 3 – 8 y No data

• 9 – 18 y No data 

• 19 – 50 y NHANES III data include people in this life stage. Analyses using 

NHANES III data (general adult populations living in the US) showed no significant 

association between baseline 25(OH)D concentrations and infectious disease mortality.

• 51 – 70 y NHANES III data also include people in this life stage.

• ≥71 y NHANES III data also include people in this life stage

• Postmenopause No data

• Pregnant & lactating women One cohort study from UK analyzed the serum 

25(OH)D concentration in white women in late pregnancy (~33 wk) and showed a 

relationship between maternal 25(OH)D concentration and the risk of eczema in their 

children. However, this analysis did not control for important confounders, and the 

25(OH)D concentrations in children were not measured.
103

Table 30. Vitamin D (mother) and immunologic outcomes (offspring): Characteristics of cohort 

studies 

Confounders/Effect Modifiers 

Author Yea Adjusted 

r 

Study Nam

e 

Location 

(Latitude) 

[PMID] 

Population Vitamin D 

Concentration 

Comparison

s 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Comment

s 

• Health 

status 

DM 7.4%, 

history of 

CVD 

7.9%, 

HTN 25% 

• Mean age 

(range), y 

45 (≥20) 

• Assay 

method 

RIA 

(DiaSorin

) 

Melamed 

200847

NHANES III 

US 

(various) 

[18695076] 

• Male (%) 46 • Seaso

n blood 

drawn 

All 

Infectious 

disease 

mortality 

stratified by 

baseline 

25(OH)D 

quartiles 

X X X X X X 

• Health 

status 

singleton 

pregnanc

y <17 wk 

• Mean age 

(range/SD), 

y 

26.3 

• Assay 

method 

Gale 2008 RIA 42

PAHSG 

UK (50oN) 

[17311057] 

• Male (%) 0 • Seaso

n blood 

drawn 

nd 

Length and 

weight in 

offspring 

stratified by 

mother’s 

25(OH)D 

X X White only 
Table 31. Vitamin D (mother) and immunologic outcomes (offspring): Results of cohort studies 

Author Year Study Name [PMID] 

Life Stage Outcome 

(n/N; 

Incidence) 

Followup 

Duration 

(Time to Dx) 

Vit D Measure Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

9

Melamed 200847

NHANES III US (various) [18695076] 

Adults, 

both 

sexes 

Infectious 

disease 

mortality 

(N=13,331) 

Median 8.7 

(IRQ 7.1-

10.2) y 

25(OH)D <44 nd 13331 

(Total) 

0.84 0.3

44-60 nd nd 0.87 0.4

61-80 nd nd 1.01 0.5

>80 nd nd 1 Re

Gale 200842

PAHSG UK (54°N) 

[17311057] 

Pregnant 

women; 

infant at 9 

mo 

Atopic eczema 

at 9 mo 

(48/440; 0.11) 

9 mo Maternal 

25(OH)D at 

late pregnancy 

<30 (Quartile) 9 440 (total) 1 Re

30-50 10 1.11A 0.450-75 15 1.75A 0.7

>75 14 1.62A 0.6

A Crude OR 
Vitamin D and Pregnancy-related Outcomes 

Preeclampsia. 

Synopsis. 

A single nested case-control study found an association between low 25(OH)D concentration 

(<37.5 nmol/L) early in pregnancy and preeclampsia. The study was rated B for methodological 

quality. 

Detailed presentation (Tables 32 & 33). 

A nested case-control study evaluated the association between 25(OH)D concentration and 

risk of preeclampsia.79 The study found an association between 25(OH)D concentrations less 

than 37.5 nmol/L (measured approximately 30 wk before outcome assessment) and increased 

risk of preeclampsia. The study was rated B for methodological quality.

Findings by life stage. 

• 0 – 6 mo No data 

• 7 mo – 2 y Not applicable 

• 3 – 8 y Not applicable

• 9 – 18 y Not applicable 

• 19 – 50 y See pregnant and lactating women.

• 51 – 70 y Not applicable

• ≥71 y Not applicable

• Postmenopause Not applicable

• Pregnant & lactating women A single nested case-control study found an 

association between low 25(OH)D concentration (<37.5 nmol/L) early in pregnancy and 

preeclampsia. 

Other outcomes. 

Synopsis. 

We did not identify any eligible studies on the relationship of vitamin D with or without 

calcium and high blood pressure, preterm birth, or small infant for gestational age. 

105 
106 

Table 32. Vitamin D and preeclampsia: Characteristics of nested case-control studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Vitamin D 

Concentration Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

• Health 

status 

Healthy 

• Age 

range, y 

20-29 

• Assay 

method 

Bodnar 2007 ELISA 79 

PEPPSA 

US 

(41°N) 

[17535985] • Male (%) 0 • Season 

blood 

drawn 

ND 

Comparison of 

mean 25(OH)D 

levels in cases 

and controls 

x x 

A

 Pregnancy Exposures and Preeclampsia Prevention Study
Table 33. Vitamin D and preeclampsia: Results of nested case-control studies 

Author Year Study Name Location (Latitude) [PMID] 

Life Stage Outcome 

(n/N; 

Incidence) 

Followup 

Duration 

(Time to Dx) 

Vit D 

Measure 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

Bodnar 200779A PEPPSB US (41°N) [17535985]

Pregnancy Preeclampsia 

(55/1198; 4%) C 

ND 25(OH)DD <37.5 (vs. >37.5) 49 265 5.0 

A This is a nested case-control study B Pregnancy Exposures and Preeclampsia Prevention Study C Incidence obtained from the “parent” cohort study in which this case control study is nested. D Early in pregnancy, approximately 30 wk before outcome assessment

107 
Vitamin D and Clinical Outcomes of Bone Health 

For bone health outcomes (e.g., bone mineral density, fracture, fall or muscle strength), we 

relied on a recent comprehensive systematic review (Effectiveness and Safety of Vitamin D in 

Relation to Bone Health) performed by the Ottawa EPC (Table 28).

6

 Because the Ottawa’s EPC 

report did not report separate analyses for the effect of vitamin D supplementation alone, the 

results for the effect of vitamin D alone or in combination with calcium supplementation were 

presented in the “Combined Vitamin D and Calcium” section. The Ottawa EPC report also did 

not report separate analyses by study designs (i.e., RCTs, prospective cohorts, before and after 

study, and case-control studies), although the report primarily included RCTs. 

 The Ottawa EPC report was updated with literature published between January 2006 and 

September 2008, selected according to our eligibility criteria. Only RCTs qualified for inclusion. 

Rickets. 

Synopsis. 

 The Ottawa EPC report concluded that there is fair evidence for an association between low 

serum 25(OH)D concentrations and confirmed rickets, regardless of the types of assay measures 

of 25(OH)D concentrations (RIA, CPBA, HPLC). According to the report, there is inconsistent 

evidence to determine whether there is a threshold concentration of serum 25(OH)D above 

which rickets do not occur.

 Our updated search did not identify new RCTs examining the effect of vitamin D 

supplementation on rickets. 

Detailed presentation (Table 34). 

Ottawa EPC Report: Rickets - infants (0 through 12 months) and young children (1 through 5 

years). 

 Overall, there is fair evidence for an association between low serum 25(OH)D concentrations 

and confirmed rickets, regardless of the types of assay measures of 25(OH)D concentrations 

(RIA, CPBA, HPLC). There is inconsistent evidence to determine whether there is a threshold 

concentration of serum 25(OH)D above which rickets do not occur.

 Six studies (one RCT, three before-after and two case-control studies) reported mean or 

median serum 25(OH)D concentrations < 30 nmol/L in children with rickets whereas the other 

studies reports the mean or median 25(OH)D concentrations were above 30 nmol/L (and up to 50 

nmol/L). In seven of eight case-control studies, serum 25(OH)D concentrations were lower in the 

children with rickets compared with controls. 

Findings by life stage. 

• 0 – 6 mo The Ottawa EPC report included infants and young children and 

concluded that there is fair evidence for an association between low serum 25(OH)D 

concentrations and confirmed rickets, regardless of the types of assay measures of 

25(OH)D concentrations (RIA, CPBA, HPLC). There were no new data since the Ottawa 

EPC report. 

• 7 mo – 2 y The Ottawa EPC report included infants and young children. There were 

no new data since the Ottawa EPC report. 

108 
• 3 – 8 y The Ottawa EPC report included young children. There were no new data 

since the Ottawa EPC report. 

• 9 – 18 y Not reviewed 

• 19 – 50 y Not reviewed 

• 51 – 70 y Not reviewed 

• ≥71 y Not reviewed 

• Postmenopause Not reviewed 

• Pregnant & lactating women Not reviewed 

Table 34. Summary of systematic review of the effect of vitamin D on bone health 

Author Year [PMID] Cranney 20076 [18088161] 

Design Systematic review of RCTs and observational studies 

Population • Include all ages 

• Exclude secondary causes of osteoporosis (e.g., glucocorticoid-induced, renal or liver 

disease) 

• Exclude studies on the treatment of vitamin D-dependent rickets (to minimize clinical 

heterogeneity as treatments is often nondietary sources of vitamin D) 

Intervention (Exposure) and 

Comparator 

Intervention (Exposure): 

• Include vitamin D2 or D3 with or without calcium. 

• Exclude vitamin D preparations, calcitriol, α-calcidol (because they are not nutritional 

supplements, and have different safety profile) 

Comparator: 

• No vitamin D or lower doses/levels of vitamin D 

Results See text for summary results for the following outcomes in both vitamin D and combined vitamin 

D and calcium sections of the report: 

• Rickets 

• Fractures, falls, or performance measures 

• Bone mineral density or bone mineral contents 

• How does dietary intake of vitamin D from fortified foods and vitamin D 

supplementation affect serum 25(OH)D Concentrations 

• Adverse events 

Comments Case-control studies were included but always summarized separately from cohort studies and 

RCTs. Meta-analyses were performed to pool results from RCTs only. 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? Yes 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? No Publication bias assessed? No 

Included and excluded studies listed? Yes Conflicts of interest stated? Yes 

Study characteristics provided? Yes 

Fractures, falls, or performance measures. 

Synopsis. 

 Overall, the Ottawa EPC report concluded that the associations between serum 25(OH)D 

concentrations and the risk of fractures, falls, and performance measures among postmenopausal 

women or elderly men are inconsistent.6

 

 Findings from three additional RCTs (published after the Ottawa EPC report)80-82 also did not 

show significant effects of either vitamin D2 or D3 supplementation (daily doses ranged from 400 

IU to 822 IU) in reducing the risk of total fractures or falls in elderly populations (≥71 years old). 

109 
Detailed presentation (Tables 35 & 36). 

Ottawa EPC Report: Fractures - Postmenopausal women or elderly men. 

 Overall, there is inconsistent evidence for an association between serum 25(OH)D 

concentrations and the risk of fractures. Fifteen studies (three prospective cohorts and twelve 

case-controls) reported on the association between serum 25(OH)D concentrations and fracture 

rates. One of three cohorts reported an inverse association between serum 25(OH)D 

concentrations and fracture rates, and nine of twelve case-control studies found significantly 

lower 25(OH)D concentrations in cases versus controls. Differences in results may be attributed 

to whether all relevant confounders were controlled for and differences in baseline serum 

25(OH)D concentrations. Other factors may also contribute to the heterogeneity, such as 

diagnosis of fractures. 

Ottawa EPC Report: Falls - Postmenopausal women or elderly men. 

 Overall, there is fair evidence of an association between lower serum 25(OH)D 

concentrations and an increased risk of falls in institutionalized elderly. One study suggested a 

serum 25(OH)D concentration below 39 nmol/L was associated with an increased risk of falls. 

Five studies (one RCT, three cohorts and one case-control) evaluated the association between 

serum 25(OH)D concentrations and risk of falls. One RCT, two of the three cohorts and one 

case-control study reported an inverse association between serum 25(OH)D concentrations and a 

risk of falls. In one cohort with a low percentage of vitamin D deficient participants, the 

association did not persist after adjustment for age and illness severity. In another cohort with an 

undetermined proportion of vitamin D deficient participants no significant association between 

serum 25(OH)D concentrations and risk of falls was observed. One case-control study reported 

no significant association between serum 25(OH)D concentrations and risk of falls after 

adjusting for serum PTH. 

Ottawa EPC Report: Performance measures - Postmenopausal women or elderly men. 

Overall, there is inconsistent evidence for an association of serum 25(OH)D concentrations 

with performance measures. In studies that reported an association, specific concentrations 

below which, declines in performance measures were increased, ranged from 50 to 87 nmol/L. 

Seven studies (three RCTs and four cohorts) assessed the relation between 25(OH)D 

concentrations and performance related measures. Two of the three RCTs and two of the four 

cohorts reported an association between 25(OH)D concentrations and performance measures. 

The other studies did not find an association between 25(OH)D concentrations and performance 

measures. 

Additional RCTs published after the Ottawa EPC report. 

We identified three additional RCTs (published after the Ottawa EPC report)80-82 that 

examined the effect of either vitamin D2 or D3 supplementation on total fractures, falls, or 

performance in elderly populations (≥71 years old). All three RCTs were rated C. In two of the 

three RCTs80,81 calcium supplementation (800 or 1200 mg/d) was given to all participants. 

Baseline serum 25(OH)D concentrations were less than 40 nmol/L. The other RCT did not 

provide any information on background calcium intake or baseline serum 25(OH)D 

concentrations.82 All three RCTs reported no significant reduction in the risk of total fracture or 

falls in elderly populations at daily vitamin D doses ranging from 400 IU to 822 IU.80-82 Only 

one of the three new RCTs among elderly reported data on performance measures. Vitamin D 

supplementation (400 IU/d) improved gait speed and body sway in healthy elderly subjects.80 

110 
Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y No data 

• 51 – 70 y The Ottawa EPC report concluded that the associations between serum 

25(OH)D concentrations and risk of fractures, falls, and performance measures are 

inconsistent. There were no new data since the Ottawa report 

• ≥71 y Findings from three new RCTs did not show significant effects of either 

vitamin D2 or D3 supplementation (daily doses ranged from 400 IU to 822 IU) in 

reducing the risk of total fractures or falls among men and women in this life stage. 

• Postmenopause The Ottawa EPC report concluded that the associations between 

serum 25(OH)D concentrations and risk of fractures, falls, and performance measures are 

inconsistent. There were no new data since the Ottawa report 

• Pregnant & lactating women Not reviewed 

111 
112 

Table 35. Vitamin D and bone health: Characteristics of RCTs published after the Ottawa EPC 

report 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium 

Intake & 

Vitamin D 

Data 

Comparisons Compliance Comments 

• Health 

status 

Living in care 

facilities including 

some elderly with 

mobility, cognitive, 

visual, hearing or 

communication 

impairments 

• Mean 

age 

(range), 

y 

84 (62-107) 

Lyons 200782

South Wales, 

UK 

(52°N) 

[17473911] 

• Male 

(%) 

23.7 

nd Vit D2 100,000 IU 

4-monthly vs. 

placebo 

80% (percentage of 

occasions observed 

to take tablets) 

• Health 

status 

Inpatient with high 

levels of comorbidity, 

mortality and 

polypharmacy 

• Mean 

age 

(SD), y 

83 (7.6) 

Burleigh 200781

Scotland 

(55° 57'N) 

[17656420] 

• Male 

(%) 

40 

25(OH)D: 22.0 

nmol/L 

Vit D3 800 IU/d + 

Ca carbonate 

1200 mg/d vs. Ca 

carbonate 1200 

mg 

Ca group=87%, Vit 

D+Ca group=89% 

(total study drug 

taken/total study 

drug prescribed, as 

recorded in drug 

prescription charts) 

• Health 

status 

Healthy 

• Mean 

age 

(SD), y 

76 (4) 

Bunout 200680

Chile 

(32°S) 

[16797903] 

• Male 

(%) 

11.6 

25(OH)D: ≤40 

nmol/L 

Ca 800 mg/d vs. 

Ca 800 mg/d + Vit 

D 400 IU/d (with 

and without 

exercise training) 

92% (tablet 

counting) 
Table 36. Vitamin D and bone health: Results of RCTs published after the Ottawa EPC report 

Author Year Study Name [PMID] 

Outcome 1°/2° Mean Followup Interventions, Daily Dose n Event N Total Outcome Metric (Comparison) Result Life Stage 

Vit D2 ~822 IUA 205 1670 HR Vit 

D/placebo 

0.95 

Lyons 200782

[17473911] 

≥71 

both 

sexes 

First 

fracture 

1° Median time to first fracture = 

387 (IQR: 220–582) d in Vit 

D2 group; 367 (IQR:139–618) 

d in placebo group 

Placebo 218 1673 

Vit D3 800 IU + Ca 

carbonate 1200 mg 

36 100 RR (Vit 

D+Ca)/Ca 

0.82 

Burleigh 200781

[17656420] 

≥71 

both 

sexes 

Fall 1° Median 1 (IQR 

15–71 d) 

Ca carbonate 1200 mg 

45 103 

Vit D3 800 IU + Ca 

carbonate 1200 mg 

Fracture 1° Median 1 (IQR 1 100 nd nd 

15–71 d) 

Ca carbonate 1200 mg 

3 103 

Ca 800 mg 13B 24 Fall free 

survival curve 

nd 

Ca 800 mg + exercise training 

6B 22 

Vit D 400 IU + Ca 800 mg 

9B 24 

Bunout 200680

[16797903] 

≥71 

both 

sexes 

Fall 2° 9 mo 

Vit D 400 IU + Ca 800 mg + Exercise training 

8B 22 

A Daily dose was calculated from the intermittent doses that were used in the study (i.e., 100,000 IU tablets every 4 months) B Estimated from figure 

113 
Vitamin D and all-cause Mortality 

Synopsis. 

This synopsis is based on our reanalysis of a systematic review of RCTs on vitamin D 

supplementation for mortality.i In addition, it summarizes four observational studies on the 

association of vitamin D and all-cause mortality. 

Three RCTs from the previous systematic review and an additional C rated RCT were 

included in our reanalysis. Three used daily doses that ranged between 400 and 880 IU, and one 

used 100,000 IU every 3 months. Our meta-analysis of the 4 RCTs (13,833 participants) shows 

absence of significant effects of vitamin D supplementation on all-cause mortality (RR = 0.97, 

95 percent CI: 0.92, 1.02; random effects model). There is little evidence for between-study 

heterogeneity in these analyses. 

One cohort study (rated B for methodological quality) found a significant trend for lower 

odds for death with increasing 25(OH)D concentrations. Three other cohort studies did not find a 

significant association between 25(OH)D concentrations and all-cause mortality. These three 

studies were rated C for their methodological quality. 

The above are applicable to older (50-70 y) and elderly (≥71 y) men and women (mean age 

was >70 y in the included studies). 

Detailed presentation (Tables 37, 38 & 39). 

As mentioned in the Methods section, we updated and reanalyzed published meta-analyses of 

mortality outcomes. We drew our own conclusions based on our analyses. We also comment on 

the concordance of our conclusions with those of the published meta-analyses. 

Relevant published systematic reviews of RCTs (with meta-analyses). 

We identified two systematic reviews (with meta-analyses) of RCTs that summarized the 

effect of vitamin D supplementation with or without calcium on mortality.83,84 One systematic 

review (Avenell 2008) examined only trials on fall prevention, and briefly described results on 

mortality.84 The second meta-analysis (Autier 2007) focused specifically on mortality.83 It 

included all RCTs identified in the first, as well as additional trials (which were not eligible for 

the primary analysis of the Avenell 2008 systematic review, namely prevention of falls).83

Therefore, the Autier 2007 meta-analysis was used as the basis for our reanalysis. 

Table 37 summarizes the findings of the Autier 2007 systematic review. 

 

i

 Numerical data were extracted from previous systematic reviews –no additional studies were identified. For this reason, we did not 

appraise studies for their methodological quality. 

114 
Table 37. Summary of systematic review on vitamin D supplementation and all-cause mortality 

Author Year [PMID] Autier 200783 [17846391] 

Design (Search Years) Randomized controlled trials (1992-2006) 

Population Community dwelling or institutionalized adults 

Intervention (Exposure) 

and Comparator 

Supplementary vitamin D (at least 1000 mg/d) without calcium vs. placebo or no treatment 

Results 18 trials of combined vitamin D and vitamin D + calcium 

RR: 0.93 (95% CI 0.87, 0.99); favoring vitamin D (± calcium) supplementation 

Statistically homogeneous 

In our reanalysis we and excluded 3 of 18 trials and separated studies with vitamin D only from 

those with vitamin D and calcium combination. 

For details and results of our reanalysis, see text. 

Comments See text in vitamin D and vitamin D + calcium sections for reanalyses of the separated trials. 

Study participants, vitamin D assays, and vitamin D status are not described in detail. 

AMSTAR Criteria 

A priori design? Yes Study quality assessment performed? No 

Two independent reviewers? No Study quality appropriately used in analysis? NA 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? Yes Publication bias assessed? No 

Included and excluded studies listed? No Conflicts of interest stated? Yes 

Study characteristics provided? Yes The meta-analysis did not perform quality assessment 

(neither using individual quality items nor using quality 

scores) 

Additional identified RCTs (not included in published systematic reviews). 

Lyons 2007 (n=3343, 24 percent males) used monthly supplementation with 100,000 IU of 

vitamin D2, orally for 3 years.82 The trial took place in South Wales (latitude ~52°N) and 

included older people (mean age 84 y) living in sheltered accommodation. The primary outcome 

was prevention of fractures. The Lyons 2007 RCT received grade “C” for the all-cause mortality 

outcome, because of inconsistencies in the reported data. This RCT is included in the reanalysis 

described below. 

Reanalysis. 

We excluded 5 of 18 trials in the Autier 2007 meta-analysis: One trial was on patients with 

congestive heart failure,85 one was published only in abstract form,86 in one trial the controls also 

received supplementation with vitamin D, albeit with a smaller dose,87 and two trials used 

vitamin D injections.88,89 One additional eligible RCT (Lyons 2007)82 was identified and 

included in our meta-analysis. 

Overall, four trials (13,899 patients) used only vitamin D supplementation without calcium. 

Among the four trials, sample sizes ranged from 2578 to 5292 participants. Followup periods 

ranged from 36 to 60 months. Vitamin D doses in most trials ranged between 400 and 830 IU per 

day. 

Overall, there were no significant effects of vitamin D supplementation on mortality. The RR 

was 0.97 (95 percent CI 0.92, 1.02), with no evidence for between-study heterogeneity (P=0.39, 

I

2

=0 percent). 

Cohort studies. 

We identified four prospective cohort studies described in 5 publications.47,90-93 The 

characteristics of the four cohorts are shown in Table 38. One was rated “B” 90 for 

methodological quality and the remaining were rated “C”. 

Table 39 summarizes the findings of the four studies. Briefly, only Jia 200790 found a 

statistically significant trend between increasing 25(OH)D concentrations and lower odds for allcause mortality (P=0.03). However, none of the odds ratios of the different 25(OH)D categories 

was significant, and if anything, they suggest an U shaped relationship between 25(OH)D and 

115 
mortality. All other cohorts did not find significant associations. Melamed 200847 performed 

analyses in subgroups of men and women, and <65 or ≥65 years of age, and found no significant 

associations (Table 33). 

Findings by life stage. 

• 0 – 6 mo No data 

• 7 mo – 2 y No data 

• 3 – 8 y No data 

• 9 – 18 y No data 

• 19 – 50 y A subgroup analysis of people younger than 65 years in NHANES III 

(Melamed 2008) found no significant associations between 25(OH)D concentrations and 

all cause mortality. 

• 51 – 70 y Overall, there were no significant effects of vitamin D supplementation on 

mortality. 

o In a random effects model meta-analysis of five RCTs (n=13,899) the summary 

RR was 0.97 (95 percent CI 0.92, 1.02), with no evidence for between-study 

heterogeneity (p=0.39, I

2

=0 percent). The mean participant age was more than 70 

years in these RCTs. 

o Overall, data from four cohorts suggest no association between baseline 25(OH)D 

measurements and all-cause mortality (one cohort found a statistically significant 

trend for ). A subgroup analysis of people aged 65 years or older in NHANES III 

(Melamed 2008) found no significant associations between 25(OH)D 

concentrations and all cause mortality. 

• ≥71 y The above (51–70 y) are applicable. 

• Postmenopause No data 

• Pregnant & lactating women No data 

116 
117 

Table 38. Vitamin D and all-cause mortality: Characteristics of cohort studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Vitamin D 

Concentration Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

• Health 

status 

Not 

terminally ill 

or 

demented 

• Age 

range, y 

>75 

• Assay 

method 

Jia 2007 RIA 90

UK 

(57°N) 

[17442130] 

• Male 

(%) 

52 • Season 

blood 

drawn 

ND 

Comparison of 

various 25(OH)D 

concentration 

categories 

X X X X

• Health 

status 

Not 

bedridden 

X X 

• Age 

range, y 

>65 

• Assay 

method 

RIA (Diasorin) 

Shambrook 

2004 & 200691,92

FREEA 

Australia 

(33°S) 

[15531500 & 

16598375] 

• Male 

(%) 

22 • Season 

blood 

drawn 

ND 

Association with 

log 25(OH)D 

• Health 

status 

General 

populationB 

X X X

• Age 

range, y 

>65 

• Assay 

method 

Competitive 

protein 

binding 

Visser 200693

Longitudinal 

Aging Study 

Netherlands 

(52°N) 

[16960177] 

• Male 

(%) 

51 • Season 

blood 

drawn 

ND 

Comparison of 

various 25(OH)D 

concentration 

categories 

• Health 

status 

General 

population 

X X X X X X

• Age 

mean 

(range), y 

45 (>=20) 

• Assay 

method 

RIA (Diasorin) 

Melamed 200847

NHANES III 

US 

(various) 

[18695076] 

• Male 

(%) 

46 • Season 

blood 

drawn 

ND 

Comparison of 

various 25(OH)D 

concentration 

categories 

A Fracture Risk Epidemiology in the Elderly 

B

~40% with CVD and ~60% arthritis
Table 39. Vitamin D and all-cause mortality: Results of cohort studies 

Author Year Study Name Location (Latitude) [PMID] 

Age range, sex 

Outcome Followup 

Duration 

(Time to 

Dx) 

Vit D 

Measure 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95

Jia 200790

UK (57°N) 

[17442130] 

>75, both 

sexes 

Mortality 69 25(OH)D 6.0-23.0 (M)/ 

7.0-19.0 (F) 

41 75 1.74 0.9

23.1-30.0 (M)/ 

29.1-24.0 (F) 

34 86 1.40 0.7

30.1-37.0 (M)/ 

24.1-30.2 (F) 

21 80 0.90 0.4

37.1-47.0 (M)/ 

30.3-39.0 (F) 

17 78 0.80 0.3

47.1-82.0 (M)/ 

39.1-82.0 (F) 

16 79 1.00 Ref

Shambrook 2004 & 200691,92

FREEA 

Australia (33°S) 

[15531500 & 16598375] 

>65, both 

sexes 

Mortality 27 25(OH)D NA 559 1112 0.87B 0.7

Visser 200693

Longitudinal Aging Study Netherlands (52°N) 

[16960177] 

>65, both 

sexes 

Mortality 72 25(OH)D <25 66 127 1.28 0.8

25-49.9 42 462 1.00 0.750-74.9 30 440 0.91 0.6

≥75 29 231 1.00 Ref

Melamed 200847

NHANES III US (various) [18695076] 

>20, both 

sexes 

Mortality 104 25(OH)D <17.8 nd nd 1.26 1.0

17.8-24.3 nd nd 1.06 0.824.4-32.1 nd nd 0.93 0.7

>32.1 nd nd 1.00 Ref

Melamed 200847

NHANES III US (various) [18695076] 

>20, men 

only 

Mortality 104 25(OH)D <17.8 nd nd 1.04 0.8

17.8-24.3 nd nd 0.94 0.724.4-32.1 nd nd 0.82 0.6

>32.1 nd nd 1.00 Ref

continued 

118 
119 

Author Year Study Name Location (Latitude) [PMID] 

Age range, sex 

Outcome Followup 

Duration 

(Time to 

Dx) 

Vit D 

Measure 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95

Melamed 200847

NHANES III US (various) [18695076] 

>20, 

women 

only 

Mortality 104 25(OH)D <17.8 nd nd 1.55 1.1

17.8-24.3 nd nd 1.27 0.924.4-32.1 nd nd 1.16 0.8

>32.1 nd nd 1.00 Ref

Melamed 200847

NHANES III US (various) [18695076] 

20-65, 

both 

sexes 

Mortality 104 25(OH)D <17.8 nd nd 1.28 0.9

17.8-24.3 nd nd 1.13 0.824.4-32.1 nd nd 0.81 0.5

>32.1 nd nd 1.00 Ref

Melamed 200847

NHANES III US (various) [18695076] 

≥65, both 

sexes 

Mortality 104 25(OH)D <17.8 nd nd 1.26 1.0

17.8-24.3 nd nd 0.99 0.824.4-32.1 nd nd 0.97 0.7

>32.1 nd nd 1.00 Ref

A Fracture Risk Epidemiology in the Elderly B Per unit change in the log-transformed concentration.
Vitamin D and Hypertension and Blood Pressure 

We searched for systematic reviews and primary studies that evaluated associations between 

vitamin D supplementation or serum concentrations and incidence of hypertension and change in 

blood pressure. For the outcome incidence of hypertension, we reviewed RCTs and other 

longitudinal studies. For the outcome change in blood pressure, we reviewed only RCTs. The 

EPC and the TEP agreed that due to the large volume of literature, the limited resources would 

not be expended on reviewing observational studies for the surrogate outcome blood pressure. 

We included only studies of adults. Studies of pregnancy-related hypertension and blood 

pressure control are included in the “Pregnancy-related outcomes” section. 

Hypertension. 

Synopsis. 

 No systematic reviews evaluated the association between vitamin D intake or serum 

25(OH)D concentrations and incidence of hypertension. A combined analysis of a small subset 

of the Health Professionals Follow-up (HPFS) and Nurses Health Studies (NHS) evaluated the 

association with serum 25(OH)D concentrations. The analysis found higher incidence of 

hypertension at 4 and 8 years in men with baseline 25(OH)D concentration less than 37.5 nmol/L 

(OR~3-6). In women, serum 25(OH)D concentrations less than 37.5 nmol/L also had a 

significantly higher incidence of hypertension at 4 years (OR~3), but not at 8 years (OR~1.5). 

Detailed presentation (Tables 40 & 41). 

 One analysis (methodological quality B) evaluated the incidence of hypertension in a 

combined set of 613 men from the HPFS and 1198 women from the NHS who had serum 

25(OH)D concentrations measured.94 The men were on average 65 years old and the women 57 

years old. Among the men at 4 years, those with serum 25(OH)D concentrations less than 37.5 

nmol/L were significantly more likely to have new onset hypertension than either men with 

25(OH)D concentrations above 75 nmol/L (OR=6.1) or above 37.5 nmol/L (OR=5.7). The 

association remained significant at 8 years, although with a smaller effect size (OR=3.5 and 3.0, 

respectively). In women, a similar, though weaker, effect was seen at 4 years, such that those 

with 25(OH)D concentrations less than 37.5 nmol/L were significantly more likely to have new 

onset hypertension than either women with 25(OH)D concentrations above 75 nmol/L (OR=2.7) 

or above 37.5 nmol/L (OR=3.0). However, this effect was smaller and nonsignificant at 8 years 

(OR=1.7 and 1.4, respectively). The study was limited primarily by its inclusion of only a 

relatively small subset of participants and its reliance on self-reported hypertension without 

assessment of blood pressure measurements. 

 In the second analysis by the same investigators, the NHS 2 study was analyzed for the 

association between serum 25(OH)D concentration and hypertension as a nested case-control 

study.95 These women were on average 43 years old. Cases and controls (per the 2005 biennial 

questionnaire) were chosen from among those women without hypertension, cardiovascular 

disease, diabetes, obesity, or cancer at baseline (blood samples drawn from 1997 to 1999). After 

approximately 7 years, a statistically significant trend was found such that women in the three 

quartiles with serum 25(OH)D concentrations of 80.5 nmol/L or less were about 50 to 60 percent 

more likely to develop hypertension than those women with higher serum concentrations of 

25(OH)D (adjusted OR = 1.52 to 1.66, each of which was statistically significant compared to 

120 
the highest quartile). The study was graded methodological quality B for similar reasons as the 

analysis of the HPFS and NHS studies. 

Findings per vitamin D concentration. 

 The HPFS and NHS studies were analyzed with 25(OH)D cutpoints of 37.5 and 75 nmol/L. 

Significant associations were found for those with serum concentrations below 37.5 nmol/L. The 

NHS 2 study was analyzed with 25(OH)D quartiles, such that significant associations were found 

for those with serum concentrations of 80.5 nmol/L or less. 

Findings per age and sex. 

See above Detailed presentation of the HPFS and NHS for the separate analyses by sex. No 

subgroup analyses were reported by life stage. The participants in the studies were approximately 

40 to 80 years old. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y The NHS 2 included all women within the life stage. After approximately 

7 years, those with serum 25(OH)D concentrations of 80.5 nmol/L or less were about 50 

to 60 percent more likely to develop hypertension. 

• 51 – 70 y HPFS and NHS included participants mostly within this life stage. In men 

and women, the study found higher incidence of hypertension at 4 years followup in 

those with serum 25(OH)D concentrations less than 37.5 nmol/L; at 8 years, the 

association was significant only for men. 

• ≥71 y A minority of the men and few of the women appear to have been in this 

life stage. No unique conclusions are possible for this life stage separate from those for 

people 51 to 70 years. 

• Postmenopause The majority of the women in NHS were postmenopausal. A 

significant association between serum 25(OH)D concentrations less than 37.5 nmol/L and 

increased hypertension was found at 4 years, but not 8 years followup. 

• Pregnant & lactating women Not reviewed 

121 
122 

Table 40. Vitamin D and hypertension: Characteristics of cohort studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Vitamin D 

Concentration Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Comments 

• Health 

status 

Any 

• Mean 

age (SD), 

y 

Men 65 (8) 

Women 57 

(7) 

• Assay 

method 

Forman RIA 

200794

HPFS, NHS 

US 

(various) 

[17372031] • Male 

(%) 

34 • Season 

blood 

drawn 

All 

Hypertension 

incidence 

stratified by 

25(OH)D 

categories (2 

and 3 

categories) 

X X X 

• Health 

status 

No HTN, 

CVD, DM, 

obesity, 

cancer 

• Mean 

age (SD), 

y 

43 (40-46) 

• Assay 

method 

EIA 

Forman 

200895

NHS 2 

US 

(various) 

[18838623] • Male 

(%) 

0 • Season 

blood 

drawn 

All 

Hypertension 

incidence 

stratified by 

25(OH)D 

categories (2 

and 3 

categories) 

X X X X 
Table 41. Vitamin D and hypertension: Results of cohort and nested case control studies 

Author Year Study Name [PMID] 

Mean (SD) 

Age, Sex 

Outcome 

(n/N; Incidence) 

Followup 

Duration 

Vit D 

Measure 

Concentration, 

nmol/L 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 95

Men 

Forman 200794

HPFS [17372031] 

65 (8), 

Men 

Hypertension 

(61/613; 0.100) 4 y 25(OH)D <37.5 6 33 6.13 1.00

37.5-75 33 247 1.12 0.51

≥75 22 233 1 Refe

<37.5 6 33 5.68 1.01

≥37.5 55 580 1 Refe

Hypertension 

(131/613; 0.214) 8 y 25(OH)D <37.5 9 33 3.53 1.02

37.5-75 nd 247 nd 

≥75 nd 233 1 Refe

<37.5 9 33 3.03 0.94

≥37.5 124 580 1 Refe

Women 

Forman 200895

NHS 2 [18838623] 

43 (40-46, 

range), 

Women 

Hypertension 

(742 cases; 742 

controls) 

Nested case 

control 

~7 y 25(OH)D 41.75 (15.5-52.5) 208 371 1.66 1.11

59.5 (52.75-66.25) 188 370 1.55 1.07

73.0 (66.5-80.5) 195 374 1.52 1.06

94.75 (80.75-224) 151 369 1 Refe

Forman 200794

NHS [17372031] 

57 (7), 

Women 

Hypertension 

(129/1198; 0.108) 4 y 25(OH)D <37.5 11 ndA 2.67 1.05

37.5-75 60 nd 0.85 0.53

≥75 58 nd 1 Refe

<37.5 11 nd 2.98 1.24

≥37.5 118 nd 1 Refe

Hypertension 

(274/613; 0.229) 8 y 25(OH)D <37.5 20 ndA 1.70 0.92

37.5-75 nd nd nd 

≥75 nd nd 1 Refe

<37.5 20 nd 1.42 0.79

≥37.5 254 nd 1 Refe

* Statistically significant (P<0.05) A Due to formatting error in study table, no data on numbers of women in each category. 

123 
Vitamin D and blood pressure. 

Synopsis. 

 No qualified systematic reviews have evaluated the association between vitamin D intake or 

serum 25(OH)D concentrations and changes in blood pressure. Three trials from Germany, UK, 

and India compared different doses of vitamin D (800 IU daily, a single dose of 100,000 IU, or 

120,000 IU every 2 weeks) with placebo, with or without supplemental calcium in both groups. 

The study participants also varied: either older men, older men and women, or men mostly in 

their 40s. Both recruited older adults (over 63 or 70 years). All trials reported no significant 

effect on diastolic blood pressure. The A quality British study of a single dose of vitamin D 

100,000 IU found no difference in systolic blood pressure after 5 weeks. The B quality German 

study found a significant net reduction of 7 mm Hg after 8 weeks in older women taking vitamin 

D 800 IU daily. The B quality Indian study of obese men mostly in their 40s, found a nearly 

significant net increase of 4 mm Hg after 6 weeks of vitamin D 120,000 IU every 2 weeks. No 

long term data were available. 

Detailed presentation (Tables 42 & 43). 

 The A quality trial of single-dose vitamin D, performed in Cambridge, UK, recruited older 

adults (63 to 76 years, mean 70 years) who were not taking antihypertensive medications.96

During the winter, they were given either a one-time dose of vitamin D3 (100,000 IU [2.5 mg]) 

or placebo, and blood pressure was rechecked at 5 weeks. In both study arms, systolic and 

diastolic blood pressures fell by equal amounts, resulting in no net difference between vitamin D 

supplemented and placebo groups. No subgroup analyses were reported. 

 The German B quality trial of supplementation with combined vitamin D and calcium versus 

calcium alone recruited older women (70 to 86 years) without severe hypertension.97 For 8 

weeks, the women took either vitamin D3 800 IU and calcium carbonate 1200 mg or calcium 

carbonate 1200 mg alone daily. Systolic blood pressure decreased by 13 mm Hg in those 

supplemented with vitamin D and calcium compared with a 6 mm Hg decrease in those taking 

calcium alone (P=0.02). Diastolic blood pressure declined by 7 mm Hg in both groups. No 

subgroup analyses were reported. The study was limited by inadequate reporting of its study 

methods and lack of blinding. 

 The Indian B quality study compared every other week vitamin D3 supplementation 120,000 

IU with placebo for 3 weeks in generally healthy but obese men without hypertension.51 The men 

who received the vitamin D supplements had a net increase in systolic blood pressure of 4 mm 

Hg, which was close to statistically significant (P=0.06), but no significant difference in diastolic 

blood pressure. The study was limited by a high dropout rate (26 percent). 

Findings per intake level. 

 No conclusions can be reached about an intake level threshold. In individual trials, a single 

dose of 100,000 IU of cholecalciferol had no significant effect on systolic and diastolic blood 

pressure after 5 weeks, a daily dose of vitamin D3 800 IU together with calcium significantly 

lowered systolic blood pressure more than calcium alone, but every other week vitamin D3

120,000 IU resulted in a nearly statistically significant increase in systolic blood pressure. 

Findings per age and sex. 

 No conclusions can be reached about differences in effect based on age or sex. The study of 

older women found a significant decrease in systolic blood pressure with relatively low dose 

124 
Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y A single study of men in this life stage found a near significant increase in 

systolic blood pressure with vitamin D and no effect on diastolic blood pressure. 

• 51 – 70 y One trial included people with an average age of 70 years, implying that 

about half were within this life stage. No significant effect on blood pressure was found 

of a single large dose of vitamin D. 

• ≥71 y Both trials included people within this life stage. The trial of people with 

an average age of 70 years found no significant effect of a single large dose of vitamin D. 

The single trial of women over age 70 years found a significant benefit for systolic blood 

pressure for vitamin D3 800 IU and calcium carbonate 1200 mg compared with calcium 

carbonate 1200 mg alone. 

• Postmenopause The women in both trials were postmenopausal. See the ≥71 y life 

stage. 

• Pregnant & lactating women Not reviewed 

125 
126 

Table 42. Vitamin D and blood pressure: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake & 

Vitamin D Data 

Comparisons Compliance Comments 

• Health 

status 

No HTN 

• Mean 

age 

(range), y 

70 (63-

76) 

Scragg 199596

Cambridge, UK 

(52°N) 

[7498100] 

• Male 

(%) 

46% 

25(OH)D: 34.5 

nmol/L (treatment 

group), 32.25 nmol/L 

(control group) 

Vit D3 100,000 

IU (2.5 mg) 

one-time dose 

vs. Placebo 

nd Complete trial 

performed in 

winter 

• Health 

status 

Healthy, 

low Vit D 

• Mean 

age 

(range), y 

75 (70-

86) 

Pfeifer 200197

Lower Saxony, 

Germany 

(52°N) 

[11297596] 

• Male 

(%) 

0 

25(OH)D < 50 

nmol/L 

Vit D3 + Ca 

supplement vs. 

Ca supplement 

95±12% for the Ca 

tablets and 96±10% 

for the Vit D3 + Ca 

tablets (pill counting) 

• Health 

status 

Healthy, 

obese 

• Mean 

age (SD), 

y 

44 (8) Nagpal 200951

New Delhi, India 

(28.5°N) 

[19125756] • Male 

(%) 

100% 

25(OH)D: 36.5 

nmol/L (treatment 

group), 30.0 nmol/L 

(control group) 

Vit D3 120,000 

IU every 2 

weeks vs. 

Placebo 

100% (implied); 

supervised home 

visits 

Excluded 

subjects who 

refused 

subsequent blood 

draws 
Table 43. Vitamin D and blood pressure: Results of RCTs 

Author Year Study Name [PMID] 

Age 

Range, 

Sex 

Outcome 1°/2° Mean Followup Interventions, Daily Dose No. Analyzed Unit Baseline Change Change 95% CI Net Diff 

SYSTOLIC BLOOD PRESSURE

Vit D3 100,000 

IU (2.5 mg), 1 

dose 

95 mm Hg 149 -5 -14.4, 4.4A 0 

Scragg 199596 UK 

[7498100] 

63-76 y, 

Both 

SBP 1° 5 wk 

Placebo 94 147 -5 -17.9, 7.9A

Vit D3 800 IU 

+Ca carbonate 

1200 mg 

73 mm Hg 144.1 -13.1 nd -7.4 

Pfeifer 200197

Germany [11297596] 

70-86 y, 

Women 

SBP 1° 8 wk 

Ca carbonate 

1200 mg 72 140.6 -5.7 nd 

Vit D3 120,000 

IU every 2 wk 35 mm Hg 124 +0.6 -2.7, 3.9 +4.0 

Nagpal 200951

New Delhi, India [19125756] 

44 (8, 

SD) 

Men 

SBP 2° 6 wk 

Placebo 36 124 -3.4 -5.8, -1.0 

DIASTOLIC BLOOD PRESSURE

Vit D3 100,000 

IU (2.5 mg), 1 

dose 

95 mm Hg 82 -1 -6.8, 4.8A 0 

Scragg 199596 UK 

[7498100] 

63-76 y, 

Both 

DBP 1° 5 wk 

Placebo 94 82 -1 -6.8, 4.8A

Vit D3 800 IU 

+Ca carbonate 

1200 mg 

73 mm Hg 84.7 -7.2 nd -0.3 

Pfeifer 200197

Germany [11297596] 

70-86 y, 

Women 

SBP 1° 8 wk 

Ca carbonate 

1200 mg 72 82.6 6.9 nd 

Vit D3 120,000 

IU every 2 wk 35 mm Hg 78 +0.4 -2.1, 3.0 +1.7 

Nagpal 200951

New Delhi, India [19125756] 

44 (8, 

SD) 

Men 

SBP 2° 6 wk 

Placebo 36 77 -1.3 -3.2, 0.7 

A Estimated from available data 

127 
Vitamin D and Bone Mineral Density or Bone Mineral Content 

 For bone health outcomes (e.g., bone mineral density, fracture, fall or muscle strength), we 

relied on a recent comprehensive systematic review performed by the Ottawa EPC (Table 28).

6

Because the Ottawa’s EPC report did not have separate analyses on the effect of vitamin D 

supplementation alone, the results for the effect of vitamin D alone or in combination with 

calcium supplementation are presented in “Combined vitamin D and Calcium” section. 

 The Ottawa EPC report was updated with literature published between January 2006 and 

September 2008, selected according to our eligibility criteria. For adults, we included only bone 

mineral density (BMD) indices. For children, we included only bone mineral content (BMC) 

indices. Only RCTs with duration more than 1 year qualified for inclusion. 

Synopsis. 

 The Ottawa EPC report concluded that observational studies suggested a correlation between 

higher serum 25(OH)D concentrations and larger values of BMC indices for older children and 

adolescents (6 months through 18 years old). Furthermore, Based on results of the observational 

studies, there is fair evidence to support an association between serum 25(OH)D and BMD or 

changes in BMD at the femoral neck in postmenopausal women and elderly men. However, there 

was discordance between the results from RCTs and the majority of observational studies.6

 Three 

new RCTs identify from our updated search all showed no significant effects of vitamin D 

supplementation on BMC or BMD in children or adults, respectively. 

 Our updated search did not identify any new RCTs examining the effect of vitamin D on 

BMD and related outcomes in pregnant or lactating women. 

Detailed presentation (Tables 44 & 45). 

Ottawa EPC Report: Bone mineral content - Infants (0 through 12 months). 

Overall, there is inconsistent evidence for an association between a specific serum 25(OH)D 

concentration and the bone health outcome BMC in infants. Of the two RCTs examining BMC, 

one demonstrated no significant benefit of higher serum 25(OH)D concentrations on radial bone 

mass while the other showed a transient increase of BMC compared to the unsupplemented 

group at 12 weeks but not 26 weeks. Of the three case-control studies, greater whole body BMC, 

was related to higher serum 25(OH)D concentrations. 

Ottawa EPC Report: Bone mineral content or density - Older children (6 months through before 

puberty) and adolescents (the onset of puberty through 18 years). 

Overall, there was fair evidence of an association between 25(OH)D concentrations and 

baseline BMD and change in BMD or BMC indices from the studies in older children and 

adolescents. However, the results from two RCTs of vitamin D supplementation have not 

confirmed a consistent benefit on BMD or BMC across sites and age groups. 

There were seven studies in older children and adolescents (two RCTs, three cohorts, one 

case-control and one before-after study) that evaluated the relationship between serum 25(OH)D 

concentrations and BMC or BMD. In older children, there was one RCT, one prospective cohort 

and one before-after study. One RCT did not find an association between serum 25(OH)D 

concentrations and distal radial BMC. Two of three studies found an association between lower 

baseline serum 25(OH)D concentrations and lower BMC or BMD. The effect of bone size and 

muscle mass on these outcomes in relation to baseline serum 25(OH)D concentrations was not 

reported. One RCT demonstrated a significant relation between baseline serum 25(OH)D 

128 
concentrations and baseline BMD of the lumbar spine, femoral neck and radius. However, only 

high dose supplementation with 14,000 IU/wk of vitamin D3 increased BMC of the total hip. 

Ottawa EPC Report: Bone mineral density – Postmenopausal women and elderly men. 

Overall, there was discordance between the results from RCTs and the majority of 

observational studies that may be due to the limitations of observational studies to control for all 

relevant confounders. Five RCTs, and three cohort studies did not find an association between 

serum 25(OH)D concentrations and BMD or bone loss. Four cohort studies found a significant 

association between 25(OH)D concentrations and bone loss, which was most evident at the hip 

sites but the evidence for an association between 25(OH)D concentrations and lumbar spine 

BMD was weak. Six case-control studies suggested an association between 25(OH)D 

concentrations and BMD and the association was most consistent at the femoral neck BMD. 

Based on the results from the observational studies, there is fair evidence to support an 

association between serum 25(OH)D and BMD or changes in BMD at the femoral neck. Specific 

circulating concentrations of 25(OH)D below which bone loss at the hip was increased ranged 

from 30-80 nmol/L. 

Ottawa EPC Report: Bone mineral density - pregnant or lactating women. 

One cohort study did not find an association between serum 25(OH)D concentrations and 

change in BMD that occurred during lactation. Limitations in the study design and sources of 

bias highlight the need for additional research on vitamin D status in pregnancy and lactation, 

and the association with bone health outcomes. 

Additional studies published after the Ottawa EPC report. 

 One A quality RCT compared the effect of vitamin D2 supplementation on hip BMC in 256 

elderly women between 70 and 90 years of age.98 All elderly women in this trial had normal 

physical functioning. They were randomly assigned to receive either vitamin D2 (1000 IU/d) plus 

calcium (1200 mg/d) supplement or calcium (1200 mg/d) supplement alone for one year. The 

mean baseline dietary calcium intake was 1097 mg/d and mean 25(OH)D concentration was 44.3 

nmol/L. Total hip BMD increased significantly in both groups, with no difference between the 

vitamin D2 plus calcium and calcium alone groups (hip BMD change: vitamin D, +0.5 percent; 

control, +0.2 percent). 

 One B quality RCT analyzed 89 and 83 healthy adult women and men separately.99 The 

participants were Pakistani immigrants living in the Copenhagen area of Denmark (latitude 55 

N°). Women and men were randomly assigned to receive either daily dose of 400 IU or 800 IU 

vitamin D3, or placebo for one year. For women, the mean baseline dietary calcium intake was 

495 mg/d and mean 25(OH)D concentration was 12 nmol/L. For men, the mean baseline dietary 

calcium intake was 548 mg/d and mean 25(OH)D concentration was 21 nmol/L. At the end of 

study, in both women and men, there were no significant differences in lumbar spine BMD 

changes between the two doses of vitamin D3 (400 IU/d or 800 IU/d) and the placebo groups.

Two RCTs, both rated C, compared the effect of vitamin D supplementation on BMC in 

healthy girls, aged between 10 and 17 years old.35,99 First RCT analyzed 26 healthy girls, who 

were Pakistani immigrants primarily living in the Copenhagen area Denmark (latitude 55 N°).99

Girls were randomly assigned to receive either daily dose 400 IU or 800 IU vitamin D3, or 

placebo for one year. The mean baseline dietary calcium intake was 510 mg/d and mean 

25(OH)D concentration was 11 nmol/L. At the end of study, there were no significant 

differences in whole body BMC changes between the two doses of vitamin D3 (400 IU/d or 800 

IU/d) and the placebo groups. Second RCT analyzed 168 healthy girls, living in the Greater 

129 
Findings by life stage. 

• 0 – 6 mo The Ottawa EPC report concluded that there is inconsistent evidence for 

an association between a specific serum 25(OH)D concentration and the bone health 

outcome BMC in infants. There were no new data since the Ottawa report. 

• 7 mo – 2 y The Ottawa EPC report concluded that there was fair evidence of an 

association between 25(OH)D concentrations and baseline BMD and change in BMD or 

BMC indices from the studies in older children and adolescents. There were no new data 

since the Ottawa report. 

• 3 – 8 y The Ottawa EPC report concluded that there was fair evidence of an 

association between 25(OH)D concentrations and baseline BMD and change in BMD or 

BMC indices from the studies in older children and adolescents. There were no new data 

since the Ottawa report. 

• 9 – 18 y The Ottawa EPC report concluded that there was fair evidence of an 

association between 25(OH)D concentrations and baseline BMD and change in BMD or 

BMC indices from the studies in older children and adolescents. Two new RCTs enrolled 

only girls in this life stage. The results showed no significant differences in whole body 

BMC changes between either lower doses of vitamin D (200 or 400 IU/d) or higher dose 

of vitamin D (800 or 2000 IU/d) and the placebo groups. 

• 19 – 50 y The Ottawa EPC report concluded that there was discordance between the 

results from RCTs and the majority of observational studies in postmenopausal women 

and elderly men. Based on results of the observational studies, there is fair evidence to 

support an association between serum 25(OH)D and BMD or changes in BMD at the 

femoral neck. One new RCT enrolled primarily men and women in this life stage. The 

results showed that there were no significant differences in lumbar spine BMD changes 

between the two doses of vitamin D3 (400 IU/d or 800 IU/d) and the placebo groups. 

• 51 – 70 y The Ottawa EPC report concluded that there was discordance between the 

results from RCTs and the majority of observational studies in postmenopausal women 

and elderly men. Based on results of the observational studies, there is fair evidence to 

support an association between serum 25(OH)D and BMD or changes in BMD at the 

femoral neck. One new RCT enrolled some men in this life stage. The results showed that 

there were no significant differences in lumbar spine BMD changes between the two 

doses of vitamin D3 (400 IU/d or 800 IU/d) and the placebo groups. 

• ≥71 y The Ottawa EPC report concluded that there was discordance between the 

results from RCTs and the majority of observational studies in postmenopausal women 

and elderly men. Based on results of the observational studies, there is fair evidence to 

130 
support an association between serum 25(OH)D and BMD or changes in BMD at the 

femoral neck. One new RCT enrolled only elderly women in this life stage. The results 

showed that vitamin D2 supplementation (1000 IU/d) had no additional effect on hip 

BMD compared to calcium supplementation alone. 

• Postmenopause There were no new data since the Ottawa report. 

• Pregnant & lactating women There were no new data since the Ottawa report. 

131 
132 

Table 44. Vitamin D and bone mineral density: Characteristics of RCTs published after the Ottawa 

EPC report 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium 

Intake & 

Vitamin D 

Data 

Comparisons Compliance Comments 

• Health 

status 

nd (based on the inclusion and 

exclusion criteria, assume subjects 

were not very healthy but normal 

physical functioning) 

• Mean 

age 

(SD), y 

77 (4.5) 

Zhu 200898

Perth, Australia 

(32 °S) 

[18410225] 

• Male 

(%) 

0 

25(OH)D: 

44.3 nmol/L 

Ca: 1097 

mg/d 

Vit D2 1000 

IU/d + Ca 

citrate 1200 

mg/d vs. Ca 

citrate 1200 

mg/d 

86.7% and 

86.8% in the 

vitamin D 

and the 

control 

groups 

(tablet 

counting) 

• Health 

status 

Healthy 

• Mean 

age 

(range), 

y 

Adolescent girls: 12.2 (10.1-14.7) 

Women: 36.2 (18.1-52.7) 

Men: 38.3 (17.9-63.5) 

Andersen 

200899

Copenhagen, 

Denmark (55 

N°) 

[18208636] 

• Male 

(%) 

42 

25(OH)D: 

Adolescent 

girls: 11 

nmol/L 

Women: 12 

nmol/L 

Men: 21 

nmol/L 

Ca: 

Adolescent 

girls: 510 

mg/d 

Women: 495 

mg/d 

Men: 548 

mg/d 

Vit D3 400 

IU/d, or Vit D3 

800 IU/d vs. 

placebo 

The median 

compliance 

was 85 

(range 43-

100), 92 

(42-115) 

and 93 (33-

105)% for 

girls, 

women, and 

men, 

respectively 

(pill 

counting) 

Pakistani, 

living in 

Denmark. 

Compliance 

was lower 

for girls. 

• Health 

status 

Healthy 

• Mean 

age 

(range), 

y 

13.2 (10-17) 

El-Hajj 200635

Beirut, Lebanon 

(33°53'N) 

[16278262] 

• Male 

(%) 

0 

25(OH)D: 

34.9 nmol/L 

Ca: 677 

mg/d 

Weekly oral 

Vit D doses of 

1400 IU (=Vit 

D 200 IU/d ) 

or 14,000 IU ( 

Vit D 2000 

IU/d) vs. 

placebo 

Placebo - 

98%, Low 

dose group - 

98%, High 

dose group - 

97% (pill 

counting) 
Table 45. Vitamin D and bone mineral density or bone mineral contents: Results of RCTs published after the Ottaw

Author Year Study Name Location (Latitude) [PMID] 

Life Stage Outcome 1°/2° 

Mean 

Followup, 

mo 

Interventions, 

Daily Dose 

No. 

Analyzed Unit Baseline Change Change 95% CI Net Diff 

Vit D2 1000 IU 

+ Ca citrate 1200 mg 

123 mg/cm2 851 0.5% -0.09, 

1.09 

Zhu 2008 0.3% 

98

Perth, Australia (32 °S) [18410225] 

71+. Women 

only 

Hip BMD 1° 12 

Ca citrate 1200 mg 

133 826 0.2% -0.19, 

0.59 

Vit D3 400 30/21A mg/cm2 1.06 0% nd -1% Vit D3 800 30/21 0.98 1% nd 0% 

Andersen 200899

Copenhagen, Denmark (55 N°) [18208636] 

18-53, Women 

only 

Lumbar 

spine 

BMD 

1° 12 

Placebo 29/18 0.99 1% nd 

Vit D3 400 25/19A mg/cm2 1.03 2% nd 0% 

Vit D3 800 31/26 0.92 7% nd 5% 

Andersen 200899

Copenhagen, Denmark (55 N°) [18208636] 

18-64, Men 

only 

Lumbar 

spine 

BMD 

1° 12 

Placebo 27/19 1.03 2% nd 

Vit D3 400 9/7A kg 1.3 22% nd 7% 

Vit D3 800 9/7 1.5 10% nd -5% 

Andersen 200899

Copenhagen, Denmark (55 N°) [18208636] 

10-15 y girls BMC 1° 12 

Placebo 8/7 1.7 15% nd 

Vit D 2000 IU 55 kg 1.2 6.2% 4.7, 7.7 0.1% Vit D 200 IU 58 1.1 6.1% 4.6, 7.6 1.1% 

El-Hajj 200635

Beirut, Lebanon (33°N) 

[16278262] 

10-17 y girls BMC 1° 12 

Placebo 55 1.1 5.0% 3.8, 6.2 

Vit D 2000 IU 14 kg 0.8 11.6% 9.4, 13.8 4.2% 

Vit D 200 IU 12 0.7 11.4% 9.1, 13.7 4.0% 

Subgroup– 

Premenarcheal 

girls, mean 

age 10 y 

BMC 1° 12 

Placebo 8 0.8 7.4% 4.7, 10.1 

A Baseline/final sample size B Downgraded to C because very small sample size (insufficient power) and no adjustments for confounders c Estimated from available data

133 
Calcium and Health Outcomes 

Calcium and Growth 

 We reviewed systematic reviews and primary studies that evaluated relationships 

between calcium intake and growth parameters in infants and children. 

Synopsis. 

 One systematic review and three primary studies evaluated supplemental intake of 

calcium and growth parameters in infants and children. The systematic review with a 

meta-analysis of 17 RCTs did not find an effect on weight and height gain attributable to 

calcium supplement in children ranging from 3 to 18 years of age. Three additional 

primary studies reported similar findings. Overall, the studies reviewed did not find a 

relationship between supplemental calcium intake and growth parameters. 

Detailed presentation (Tables 46, 47 & 48). 

0 - 6 months; 3 - 8 years; 9 - 18 years; pregnant women. 

 One systematic review of RCTs of supplemental calcium on bone related outcomes in 

children (age 3-18 y) also examined changes in height and weight at followup.100 The 

systematic review (comprised of studies in Australia, China, Gambia, Israel, Switzerland, 

and US) conducted a meta-analysis of 17 RCTs with a total of 2088 subjects and found 

no significant difference in weight (weighted mean difference +0.14 kg (favors 

control)(95 percent CI -0.28, +0.57 kg)) and height gain (weighted mean difference +0.22 

cm (favors control)(95 percent CI -0.30, +0.74 cm)) between those who were and those 

who were not supplemented. There was no significant statistical heterogeneity in the 

included studies. The calcium intake ranged from 300 to 1200 mg/d lasting from 0.7 to 4 

years. The majority of the supplement used was calcium carbonate. This systematic 

review met seven of 11 AMSTARi

 quality checklist items. 

 Two primary studies rated B in methodological quality and one primary study rated C 

provided additional information. One RCT from Denmark randomly assigned 110 girls 

(mean age 13 years) with either low (<713 mg/d) or medium (1000 to 1304 mg/d) 

habitual calcium intake to a supplement of calcium 500 mg/d (calcium carbonate) or 

placebo for 1 year.101 There was no significant difference in height or weight gain among 

the groups at followup. One post hoc analysis of an RCT in Nebraska on bone mass 

analyzed 59 girls (mean age 9.5 years) who were randomly assigned to either a calcium 

enriched diet, supplying at least 1500 mg of calcium per day (~1656 mg/d), or usual diet 

(961 mg/d).102 There was no significant difference in weight gain at 2 years followup. A 

cohort study in Washington DC analyzed dietary intake data from 322 pregnant African 

American women (mean age 21.6 years; 39 percent 16-19 years) and found that “none of 

the food energy and nutrient intakes [mean calcium intake 933 mg ± 52 (SE)] was 

significantly correlated with any of the pregnancy outcome measures”. No specific 

quantitative relationship between calcium intake and infant birth weight or length was 

reported.103

 

i

 A measurement tool to assess the methodological quality of systematic reviews 

134 
Findings by life stage. 

• 0 – 6 mo A cohort study of dietary intake in 322 pregnant African American 

women found that calcium intake was not significantly correlated with any 

pregnancy outcome measures, including infant birth weight or length. 

• 7 mo – 2 y No study covered this life stage.

• 3 – 8 y One meta-analysis of 17 RCTs in children (age 3-18 y) found no 

significant difference in weight and height gain between those who were and 

those who were not supplemented at followup. The calcium intake ranged from 

300 to 1200 mg/d lasting from 0.7 to 4 years.

• 9 – 18 y In addition to the findings from the above meta-analysis, two 

primary studies provided additional information. One RCT of calcium 500 mg/d 

(calcium carbonate) versus placebo for 1 year found no significant difference in 

height or weight gain among the 110 girls (mean age 13 years) at followup. A 

post hoc analysis of an RCT of calcium enriched diet (~1656 mg/d) versus usual 

diet (~961 mg/d) on bone mass found no significant difference in weight gain at 2 

years followup in 59 girls (mean age 9.5 years).

• 19 – 50 y Not reviewed

• 51 – 70 y Not reviewed

• ≥71 y Not reviewed

• Postmenopause Not reviewed

• Pregnant & lactating women See 0 – 6 month results. 

135 
136 

Table 46. Summary of systematic review of calcium on growth in children 

Author Year [PMID] Winzenberg 2007100 [17636098] 

Design (Search Years) Randomized controlled trials (1966-2005) 

Population Children <18 y 

Intervention (Exposure) 

and Comparator 

Supplemental and dietary calcium 300-1200 mg/d vs. placebo 

Results 17 trials (2088 participants) 

Weighted mean difference: +0.14 (95% CI -0.28, +0.57) kg; favors control 

Weighted mean difference: +0.22 (95% CI -0.30, +0.74) cm; favors control 

 No significant statistical heterogeneity 

Comments Post hoc analysis performed on trials identified for a meta-analysis of randomized 

controlled trials of calcium on bone outcomes 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? No 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages 

included? 

No Publication bias assessed? Yes 

Included and excluded studies listed? No Conflicts of interest stated? No 

Study characteristics provided? Yes Unclear if all languages included; study quality assessed 

but not factored into the M-A 

Table 47. Calcium and growth: Characteristics of primary studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium 

Intake & 

Vitamin D 

Data 

Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Comments 

• Health 

status 

no specific 

health issue 

reported 

• Mean age 

(range/SD), 

y 

13 

Lorenzen 

2006101

Denmark 

(55oN) 

[16400044] 

• Male (%) 0 

88-item FFQ 

(no internal 

validation); 

dietary 

calcium: 957 

mg/d; 

25(OH)D: 

34.5 nmol/L 

Ca CO3 (Ca 

500 mg/d) X 1 

y vs. placebo 

x x x RCT; 

Danish 

surnames 

only 

• Health 

status 

healthy 

• Mean age 

(range/SD), 

y 

9.5 

Lappe 

2004102

Omaha, NE 

US 

(41oN) 

[15354150] • Male (%) 0 

3-d food 

record (no 

internal 

validation); 

dietary 

intake 

calcium: 819 

mg/d; dietary 

vit D 180 

IU/d (4.5 

μg/d) 

Calcium rich 

diet (~1656 

mg/d) vs. 

usual diet 

(~961 mg/d); 

wt & ht 

change at 2 y 

x x x x Post hoc 

of RCT 

on bone 

mass; 

95% 

white, 5% 

black 

• Health 

status 

pregnant; no 

DM, sickle, 

thalassemia, 

HbC 

disease 

• Mean age 

(range/SD), 

y 

22 (39% 16-

19) 

Johnson 

1994103

Washington 

DC, US 

(38oN) 

[8201444] 

• Male (%) 0 

FFQ (no 

internal 

validation); 

calcium 

933.4 mg/d 

Relationship 

between 

maternal 

calcium intake 

and birth 

weight, height 

Cohort 

study; all 

African 

American; 

Total Ca 

(from 

food) 
Table 48. Calcium and growth: Results of primary studies 

Author Year Study Name PMID 

Life 

Stage Outcome 1°/2° 

Mean 

Followup, 

Y 

Interventions, Ca daily Dose 

No. 

Analyzed Unit Baseline Change Change 95% CI Net Diff 

RCT 

500 mg/d x 1 y 30 kg 51.8 5.1 1.7, 8.5A 0.2 

Lorenzen 2006101

(55oN) 

9-18 

female 

wt in medium Ca intake group (1000-1304 mg/d) 

1o 1 Placebo 30 kg 

50.7 4.9 1.8, 8.0 [16400044] A 

500 mg/d x 1 y 30 kg 52.2 4.1 0.7, 7.5A 1.1 

wt in low Ca intake group (<713 mg/d) 

1o 1 Placebo 30 kg 49.5 3.0 -0.2, 6.2A

1.6, 5.8A 500 mg/d x 1 y 30 cm 162.5 3.7 -0.3 

ht in medium Ca intake group (1000-1304 mg/d) 

1o 1 Placebo 30 cm 161.9 4.0 1.7, 6.3A

1.1, 6.1A 0.5 

ht in low 500 mg/d x 1 y 30 cm 159.6 3.6 Ca intake group (<713 mg/d) 

1o 1 Placebo 30 cm 160.1 3.1 0.3, 5.9A

Post hoc analysis of an RCT on bone outcomes 

Ca enriched diet (~1656 mg) 

Lappe 9-18 

female 27 kg 32.2 10.7 8.2, 13.2A -0.2 

2004102

(41oN) [15354150] 

wt 2o 2 Usual diet 

(~961 mg) 32 kg 33.2 10.9 7.9, 13.9A

Ca enriched diet (~1656 mg) 27 cm 137 14 11.5, 16.5A 1 

ht 2o 2 Usual diet 32 cm (~961 mg) 138 13 11, 15A

Cohort Johnson 1994103

(38oN) [8201444] 

9-18 female; infant 0-6 mo 

birth wt & length 1o until delivery 

322 African American women with a mean dietary calcium intake of 933 mg/d; “None of the food energy and nutrient intakes was significantly correlated with any of the outcome measures”. No specific quantitative relationship between calcium intake and inlength was reported. A Estimated from reported data 

137 
Calcium and Cardiovascular Disease 

Synopsis. 

 No qualified systematic reviews evaluated the association between calcium intake and 

incidence of cardiovascular disease. No calcium intervention trials evaluated cardiovascular 

outcomes. Ten longitudinal cohort studies and one nested case-control study analyzed 

associations with various specific cardiovascular events. In all studies, baseline calcium intake, 

assessed by food frequency questionnaires, were analyzed as predictors of long-term 

cardiovascular outcomes. We point out where there were "suggestions" of associations in cases 

where P values were about 0.10 and/or there were consistent, though not statistically significant 

differences in risk compared to the lowest risk category of at least 20 percent. 

 Notably, the implied ranges of calcium intake within studied populations varied widely 

across studies. At one extreme, men and women in the Japan CC study had mean calcium intakes 

in the lowest quintile of 250 or 266 mg/day and in the highest quintile of 665 and 667 mg/day. 

The Japan PHC study and the Taiwanese CVD-FACTS study had similarly low calcium intake. 

The study with the highest calcium intake was the ATBC study of men in Finland. Median 

calcium intakes in the lowest and highest quintiles were 876 and 1916 mg/day, respectively; the 

overall median intake was 1379 mg/day. 

 Cardiovascular death was analyzed in two large studies analyzed, separately in men and 

women. Neither found a significant association between calcium intake and cardiovascular death 

after 9 or 28 years in either men or women. 

 Combined fatal and nonfatal cardiac events were analyzed in two large and one relatively 

small studies, in either both sexes together or just men. None found a significant association 

between calcium intake and cardiac events after 10 to 13 years. 

 Cardiac death was analyzed in three large and one relatively small studies, separately in men 

and women. Overall, no consistent significant association between calcium intake and cardiac 

death after 8, 9, 12, or 28 years of followup was found in the various studies, in either men or 

women. One study (the Iowa WHS) found a significant association between calcium intake of 

less than 696 mg/day and higher risk of ischemic heart disease death in white women aged 55 to 

69 years. 

 Nonfatal myocardial infarction was analyzed by one large study of men. No significant 

association was found with calcium intake after 12 years of followup. 

 Total strokes were analyzed in five large and one relatively small studies, in both sexes 

combined, and separately for men and women. The studies had disparate findings. A Japanese 

and a Taiwanese study of men and women (40-59 y and ≥40 y, respectively) found progressively 

lower risks for stroke in people in higher quintiles of calcium intake after 13 and 11 years, 

respectively, in the setting of overall relatively low dietary calcium intake. A small Finnish study 

of both men and women (65-99 y) found no significant association after 10 years. The two 

studies of men (40 to 75 years old) found suggestions of associations (not statistically 

significant), though with trends in opposite directions; one suggested the highest risk for stroke 

in men with calcium intake below approximately 750 mg/day after 8 years; one suggested the 

highest risk for cerebral infarctions in men with calcium intake above about 1000 mg/day after 

14 years. The study of women (32-57 y) found a nonsignificant trend after 14 years, but 

significantly higher stroke risk in those with calcium intake less than about 500 mg/day 

compared with women in the next two higher quintiles of calcium intake. 

138 
 Fatal strokes were analyzed in one large cohort study and a nested case-control study, 

separately in men and women. None found a significant association between calcium intake and 

cardiac events after 10 to 13 years of followup. 

Detailed presentation (Tables 49 & 50, Figures 11 & 12). 

Cardiovascular death. 

 Two longitudinal cohort studies analyzed risk of cardiovascular death (death from cardiac or 

cerebrovascular events), separately in men and women, according to quintiles. 

 In the Japan Collaborative Cohort (Japan CC),104 about 23,000 men aged 40 to 79 years 

without a history of cardiovascular disease were followed for 8.9 years; 3 percent died of a 

cardiovascular event. Men within the calcium quintiles had mean calcium intakes that ranged 

from 250 to 665 mg/day. No significant association was found between calcium quintile and 

cardiovascular death risk. In a study of Dutch civil servants (and spouses),105 1340 men aged 40 

to 65 years (regardless of cardiovascular history) were followed for 28 years. About 27 percent 

(age-adjusted) had a cardiovascular death. The calcium intake quintiles ranged from less than 

585 mg/day to more than 1245 mg/day. No significant associations were found between calcium 

intake and risk of cardiovascular death; however, men in the lowest quintile (≤585 mg/day) had 

an adjusted odds ratio of cardiovascular death of 1.3 (95 percent CI 0.8, 1.9) compared to those 

in the highest quintile. Both studies had methodological quality B. The Japanese study did not 

define cardiovascular mortality and the Dutch study did not report a complete analysis of the 

calcium intake quintiles. 

 In the Japan CC, about 35,600 women aged 40 to 79 years without a history of 

cardiovascular disease were followed for 8.9 years; 1.8 percent died of a cardiovascular event. 

Women within the calcium quintiles had mean calcium intakes that ranged from 266 to 667 

mg/day. No significant trend across quintiles or associations among quintiles was found for risk 

of cardiovascular death. However, women in the lowest quintile had about 25 to 30 percent 

lower risks of cardiovascular death than women in the next two higher quintiles. In the Dutch 

civil servants study, 1265 women were followed for 28 years. About 14 percent had a 

cardiovascular death. The calcium intake quintiles ranged from less than 445 mg/day to more 

than 850 mg/day. No significant associations were found between calcium intake and risk of 

cardiovascular death. 

Cardiac events, total. 

 Three longitudinal cohort studies analyzed combined fatal and nonfatal cardiac events, 

including coronary heart disease, acute myocardial infarction, and ischemic heart disease; two 

combined both sexes, one included only men. 

 In the Japan Public Health Center (Japan PHC) study (methodological quality A),106 about 

41,500 people aged 40 to 59 years, without cardiovascular disease, were followed for 13 years; 

0.8 percent had cardiac events. People within the calcium intake quintiles had median calcium 

intakes that ranged from 233 to 753 mg/day. No association was found between calcium intake 

and risk of coronary heart disease events. In a small Finnish longitudinal study,48 755 people 

aged 65 to 99 years, regardless of cardiovascular history were followed for 10 years; 17 percent 

had a cardiac event. No significant association was found between tertiles of calcium intake and 

all acute myocardial infarctions. This methodological quality C study did not report relevant data 

including information on the calcium intake within the tertiles. 

 In the Health Professionals Follow-up Study (HPFS),107 about 39,000 men with a mean age 

of 54 years, without cardiovascular disease were followed for 12 years; 3.7 percent had an 

139 
ischemic heart disease event. The study was of methodological quality A. Men within the 

calcium quintiles had mean calcium intakes that ranged from 523 to 1377 mg/day. No significant 

association was found between calcium intake and risk of cardiac events. 

Cardiac death. 

 Four longitudinal cohort studies analyzed death from cardiac events, separately in men (3 

studies) and women (3 studies). 

 In the three studies of men, all found no significant association between calcium intake and 

cardiac death. All three studies are described above. In HPFS 1.1 percent of men died of a 

cardiac event during 12 years of followup.107 In the Japan CC study 0.6 percent of men died of a 

cardiac event during 9 years of followup (methodological quality A for this outcome).104 In the 

Dutch civil servants study about 15 percent (age-adjusted) died of a cardiac event during 28 

years of followup.105

 Three studies analyzed cardiac death in women. In two studies, both described above, there 

was no significant association between calcium intake and cardiac death. In the Japan CC study 

0.3 percent of women died of a cardiac event during 9 years of followup.104 In the Dutch civil 

servants study about 6 percent (age-adjusted) died of a cardiac event during 28 years of 

followup.105 The Iowa Women’s Health Study (Iowa WHS) analyzed about 34,500 white 

women, aged 55 to 69 years, without ischemic heart disease. During 8 years of followup, 1.1 

percent died of a cardiac event. However, the study was of methodological quality B for this 

outcome because the outcome was not fully ascertained. The calcium intake quartiles ranged 

from less than 696 mg/day to more than 1425 mg/day. There was a suggestion of an association 

between lower calcium intake and higher risk of cardiac death, with a P value of 0.09 for the 

trend across quartiles and statistically significant adjusted relative risks of cardiac death for 

women with calcium intakes above 696 mg/day of 0.62 to 0.75 (compared to the lowest quartile). 

Cardiac events, nonfatal. 

 Only the HPFS, described above, analyzed nonfatal cardiac events (methodological quality 

A).107 During 12 years of followup 2.6 percent of almost 40,000 men had nonfatal myocardial 

infarctions. No significant association was found between calcium intake and nonfatal cardiac 

events. 

Stroke, total. 

 Six longitudinal cohort studies analyzed combined fatal and nonfatal strokes, in either both 

sexes combined, or men and women separately. 

 In the Japan PHC study, described above (cardiac events, total), 3 percent of people suffered 

strokes during 13 years of followup (methodological quality A).106 The study found a significant 

association between baseline calcium intake and risk of stroke. The risk of stroke was 

progressively lower in progressively higher quintiles of calcium intake. People with a median 

calcium intake of 439 mg/day (middle quintile) had a statistically significant adjusted hazard 

ratio (HR) of 0.79 compared to those with a median calcium intake of 233 mg/day. Those in 

higher quintiles had lower HRs; across quintiles, the trend had a P value of 0.02. As is evident 

from the median calcium intake levels within the quintiles, the middle-aged Japanese in this 

study had considerably lower average calcium intake than in most other studies (particularly 

those performed in the US). Compared to similar studies evaluated here, the calcium intake was 

approximately half of that in the HPFS or Iowa WHS. The CVD-FACTS study, performed in 

men and women at least 40 years old in Taiwan, evaluated ischemic strokes.108 After a mean 

followup of 10.6 years, 7.4 percent of the cohort had an ischemic stroke. The B quality study 

140 
divided the cohort into tertiles. Similar to the Japanese study, the typical calcium intake was 

relatively low by Western standards (the average dietary calcium intake was approximately 520 

mg/day). Those in the lower two tertiles had about a 50 percent increased risk of ischemic stroke 

than those in the highest tertile (>591 mg/day). While the adjusted OR for each tertile were not 

quite statistically significant (1.52 [95 percent CI 0.98-2.35] for lowest tertile; 1.49 [95 percent 

CI 0.99-2.24] for middle tertile; compared to highest tertile), the trend across tertiles had a P 

value of 0.03. The third study of combined men and women, of older Finns (described above 

under Cardiac events, total), found no significant association with stroke among 755 people 

followed for 10 years (stroke incidence 9.3 percent; methodological quality C).48

 Both studies of men alone suggest trends across quintiles of calcium intake and stroke risk; 

however, the associations were in opposite directions. The HPFS, described above (cardiac 

events, total; methodological quality A) had a stroke incidence of 0.75 percent during 8 years of 

followup. Men in higher quintiles of calcium intake had generally lower adjusted relative risks 

(RR) of stroke compared to the lowest quintile (median calcium intake 500 mg/day); though 

none of the RRs was statistically significant and the P value for the trend across quintiles was 

0.10. Notably, the RR of stroke for men in the middle quintile (median calcium intake 800 

mg/day) was 0.72 (95 percent CI 0.50, 1.03); though the RRs for men in higher quintiles were 

closer to 1 with wider 95 percent confidence intervals. In the Alpha-Tocopherol, Beta-Carotene 

Cancer Prevention (ATBC) Study, performed in southern Finland, about 26,500 men aged 50 to 

69 years without a history of stroke were followed for almost 14 years; 10 percent suffered a 

stroke. The study was of methodological quality C because there was large misclassification of 

stroke outcomes in a sample of subjects (5-21 percent). Men in the lowest quintile of calcium 

intake (median 876 mg/day) had the lowest adjusted RR for cerebral infarction. Men in all higher 

quintiles (medians ranging from 1178 to 1916 mg/day) all had RR of about 1.10 that were near 

statistical significance (e.g., 95 percent CI for highest quartile was 0.98, 1.26). The P value of the 

trend of association across quintiles was 0.09. 

 One study evaluated total strokes in women alone. The Nurses Health Study (NHS) evaluated 

about 86,000 women aged 32 to 57 years with no history of cardiovascular disease. The study 

was rated methodological quality A. During 14 years of followup 0.8 percent of women suffered 

a stroke. The women in the four quintiles above the lowest quintile (who had a median calcium 

intake of 395 mg/day) all had similar adjusted RR of stroke (0.71-0.87); the RRs of those women 

in the second and third quintiles were statistically significant. However, the trend of associations 

across quintiles was not statistically significant. 

Stroke death. 

 One longitudinal cohort study (with subanalyses in men and women separately) and one 

nested case-control study (in men) evaluated fatal strokes. 

 Both studies of men found no significant association between calcium intake and risk of 

stroke death. In the Japan CC study (described above, methodological quality A for this 

outcome) 1.4 percent of men died of stroke during 9 years of followup. The second study was a 

nested case-control study performed in China. In a prospective cohort of about 18,000 men aged 

45 to 64 years, regardless of cardiovascular history, 245 died of stroke (1.3 percent) during 12 

years of followup. These cases were matched with 1225 controls. The remaining 17,000 men 

were omitted from the analysis. The study also did not report data on the calcium intake within 

the tertiles. The methodological quality was C. 

 In the Japan CC study, 0.9 percent of women died of stroke. The study also found no 

consistent association between calcium intake and stroke death. 

141 
Findings per calcium intake level. 

 Among the outcomes for which studies had either statistically significant associations or 

suggestions of associations between calcium intake and cardiovascular events, the following 

findings of calcium intake level were reported. 

 Regarding the risk of overall cardiovascular mortality, one of two studies in women (Japan 

CC) found a suggestion that higher calcium intake may be associated with increased risk of 

cardiovascular death. The association can be seen for quintiles 2 to 4, where women in the lowest 

quintile had a median calcium intake of 266 mg/day and those in the second quintile had a 

median calcium intake of 379 mg/day. 

 Regarding the risk of cardiac mortality, one of three studies in women (Iowa WHS) found 

that women in the lowest quartile of calcium intake, below 696 mg/day, had the highest risk of 

cardiac mortality. 

 Regarding the risk of stroke, among studies of both sexes combined, two (Japan PHC and the 

Taiwanese CVD-FACTS) of three studies found a statistically significant association between 

lower calcium intake and higher risk of stroke. In Japan PHC, those in the third to fifth quintiles, 

with median calcium intakes of 439 mg/day or higher, had lower risks than those in the lowest 

quintile. Those in the second quintile had a median calcium intake of 344 mg/day and those in 

the lowest quintile 233 mg/day. In CVD-FACTS, those in the two tertiles with calcium intake 

below 591 mg/day had about a 50 percent increased risk of stroke compared to those with higher 

calcium intake. The two studies restricted to men had opposite findings. The HPFS found lower 

risks of stroke among men in the third to fifth quintiles of calcium intake (median 800 mg/day or 

higher) compared to the lowest quintile (median 500 mg/day). Those in the second quintile had a 

median calcium intake of 700 mg/day. In contrast, the ATBC study in Finland found somewhat 

higher risks of stroke (RR~1.1) in all quintiles above the lowest quintile. The median calcium 

intakes in the first and second quintiles were 876 and 1178 mg/day, respectively. The one study 

of women (NHS) had lower risks of stroke in all quintiles above the lowest quintile. The median 

calcium intakes in the first and second quintiles were 395 and 645 mg/day, respectively. 

Findings per age and sex. 

 The majority of studies (and the large majority of individuals) included mostly people 

between the ages of about 40 and 70 years. The youngest individuals included were 32 year old 

women in the NHS. Apparently very few individuals were over the age of 70 years. Only a small 

Finnish study (Marniemi 200548) restricted the study cohort to only older adults (65 years and 

older). This study found no significant associations between calcium intake and cardiovascular 

events. No study reported a subgroup analysis based on age. The reported data do not allow 

further conclusions based on age. 

 Almost all studies or analyses separately evaluated men and women. The findings that could 

be interpreted as an association between calcium intake and cardiovascular risk were mostly 

found in women (low calcium intake being associated with increased risk of cardiac death (in 

one of three studies) and stroke (in a single study), but with lowered risk of overall 

cardiovascular death (in one of two studies). The only potential associations between calcium 

intake and cardiovascular events in men were found for stroke; however, the two studies had 

opposite findings about the direction of the association. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

142 
• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y Overall, the studies included relatively few people in this life stage. All 

were at least 32 years old, and most were at least 40 to 45 years old. However, the one 

study of stroke in women was conducted in women who were mostly in this life stage. 

Those in the lowest quintile of the NHS appear to have had higher risks of stroke than 

those women with greater calcium intake. 

• 51 – 70 y The majority of evidence regards people in this life stage. Overall, the 

majority of analyses found no significant association between calcium intake and most 

cardiovascular events. Only for stroke did at least two studies find significant 

associations between calcium intake and the outcome. In two Asian studies, where the 

average dietary calcium intake was about half that in the US and which also included 

people in the younger life stage, stroke risk was progressively higher in lower quantiles 

(maximum quantiles were median of 753 mg/day and >591 mg/day). For studies of 

people within this life stage, other significant associations were found in one of three 

studies of cardiac death in women (calcium intake below 696 mg/day was associated with 

increased risk) and in one of two studies of cardiovascular death in women (calcium 

intake above about 300 mg/day may be associated with increased risk). 

• ≥71 y Few studies included people in this life stage. The one study of people in 

this life stage found no association between calcium intake and cardiac events or stroke in 

a relatively small, quality C study. 

• Postmenopause Only the Iowa WHS included primarily postmenopausal women. 

In their analysis, calcium intake below 696 mg/day was associated with increased risk of 

ischemic heart disease death. 

• Pregnant & lactating women Not reviewed 

143 
Table 49. Calcium and cardiovascular outcomes: Characteristics of cohort studiesB

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Dietary Calcium 

intake 

Nutrients Demograph Anthrop Medical UV exposure 

Specific CVD 

Outcomes Comparisons Lifestyle 

• Health 

status 

No 

CVD 

Outcome 

stratified by 

total Ca intake 

quintiles 

X X X X X IHD 

MI 

• Mean 

age 

(SD), y 

54 (9) 

• Dietary 

assessment 

method 

Al-Delaimy FFQ 

2003107

HPFS 

US 

(various) 

[12663277] • Male 

(%) 

Cardiac death 

100 • Internal Yes 

validation? 

(y/n) 

Total Ca 

(both) 

• Health 

status 

No 

CVD 

Outcome 

stratified by 

total Ca intake 

quintiles 

X X X X X Stroke 

• Mean 

age 

(range), 

y 

nd 

(40-75) 

• Dietary 

assessment 

method 

Ascherio FFQ 

1998109

HPFS 

US 

(various) 

[9743511] 

• Male 

(%) 

100 • Internal Yes 

validation? 

(y/n) 

Total Ca 

(both) 

• Health 

status 

No IHD Outcome 

stratified by 

total Ca intake 

quartiles 

X X X X X Cardiac death 

• Mean 

age 

(range), 

y 

61 

(55-69) 

• Dietary 

assessment 

method 

Bostick FFQ 

1999110

Iowa WHS 

Iowa 

(42°) 

[9921960] 

• Male 

(%) 

0 • Internal Yes 

validation? 

(y/n) 

Total Ca 

(both) 

• Health 

status 

No 

CVD 

• Mean 

age 

(range), 

y 

46 

(32-57) 

• Dietary 

assessment 

method 

Iso 1999 FFQ 111

NHS 

US 

(various) 

[10471422] 

• Male 

(%) 

Outcome 

stratified by 

total Ca intake 

quintiles 

X X Stroke 

0 • Internal No 

validation? 

(y/n) 

Total Ca 

(food) 

• Health 

status 

No 

stroke 

Outcome 

stratified by 

total Ca intake 

quintiles 

X X X X X Stroke 

(cerebral 

57 infarct) 

(50-69) 

• Mean 

age 

(range), 

y 

• Dietary 

assessment 

method 

Larsson FFQ 

2008112

ATBC 

SW Finland 

(~60°N) 

[18332289] 

• Male 

(%) 

100 • Internal No 

validation? 

(y/n) 

Total Ca 

(food) 

• Health 

status 

Any Outcome 

stratified by 

total Ca intake 

tertiles 

X X X MI 

• Mean 

age 

(range), 

y 

79 

(65-99) 

• Dietary 

assessment 

method 

Marniemi Interview 

200548

Turku 

Finland 

(60°N) 

[15955467] 

• Male 

(%) 

Stroke 

48% • Internal No 

validation? 

(y/n) 

Total Ca 

(both) 

continued 

144 
145 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Dietary Calcium 

intake Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Specific CVD 

Outcomes 

• Health 

status 

Cases 

& 

controls 

• Mean 

age 

(range), 

y 

nd 

(45-64) 

• Dietary 

assessment 

method 

Ross FFQ 

1997113A 

Shanghai 

China 

(31°N) 

[9236416] 

• Male 

(%) 

100 • Internal 

validation? 

(y/n) 

nd 

Outcome 

stratified by 

total Ca intake 

tertiles 

X X X X Fatal stroke 

Total Ca 

(food) 

• Health 

status 

No 

CVD 

• Mean 

age 

(range), 

y 

56 

(40-79) 

• Dietary 

assessment 

method 

Umesawa FFQ 

2006104

Japan CC 

Japan 

(various) 

[16339476] 

• Male 

(%) 

39 • Internal 

validation? 

(y/n) 

No 

Outcome 

stratified by 

total Ca intake 

quintiles 

X X X X X Cardiac death 

Stroke death 

CVD death 

Total Ca 

(food) 

• Health 

status 

No 

CVD 

• Mean 

age 

(range), 

y 

49 

(40-59) 

• Dietary 

assessment 

method 

Umesawa FFQ 

2008106

Japan PHC 

Japan 

(various) 

[18635855] 

• Male 

(%) 

48 • Internal 

validation? 

(y/n) 

Yes 

Outcome 

stratified by 

total Ca intake 

quintiles 

X X X X X CHD 

Stroke 

Total Ca 

(food) 

• Health 

status 

Any 

• Mean 

age 

(range), 

y 

52 

(40-65) 

• Dietary 

assessment 

method 

van der FFQ 

Vijver 

1992105

Dutch civil 

servants 

Amsterdam 

Netherlands 

(52°) 

[1544755] 

• Male 

(%) 

51 • Internal 

validation? 

(y/n) 

No 

Outcome 

stratified by 

total Ca intake 

quintiles 

X X X Cardiac death 

CVD death 

Total Ca 

(food) 

• Health 

status 

No 

stroke, 

cancer 

• Mean 

age 

(range), 

y 

57 

(≥40) 

• Dietary 

assessment 

method 

Weng FFQ 

2008108

CVD—

FACTS 

Taiwan 

(22°-25°) 

[18988909] 

• Male 

(%) 

44 • Internal 

validation? 

(y/n) 

No 

Outcome 

stratified by 

total Ca intake 

quartiles (top 

2 quartiles 

combined) 

X X X X Ischemic 

stroke 

Total Ca 

(both) 

A

 Nested case-control study 

B This table is ordered alphabetically by study author 
Table 50. Calcium and cardiovascular outcomes: Results of cohort studies 

Author Year Study Name PMID 

Age 

Range, Sex 

Outcome (n/N; 

Incidence) 

Followup 

Duration 

Total Ca 

Intake, mg/day 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95% 

CVD Death 

Men 

Umesawa 2006104

Japan CC [16339476] 

40-79 y, 

Men 

CVD death 

(685/23,117; 0.030) 

8.9 y 250, mean 140 4623 1 Refere

363 141 4624 0.98 0.75, 1449 135 4623 0.93 0.67, 1

536 135 4624 0.92 0.64, 1

665 134 4623 0.97 0.64, 1

van der Vijver 1992105

Dutch civil servants [1544755] 

40-65 y, 

Men 

CVD death 

(nd/1340; ~0.27, 

age-adjusted) 

28 y ≤585 31.9%, 

ageadjusted 

271 1.3 0.8, 1

585-1245 26.7% 798 1.1 0.8, 1

>1245 24.9% 271 1 Refere

Women 

Umesawa 2006104

Japan CC [16339476] 

40-79 y, 

Women 

CVD death 

(644/35,609; 0.018) 

8.9 y 266, mean 153 7121 1 Refere

379 156 7122 1.29 0.99, 1462 136 7122 1.24 0.90, 1

545 98 7122 0.92 0.64, 1

667 101 7122 1.14 0.74, 1

van der Vijver 1992105

Dutch civil servants [1544755] 

40-65 y, 

Women 

CVD death 

(nd/1265; ~0.14, 

age-adjusted) 

28 y ≤445 14.6%, 

ageadjusted 

258 1.1 0.6, 2

445-850 14.4% 750 1.1 0.7, 1

>850 12.6% 257 1 Refere

Cardiac Events, Total 

Both Sexes 

Umesawa 2008106

Japan PHC [18635855] 

40-59 y, 

Both 

CHD 

(322/41,526; 0.0078) 

13 y 233, median 72 ~8305 1 Refere

344 72 ~8305 1.18 0.83, 1439 56 ~8305 0.91 0.60, 1603 58 ~8305 1.08 0.71, 1753 64 ~8305 0.93 0.58, 1

continued 
Author Year 

Study Name PMID 

Age 

Range, Sex 

Outcome (n/N; 

Incidence) 

Followup 

Duration 

Total Ca 

Intake, mg/day 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95% 

Marniemi 200548

(Finland) [15955467] 

65-99 y, 

Both 

AMI 

(130/755; 0.172) 

10 y nd nd ~252 1 Refere

nd nd ~252 0.87 0.57, 1nd nd ~252 1.14 0.70, 1

Men 

Al-Delaimy 2003107

HPFS [12663277] 

Mean (SD) 

54 (9) y, 

Men 

IHD, total 

(1458/39,800; 0.037) 

12 y 523, mean 300 7960 1 Refere

670 296 7960 1.03 0.88, 1803 267 7960 0.92 0.78, 1995 299 7960 1.01 0.85, 1

1377 296 7960 0.94 0.79, 1

Cardiac Death 

Men 

Al-Delaimy 2003107

HPFS [12663277] 

Mean (SD) 

54 (9) y, 

Men 

IHD death 

(428/39,800; 0.011) 

12 y 523, mean 88 7960 1 Refere

670 90 7960 1.17 0.87, 1803 70 7960 0.93 0.67, 1995 79 7960 1.06 0.77, 1

1377 101 7960 1.10 0.79, 1

Umesawa 2006104

Japan CC [16339476] 

40-79 y, 

Men 

CHD death 

(148/23,117; 0.0064) 

8.9 y 250, mean 37 4623 1 Refere

363 26 4624 0.84 0.47, 1449 33 4623 1.20 0.62, 2536 32 4624 1.27 0.60, 2665 20 4623 0.92 0.37, 2

van der Vijver 1992105

Dutch civil servants 1544755 

40-65 y, 

Men 

CHD death 

(nd/1340; ~0.15, 

age-adjusted) 

28 y ≤585 16.6%, 

ageadjusted 

271 0.9 0.6, 1

585-1245 15.1% 798 1.0 0.6, 1

>1245 14.5% 271 1 Refere

Women 

Umesawa 2006104

Japan CC [16339476] 

40-79 y, 

Women 

CHD death 

(116/35,609; 0.0033) 

8.9 y 266, mean 38 7121 1 Refere

379 21 7122 0.88 0.48, 1462 25 7122 1.28 0.62, 2

545 17 7122 0.84 0.35, 2

667 15 7122 0.87 0.31, 2

continued 

147 
Author Year 

Study Name PMID 

Age 

Range, Sex 

Outcome (n/N; 

Incidence) 

Followup 

Duration 

Total Ca 

Intake, mg/day 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95% 

Bostick 1999110

Iowa WHS [9921960] 

55-69 y, 

Women 

IHD death 

(387/34,486; 0.011) 

8 y <696 127 ~8621 1 Refere

696-1051 84 ~8621 0.62 0.45, 0

1052-1425 94 ~8621 0.75 0.55, 1

>1425 82 ~8621 0.67 0.47, 0

van der Vijver 1992105

Dutch civil servants [1544755] 

40-65 y, 

Women 

CHD death 

(nd/1265; ~0.06, 

age-adjusted) 

28 y ≤445 6.2%, 

ageadjusted 

258 1.1 0.5, 2

445-850 6.3% 750 1.2 0.6, 2

>850 4.4% 257 1 Refere

Cardiac Event, Nonfatal 

Men 

Al-Delaimy 2003107

HPFS [12663277] 

Mean (SD) 

54 (9) y, 

Men 

Nonfatal MI 

(1030/39,800; 0.026) 

12 y 523, mean 212 7960 1 Refere

670 206 7960 1.01 0.83, 1803 197 7960 0.96 0.78, 1995 220 7960 1.04 0.85, 1

1377 195 7960 0.92 0.74, 1

Stroke 

Both Sexes 

Umesawa 2008106

Japan PHC [18635855] 

40-59 y, 

Both 

Stroke, Total 

(1321/41,526; 0.032) 

13 y 233, median 314 ~8305 1 Refere

344 257 ~8305 0.94 0.79, 1439 252 ~8305 0.79 0.65, 0603 247 ~8305 0.78 0.63, 0753 251 ~8305 0.71 0.56, 0

Weng 2008108

CVD—FACTS [18988909] 

≥40 y 

Both 

Stroke, Ischemic 

(132/1772; 0.074) 

10.6 y <451 nd 443 1.52 0.98, 2

451-591 nd 443 1.49 0.99, 2

>591 nd 886 1 Refere

Marniemi 200548

(Finland) [15955467] 

65-99 y, 

Both 

Stroke, Total 

(70/755; 0.093) 

10 y nd nd ~252 1 Refere

nd nd ~252 0.981 0.53, 1nd nd ~252 1.34 0.70, 2

Men 

continued 

148 
Author Year 

Study Name PMID 

Age 

Range, Sex 

Outcome (n/N; 

Incidence) 

Followup 

Duration 

Total Ca 

Intake, mg/day 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95% 

Ascherio 1998109

HPFS [9743511] 

40-75 y, 

Men 

Stroke, Total 

(328/43,738; 0.0075) 

8 y 500, median 75 ~8748 1 Refere

700 69 ~8748 0.95 0.68, 1800 51 ~8748 0.72 0.50, 1

1000 63 ~8748 0.84 0.60, 11400 70 ~8748 0.88 0.63, 1

Larsson 2008112

ATBC [18332289] 

50-69 y, 

Men 

Cerebral infarction 

(2702/26,556; 0.102) 

13.6 y 876, median 518 ~5311 1 Refere

1178 541 ~5311 1.08 0.95, 11379 542 ~5311 1.09 0.96, 11581 546 ~5311 1.11 0.98, 11916 555 ~5311 1.10 0.98, 1

Women 

Iso 1999111

NHS [10471422] 

32-57 y, 

Women 

Stroke, Total 

(690/85,764; 0.0080) 

14 y 395, median 165 ~17153 1 Refere

645 132 ~17153 0.79 0.63, 1675 117 ~17153 0.71 0.56, 0837 142 ~17153 0.87 0.70, 1

1145 134 ~17153 0.83 0.66, 1

Stroke, Fatal 

Men 

Umesawa 2006104

Japan CC [16339476] 

40-79 y, 

Men 

Stroke death 

(322/23,117; 0.014) 

8.9 y 250, mean 61 4623 1 Refere

363 76 4624 1.14 0.76, 1449 69 4623 0.90 0.56, 1

536 59 4624 0.69 0.40, 1

665 57 4623 0.68 0.37, 1

Ross 1997113A (China) [9236416] 

45-64 y, 

Men 

Stroke death 

(245/18,244;0.013) 

[245 cases vs. 1225 

controls] 

12 y nd 103 460 controls 1 Refere

nd 68 369 controls 0.8 0.6, 1nd 74 396 controls 1.0 0.8, 1

Women 

Umesawa 2006104

Japan CC [16339476] 

40-79 y, 

Women 

Stroke death 

(322/35,609; 0.0090) 

8.9 y 266, mean 70 7121 1 Refere

379 82 7122 1.38 0.95, 2462 73 7122 1.24 0.79, 1545 42 7122 0.69 0.40, 1667 55 7122 0.94 0.51, 1

149 
150 

* Statistically significant (P<0.05) A Case-control study from prospective, longitudinal cohort. 
Figure 11. Cardiovascular outcomes risk stratified by calcium intake 
Figure 12. Stroke risk stratified by calcium intake 

152 
Calcium and Body Weight 

 We searched for systematic reviews and primary studies that evaluated associations between 

calcium intake or body stores and incidence of overweight or obesity; no such studies were 

found. For the outcome weight change (in kilograms or body mass index units), we included 

only randomized controlled trials. The EPC and the TEP agreed that the limited resources would 

not be expended on reviewing observational studies for the surrogate outcome body weight 

(where overweight or obesity are considered to be the clinical outcomes). We included only 

studies of adults. Studies of weight gain in children are included in the “Growth” section. 

Synopsis. 

 No studies evaluated the association of calcium intake and incidence of overweight or 

obesity. We identified three systematic reviews that evaluated RCTs of calcium intake and 

changes in body weight. Eight additional trials not identified by these systematic reviews met 

eligibility criteria for this report and are summarized together with the systematic reviews. 

Altogether, 49 trials have been identified by the previous and current systematic reviews. 

Because the systematic reviews all used somewhat different eligibility criteria, they included 

overlapping groups of trials. No one or two systematic reviews captured most of the relevant 

trials; therefore, all systematic reviews are included here. 

 The three systematic reviews performed separate analyses for calcium supplementation and 

dairy product intake. Only one of the systematic reviews separately analyzed studies of people 

on isocaloric diets (where weight loss was not a goal) and studies of people on energy-restricted 

diets. Overall, 24 included trials investigated calcium supplementation and 15 investigated dairy 

product intake; 29 trials had isocaloric background diets and 13 evaluated calcium 

supplementation in the setting of an energy-restricted (weight loss) diets. Although there was not 

complete agreement among the systematic reviews, overall, the trials in the systematic review do 

not support an effect of calcium (or dairy) supplementation on body weight. No systematic 

review analyzed effects of calcium supplementation based on life stage or calcium dose. 

 Seven of the eight additional trials investigated calcium supplements in the setting of 

isocaloric diets; two of the trials investigated calcium supplements in overweight people on 

energy-restricted diets. All these trials found no significant effect of calcium supplementation on 

body weight. 

Detailed presentation (Tables 51, 52, & 53). 

 The three systematic reviews explicitly or implicitly used generally different eligibility 

criteria, resulting in large overlaps in the trials included among the reports.114-116. Overall, the 

systematic reviews included 42 trials. All systematic reviews separately analyzed calcium 

supplementation and dairy product intake. The largest, most recent systematic review114 included 

trials up to 2007, separated isocaloric from energy-restricted trials, but did not perform metaanalysis. The next largest systematic review115 included trials through 2004. The last systematic 

review,116 through 2001, also did not perform meta-analyses. All the dairy product trials in this 

review were also included in the most recent systematic review and are thus not discussed further 

here. Seven more recent calcium supplementation trials not included in any of the systematic 

reviews were found.117-123

153 
Isocaloric trials. 

 The systematic review by Lanou et al. (2008)114 evaluated 19 isocaloric trials of increased 

calcium intake in adults. Nine trials compared calcium supplements to placebo; 10 trials 

compared high calcium dairy intake to lower calcium nondairy intake. The systematic review did 

not provide details of every included trial, nor was meta-analysis performed. In summary, 16 

trials (8 calcium supplement, 8 dairy product) of the 19 trials reported no significant effect of 

increased calcium intake on body weight, 1 calcium trial found significantly greater weight loss 

in those receiving calcium supplements, and 2 dairy trials found significantly greater weight gain

in those in the dairy product group. This latter finding was theorized to be due to the extra 

calories from the dairy products. 

 Seven additional isocaloric trials were not included in the systematic reviews.117-122,124 Four 

of these trials were conducted in postmenopausal women, two in young women (age early 20s), 

and one in men and women aged 30 to 34 years. The trials used a variety of calcium compounds 

with doses ranging from 800 to 2000 mg; one compared dairy (~1250 mg calcium) to nondairy 

(~375 mg calcium) intakes.120 The studies ranged in duration from 1 month to almost 3 years. 

Among the studies, one was of methodological quality A, three B, and three C. Methodological 

limitations included inadequate reporting of methodology or outcomes, statistical issues, high 

dropout rates, and large difference in baseline weights between groups. The participants’ weights 

were generally stable, on average changing less than 1 kg during 6 weeks to 3 years of followup. 

The net weight changes (calcium group minus control group) ranged from -0.8 to +0.5 kg. No 

trial found a significant effect of calcium. 

Findings per calcium intake level. 

 Overall, there was no evidence of different effects related to calcium intake level. No study 

directly compared a range of calcium intake levels. 

Findings per age and sex 

 The systematic review did not address the question of different effects based on age or sex. 

Among the additional trials reviewed here, no significant difference was found across trials of 

different populations. Most were conducted in postmenopausal women. 

Energy-restricted diets. 

 The systematic review by Lanou et al. (2008)114 evaluated 11 trials that compared dairy 

intake (6 trials) or calcium supplements (5 trials) in the setting of energy-restricted diets with the 

goal of weight loss. Of the six dairy product trials, three were conducted by the same 

investigators. These three trials all reported significantly more weight loss in participants with 

high dairy product intake than those with low or no dairy product intake (1137 vs. 430 mg Ca; 

1100 vs. 500 mg; 3 vs. <1 servings). The systematic review authors note that due to incomplete 

reporting in the trials, it was impossible to determine whether the difference in weight loss may 

have been due to differences in calcium (or dairy) intake or differential compliance with the 

calorie restriction protocol. One of the five calcium supplement trials, which was part of one of 

the positive dairy trials by the same researchers, found greater weight loss with calcium 

supplementation; the others found no significant effect. 

 The two additional trials not included in the systematic reviews reported no significant 

effects of calcium supplementation on body weight loss.119,123 Both trials were conducted in 

overweight women, one trial with a mean age of 49 years and one trial of postmenopausal 

women. One trial compared two different formulations of 500 mg calcium with placebo in the 

154 
setting of a low calcium intake (350 mg/day); the other compared higher (1200 mg) to lower 

(400 mg) doses of calcium citrate. Over 3 or 6 weeks, women in all trial groups lost between 3.3 

and 4.3 kg, with no significant differences between those with higher than lower calcium intake. 

Findings per calcium intake level. 

 Overall, there was no evidence of different effects related to calcium intake level. No study 

directly compared a range of calcium intake levels. 

Findings per age and sex. 

 The systematic review did not address the question of different effects based on age or sex. 

The two additional trials did not add any information regarding age or sex subgroups. 

Combined isocaloric and energy-restricted diets. 

 Two of the systematic reviews did not separately analyze studies based on background diet 

(regarding weight). The systematic review by Trowman et al. (2006)115 performed meta-analyses 

of 13 trials, separately for calcium supplement and dairy product trials. This systematic review 

found a significant effect of calcium supplements (weighted mean difference = -1.79 [95 percent 

CI -3.04, -0.55]) suggesting greater weight loss (or smaller weight gain) in adults taking calcium 

supplements. However, the investigators noted that the difference in effect of calcium 

supplement trials may be due to significant differences (in aggregate) in the baseline weights of 

the two arms. Across studies, the calcium supplement group participants had significantly lower 

body weights at baseline. The meta-analysis of dairy trials found no significant effect of dairy 

products on body weight. The systematic review by Barr et al. (2003)116 reviewed both calcium 

supplement and dairy trials; however, the dairy trials were all included in the later systematic 

review by Lanou et al. (2008)114 and are thus not repeated here. Among the eight trials of 

calcium supplementation, all but one found no significant effect on body weight. Between the 

two systematic reviews, over two-thirds of the trials were conducted in post- or perimenopausal 

women; the mean age of participants (among trials with data reported in the systematic reviews) 

ranged from 36 to 72 years. Only four of the trials were conducted in men. The range of calcium 

supplement doses was 700 to 1600 mg/day, with most studies using 1000 mg. The range of 

calcium intake among the dairy trials was 610 to 2400 mg/day. In the Trowman et al. (2006) 

systematic review,115 the range of followup durations of the trials was 12 weeks to 3 years. The 

Barr et al. (2003) systematic review116 included longer duration trials, ranging from 6 months to 

4 years. 

Findings per calcium intake level. 

 The systematic reviews did not find evidence of differential effects based on calcium intake 

level (supplement dose or dairy calcium). 

Findings per age and sex. 

 The large majority of trials reviewed in the systematic reviews were conducted in 

postmenopausal women. The systematic reviews did not find evidence of differential effects 

based on age or sex. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

155 
• 19 – 50 y Many of the trials are applicable to people within this life stage; though 

relatively few trials included men. For both people on energy-restrictive diets and on 

isocaloric diets, overall, the evidence suggests no significant effect on body weight with 

increased calcium intake, either as supplements or from dairy product intake. 

• 51 – 70 y The majority of studies are applicable to women within this life stage; few 

trials included men. The conclusions are the same as for those in the 19-50 y life stage. 

• ≥71 y The evidence is scant for this life stage. Few of the studies appear to have 

included people over age 70 years. 

• Postmenopause The majority of studies are applicable to postmenopausal women. 

The conclusions are the same as for those in the 19-50 y life stage. 

• Pregnant & lactating women Not reviewed 

Table 51. Systematic reviews of calcium supplementation and weight 

Author Year [PMID] Lanou 2008114 [18454813] 

Design (Search Years) Randomized controlled trials (1966-2007) 

Population All, generally healthy (adults and children, only studies of adults included here) 

Intervention and Comparator Calcium supplements or dairy intake versus no supplement or low calcium intake 

Results 29 trialsA

No energy restriction 

 Calcium supplement: 8/9 trials no significant effect. 1 found significantly more weight loss 

on calcium supplement. 

 Dairy supplementation: 8/10 trials no significant effect. 2 found significantly more weight 

gain among those on dairy 

Energy restriction 

 Calcium supplement: 4/5 trials no significant effect. 1 found significantly more weight loss 

with calcium. 

 Dairy supplementation: 3/6 trials significantly more weight loss on high calcium intake 

 All 4 trials with significant differences were by same study investigators 

Comments 

AMSTAR 

A priori design? Yes Study quality assessment performed? No 

Two independent reviewers? nd Study quality appropriately used in analysis? NA 

Comprehensive literature search? Yes Appropriate statistical synthesis? None 

All publication types and languages included? No Publication bias assessed? No 

Included and excluded studies listed? No Conflicts of interest stated? No 

Study characteristics provided? Only published trials. Excluded studies not enumerated or listed. 

Author Year [PMID] Trowman 2006115 [16768823] 

Design (Search Years) Randomized controlled trials (1800B/2002-2004) 

Population Nonpregnant, nonlactating, ≥18 y 

Intervention and Comparator Calcium supplements or dairy intake versus no supplement or low calcium intake 

Results 13 trials 

Calcium supplement WMD = -1.79 (-3.04, -0.55)C

, statistically homogeneous 

Dairy supplementation WMD = +0.85 (-4.39, +6.08), statistically heterogeneous 

 ANCOVA, adjusting for baseline weight: 

 Calcium Effect = -0.41 (-1.07, +0.25) kg 

 Dairy Effect = +0.23 (-2.88, +3.34) kg 

Comments Apparent difference in effect of calcium supplement trials may be due to significant differences (in 

aggregate) in baseline weights of two arms across studies (intervention arm participants were 

significantly lighter at baseline). 

AMSTAR 

A priori design? Yes Study quality assessment performed? No 

Two independent reviewers? nd Study quality appropriately used in analysis? NA 

Comprehensive literature search? Yes Appropriate statistical synthesis? Debatable 

All publication types and languages included? Yes 

(implied) 

Publication bias assessed? Yes 

Included and excluded studies listed? No Conflicts of interest stated? Yes 

Study characteristics provided? Yes Excluded studies not enumerated or listed. Used WMD instead of 

net difference, then needed to perform an ANCOVA to adjust for 

baseline differences. 

continued 

156 
Author Year [PMID] Barr 2003116 [12514301] 

Design (Search Years) Randomized controlled trials (1966-2001) 

Population All, generally healthy (adults and children, only studies of adults included here) 

Intervention and Comparator Calcium supplement or dietary calcium versus no supplement or usual calcium intake (see 

Comment) 

Results 8 trials 

Calcium supplement 7/8 trials found no significant effect 

Comments 6 dairy supplementation trials reviewed. Not included here. These represent a subset of the dairy 

trials reviewed by Lanou 2008114

AMSTAR 

A priori design? Yes Study quality assessment performed? No 

Two independent reviewers? nd Study quality appropriately used in analysis? NA 

Comprehensive literature search? Yes Appropriate statistical synthesis? None 

All publication types and languages included? No Publication bias assessed? No 

Included and excluded studies listed? No Conflicts of interest stated? No 

Study characteristics provided? Yes Studies published in English only. Excluded studies not 

enumerated or listed. 

WMD, weighted mean difference 

A

 The systematic review included the Women's Health Initiative (WHI) trial of vitamin D + calcium supplementation. This trial is

omitted here and is discussed separately in the vitamin D + calcium and body weight section. B

 Cochrane Library Database of Controlled Trials 

C

 Numbers in parentheses are 95% confidence intervals

157 
158 

Table 52. Calcium and weight: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium 

Intake & 

Vitamin D 

Data 

Comparisons Compliance Comments 

• Health 

status 

Healthy 

• Mean age 

(range), y 

43 (30-54) 

Yamamoto 

1995117

TOHP 

US 

(various) 

[7795837] • Male (%) 69 

Ca 970 mg/d Ca carbonate vs 

placebo 

Eligibility for 

randomization required 

consumption of at least 

two-thirds of 6 wks of 

supplement placebo 

dosing. During the study, 

pill counts averaged 95% 

(with three-fourths taking 

at least 95% of their 

supplements). 

• Health 

status 

Healthy 

• Mean age 

(range/SD), 

y 

21 (20-23) 

van 

Beresteyn 

1986118

Netherlands 

(52°N) 

[3788835] • Male (%) 0 

nd Ca carbonate vs 

placebo 

nd 

• Health 

status 

Overweight, 

postmenopause 

• Mean age 

(range), y 

61 (52-75) 

Cifuentes 

2004119

New 

Brunswick, 

NJ 

(40°N) 

[15213038] 

• Male (%) 0 

nd Ca supplement 

vs placebo 

nd Factorial design 

with weight loss 

and 

maintenance 

diets 

• Health 

status 

Healthy, 

postmenopause 

• Mean age 

(range), y 

~80 (~≥50) 

Ghadirian 

1995120

Montreal, 

Canada 

(46°N) 

[7493659] • Male (%) 0 

Ca 776 mg/d Dairy vs dairy 

free intake 

Non-compliant and those 

who provided incomplete 

data were excluded. 

• Health 

status 

Healthy, 

postmenopause 

• Mean age 

(SD), y 

53 (0.6) 

Aloia 1995121

Mineola, NY 

(41°N) 

[7892882] 

• Male (%) 0 

nd Ca supplement 

vs placebo (Vit D 

in both groups) 

nd 

• Health 

status 

Healthy, 

postmenopause 

• Mean age 

(range/SD), 

y 

nd 

Thomsen 

1987122

Copenhagen, 

Denmark 

(55°N) 

[3307307] 

• Male (%) 0 

nd Combination Ca 

lactategluconate & Ca 

carbonate vs 

placebo 

nd 

• Health 

status 

Healthy 

• Mean age 

(SE), y 

22 (1.2) 

Bortolotti 

2008124

Lausanne, 

Switzerland 

(47°N) 

[18842771] • Male (%) 30 

Ca 586 (137 

SE) mg/d, all 

<800 mg/d 

Ca phosphate vs 

placebo 

Measured but not 

reported 

Crossover 

study (5 wk with 

10 wk 

washout), 1° 

outcomes were 

metabolic 

• Health 

status 

Overweight, 

healthy 

• Mean age 

(SD), y 

49 (12) 

• Male (%) 0 

KabrnovaHlavata 

2008123

Lausanne, 

Czech Rep 

(50°N) 

[17552880] • Male (%) 0 

nd Ca carbonate vs 

“lactoval” vs 

placebo 

nd (a dietitian checked 

that subjects took 

tablets) 

Energy 

restriction 
Table 53. Calcium and weight: Results of RCTs 

Author Year Study Name [PMID] 

Age Range, 

Sex Outcome 1°/2° Mean Followup Interventions, Daily Dose No. Analyzed Unit Baseline Change Change 95% CI Net Diff 

Isocaloric 

Ca carbonate 

1000 mg 217 Kg/m2 27.4 +0.07 -0.05, 0.19 -0.05A 

Yamamoto 1995117

TOHP [7795837] 

30-54 y, 

Both BMI 2° 6 mo Placebo 218 27.0 +0.12 -0.02, 0.26 

Ca carbonate 

1500 mg 29 Kg 61.8 -0.3 -2.7, 2.1B -0.8 

Weight 2° 6 wk 

Placebo 29 62.5 +0.5 -2.0, 3.0B

Ca 29 Kg/m2 20.8 -0.1 -0.8, 0.6B -0.2 

van Beresteyn 1986118

Netherlands [3788835] 

20-23 y, 

Women 

BMI 2° Placebo 29 21.0 +0.1 -0.6, 0.8B

Ca citrate 

1200 mg 10 Kg 70.9 0 -3.3, 3.3B -0.4C 

Cifuentes 2004119

New Jersey [15213038] 

52-75 y, 

Women Weight 1° 6 wk Ca citrate 400 

mg 

15 68.0 +0.4 -3.4, 4.2B

Dairy intake 

(1242 mg Ca) 81 Kg 59.84 +0.10 -2.4, 2.6B +0.5 

Ghadirian 1995120

Canada [7493659] 

~>=50 y, 

Women Weight 2° 1 mo Nondairy intake (377 

mg) 

77 59.65 -0.40 -3.8, 3.0B

Ca 1700 mgD

+ Vit D 400 IU 36 Kg/y 65.8 +0.1 nd 0 

Aloia 1995121 New York 

[7892882] 

Mean (SD) 

53 (0.6) y, 

Women 

Weight 2° 2.9 y 

Vit D 400 IU 28 65.6 +0.1 nd 

Ca lactategluconate & 

carbonate 

2000 mg 

14 Kg 60.6 +0.4 -2.4, 3.2B -0.2 

Thomsen 1987122

Denmark [3307307] 

Early postmenopause, 

Women 

Weight 2° 1 y 

Placebo 14 66.4 +0.6 -6.7, 7.9B

Ca phosphate 

800 mg Kg Final 80.0 Diff Final +0.4 

Bortolotti 2008124 Switzerland 

[18842771] 

Mean (SE) 

22 (1.2) y, 

Both 

Weight 2° 5 wk 

Placebo 

10E 78.1 

79.6 

Energy Restricted continued 
160 

Author Year Study Name [PMID] 

Age Range, 

Sex Outcome 1°/2° Mean Followup Interventions, Daily Dose No. Analyzed Unit Baseline Change Change 95% CI Net Diff 

KabrnovaHlavata 2008123

Czech Rep [17552880] 

49 (SD) y, 

Women Weight 2° 3 wk 

Ca carbonate 

500 mg + 350 

mg Ca in diet 

(4.5 MJ/d) 

21 Kg 85.37 -4.34 -4.9, -3.8 -0.47 

Lactoval (Ca 

phosphate, 

citrate, & 

lactate) 500 

mg + 350 mg 

Ca in diet (4.5 

MJ/d) 

25 84.95 -3.34 -4.0, -2.6 +0.53 

Placebo + 350 

mg Ca in diet 

(4.5 MJ/d) 

21 83.43 -3.87 -4.6, -3.2 

Ca citrate 

1200 mg 

(>=2.5% wt 

loss goal) 

16 Kg 71.5 -3.6 -6.4, -0.8B -0.3E Cifuentes 

2004119

New Jersey [15213038] 

52-75 y, 

Women Weight 1° 6 wk Ca citrate 400 

mg (>=2.5% wt 

loss goal) 

16 74.5 -3.3 -6.8, 0.2B

A Subgroup data available for black and white men and women (4 groups). No substantive differences among groups. All statistically nonsignificant. B Estimated from reported data C Adjusted for multiple factors, including baseline weight. D No data on calcium type E Crossover study F Adjusted for multiple factors, including baseline weight
Calcium and Cancer 

Cancer from all cause and total cancer mortality. 

Synopsis. 

No qualified systematic review evaluated associations between calcium intake and incidence 

of all cancer and total cancer mortality. One RCT showed a borderline nonsignificant reduction 

of the risk of total cancer among healthy postmenopausal women (>55 years old) living in 

Nebraska (latitude 41°N) who received calcium supplementation (either calcium citrate 1400 

mg/d or calcium carbonate 1500 mg/d). However, one cohort study analyzed US AARP cohort 

(men and women 50-71 y) showed that that total calcium intake was not associated with the risk 

of total cancer incident. 

There is insufficient data to draw a conclusion regarding association between dietary calcium 

intakes and total cancer mortality. 

Detailed presentation (Tables 54, 55, 56 & 57). 

A 4-year population-based RCT,52 sampled from a 9-county, largely rural area in eastern 

Nebraska (latitude 41°N), aimed to compare the efficacy of vitamin D3 (1000 IU/d) plus calcium 

(either calcium citrate 1400 mg/d or calcium carbonate 1500 mg/d) or calcium alone (either 

calcium citrate 1400 mg/d or calcium carbonate 1500 mg/d) to placebo in reducing fracture 

incidence. Incidence of cancer was a secondary outcome of this trial. A total of 743 

postmenopausal women over 55 years old were analyzed for the effect of calcium 

supplementation alone. The mean serum 25(OH)D concentration at baseline was 72 nmol/L. 

At the end of study the relative risk of developing cancer was 0.53 (95 percent CI 0.27, 1.03; 

P=0.06) comparing calcium supplementation (either calcium citrate 1400 mg/d or calcium 

carbonate 1500 mg/d) to the placebo. This study was rated B. 

 A cohort study analyzed data from AARP (the American Association of Retired Persons) 

members, aged 50 to 71 years old, living in six specific states in the US.125 During 3,383,377 

person-years of followup (over 7 years), a total of 36,965 cancer cases in men and 16,605 cancer 

cases in women were identified. The results showed that that total calcium intake was not 

associated with the risk of total cancer after controlling for potential risk factors pertinent to 

individual cancers. Methodological quality of this study was rated B. 

Findings by age, sex and/or ethnicity. 

A cohort study analyzing a total of 1553 men and 1397 women, aged between 40 and 65 

years, living in Amsterdam (52°N) showed that there was no significant association between 

dietary calcium from foods and total cancer mortality in either men or in women after 28 years of 

followup.126 This study was rated C because the food frequency questionnaire was not internally 

validated and could not estimate usual intake through 1-week food frequency recall. 

Findings by life stage. 

• 0 – 6 mo No data 

• 7 mo – 2 y No data 

• 3 – 8 y No data 

• 9 – 18 y No data 
• 19 – 50 y A cohort study in Amsterdam included some men and women in this life 

stage. However, this study provided insufficient data regarding association between 

dietary calcium intakes and total cancer mortality. 

• 51 – 70 y The cohort study in Amsterdam also included some men and women in 

this life stage. However, this study provided insufficient data regarding association 

between dietary calcium intakes and total cancer mortality. One study analyzed US 

AARP cohort with men and women in this life stage showed that that total calcium intake 

was not associated with the risk of total cancer incident 

• ≥71 y No data 

• Postmenopause One RCT with healthy postmenopausal women showed a 

borderline nonsignificant reduction of risk of total cancer by calcium supplementation 

(either calcium citrate 1400 mg/d or calcium carbonate 1500 mg/d). 

• Pregnant & lactating women No data 

162 
163 

Table 54. Calcium and total cancer mortality: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake 

& Vitamin D 

Data 

Comparisons Compliance Comments 

• Health 

status 

Mentally 

and 

physically 

fit 

• Mean age 

(range/SD), y 

67 (7.3) 

Lappe 

200752

Nebraska, US 

41o N 

[17556697] 

• Male (%) 0 

25(OH)D: 71.8 

nmol/L 

Vit D3 1000 IU/d + Ca (citrate 

1400 mg/d or carbonate 1500 

mg/d) vs. Ca (citrate 1400 

mg/d or carbonate 1500 mg/d) 

vs. placebo 

Table 55. Calcium and total cancer incidence or mortality: Characteristics of cohort studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Dietary Calcium intake Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Comments 

Cohort 

• Health 

status 

No 

cancer 

• Mean 

age 

(range/), 

y 

50-71 

• Dietary 

assessment 

method 

FFQ 

(NCIDHQ) 

USDA 

Nutrient 

Database 

Park 2009125

NIH-AARP 

US 

38o N 

[19237724] 

• Male 

(%) 

60 • Internal 

validation? 

(y/n) 

y 

Total cancer 

risk stratified by 

quintile of total 

calcium intake 

X X X X X Total 

calcium 

intake from 

diet and 

supplement 

• Health 

status 

nd 

• Mean 

age 

(range), 

y 

53 

(40-

65) 

• Dietary 

assessment 

method 

Slob 1993 FFQ 126

Amsterdam 

52° N 

[8478144] 

• Male 

(%) 

51 • Internal 

validation? 

(y/n) 

no 

Cancer 

mortality 

stratified by 

dietary calcium 

intake quintiles 

(from foods 

only) 

X X 
Table 56. Calcium and total cancer mortality: Results of RCTs 

Author Year Study Name [PMID] 

Life Stage Outcome 1°/2° Followup, y Interventions, Daily Dose n Event N Total Outcome Metric (Comparison) Result 95

Ca (citrate 1400 mg or carbonate 1500 mg)

17 445 RR 

Ca/placebo 

Lappe 0.53 0.2200752

nd [17556697] 

Postmenopausal 

women 

Incident cancer (all causes) 

2° 4 

Placebo 20 288 

Ca (citrate 1400 mg or carbonate 1500 mg)

15 416 RR 

Ca/placebo 

Post- 0.59 0.2

menopausal 

women 

Incident cancer (restrict to subjects who were free of cancer at 1 y intervention) 

2° 4 

Placebo 18 266 

164 
165 

Table 57. Calcium and total cancer incidence or mortality: Results of cohort studies Author Year Study Name [PMID] 

Life 

Stage 

Outcome (n/N; 

Incidence) 

Followup 

Duration 

(Time to 

Dx) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases No. in Category Adjusted OR 95

Park 2009 NIH-AARP125

[19237724] 

50-71, males 

Total cancer 

(36,965/3,383,377 

person-years) 

7 y 526 36,965 

(total) 

3,383,377 personyears (total, both 

males and females) 

1 (HR) Refe

498 0.99 0.96857 0.99 0.96

1073 0.95A 0.96

1530 0.99 0.95

50-71, 

females 

Total cancer 

(16,605/3,383,377 

person-years) 

7 y 494 16,605 

(total) 

3,383,377 personyears (total, both 

males and females) 

1 (HR) Refe

717 0.98 0.93969 0.94 0.89

1296 0.93 0.88

1881 0.96 0.91

Slob 1993126

nd [8478144] 

40-65 y, 

males 

Cancer mortality 

(232/1553; 0.15) 

28 y ≤585 nd nd 1.0 0.6

585 to ≤725 nd nd 1.0 0.6725 to ≤935 nd nd 1.0 0.6

935 to 

≤1245 

nd nd 0.8 0.5

>1245 nd nd 1.0 Refe

40-65 y, 

females 

Cancer mortality 

(127/1397; 0.09) 

28 y ≤445 nd nd 1.1 0.6

445 to 

≤540 

nd nd 0.8 0.4

540 to ≤640 nd nd 1.6 0.9640 to ≤850 nd nd 1.4 0.7

>850 nd nd 1.0 Refe

A Not a reasonable number based on the reported confidence interval; probably a typographical error in the article. 
Prostate cancer. 

 We reviewed primary studies that evaluated associations between calcium intake and 

incidence and mortality of prostate cancer. 

Synopsis. 

 No trials of calcium interventions evaluated prostate cancer. Four cohort studies rated A in 

methodological quality reported on the association between total calcium intake and the risk of 

prostate cancer. Three studies found significant associations between higher calcium intake and 

increased risk of prostate cancer. One study found the risk was higher in the group that took 

more than 1500 mg/d of calcium compared to those that took less than 700 mg/d (adjusted RR 

1.3). A second study found only the group that took more than 2000 mg/d of calcium had higher 

risk of prostate cancer compared to those that took 500 to 749 mg/d of calcium (adjusted RR 

1.26). A third study also found that male smokers who took more than 2000 mg/d of calcium 

had higher risk compared to those who took less than 1000 mg/d (adjusted RR 1.63). The fourth 

study found no relation between calcium intake (<500 to ≥2000 mg/d) and the risk of prostate 

cancer in men aged 50-70 years. 

Detailed presentation (Tables 58 & 59; Figure 13). 

 A total of 12 cohort studies in 13 publications reported on the association between calcium 

intake and the risk of prostate cancer.56,127-138 One of the studies also provided a post hoc analysis 

of an RCT on calcium supplement.56 The incidence of prostate cancer in these studies ranged 

from 0.008 to 0.10. Most of the studies were conducted in Europe or North America, one study 

was conducted in Japan. Mean age of the subjects ranged from 53 to 67 years. Total calcium 

intake ranged from less than 500 mg/d to at least 2000 mg/d. Time between dietary assessment 

and the diagnosis of prostate cancer varied from 1 to 17 years. Methodological quality of four 

studies was rated A, seven studies were rated B, and one study was rated C. 

19-50 years. 

 No study specifically targeted men between 19 to 50 years old. 

51-70 years. 

 Twelve studies reported data on subjects with a mean age ranged from 53 to 67 years. Seven 

studies did not find an association between calcium intake and the risk of prostate 

cancer.56,130,131,133,134,136,137 Five studies found that the risk was higher in the groups that took 

more calcium compared to the groups that took lower amount (adjusted OR 1.2-

2.2).127,129,132,135,138 The higher amount ranged from 921 to at least 2000 mg/d of calcium; the 

lower amount ranged from 455 to 1000 mg/d. Three studies also reported on the association 

between calcium intake and mortality from prostate cancer. Two studies found no 

association130,134 and one study found an increased risk comparing the group that took at least 

2000 mg/d of calcium with the group that took 500 to 749 mg/d (adjusted RR 2.02, 95 percent CI 

1.14, 3.58).129 One study was a post hoc analysis of an RCT of high calcium supplement (1200 

mg/d) to prevent colorectal adenoma.56 This study did not find an increased risk of prostate 

cancer in those supplemented with calcium compared to those who were not (unadjusted RR 

0.83, 95 percent CI 0.52, 1.32). This study did not adjust for factors potentially relevant to 

prostate cancer. 

166 
167 

Findings by life stage. 

• 0 – 6 mo Not applicable

• 7 mo – 2 y Not applicable

• 3 – 8 y Not applicable

• 9 – 18 y Not reviewed

• 19 – 50 y No study specifically targeted men 19 to 50 years old.

• 51 – 70 y Seven studies did not find an association between calcium intake and the 

risk of prostate cancer. Five studies found that the risk was higher in the groups that took 

more calcium compared to the groups that took lower amount (adjusted OR 1.2-2.2). The 

higher amount ranged from 921 to at least 2000 mg/d; the lower amount ranged from 455 

to 1000 mg/d.

• ≥71 y No study specifically targeted men older than 70 years.

• Postmenopause Not applicable

• Pregnant & lactating women Not applicable
Table 58. Calcium and prostate cancer: Characteristics of observational studies 

Confounders/Effect Modifiers 

Adjusted Author, 

Year 

Trial/Cohort 

Name 

Country 

(Latitude) 

[PMID] 

Population Dietary calcium intake Comparisons 

Nutrients Demographic Anthrop Medical UV exposure Life styles Comments 

Health 

status 

12% 

current 

smoker 

Mean age 

(range/SD), 

y 

50-

71(est.) 

Dietary 

assessment 

method 

124-item 

FFQ 

Park 

2007134

NIH-AARP 

Diet & 

Health 

US 

(multiple 

latitudes) 

[18000020] 

Prostate 

cancer risk 

stratified by 

different 

intakes of 

calcium 

(dietary and 

supplement 

combined) 

X X X X X 92% white; 

Male (%) 100 Internal 

validation? 

(y/n) 

y 

Total Ca 

(both) 

Health 

status 

9.5% 

current 

smoker 

Prostate 

cancer risk 

stratified by 

different 

intakes of 

calcium 

(dietary and 

supplement 

combined & 

dietary 

calcium 

alone) 

X X X 

Mean age 

(range/SD), 

y 

64 

Dietary 

assessment 

method 

68-item FFQ 

(modified 

Block) 

Rodriguez 

2003135

CPS II 

Nutrition 

Cohort 

US 

(multiple 

latitudes) 

[12869397] 

Male (%) 100 Internal 

validation? 

(y/n) 

y 

X Total Ca 

(both) 

Health 

status 

~10% 

current 

smoker 

Prostate 

cancer risk 

stratified by 

different 

intakes of 

calcium 

(dietary and 

supplement 

combined) 

X X X X 

Mean age 

(range/SD), 

y 

40-75 

Dietary 

assessment 

method 

Semiquantitative 

FFQ 

Giovannucci 

2006128

2007129

HPFS 

US 

(multiple 

latitudes) 

[16492906] 

[17450530] 

Male (%) 100 Internal 

validation? 

(y/n) 

y 

X >91% 

white; 

Total Ca 

(both) 

Health 

status 

all 

smokers 

Prostate 

cancer risk 

stratified by 

different 

intakes of 

calcium 

(dietary and 

supplement 

combined) 

X X X X X 100% 

white; 

Mean age 

(range/SD), 

y 

57 (est.) 

Dietary 

assessment 

method 

276-item 

FFQ 

Mitrou 

2007132

ATBC 

Finland 

(60°N) 

[17106437] Male (%) 100 Internal 

validation? 

(y/n) 

y 

Total Ca 

(food) 

Health 

status 

~17% 

current 

smoker 

Prostate 

cancer risk 

stratified by 

different 

intakes of 

dietary 

calcium 

X X X X ~equal % 

of African 

Americans, 

Mean age native 

(range/SD), 

y 

45-75 

Dietary 

assessment 

method 

selfadministered 

FFQ 

Park 

2007133

MCS, HI, 

CA 

US 

(multiple 

latitudes) 

[17925283] 

Male (%) 100 Internal 

validation? 

(y/n) 

y 

Hawaiians, 

Japanese 

Americans, 

Hispanics, 

whites; 

Total Ca 

(both) 

continued 

168 
Confounders/Effect Modifiers 

Adjusted Author, 

Year 

Trial/Cohort 

Name 

Country 

(Latitude) 

[PMID] 

Population Dietary calcium intake Comparisons 

Nutrients Demographic Anthrop Medical UV exposure Life styles Comments 

Health 

status 

on ASA, 

βcarotene, 

placebo 

trial; 

~11% 

current 

smoker 

Dietary 

assessment 

method 

short selfadministered 

questionnaire 

Chan 

2001127

PHS 

US 

(multiple 

latitudes) 

[11566656] 

Prostate 

cancer risk 

stratified by 

different 

intakes of 

dietary 

calcium 

X X 

Mean age 

(range/SD), 

y 

53 

Male (%) 100 Internal 

validation? 

(y/n) 

n 

X Total Ca 

(dairy) 

Health 

status 

7.5% 

smoker 

Prostate 

cancer risk 

stratified by 

different 

intakes of 

dietary 

calcium 

X X X 

Mean age 

(range/SD), 

y 

67 

Dietary 

assessment 

method 

23-item FFQ 

(Willett 1985, 

1987) 

Koh 

2006130

HAH 

US 

(multiple 

latitudes) 

[17106437] 

Male (%) 100 Internal 

validation? 

(y/n) 

n 

X Total Ca 

(dairy) 

Health 

status 

nd Prostate 

cancer risk 

stratified by 

quintile of 

dietary 

calcium 

intakes 

X X 

Mean age 

(range/SD), 

y 

61 

Dietary 

assessment 

method 

150-item 

semiquantitative 

FFQ 

Schurrman 

1999137

Netherlands 

Cohort 

(52°N) 

[10362125] Male (%) 100 Internal 

validation? 

(y/n) 

n 

Total Ca 

(food) 

Health 

status 

~44% 

current 

smoker 

Mean age 

(range/SD), 

y 

45-74 

Dietary 

assessment 

method 

Kurahashi FFQ 

2008131

Japan PHC 

(multiple 

latitudes) 

[18398033] 

Prostate 

cancer risk 

stratified by 

quartiles of 

dietary 

calcium 

intakes 

X X 

Male (%) 100 Internal 

validation? 

(y/n) 

y 

X Total Ca 

(food) 

Health 

status 

17% 

current 

smoker 

Mean age 

(range/SD), 

y 

54 

Dietary 

assessment 

method 

60-item FFQ 

(Block) 

Rohrmann 

2007136

WCC, MD 

US 

(39oN) 

[17315319] 

Prostate 

cancer risk 

stratified by 

tertiles of 

calcium 

intakes 

(dietary and 

supplement 

combined) 

X X X 

Male (%) 100 Internal 

validation? 

(y/n) 

n 

99% white; 

Total Ca 

(both) 

continued 

169 
170 

Confounders/Effect Modifiers 

Adjusted Author, 

Year 

Trial/Cohort 

Name 

Country 

(Latitude) 

[PMID] 

Population Dietary calcium intake Comparisons 

Nutrients Demographic Anthrop Medical UV exposure Life styles Comments 

Health 

status 

nd 

Mean age 

(range/SD), 

y 

58(14.6) 

Dietary 

assessment 

method 

105-item 

FFQ 

Tseng 

2005138

NHEFS 

US 

(multiple 

latitudes) 

[15883441] Male (%) 100 Internal 

validation? 

(y/n) 

n 

Prostate 

cancer risk 

stratified by 

tertiles of 

calcium 

intakes 

(dietary and 

supplement 

combined) 

X X X X 88% white; 

11% black; 

Total Ca 

(both) 

Health 

status 

had >1 

colon 

adenoma 

removal 

Mean age 

(range/SD), 

y 

62 (8.7) 

Dietary 

assessment 

method 

FFQ (Block, 

1986) 

Baron 

200556

CPP 

US 

(multiple 

latitudes) 

[15767334] 

Male (%) 100 Internal 

validation? 

(y/n) 

N 

Prostate 

cancer risk 

stratified by 

tertiles of 

dietary 

calcium 

intakes 

X X 5% black; 

Total Ca 

(suppl) 
Table 59. Calcium and prostate cancer: Results of observational studies 

Author Year Study Name [PMID] 

Life 

Stage 

(male), y 

Outcome 

(n/N; Incidence) 

Followup 

Duration 

Total Ca 

intake in 

mg/d 

No. of 

Cases 

Total no. in 

Category 

Adjusted 

RR 95% 

51-70 

Prostate cancer 

(10,180/293,888; 

0.035) 

8 y <500 767 nd 1.01 0.93

500-<750 2927 nd 1 Refe

750-<1000 2808 nd 0.99 0.93

1000-

<1500 2572 nd 0.99 0.93

1000-

<1500 2572 nd 0.99 0.93

≥2000 309 nd 0.97 0.85

Mortality 

Prostate cancer <500 11 nd 0.76 0.38

500-<750 43 nd 1 Refe

750-<1000 56 nd 1.50 0.97

1000-

<1500 50 nd 1.42 0.86

1500-

<2000 18 nd 1.05 0.54

Park 2007134

NIH-AARP Diet & Health [18000020] 

≥2000 0 nd - 

51-70 Prostate cancer (3811/65,321; 0.058) ≤7 y <700 1323 23,653 1 Refe

700-999 1293 nd 1.0 0.9

1000-1499 835 nd 1.0 0.91500-1999 265 nd 1.3 1.1, 

Rodriguez 2003135

CPS II [12869397] 

≥2000 95 1330 1.2 1.0, 

19-50 51-70 

Prostate cancer 

(3544/47,750; 0.074) ≤16 y <500 183 nd 0.98 0.84

750-999 1099 nd 1.07 0.98

500-749 1072 nd 1 Refe

1500-1999 207 nd 1.06 0.911000-1499 898 nd 1.03 0.94

≥2000 85 nd 1.28 1.02, 

Mortality 

Prostate cancer <500 21 nd 1.05 0.65

750-999 81 nd 0.95 0.70

500-749 94 nd 1 Refe

1500-1999 26 nd 1.56 1.0, 1000-1499 76 nd 1.04 0.77

Giovannucci 2006128 2007129

HPFS [16492906] [17450530] 

≥2000 14 nd 2.02 1.14

Continued 

171 
Author Year 

Study Name 

Life 

Stage 

(male), y 

Outcome 

(n/N; Incidence) 

Followup 

Duration 

Total Ca 

intake in 

mg/d 

No. of 

Cases 

Total no. in 

Category 

Adjusted 

RR 95% 

[PMID] 

51-70 Prostate cancer (1267/27,028; 0.047) ≤17 y <1000A 151 nd 1 Refe

Mitrou 2007132

1000-1499 611 nd 1.28 1.07

1500-1999 402 nd 1.38 1.14

ATBC [17106437] 

≥2000 103 nd 1.63 1.27

19-50 51-70 

Prostate cancer 

(4404/82,483; 0.053) 8 y <470 706 nd 1 Refe

470-692 925 nd 1.03 0.93692-935 949 nd 1.04 0.93

935-1300 936 nd 1.05 0.93

Park 2007133

MCS [17925283] 

≥1301 888 nd 1.04 0.91

51-70 Prostate cancer (1012/20,885; 0.048) ≤11 y 0-150A 155 nd 1 Refe

151-300 206 nd 1.21 0.96301-600 377 nd 1.35 1.09

Chan 2001127

PHS [11566656] 

>600 274 nd 1.29 1.04

51-70 Prostate cancer (815/10,011; 0.081) ≤10 y 0-199A 209 nd 1 Refe

200-449 167 nd 0.81 0.64450-599 238 nd 0.91 0.73

≥600 201 nd 0.91 0.70

Mortality 

Prostate cancer 0-199 30 nd 1.00 Refe

200-449 21 nd 0.57 0.27450-599 23 nd 0.60 0.29

Koh 2006130

HAH [17106437] 

≥600 25 nd 0.81 0.38

51-70 Prostate cancer (704/58,279; 0.012) ≤6.3 y 602A,B 120 nd 1 Refe

780 126 nd 1.10 0.80911 127 nd 1.04 0.76

1064 140 nd 1.21 0.89

Schuurman 1999137

Netherlands Cohort [10362125] 

1329 129 nd 1.09 0.79

19-50 51-70 

Prostate cancer 

(329/43,435; 0.008) ≤7.5 y 283A,B 56 nd 1 Refe

404 68 nd 1.03 0.70522 98 nd 1.32 0.92

Kurahashi 2008131

Japan PHC [18398033] 

725 107 nd 1.24 0.85

51-70 Prostate cancer (199/3892; 0.051) ≤15 y <686 58 nd 1 Refe

686-958 65 nd 0.98 0.72

Rohrmann 2007136

WCC [17315319] >958 76 nd 0.99C 0.70

Continued 

172 
173 

Author Year Study Name [PMID] 

Life 

Stage 

(male), y 

Outcome 

(n/N; Incidence) 

Followup 

Duration 

Total Ca 

intake in 

mg/d 

No. of 

Cases 

Total no. in 

Category 

Adjusted 

RR 95% 

51-70 Prostate cancer (131/3779; 0.035) 7.7 y 455B 28 nd 1 Refe

642 37 nd 1.0 0.6

Tseng 2005138

NHEFS [15883441] 921 66 nd 2.2 1.4

51-70 Prostate cancer (70/672; 0.10) ≤12 y <675A,B nd nd 1 Refe

675-991 nd nd 1.48 0.81

Baron 200556

CPP [15767334] >991 nd nd 1.20 0.64

* Statistically significant (P<0.05) A Dietary calcium B median of tertile, quartile or quintile C Adjusted hazard ratio 
Figure 13. Prostate cancer risk stratified by calcium intake 

174 
Colorectal cancer. 

Synopsis. 

This synopsis is based on one systematic review, 19 cohort studies in 20 publications, and 

one nested case-control study. The systematic review of two RCTs that evaluated high risk 

population found no difference in colorectal cancer incidence between those participants who 

received supplemental calcium and those who did not. Among five cohort studies and one nested 

case-control study with methodological quality B, two cohort studies showed a significant 

inverse association between total calcium intake and colorectal cancer. Among 14 cohort studies 

with methodological quality C, five studies showed a significant inverse association between 

total calcium intake and colorectal cancer, one found an inverse association between total 

calcium intake and colon cancer, and two showed an inverse association between calcium and 

rectal cancer. All the studies that found a significant association recruited men or women who 

were followed for a period that ranged between 1.4 and 11.3 years. None of these studies 

included participants younger than 45 years. 

Detailed presentation (Tables 60, 61, 62 & 63; Figures 14, 15, 16, 17 & 18) 

One systematic review of two RCTs of supplemental calcium on prevention of recurrent 

colorectal adenoma comprising 1346 adults (mean age 59 to 61 years) examined colorectal 

cancer incidence.139 A fixed-effects model meta-analysis found no significant difference in 

colorectal cancer incidence between supplemental calcium and no supplements. This metaanalysis is considered inconclusive because only 5 colorectal cancer cases were diagnosed during 

the study period. 

Nineteen cohort studies in 20 publications125,140-158 and one nested case-control study159

evaluated the association between calcium intake and colorectal, colon, or rectal cancer. Sample 

sizes ranged from 1954 to 492,810. Half of the studies were conducted in the US (latitude ranged 

from 21° N to 54° N),125,140,142,144,145,147,150-152,154,155,158 one study was conducted in China 

(latitude 31° N),149 and the rest were conducted in Europe including France (latitude 46° N),141

the Netherlands (latitude 52° N),159 the United Kingdom (latitude ranged between 54° N and 55° 

N),156 and Scandinavia (latitude ranged between 59° N and 69° N).143,146,148,153,157 For colorectal 

cancer, the incidence ranged from 0.003 to 0.025 for cohorts, while in the nested case-control 

study, the colorectal cancer incidence was 0.142; for colon cancer, the incidence ranged from 

0.003 to 0.024; and for rectal cancer, the incidence ranged from 0.003 to 0.004. The participants’ 

mean age ranged from 7.6 to 61.9 years. Average followup ranged from 1.4 to 19.6 years. Only 

one study reported that exposure assessors were blinded to outcome.154 No studies mentioned 

that outcome assessors were blinded to exposure. None of the studies reported power 

calculations. The majority of the studies evaluated the potential effect of various factors besides 

calcium on colorectal cancer. All performed analyses adjusted at least for age. Except for four 

studies151,156-158 that used dietary history, all other studies used a food frequency questionnaire to 

assess dietary intake. More than half of the studies did not confirm all or part of cancer cases 

with pathology reports. Six studies125,140-143,159 were rated B, and 15 publications144-158 were rated 

C for methodological quality. 

175 
Findings by age, sex and/or ethnicity. 

One cohort study analyzed a total of 4374 children (IQR 4-11 years old) living in the United 

Kingdom. It found no significant association between total calcium intake and colorectal cancer 

in these children after 65 years of followup.156

One cohort study analyzed a total of 127,749 adults aged between 50 and 74 years old living 

in US. It found an inverse association between total calcium intake and colorectal cancer.145

However, another cohort study and one nested case-control study did not find such an 

association.157,159 The only cohort study that analyzed subjects older than 15 years did not find a 

significant association between total calcium intake and colon cancer as well as rectal cancer in 

subgroup analyses.157 Out of seven cohort studies125,140,143-145,148,154 that analyzed male adults 

older than 40 years living in US, or Scandinavia, five125,143-145,148 found an inverse association 

between total calcium intake and colorectal cancer. Out of eleven cohort studies125,140-142,144-

147,149,154,155 that analyzed women, four125,144,146,147 found an inverse association between total 

calcium intake and colorectal cancer. 

Out of four cohort studies145,148,151,153 that analyzed men, one145 found an inverse association 

between total calcium intake and colon cancer in a subgroup analysis. Out of four cohort 

studies146,147,150,153 that analyzed women, none found an association between total calcium intake 

and colon cancer. For rectal cancer, one148 of two145,148 studies that analyzed men and one152 of 

three146,147,152 studies that analyzed women found an inverse association between total calcium 

intake and rectal cancer.148,152 

One cohort study in the US found an inverse association between total calcium intake and 

colorectal cancer in a subgroup analysis of Japanese Americans aged 45 to 75 years, and a 

borderline inverse association in Caucasians of the same age range; however, the same cohort 

study did not find any significant association in subgroup analyses of African Americans, Native 

Hawaiians, and Latinos.144 Another cohort study in the US that recruited only Japanese 

American men living in Hawaii did not find an association between total calcium intake and 

colon cancer.151 One cohort study did not find any association in Chinese women (aged 40 to 70 

years) living in Shanghai,149

Findings by life stage. 

• 0 – 6 mo No data 

• 7 mo – 2 y No data 

• 3 – 8 y One study that followed up children with an interquartile range of age of 4 

to 11 years for 65 years found no significant association between total calcium intake at 

baseline and the risk of colorectal cancer. 

• 9 – 18 y Three studies included some children and/or adolescents in this life stage, 

but no studies adequately evaluated this life stage. 

• 19 – 50 y Four studies included people with a mean or median age ranging from 39 

to 50 years. No significant association was found between total calcium intake and 

colorectal cancer risk. Ten additional studies may have included participants in this life 

stage; however in these studies, no conclusions are possible for the subgroup in this life 

stage. 

• 51 – 70 y One inconclusive meta-analysis of 2 RCTs in adults with previous 

adenomatous polyps (mean age 59-61 years) found no significant difference in colorectal 

cancer incidence between those who were and those who were not supplemented at 

followup. Ten studies included people with a mean or median age ranged from 53 to 69 

176 
177 

years. An association between higher total calcium intake and lower colorectal cancer 

risk was found in three studies in men and two studies in women. Another study of 

women found an association between higher total calcium intake and lower rectal cancer 

risk. Ten additional studies may also have included participants in this life stage An 

association between higher total calcium intake and lower colorectal cancer risk was 

found in two studies in men and two studies in women. However in these studies, the 

results are inconclusive for the subgroup in this life stage. 

• 71+ One study that specifically included people in the retirement community 

found no association between total calcium intake and colorectal cancer risk. Nine 

additional studies may have also recruited participants in this life stage; however in these 

studies, no conclusions are possible for the subgroup in this life stage. 

• Postmenopause One study focused on postmenopausal women. This study found 

an association between higher calcium intake and lower rectal cancer risk. However, it 

did not find any association for colon cancer risk. 

• Pregnant & lactating women No data 
Table 60. Systematic review of calcium supplementation and colorectal cancer incidence or 

adenoma recurrence 

Weingarten, 2008139 Author Year [PMID] [18254022] 

Design Randomized controlled trials: Cochrane Library Issue 2, 2007, the Cochrane Colorectal Cancer 

Group (CCCG) specialized register, MEDLINE (1966 to July 2007 ), Cancerlit (1963 to April 

2002), Embase (1980 to July 2007) 

Population Healthy adults and studies of adults at higher risk of colon cancer due to family history, previous 

adenomatous polyps, or inflammatory bowel disease 

Intervention (Exposure) and 

Comparator 

Calcium (>1200 mg/d) vs. placebo 

Results Calcium vs. placebo 

Colorectal cancer incidence: OR 0.34, CI 0.05-2.15, P=0.20 (I2

=0%) 

Colorectal adenoma recurrence: OR 0.74; 95%CI 0.58, 0.95, P=0.02 (I2

=0%) 

At least one adverse event requiring discontinuation: OR 0.93; 95% CI 0.42, 2.05, P=0.80 

Comments Based only on two RCTs (1346 participants). Heterogeneity due to different dose of 

supplementation (one RCT supplemented with 1200 mg/d and the other RCT with 2000 mg/d). 

Analysis based on fixed effects model; however, considering there are only two studies, random 

effects model might have been more appropriate. The result of no significant difference in 

colorectal cancer incidence is inconclusive since there were only 5 colorectal cancer cases 

during the study period. Analysis on adverse events is based only on reported data of one out of 

the two RCTs (Barron 1999).160 Only participants with high risk due to previous adenomas were 

recruited in these two RCTs; therefore, applicability of the results can only be considered for 

high risk population. Insufficient evidence to recommend the general use of calcium 

supplements to prevent colorectal adenoma or colorectal cancer 

AMSTAR 

A priori design? X Study quality assessment performed? X 

Two independent reviewers? X Study quality appropriately used in analysis? X 

Comprehensive literature search? X Appropriate statistical synthesis? X 

All publication types and languages included? Publication bias assessed? 

Included and excluded studies listed? X Conflicts of interest stated? X 

Study characteristics provided? X 

178 
Table 61. Calcium and colorectal cancer: Characteristics of observational studies 

Confounders/Effect 

Modifiers Adjusted Author, Year 

Trial/Cohort 

Name 

Country 

(Latitude) 

[Pubmed ID] 

Comparisons 

Nutrients Demographic 

Population Dietary Calcium intake Comments Anthrop Medical Seasons Life styles 

Cohort 

• Health 

status 

Generally 

healthy 

men and 

women 

• Mean age 

range, yr 

50-71 

• Dietary 

assessment 

method 

Semiquantitati

ve FFQ 

(NCIDHQ) 

Park, 2009125

NIH-AARP 

Diet & Health 

(various) 

US 

[19237724] 

CRC across 5 

categories of 

total calcium 

intake 

X X X X 

• Male (%) 60 • Internal 

validation? 

(y/n) 

y 

X White 

Male ~92%; 

Female 

~89%; Total 

Ca (both)

• Health 

status 

HPFS: 

generally 

healthy 

male health 

professional

s 

NHS: 

generally 

healthy 

female 

nurses 

• Mean age 

(range/SD), 

yr 

HPFS: 54.4 

NHS: 46.6 

• Dietary 

assessment 

method 

HPFS: 

131-item 

semiquantitati

ve FFQ 

(by 

Willet) 

NHS: 61-

item 

semiquantitati

ve FFQ 

(by 

Willet) 

Wu, 2002140

HPFS 

NHS 

(various) 

US 

[11904316] 

For HPFS, 

NHS 

separately: 

CRC across 7 

categories of 

cumulative 

average 

calcium intake 

X X 

• Male (%) HPFS: 100 

NHS: 0 

• Internal 

validation? 

(y/n) 

y 

X X X Total Ca 

(both) 

• Health 

status 

Generally 

healthy 

women 

CRC across 

total calcium 

intake 

quartiles 

X X 

• Mean age 

(range/SD), 

yr 

52.7 

• Dietary 

assessment 

method 

Kesse, FFQ 

2005141

Etude 

Epidémiologi

que auprès 

de femmes 

de 

l'Education 

Nationale 

France 

(46°N) 

[15880532] 

• Male (%) 0 • Internal 

validation? 

(y/n) 

y 

X X Total Ca 

(food) 

• Health 

status 

Generally 

healthy 

women 

• Mean age 

(range/SD), 

yr 

nd 

• Dietary 

assessment 

method 

131-item 

FFQ 

Lin, 2005142

WHS 

US 

(various) 

[15800268] 

CRC across 

total calcium 

intake 

quintiles 

X X 

• Male (%) 0 • Internal 

validation? 

(y/n) 

y 

X X X Total Ca 

(both) 

continued 

179 
Confounders/Effect 

Modifiers Adjusted Author, Year 

Trial/Cohort 

Name 

Country 

(Latitude) 

[Pubmed ID] 

Dietary Calcium intake Comparisons 

Nutrients Demographic 

Population 

Anthrop Medical Seasons Life styles 

Comments 

• Health 

status 

Generally 

healthy 

men; 

smokers 

CRC across 

total calcium 

intake 

quartiles 

X X X 

• Mean age 

(range/SD), 

yr 

Median, 

cases: 60.1; 

non cases: 

57.1 

• Dietary 

assessment 

method 

276-item 

FFQ 

Pietinen, 

1999143

ATBC 

Finland 

(~64°N) 

[10530608] 

• Male (%) 100 • Internal 

validation? 

(y/n) 

y 

X Total Ca 

(food) 

• Health 

status 

Generally 

healthy 

men and 

women 

• Mean age 

(range/SD), 

yr 

nd 

• Dietary 

assessment 

method 

Park, 2007 FFQ 144

The 

Multiethnic 

Cohort Study 

US 

(various) 

[17215380] 

CRC per 

gender across 

total calcium 

intake 

quintiles 

X X X X 

• Male (%) 45 • Internal 

validation? 

(y/n) 

y 

X Total Ca 

(both) 

CRC across 

total calcium 

intake 

quintiles 

Subgroup 

analyses per 

gender 

For men, 

subgroup 

analyses per 

site (colon, 

rectal) 

• Health X X 

status 

Generally 

healthy 

men and 

women 

• Mean age 

(range/SD), 

yr 

nd 

• Dietary 

assessment 

method 

68-item 

semiquantitati

ve FFQ 

(modifica

tion of 

the brief 

Health 

Habits 

and 

History 

Question

naire 

(HHHQ) 

by Block) 

McCullough, 

2003145

CPS II 

US 

(various) 

[12708719] 

• Male (%) 48 • Internal 

validation? 

(y/n) 

y 

X X X Total Ca 

(both) 

• Health 

status 

Generally 

healthy 

women 

• Mean age 

(range/SD), 

yr 

Cases: 59 

(8.5); noncases: 52 

(9.1) 

• Dietary 

assessment 

method 

77-item 

FFQ 

used in 

Shanghai 

Women’s 

Health 

Study 

Shin, 2006149

Shanghai 

Women’s 

Health Study 

China 

(31°N) 

[17019716] 

CRC across 

total calcium 

intake 

quintiles 

Subgroup 

analyses per 

site (colon, 

rectal) 

X X X 

• Male (%) 0 • Internal 

validation? 

(y/n) 

y 

X Chinese; 

Total Ca 

(food) 

continued 

180 
Confounders/Effect 

Modifiers Adjusted Author, Year 

Trial/Cohort 

Name 

Country 

(Latitude) 

[Pubmed ID] 

Dietary Calcium intake Comparisons 

Nutrients Demographic 

Population 

Anthrop Medical Seasons Life styles 

Comments 

• Health 

status 

Generally 

healthy 

women 

CRC across 

total calcium 

intake 

quartiles 

Subgroup 

analyses per 

site (colon, 

rectal) 

Subgroup 

analyses per 

age (< 55 vs. 

≥ 55 years 

old) and site 

(colon, rectal) 

X X X 

• Mean age 

(range/SD), 

yr 

nd 

• Dietary 

assessment 

method 

Selfadminist

ered 67-

item FFQ 

Terry, 

2002146

Swedish 

Mammograp

hy Screening 

Cohort 

Sweden 

(59°N) 

[12467133] 

• Male (%) 0 • Internal 

validation? 

(y/n) 

y 

X Total Ca 

(food) 

• Health 

status 

Generally 

healthy 

men and 

women 

• Mean age 

(range/SD), 

yr 

43 

• Dietary 

assessment 

method 

semiquantitati

ve FFQ 

(Oslo 

Universit

y) 

Gaard,199615

3

nd 

Norway 

(60°-69°N) 

[9061275] 

Colon cancer 

per gender 

across total 

calcium intake 

quartiles 

X X 

• Male (%) 49 • Internal 

validation? 

(y/n) 

y 

X Total Ca 

(food) 

• Health 

status 

Generally 

healthy 

women 

CRC cancer 

across total 

calcium intake 

quintiles 

Subgroup 

analyses per 

site (colon, 

rectal) 

X X 

• Mean age 

(range/SD), 

yr 

61.9 

• Dietary 

assessment 

method 

62-item 

semiquantitati

ve FFQ 

(by 

Block) 

Flood, 

2005147

The Breast 

Cancer 

Detection 

Demonstratio

n Project 

(BCDDP) 

US 

(various) 

[15668485] 

• Male (%) 0 • Internal 

validation? 

(y/n) 

y 

X X X Total Ca 

(both) 

CRC across 

total calcium 

intake 

quartiles 

Subgroup 

analyses per 

site (colon, 

rectal) 

• Health X X 

status 

Generally 

healthy 

men 

• Mean age 

(range/SD), 

yr 

60.3 

• Dietary 

assessment 

method 

96-item 

semiquantitati

ve FFQ 

Larsson, 

2006148

The Cohort 

of Swedish 

Men 

Sweden 

(59°N) 

[16522915] 

• Male (%) 100 • Internal 

validation? 

(y/n) 

y 

X X X Total Ca 

(both) 

• Health 

status 

Generally 

healthy 

postmenopausa

l women 

Colon cancer 

across total 

calcium intake 

quintiles 

X X 

• Mean age 

(range/SD), 

yr 

61.5 

• Dietary 

assessment 

method 

127-item 

semiquantitati

ve FFQ 

(by 

Willet) 

Bostick, 

1993150

Iowa 

Women’s 

Health Study 

US 

(40°N ) 

[8333412] 

• Male (%) 0 • Internal 

validation? 

(y/n) 

y 

X Same cohort 

as Zheng 

1998; Total 

Ca (both) 

continued 

181 
Confounders/Effect 

Modifiers Adjusted Author, Year 

Trial/Cohort 

Name 

Country 

(Latitude) 

[Pubmed ID] 

Dietary Calcium intake Comparisons 

Nutrients Demographic 

Population 

Anthrop Medical Seasons Life styles 

Comments 

• Health 

status 

Generally 

healthy 

postmenopausa

l women 

Rectal cancer 

across total 

calcium intake 

tertiles 

X X 

• Mean age 

(range/SD), 

yr 

61.5 

• Dietary 

assessment 

method 

127-item 

semiquantitati

ve FFQ 

(by 

Willet) 

Zheng, 

1998152

Iowa 

Women’s 

Health Study 

US 

(40°N) 

[9521437] 

• Male (%) 0 • Internal 

validation? 

(y/n) 

y 

X X X Same cohort 

as Bostick 

1993; Total 

Ca (both) 

• Health 

status 

Generally 

healthy 

women 

• Mean age 

(range/SD), 

yr 

nd 

• Dietary 

assessment 

method 

70-item 

semiquantitati

ve FFQ 

(slightly 

modified 

from 

Block’s) 

Kato, 1997155

New York 

University 

Women’s 

Health Study 

US 

(various) 

[9343837] 

CRC across 

total calcium 

intake 

quartiles 

X X 

• Male (%) 0 • Internal 

validation? 

(y/n) 

y 

Total Ca 

(food) 

• Health 

status 

Generally 

healthy 

men and 

women 

• Mean age 

(range/SD), 

yr 

nd 

• Dietary 

assessment 

method 

56-item 

FFQ 

Wu, 1987154

US 

(21°N) 

[3620314] 

CRC per 

gender across 

total calcium 

intake tertiles 

X 

• Male (%) 33 • Internal 

validation? 

(y/n) 

n 

Total Ca 

(dairy) 

• Health 

status 

Generally 

healthy 

men and 

women 

CRC across 

total calcium 

intake 

quartiles 

Subgroup 

analyses per 

site (colon, 

rectal) 

X X X 

• Mean age 

(range/SD), 

yr 

39.1 

• Dietary 

assessment 

method 

Diet 

history 

Jarvinen, 

2001157

nd 

Finland 

(64°N) 

[11641750] 

• Male (%) nd • Internal 

validation? 

(y/n) 

y 

X Total Ca 

(food) 

Colon cancer 

across total 

calcium intake 

tertiles 

• Health X 

status 

Generally 

healthy 

men 

• Mean age 

(range/SD), 

yr 

nd 

• Dietary 

assessment 

method 

24-hour 

diet 

recall 

interview 

Stemmerman

n, 1990151

Japan Hawaii 

Cancer Study 

US 

(21°N) 

[2311461] • Male (%) 100 • Internal 

validation? 

(y/n) 

y 

Japanese; 

Total Ca 

(food) 

continued 

182 
183 

Confounders/Effect 

Modifiers Adjusted Author, Year 

Trial/Cohort 

Name 

Country 

(Latitude) 

[Pubmed ID] 

Population Dietary Calcium intake Comparisons 

Nutrients Demographic Anthrop Medical Seasons Life styles 

Comments 

• Health 

status 

Generally 

healthy 

children 

• Mean age 

(range/SD), 

yr 

7.6 

• Dietary 

assessment 

method 

7-day 

househol

d 

inventory 

method 

van der Pols, 

2007156

The Boyd Orr 

Cohort 

UK 

(54°-55°N) 

[8333412] • Male (%) 49.5 • Internal 

validation? 

(y/n) 

n 

CRC between 

lowest and 

highest total 

calcium intake 

groups 

X X X X Total Ca 

(food) 

• Health 

status 

Generally 

healthy 

men 

• Mean age 

(range/SD), 

yr 

48.7 (4.4) 

• Dietary 

assessment 

method 

28-day 

diet 

histories 

Garland, 

1985158

Western 

Electric 

Health Study 

US 

(41°N) 

[2857364] 

• Male (%) 100 • Internal 

validation? 

(y/n) 

n 

CRC across 

total calcium 

intake 

quartiles 

X X X X Total Ca 

(food) 

Nested case-control 

• Health 

status 

Generally 

healthy 

men and 

women 

• Mean age 

(range/SD), 

yr 

nd 

• Dietary 

assessment 

method 

150-item 

semiquantitati

ve FFQ 

Kampman, 

1994159

The 

Netherlands 

Cohort Study 

Netherlands 

(52°N) 

[8205538] • Male (%) nd • Internal 

validation? 

(y/n) 

y 

CRC across 

total calcium 

intake 

quintiles 

X X X X Total Ca 

(food) 
Table 62. Calcium and colorectal cancer: Results of cohort studies 

Author Year Study Name Location (Latitude) PMID 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to 

Dx) 

Adjusted 

RR 

95

Park, 2009125

NIH-AARP Diet & Health US (various) [19237724] 

Male adult 

(50-71 y) 

CRC (nd) 526 nd nd 84 mo 1.0 Refe

CRC (nd) 498 nd nd 84 mo 0.89 0.80CRC (nd) 857 nd nd 84 mo 0.83 0.75CRC (nd) 1073 nd nd 84 mo 0.87 0.78CRC (nd) 1530 nd nd 84 mo 0.79 0.70

Female adult 

(50-71 y) 

CRC (nd) 494 nd nd 84 mo 1.0 Refe

CRC (nd) 717 nd nd 84 mo 0.87 0.75CRC (nd) 969 nd nd 84 mo 0.83 0.71CRC (nd) 1296 nd nd 84 mo 0.71 0.60CRC (nd) 1881 nd nd 84 mo 0.72 0.61

Wu 2002140

HPFS: Health Professionals Follow-up Study NHS: Nurses’ Health Study US (various) [11904316] 

Male adult 

(40-75 y) 

CRC (nd) ≤ 500 47 nd nd 1.0 Refe

CRC (nd) 501-600 48 nd nd 0.69 0.46CRC (nd) 601-700 58 nd nd 0.69 0.47CRC (nd) 701-800 51 nd nd 0.60 0.40CRC (nd) 801-1000 81 nd nd 0.67 0.47CRC (nd) 1001-1250 84 nd nd 0.62 0.42CRC (nd) >1250 60 nd nd 0.64 0.43

Female adult 

(30-55 y) 

CRC (nd) ≤ 500 70 nd nd 1.0 Refe

CRC (nd) 501-600 79 nd nd 1.19 0.86CRC (nd) 601-700 83 nd nd 1.07 0.77CRC (nd) 701-800 90 nd nd 1.18 0.86CRC (nd) 801-1000 130 nd nd 1.04 0.77CRC (nd) 1001-1250 106 nd nd 1.05 0.77CRC (nd) >1250 68 nd nd 0.94 0.66

continued 

184 
Author Year 

Study Name Location (Latitude) PMID 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to 

Dx) 

Adjusted 

RR 

95

Kesse 2005141

Etude Epidémiologique auprès de femmes de l'Education Nationale France (46°N) [15880532] 

Female adult 

(40-65 y) 

CRC (nd) <766.22 163 nd 82.8 mo 1.0 Refe

CRC (nd) 766.22-

962.63 

154 nd 82.8 mo 0.94 0.63

CRC (nd) 962.63-

1201.81 

150 nd 82.8 mo 0.78 0.51

CRC (nd) > 1201.81 131 nd 82.8 mo 0.72 0.47

Lin 2005142

The Women’s Health Study US (various) [15800268] 

Female adult 

(≥ 45 y) 

CRC (41/7691; 

0.01) 

<614 41 7691 120 mo 1.0 Refe

CRC (nd) 614-785 31 nd 120 mo 0.74 0.46

CRC (0.01) 785-1016 52 7690 120 mo 1.19 0.78

CRC (nd) 1016-1357 41 nd 120 mo 0.92 0.58

CRC (58/7690; 

0.01) 

> 1357 58 7690 120 mo 1.20 0.79

Pietinen 1999143

ATBC Finland (~64°N) [10530608] 

Male adult 

(50-69 y) 

CRC (nd) Median Q1, 

856 

60 nd 96 mo 1.0 Refe

CRC (nd) Median Q2, 

1241 

41 nd 96 mo 0.7 0.5

CRC (nd) Median Q3, 

1484 

45 nd 96 mo 0.7 0.5

CRC (nd) Median Q4, 

1789 

39 nd 96 mo 0.6 0.6

continued 

185 
Author Year 

Study Name Location (Latitude) PMID 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

Adjusted 

RR 

95

(Time to 

Dx) 

Park 2007144

The Multiethnic Cohort Study US (various) [17215380] 

Male adult 

(45-75 y) 

CRC (nd) < 288 /1000 

kcal 

342 nd 87.6 mo 1.0 Refe

CRC (nd) 288-369 

/1000 kcal 

271 nd 87.6 mo 1.02 0.86

CRC (nd) 369-457 

/1000 kcal 

258 nd 87.6 mo 1.08 0.89

CRC (nd) 457-611 

/1000 kcal 

177 nd 87.6 mo 0.85 0.68

CRC (nd) ≥ 611 /1000 

kcal 

90 nd 87.6 mo 0.70 0.52

Female adult 

(45-75 y) 

CRC (nd) < 288 /1000 

kcal 

172 nd 87.6 mo 1.0 Refe

CRC (nd) 288-369 

/1000 kcal 

175 nd 87.6 mo 0.77 0.60

CRC (nd) 369-457 

/1000 kcal 

194 nd 87.6 mo 0.76 0.60

CRC (nd) 457-611 

/1000 kcal 

197 nd 87.6 mo 0.74 0.57

CRC (nd) ≥ 611 /1000 

kcal 

234 nd 87.6 mo 0.64 0.50

McCullough 2003145

CPS II US (various) [12708719] 

Adult 

(50-74 y) 

CRC (nd) <561 156 nd nd 1.0 Refe

CRC (nd) 561-731 165 nd nd 1.05 0.84CRC (nd) 732-925 137 nd nd 0.88 0.70CRC (nd) 926-1255 108 nd nd 0.72 0.56CRC (nd) >1255 117 nd nd 0.87 0.67

Male adult 

(50-74 y) 

CRC (nd) <561 89 nd nd 1.0 Refe

CRC (nd) 561-731 106 nd nd 1.01 0.76CRC (nd) 732-925 98 nd nd 0.93 0.70CRC (nd) 926-1255 70 nd nd 0.71 0.52CRC (nd) >1255 58 nd nd 0.82 0.58

continued 

186 
Author Year 

Study Name Location (Latitude) PMID 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to 

Dx) 

Adjusted 

RR 

95

Colon cancer (nd) <561 64 nd nd 1.0 RefeColon cancer (nd) 561-731 82 nd nd 1.08 0.77Colon cancer (nd) 732-925 67 nd nd 0.89 0.63Colon cancer (nd) 926-1255 51 nd nd 0.72 0.49Colon cancer (nd) >1255 38 nd nd 0.74 0.49

Rectal cancer 

(nd) 

<561 23 nd nd 1.0 Refe

Rectal cancer 

(nd) 

561-731 22 nd nd 0.78 0.43

Rectal cancer 

(nd) 

732-925 29 nd nd 1.02 0.58

Rectal cancer 

(nd) 

926-1255 16 nd nd 0.60 0.31

Rectal cancer 

(nd) 

>1255 19 nd nd 1.01 0.53

Female adult 

(50-74 y) 

CRC (nd) <561 67 nd nd 1.0 Refe

CRC (nd) 561-731 59 nd nd 1.16 0.82CRC (nd) 732-925 39 nd nd 0.80 0.54CRC (nd) 926-1255 38 nd nd 0.78 0.51CRC (nd) >1255 59 nd nd 0.94 0.63

Shin 2006149

Shanghai Women’s Health Study China (31°N) [17019716] 

Female adult 

(40-70) 

CRC (nd) ≤ 291.9 nd nd Median, 

68.9 mo 

1.0 Refe

CRC (nd) ≤ 389.9 nd nd Median, 

68.9 mo 

1.0 0.7

CRC (nd) ≤ 488.2 nd nd Median, 

68.9 mo 

1.0 0.7

CRC (nd) ≤ 610.8 nd nd Median, 

68.9 mo 

0.9 0.6

CRC (nd) > 610.8 nd nd Median, 

68.9 mo 

0.9 0.6

continued 

187 
Author Year 

Study Name Location (Latitude) PMID 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to 

Dx) 

Adjusted 

RR 

95

Terry 2002146

Swedish Mammography Screening Cohort Sweden (59°N) [12467133] 

Female adult 

(≤ 76 y) 

CRC (nd) Mean (SD) 

Q1, 486 (79) 

156 nd 135.6 mo 1.0 Refe

CRC (nd) Mean (SD) 

Q2, 631 (34) 

149 nd 135.6 mo 0.97 0.77

CRC (nd) Mean (SD) 

Q3, 747 (37) 

145 nd 135.6 mo 0.95 0.75

CRC (nd) Mean (SD) 

Q4, 914 (136) 

122 nd 135.6 mo 0.72 0.56

Colon cancer (nd) Mean (SD) 

Q1, 486 (79) 

100 nd 135.6 mo 1.0 Refe

Colon cancer (nd) Mean (SD) 

Q2, 631 (34) 

97 nd 135.6 mo 0.97 0.74

Colon cancer (nd) Mean (SD) 

Q3, 747 (37) 

92 nd 135.6 mo 0.93 0.70

Colon cancer (nd) Mean (SD) 

Q4, 914 (136) 

82 nd 135.6 mo 0.74 0.54

Rectal cancer 

(nd) 

Mean (SD) 

Q1, 486 (79) 

55 nd 135.6 mo 1.0 Refe

Rectal cancer 

(nd) 

Mean (SD) 

Q2, 631 (34) 

48 nd 135.6 mo 0.89 0.60

Rectal cancer 

(nd) 

Mean (SD) 

Q3, 747 (37) 

49 nd 135.6 mo 0.94 0.63

Rectal cancer 

(nd) 

Mean (SD) 

Q4, 914 (136) 

39 nd 135.6 mo 0.70 0.45

Female adult 

(< 55 y) 

CRC (nd) 176-568 nd nd 135.6 mo 1.0 Refe

CRC (nd) 568-688 nd nd 135.6 mo 1.06 0.68CRC (nd) 688-816 nd nd 135.6 mo 1.11 0.71CRC (nd) 816-1300 nd nd 135.6 mo 0.91 0.56

Female adult 

(≥ 55 y) 

CRC (nd) 176-568 nd nd 135.6 mo 1.0 Refe

CRC (nd) 568-688 nd nd 135.6 mo 0.93 0.71CRC (nd) 688-816 nd nd 135.6 mo 0.89 0.68CRC (nd) 816-1300 nd nd 135.6 mo 0.66 0.49

Female adult 

(< 55 y) 

Colon cancer (nd) 176-568 nd nd 135.6 mo 1.0 RefeColon cancer (nd) 568-688 nd nd 135.6 mo 1.32 0.7Colon cancer (nd) 688-816 nd nd 135.6 mo 1.02 0.55Colon cancer (nd) 816-1300 nd nd 135.6 mo 1.11 0.60

continued 

188 
Author Year 

Study Name Location (Latitude) PMID 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to 

Dx) 

Adjusted 

RR 

95

Female adult 

(≥ 55 y) 

Colon cancer (nd) 176-568 nd nd 135.6 mo 1.0 RefeColon cancer (nd) 568-688 nd nd 135.6 mo 0.89 0.64Colon cancer (nd) 688-816 nd nd 135.6 mo 0.91 0.65Colon cancer (nd) 816-1300 nd nd 135.6 mo 0.64 0.44

Female adult 

(< 55 y) 

Rectal cancer 

(nd) 

176-568 nd nd 135.6 mo 1.0 Refe

Rectal cancer 

(nd) 

568-688 nd nd 135.6 mo 0.33 0.34

Rectal cancer 

(nd) 

688-816 nd nd 135.6 mo 1.30 0.66

Rectal cancer 

(nd) 

816-1300 nd nd 135.6 mo 0.70 0.31

Female adult 

(≥ 55 y) 

Rectal cancer 

(nd) 

176-568 nd nd 135.6 mo 1.0 Refe

Rectal cancer 

(nd) 

568-688 nd nd 135.6 mo 0.96 0.61

Rectal cancer 

(nd) 

688-816 nd nd 135.6 mo 0.79 0.48

Rectal cancer 

(nd) 

816-1300 nd nd 135.6 mo 0.70 0.42

Gaard 1996153

Norway (60°-69°N) [9061275] 

Male adult 

(20-53 y) 

Colon cancer (nd) <758 22 nd 134.4 mo 1.0 Refe

Colon cancer (nd) 759-912 24 nd 134.4 mo 1.02 0.57Colon cancer (nd) 913-1066 24 nd 134.4 mo 1.04 0.58Colon cancer (nd) >1067 13 nd 134.4 mo 0.57 0.29

Female adult 

(20-53 y) 

Colon cancer (nd) <527 15 nd 134.4 mo 1.0 Refe

Colon cancer (nd) 528-628 20 nd 134.4 mo 1.25 0.63Colon cancer (nd) 629-743 7 nd 134.4 mo 0.46 0.19Colon cancer (nd) >744 18 nd 134.4 mo 1.20 0.60

continued 

189 
Author Year 

Study Name Location (Latitude) PMID 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to 

Dx) 

Adjusted 

RR 

95

Flood 2005147

The Breast Cancer Detection Demonstration Project (BCDDP) US (various) [15668485] 

Female adult 

(nd) 

CRC (nd) <472 102 nd 17 mo 1.0 Refe

CRC (nd) 472-635 110 nd 17 mo 1.03 0.79CRC (nd) 636-844 86 nd 17 mo 0.80 0.60CRC (nd) 845-1270 106 nd 17 mo 0.96 0.73CRC (nd) >1270 80 nd 17 mo 0.74 0.55

Colon cancer (nd) <472 nd nd 17 mo 1.0 RefeColon cancer (nd) 472-635 nd nd 17 mo 0.84 0.59Colon cancer (nd) 636-844 nd nd 17 mo 0.66 0.46Colon cancer (nd) 845-1270 nd nd 17 mo 0.78 0.55Colon cancer (nd) >1270 nd nd 17 mo 0.69 0.48

Rectal cancer 

(nd) 

<472 nd nd 17 mo 1.0 Refe

Rectal cancer 

(nd)

472-635 nd nd 17 mo 1.19 0.57

Rectal cancer 

(nd)

636-844 nd nd 17 mo 1.10 0.52

Rectal cancer 

(nd)

845-1270 nd nd 17 mo 1.23 0.60

Rectal cancer 

(nd)

>1270 nd nd 17 mo 0.93 0.43

Larsson 2006148

The Cohort of Swedish Men Sweden (59°N) [16522915] 

Male adult 

(45-79 y) 

CRC 

(111/11,341; 

0.011) 

<956 127 11,348 80.4 mo 1.0 Refe

CRC (107/11295; 

0.010) 

956-1179 111 11,341 80.4 mo 0.80 0.61

CRC 

(104/11,322; 

0.009) 

1180-1444 107 11,295 80.4 mo 0.73 0.56

CRC (67/11,322; 

0.009) 

>1445 104 11,322 80.4 mo 0.68 0.51

Colon cancer 

(77/11,348; 

0.006) 

<956 67 11,322 80.4 mo 0.72 0.50

Colon cancer 

(70/11,295; 

0.007) 

956-1179 77 11,348 80.4 mo 1.0 Refe

continued 

190 
Author Year 

Study Name Location (Latitude) PMID 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to 

Dx) 

Adjusted 

RR 

95

Colon cancer 

(67/11,322; 

0.006) 

1180-1444 70 11,295 80.4 mo 0.80 0.57

Colon cancer 

(50/11,348; 

0.006) 

>1445 67 11,322 80.4 mo 0.72 0.50

Rectal cancer 

(49/11,341; 

0.004) 

<956 50 11,348 80.4 mo 1.0 Refe

Rectal cancer 

(37/11,295; 

0.004)

956-1179 49 11,341 80.4 mo 0.91 0.61

Rectal cancer 

(37/11,322; 

0.003)

1180-1444 37 11,295 80.4 mo 0.63 0.40

Rectal cancer 

(37/11,322; 

0.003)

>1445 37 11,322 80.4 mo 0.61 0.38

Bostick 1993150

Iowa Women’s Health Study US (40°N) [8333412] 

Female adult 

(55-69 y) 

Colon cancer (nd) <629 54 nd nd 1.0 Refe

Colon cancer (nd) 629-896 44 nd nd 0.89 0.59Colon cancer (nd) 897-1188 42 nd nd 0.88 0.58Colon cancer (nd) 1189-1547 44 nd nd 0.97 0.63Colon cancer (nd) >1548 28 nd nd 0.68 0.41

Zheng 1998152

Iowa Women’s Health Study US (40°N) [9521437] 

Female adult, 

(55-69 y) 

Rectal cancer 

(nd) 

<800.8 56 nd 108 mo 1.0 Refe

Rectal cancer 

(nd) 

800.8-1278.7 52 nd 108 mo 0.90 0.61

Rectal cancer 

(nd) 

≥1278.7 36 nd 108 mo 0.59 0.37

continued

191 
Author Year 

Study Name Location (Latitude) PMID 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to 

Dx) 

Adjusted 

RR 

95

Kato 1997155

New York University Women’s Health Study US (various) [9343837] 

Female adult 

(34-65 y) 

CRC (nd) Lowest, Q1 

(nd) 

nd nd 85.2 mo 1.0 Refe

CRC (nd) Q2 (nd) nd nd 85.2 mo 1.15 0.67CRC (nd) Q3 (nd) nd nd 85.2 mo 0.90 0.52CRC (nd) Highest Q4 

(nd) 

nd nd 85.2 mo 0.71 0.39

Wu 1987154

US (21°N) [3620314] 

Male adult 

(nd) 

CRC (nd) Low tertile 

(nd) 

nd nd nd 1.0 Refe

CRC (nd) Medium 

tertile (nd) 

nd nd nd 1.19 0.6

CRC (nd) High tertile 

(nd) 

nd nd nd 0.86 0.4

Female adult 

(nd) 

CRC (nd) Low tertile 

(nd) 

nd nd nd 1.0 Refe

CRC (nd) Medium 

tertile (nd) 

nd nd nd 0.9 0.5

CRC (nd) High tertile 

(nd) 

nd nd nd 0.89 0.5

Jarvinen 2001157

Finland (64°N) [11641750] 

Adolescent 

and adult 

(> 15 y) 

CRC (nd) Male: 

<1178.2 

Female: 

<862.5 

20 nd 235.2 mo 1.0 Refe

CRC (nd) Male: 1178.2-

1557.1 

Female: 

862.5-1110.7 

19 nd 235.2 mo 1.17 0.60

CRC (nd) Male: 1557.2-

1953.2 

Female: 

1110.8-

1416.6 

18 nd 235.2 mo 1.37 0.67

CRC (nd) Male: >

1953.3 

Female: > 

1416.7 

15 nd 235.2 mo 1.43 0.61

continued

192 
Author Year 

Study Name Location (Latitude) PMID 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to 

Dx) 

Adjusted 

RR 

95

Colon cancer (nd) Male: 

<1178.2 

Female: 

<862.5 

10 nd 235.2 mo 1.0 Refe

Colon cancer (nd) Male: 1178.2-

1557.1 

Female: 

862.5-1110.7 

14 nd 235.2 mo 1.44 0.61

Colon cancer (nd) Male: 1557.2-

1953.2 

Female: 

1110.8-

1416.6 

9 nd 235.2 mo 1.04 0.38

Colon cancer (nd) Male: >

1953.3 

Female: > 

1416.7 

5 nd 235.2 mo 0.63 0.17

Rectal cancer 

(nd)

Male: 

<1178.2 

Female: 

<862.5 

10 nd 235.2 mo 1.0 Refe

Rectal cancer 

(nd)

Male: 1178.2-

1557.1 

Female: 

862.5-1110.7 

5 nd 235.2 mo 0.77 0.25

Rectal cancer 

(nd)

Male: 1557.2-

1953.2 

Female: 

1110.8-

1416.6 

9 nd 235.2 mo 1.88 0.67

Rectal cancer 

(nd)

Male: >

1953.3 

Female: > 

1416.7 

10 nd 235.2 mo 3.01 0.93

continued 

193 
194 

Author Year Study Name Location (Latitude) PMID 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to 

Dx) 

Adjusted 

RR 

95

Stemmermann 1990151

Japan Hawaii Cancer Study US (21°N) [2311461]

Male adult 

(nd) 

Colon cancer 

(74/2466; 0.02) 

Low (nd) 74 2466 nd 1.3 0.9

Colon cancer 

(57/2456; 0.02) 

Medium (nd) 57 2456 nd 1.0 0.7

Colon cancer 

(58/2461; 0.03) 

High (nd) 58 2461 nd 1.0 Refe

van der Pols 2007156

The Boyd Orr Cohort UK (54°-55°N) [8333412] 

Children 

(IQR 4-11 y) 

CRC (nd) Lowest Q1, 

(nd) 

nd nd nd 1.0 Refe

CRC (nd) Highest Q4, 

(nd) 

nd nd nd 1.91 0.84

Garland 1985158

Western Electric Health Study US (41°N) [2857364] 

Male adult 

(40-55 y) 

CRC (19/488; 

0.04) 

102-241 

/1000 kcal 

19 488 nd nd 

CRC (12/489; 

0.02) 

242-306 

/1000kcal 

12 489 nd nd 

CRC (12/489; 

0.02) 

307-383 

/1000 kcal 

12 489 nd nd 

CRC (6/458; 

0.01) 

384-906 

/1000 kcal 

6 458 nd nd 
Table 63. Calcium and colorectal cancer: Results of nested case-control studies 

Author Year Study Name Location (Latitude) PMID 

Life 

Stage 

Outcome (n/N, 

Incidence) 

Total Ca 

Intake, mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to Dx) 

Adjusted 

RR 

95% 

Kampman 1994159

The Netherlands Cohort Study Netherlands (52°N) [8205538] 

Adult (55-

69 y) 

CRC (443/3111, 0.14) 

Median Q1, 596

98 623 39.6 mo 1.0 Refere

Median Q2, 768 

89 619 39.6 mo 0.83 0.58, 

Median Q3, 893 

87 622 39.6 mo 0.96 0.67, 

Median Q4, 1032 

81 627 39.6 mo 0.93 0.64, 

Median Q5, 1288 

88 620 39.6 mo 0.92 0.64, 

195 
Figure 14 Colorectal cancer risk in both sexes stratified by calcium intake 

196 
Figure 15 Colorectal cancer risk in men stratified by calcium intake 

197 
Figure 16 Colorectal cancer risk in women stratified by calcium intake 

198 
Figure 17 Colon cancer risk stratified by calcium intake 

199 
Figure 18. Rectal cancer risk stratified by calcium intake 

200 
Colorectal adenoma. 

Synopsis. 

This synopsis is based on one systematic review, two comparative trials (one post hoc followup 

study of an RCT and one nonrandomized trial), and four cohort studies. The systematic review 

that included two RCTs which evaluated high risk population for the prevention of colorectal 

adenoma recurrence showed a reduction in the risk of colorectal adenoma with calcium 

supplementation (OR 0.74, 95 percent CI 0.58, 0.95; P=0.02). The B quality long-term 

followup study of an RCT of calcium supplementation (1200 mg/d) versus placebo in healthy 

adults showed no significant difference in the risk of recurrence of colorectal adenoma. The 

nonrandomized comparative trial (methodological quality C) also found a significant reduction 

in adenoma recurrence risk among healthy adults who received calcium supplementation. 

Among four cohort studies (methodological quality B), two found an inverse association 

between total calcium intake and the risk of colorectal adenoma, while the others found no 

significant association. 

Detailed presentation (Tables 64, 65, 66, 67 & 68; Figure 19). 

One systematic review included two RCTs that recruited high risk population for colorectal 

adenoma due to previous adenomatous polyps.139 A total of 1346 participants were analyzed for 

the effect of calcium supplementation (1200 to 2000 mg elemental calcium daily). The odds ratio 

of colorectal adenoma recurrence was 0.74 (95 percent CI 0.58, 0.95; P=0.02), comparing 

calcium supplementation to the placebo. A B quality post hoc followup analysis161 of one of the 

two RCTs that were included in the meta-analysis examined the long-term effect of calcium 

supplementation to prevent colorectal adenoma recurrence. The trial recruited participants with 

previous colorectal adenoma, and compared the preventative efficacy of calcium 

supplementation (1200 mg/d) to placebo. Adenoma recurrence at 4 years was the original 

primary outcome. During the followup period after the trial treatment, about 50 percent of 

participants in both groups took some calcium supplements. In 347 participants who underwent 

colonoscopy during the first 5 years after the intervention period, the relative risk of adenoma 

recurrence was 0.63 (95 percent CI 0.46, 0.87; P=0.005) comparing calcium supplementation to 

placebo, whereas no difference was found in 424 participants who underwent colonoscopy in the 

subsequent 5 to 10 years after the trial treatment. 

A nonrandomized comparative study162 presented the percentage of adenoma recurrence in a 

group of men and women who underwent polypectomy, and received calcium supplementation 

(2000 mg/d) as chemoprevention. The same study also presented the percentage of adenoma 

recurrence in a group of men and women who underwent polypectomy but were not 

supplemented with calcium. The intervention group included 175 participants while the 

nonsupplemented group included nine patients. The two groups were followed for an average of 

3.1 years. The trial was rated C for methodological quality. In this study,162 the percentage of 

participants with adenoma recurrence was lower in the intervention group compared to the 

nonsupplemented participants (13 percent versus 55 percent); however, no further statistical 

analysis was provided. 

Four cohort studies evaluated the association between calcium intake and colorectal 

adenoma.141,163-165 Three studies were conducted in the US (latitude range between 33°N and 

38°N), and one in France (latitude 46°N). Sample sizes ranged from 1304 to 48,115. Two 

studies recruited participants with a history of colorectal adenoma, and the other two recruited 

201 
healthy subjects without a history of adenoma. The incidence rate of colorectal adenomas ranged 

between 0.003 and 0.025. The participants’ mean age ranged from 52.7 to 61.1 years. Average 

followup ranged from 36.8 to 44.4 months. Three of the four studies did not report information 

on assessor blinding.141,164,165 All studies assessed dietary intake with food frequency 

questionnaires and confirmed cases with pathology reports. The quality of all four studies was 

rated B. 

Findings by age and sex. 

One cohort study165 that analyzed men and women (aged 40-80 y) with a history of colorectal 

adenoma found an inverse association between total calcium intake and colorectal adenoma 

recurrence after an average of 3.1 years of followup (RR 0.62, highest [>1279 mg/d] compared 

with lowest intake [<778 mg/d]; P for trend = 0.005). The study did not test statistically whether 

the strength of the association differed between men and women. Another study of both men and 

women with previous adenomatous polyps found no significant association between total 

calcium intake and colorectal adenoma recurrence. 

One cohort study that analyzed exclusively women (aged 40-65 y) without a history of 

colorectal adenoma found an inverse association between total calcium intake and colorectal 

adenoma (RR 0.80, highest [>1226 mg/d] compared with lowest intake [<786 mg/d]; P for trend 

= 0.04).141 Another study of women without previous adenomatous polyps found no significant 

association.163

Findings by life stage. 

• 0 – 6 mo No data 

• 7 mo – 2 y No data 

• 3 – 8 y No data 

• 9 – 18 y No data 

• 19 – 50 y One cohort study of women age 30 to 55 years found no association 

between total calcium intakes and colorectal adenoma. Three additional studies included 

some men or women in this life stage. Two of these studies reported a significant inverse 

association between total calcium intake and colorectal adenoma. However, their results 

are inconclusive for adults in this life stage. 

• 51 – 70 y One meta-analysis of 2 RCTs in adults with previous adenomatous polyps 

(mean age 59 to 61 years) found a significant decrease in colorectal adenoma recurrence 

in supplemental calcium (1200 to 2000 mg elemental calcium daily) compared to no 

supplements (odds ratio, 0.74 [95 percent CI 0.58, 0.95]; P=0.02). A long-term followup 

study of one of the two trials found no difference in recurrence after 5 to 10 years after 

the intervention. One nonrandomized comparative trial also found a significant reduction 

in adenoma recurrence risk among healthy adults with a mean age 55 years who received 

calcium supplementation compared to no supplements (13 percent vs. 55 percent; P value 

not reported). Two cohort studies evaluated participants with a mean age 53 and 61 years 

respectively. One additional study recruited adults in this life stage. Two of the three 

studies, one including adults with a history of adenoma and another including women 

without adenoma history, found an inverse association between total calcium intake and 

colorectal adenoma. 

• 71+ No studies specifically focused on this life stage. Two studies also 

included some men and women with a history of adenoma corresponding to this life 

202 
stage. One found an inverse association between total calcium intake and colorectal 

adenoma, while the other did not find such an association. 

• Postmenopause No data 

• Pregnant & lactating women No data 

203 
204 

Table 64. Calcium and colorectal adenoma: Characteristics of interventional studies 

Author, Year 

Trial/Cohort 

Name 

Country 

(Latitude) 

[Pubmed ID] 

Population 

Vit D & Ca 

Background 

Diets 

Interventions Compliance Comments 

RCTs 

• Health 

status 

Generally healthy 

men and women

with a recent 

colorectal adenoma 

• Mean age 

(range/SD), y 

60.6 

Grau, 2007161

Calcium Polyp 

Prevention 

StudyA

US 

(34°-44°N) 

 [17227996] • Male (%) 71.7 

Calcium, 

mean: 876 

mg/dB

Elemental 

calcium,1200 

mg/d 

nd Duplicated with 

Wallace; results 

during the 

observational postintervention phase 

(5-10 years) 

Nonrandomized 

comparative 

study 

• Health 

status 

Generally healthy 

men and women; 

history of 

adenomatous 

polyps after 

polypectomy 

• Mean age 

(range/SD), y 

54.7 

Duris, 1996162

nd 

Slovakia 

(48°N) 

[8682453]

• Male (%) 62 

nd Calcium 

carbonicum (2 

g/d) 

No statistical 

comparison 

between groups 

A

 A post-hoc followup study (Calcium Follow-up Study) of a RCT (Calcium Polyp Prevention Study). 

B

 Two percent of the participants in the both groups took calcium supplements during the intervention period. Forty-seven percent in 

the placebo group and 49 percent in the supplement arm took any calcium supplements during the followup period after the 

intervention. The dosage was not reported (based on the self-reported data in the earlier report).160 
Table 65. Calcium and colorectal adenoma: Characteristics of cohort studies 

Confounders/Effect Modifiers 

Adjusted Author, Year 

Trial/Cohort 

Name 

Comments 

Demographic Anthrop Medical Seasons Life styles 

Population Dietary Calcium intake Comparisons Country 

(Latitude) 

Nutrients 

[Pubmed ID] 

Cohort 

• Health 

status 

Generally 

healthy 

women 

• Mean age 

(range/SD), 

y 

30-55 

• Dietary 

assessment 

method 

61-item semiquantitative 

FFQ (by 

Willet) 

Oh, 2007163

The Nurses 

Health Study 

US 

(38°N) 

[17379616] 

• Male (%) 0 • Internal 

validation? 

(y/n) 

y 

Colorectal 

adenoma 

across total 

calcium intake 

quintiles 

x x x x x Total 

Ca 

(both) 

• Health 

status 

Generally 

healthy 

women 

• Mean age 

(range/SD), 

y 

52.7 

• Dietary 

assessment 

method 

Kesse, 2005 FFQ 141

Etude 

Epidémiologique 

auprès de 

femmes de 

l'Education 

Nationale 

France 

(46°N) 

[15880532] 

• Male (%) 0 • Internal 

validation? 

(y/n) 

y 

Colorectal 

adenomas 

across total 

calcium intake 

quartiles 

x x x x Total 

Ca 

(both) 

• Health 

status 

Generally 

healthy 

men and 

women; 

history of at 

least one 

colorectal 

adenoma; 

90% 

Caucasian 

• Mean age 

(range/SD), 

y 

61.1 (9.9) 

• Dietary 

assessment 

method 

Hartman, FFQ 

2005164

The Polyp 

Prevention Trial 

US 

(38° N) 

[15671222] 

• Male (%) 64 • Internal 

validation? 

(y/n) 

y 

Adenoma 

recurrence 

across total 

calcium intake 

quintiles 

x x x x Total 

Ca 

(both) 

• Health 

status 

Generally 

healthy 

men and 

women; 

history of 

colorectal 

adenoma(s) 

• Mean age 

(range/SD), 

y 

nd 

• Dietary 

assessment 

method 

113-item 

Arizona Food 

Frequency 

Questionnaire 

(AFFQ) 

Martinez, 

2002165

Wheat Bran 

Fiber (WBF) trial 

US 

(33°N) 

[12020102] 

• Male (%) 57.1 • Internal 

validation? 

(y/n) 

y 

Adenoma 

recurrence 

across total 

calcium intake 

quartiles 

Subgroup 

analyses per 

gender 

x x x Total 

Ca 

(food) 

205 
Table 66. Calcium and colorectal adenoma recurrence: Results of RCTs 

Author Year Name Location (Latitude) [PMID] 

Life 

Stage 

Outcome 1°/2° Mean 

Followup, mo 

Interventions, 

Daily Dose 

n 

Event 

N 

Total 

Outcome 

Metric 

(Comparison) 

Result 9

Calcium carbonate 

(1200 mg/d) 

Grau 82 208 RR 1.09 0.2007161

Calcium Polyp Prevention Study US (various) [17227996] 

Adult All 

adenomas 

1° 92.4 

Placebo 82 216 

Table 67. Calcium and colorectal adenoma recurrence: Results of nonrandomized comparative study Author Year Study Name [PMID] 

Life 

Stage 

Outcome 1°/2° Mean 

Followup, mo 

Interventions, Daily 

Dose 

n 

Event 

N 

Total 

Outcome 

Metric 

(Comparison) 

Result 

Calcium carbonicum, 2g/d 

Duris 1996 12 175 RR nd 

162

Slovakia (48°N) [8682453] 

Adult (30-75 y) 

Adenoma recurrence 

nd 37.2 

No chemoprevention 5 9 

206 
Table 68. Calcium and colorectal adenoma: Results of cohort studies 

Author Year Study Name Location (Latitude) [PMID] 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to 

Dx) 

Adjusted 

RR 

95% 

Oh 2007163

The Nurses Health Study US (38°N)[17379616] 

Female 

adult (30-55 

y) 

Adenoma (nd) Median Q1, 

584 

nd nd nd 1.0 Refe

Adenoma (nd) Median Q2, 

779 

nd nd nd 1.05 0.93

Adenoma (nd) Median Q3, 

949 

nd nd nd 0.96 0.84

Adenoma (nd) Median Q4, 

1139 

nd nd nd 0.96 0.82

Adenoma (nd) Median Q5, 

1451 

nd nd nd 0.88 0.74

Kesse 2005141

Etude Epidémiologique auprès de femmes de l'Education Nationale France (46°N) [15880532] 

Female 

adult (40-65 

y) 

Adenoma (nd) <785.62 154 nd 44.4 mo 1.0 Refe

Adenoma (nd) 785.62-

1226.16 

150 nd 44.4 mo 0.97 0.76

Adenoma (nd) 981.67-

1226.16 

131 nd 44.4 mo 0.83 0.65

Adenoma (nd) >1226.16 156 nd 44.4 mo 0.80 0.62

Hartman 2005164

The Polyp Prevention Trial US (38° N) [15671222] 

Adult (≥ 35 

y) 

Adenoma 

recurrence (nd) 

< 666 156 nd nd 1.0 Refe

Adenoma 

recurrence (nd) 

666-814 163 nd nd 1.12 0.83

Adenoma 

recurrence (nd) 

815-969 154 nd nd 1.02 0.76

Adenoma 

recurrence (nd) 

970-1226 150 nd nd 1.00 0.74

Adenoma 

recurrence (nd) 

>1226 131 nd nd 0.86 0.62

continued 

207 
208 

Author Year Study Name Location (Latitude) [PMID] 

Life Stage Outcome (n/N, 

Incidence) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Follow up 

Duration 

(Time to 

Dx) 

Adjusted 

RR 

95% 

Martinez 2002165

Wheat Bran Fiber (WBF) trial US (38° N) [12020102] 

Adult (40-80 

y) 

Adenoma 

recurrence 

(178/326; 0.55) 

< 778 178 326 36.8 mo 1.0 Refe

Adenoma 

recurrence 

(175/326; 0.54) 

778-996 175 326 36.8 mo 0.94 0.66

Adenoma 

recurrence 

(148/326; 0.45) 

997-1279 148 326 36.8 mo 0.68 0.48

Adenoma 

recurrence 

(138/326; 0.42) 

>1279 138 326 36.8 mo 0.62 0.42

Male adult 

(40-80 y) 

Adenoma 

recurrence (nd) 

< 778 nd nd 36.8 mo 1.0 Refe

Adenoma 

recurrence (nd) 

778-996 nd nd 36.8 mo 1.01 0.68

Adenoma 

recurrence (nd) 

997-1279 nd nd 36.8 mo 0.83 0.54

Adenoma 

recurrence (nd) 

>1279 nd nd 36.8 mo 0.67 0.40

Female 

adult (40-80 

y) 

Adenoma 

recurrence (nd) 

< 778 nd nd 36.8 mo 1.0 Refe

Adenoma 

recurrence (nd) 

778-996 nd nd 36.8 mo 0.81 0.40

Adenoma 

recurrence (nd) 

997-1279 nd nd 36.8 mo 0.42 0.21

Adenoma 

recurrence (nd) 

>1279 nd nd 36.8 mo 0.52 0.28
Figure 19. Colorectal adenomatous polyp risk stratified by calcium intake 

209 
Breast cancer incidence. 

Synopsis. 

 No qualified systematic reviews evaluated the association between dietary and supplemental 

calcium intake and the risk of breast cancer. No RCTs were identified. Six cohort studies 

compared calcium intake and the risk of breast cancer. In four studies, premenopausal women 

with calcium intakes in the range of 780-1750 mg/d had a decreased risk of incident breast 

cancer.125,166-170 Only one study reported decreased risk of breast cancer in both premenopausal 

and postmenopausal women for calcium intake ranged from 1250 to 1750 mg/d compared with 

the lowest quintile of intake of less than 500 mg/d.168 In two of six studies, there was no 

association between calcium intake and breast cancer (both overall and by menopausal 

status).125,170 Five studies were rated B and one study rated C. 

Detailed presentation (Tables 69 & 70; Figure 20). 

 Six studies recruited a total of 452,398 (ranged from 3600 to 198,903) pre-and 

postmenopausal women and followed them for a period of 7 to 16 years. The participants had an 

average age ranged from 47 to 63 years. Four studies conducted in the US and one study 

conducted in Sweden used validated food frequency questionnaire to quantify calcium intake 

levels. One study conducted in France used computerized questionnaire to quantify calcium 

intake levels. The incidence of breast cancer in these studies ranged from 2.5 to 4.8 percent. In 

four of the six cohort studies, premenopausal women with calcium intakes in the range of 780 to 

1750 mg/d had a decreased risk of incident breast cancer compared to those with lowest quintile 

intake levels in each study. There was no association between calcium intake and breast cancer 

in the two of six studies.125,170 

Findings by age and sex. 

 In subgroup analysis of four cohort studies, premenopausal women had a consistently 

decreased risk of breast cancer. No association was found for postmenopausal women. 

Findings by life stage. 

• 0 – 6 mo Not applicable 

• 7 mo – 2 y Not applicable 

• 3 – 8 y Not applicable 

• 9 – 18 y Not applicable 

• 19 – 50 y A cohort study of Nurses’ Health Study including women with an average 

age of 47 years had a decrease risk (RR 0.75, 95 percent CI 0.55, 0.99) in breast cancer 

among those with calcium intake levels of 1000-1250 mg/d compared to those with 

intake levels lesser than 500 mg/d. 

• 51 – 70 y Three of the five cohort studies of women with an average age between 

51- 63 years, found a decreased risk of breast cancer among those with calcium intakes in 

the range of 780-1750 mg/d compared to those with lowest quintile intake levels in each 

study. 

• ≥71 y Not reviewed 

• Postmenopause Cohort studies did not find an association between breast cancer 

risk and calcium intake levels among postmenopausal women. 

• Pregnant & lactating women Not reviewed 

210 
Table 69. Calcium and breast cancer: Characteristics of cohort studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location Population Dietary Calcium intake 

(Latitude) 

[PMID] 

Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Comments 

Cohort 

• Health 

status 

No 

cancer 

FFQ (NCIDHQ) 

USDA 

Nutrient 

Database 

• Mean age 

(range/SD), 

y 

50-71 

• Dietary 

assessment 

method 

Park 2009 

NIH-AARP 

US 

38o N 

[19237724] 

• Internal 

validation? 

(y/n) 

y 

Quintile 1 vs. 

Quintile 2, 3, 

4, 5 

x x x x x Total 

calcium 

intake from 

diet and 

supplement 

• Health 

status 

No 

cancer 

• Mean age 

(range/SD), 

y 

47 

(ND) 

• Dietary 

assessment 

method 

61 item FFQ 

USDA 

Nutrient 

Database 

Shin 2002169

NHS 

US 

38° N 

[12208895] 

• Internal 

validation? 

(y/n) 

y 

500 mg vs. 

500-600, 600-

700, 700-800, 

800-1000, 

1000-1250, 

>1250 

x x x x x x Total 

calcium 

intake from 

diet and 

supplement 

• Health 

status 

No 

cancer 

• Mean age 

(range/SD), 

y 

63 

(ND) 

• Dietary 

assessment 

method 

Modified FFQ 

of Block et al. 

McCullough 

2005168

CPS II 

Nutrition 

Cohort 

US 

38° N 

[16365007] 

• Internal 

validation? 

(y/n) 

y 

500 mg vs. 

500-750, 750-

1000, 1000-

1250, 1250-

1500, 1500-

1750, >1750 

x x x x x x Total 

calcium 

intake from 

diet and 

supplement 

• Health 

status 

No 

cancer 

<727 vs. 

727-862, 863-

980, 980-

1125, >1125 

x x x x x Total 

calcium 

intake from 

diet and 

supplement 

• Mean age 

(range/SD), 

y 

53.7 

(9.7) 

• Dietary 

assessment 

method 

FFQ 

Swedish 

National Food 

Administration 

Database 

Larsson 

2009170

Swedish 

Mammography 

Cohort 

Sweden 

62° N 

[19056569] 

• Internal 

validation? 

(y/n) 

y 

• Health 

status 

No 

cancer 

or 

CVD 

• Mean age 

(range/SD), 

y 

55 

(55-

56) 

• Dietary 

assessment 

method 

Willet method 

USDA 

Nutrient 

Database 

Lin J 2007167

WHS 

US 

38o N 

[17533208] 

• Internal 

validation? 

(y/n) 

y 

Quintile 1 vs. 

Quintile 2, 3, 

4, 5 

x x x x x Total 

calcium 

intake from 

diet and 

supplement 

continued 

211 
212 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

(Latitude) 

[PMID] 

Location Population Dietary Calcium intake Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Comments 

• Health 

status 

No 

cancer 

• Mean age 

(range/SD), 

y 

51 

(6.3) 

• Dietary 

assessment 

method 

Computerized 

questionnaires 

Kesse-Guyot 

2007166

SU.VI.MAX 

France 

46° N 

[17536191] • Internal 

validation? 

(y/n) 

ND 

Quintile 1 vs. 

Quintile 2, 3, 

4 

x x x x x Dietary 

calcium 

intake 
Table 70. Calcium and breast cancer: Results of cohort studies 

Author Year Study Name [PMID] 

Life Stage Outcome (n/N; Incidence) 

Followup 

Duration 

(Time to 

Dx) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Adjusted 

RR 95

Park 2009125

NIH-AARP [19237724] 

Pre- and Postmenopausal 

women 

Breast cancer 

(5856/198,903; 2.9%) 7 y Q1 494 5856 HR 1 Refe

Q2 717 5856 0.96 0.88Q3 969 5856 0.95 0.87Q4 1296 5856 0.94 0.86Q5 1881 5856 0.98 0.90

Shin 2002169

NHS [12208895] 

Pre-menopausal 

women 

Breast cancer 

(3172/88,381; 3.6%) 16 y ≤ 500 142 ND 1 Refe

500-600 106 ND 0.88 0.68600-700 133 ND 0.97 0.76700-800 119 ND 0.95 0.74

800-1000 161 ND 0.82 0.64

1000-1250 104 ND 0.75 0.57

>1250 62 ND 0.80 0.58

Post-menopausal 

women ≤ 500 240 ND 1 Refe

500-600 216 ND 0.86 0.72600-700 293 ND 0.94 0.79700-800 292 ND 0.92 0.77

800-1000 518 ND 0.93 0.79

1000-1250 433 ND 0.90 0.76

>1250 353 ND 0.93 0.77

McCullough 2005168

CPS II Nutrition Cohort [16365007] 

Pre- and Postmenopausal 

women 

Breast cancer 

(2855/68,567; 4.1%) 8 y ≤500 457 10,620 1 Refe

500-750 729 17,880 0.91 0.81

750-1000 581 14,023 0.92 0.81

1000-1250 407 9120 0.97 0.851250-1500 248 6296 0.84 0.721500-1750 144 3983 0.76 0.63

1750 289 6645 0.91 0.79

continued 

213 
Author Year 

Study Name [PMID] 

Life Stage Outcome (n/N; Incidence) 

Followup 

Duration 

(Time to 

Dx) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Adjusted 

RR 95

Larsson 2009170

Swedish Mammography Cohort [19056569] 

Pre- and Postmenopausal 

women 

Invasive Breast 

cancer 

(2952/61,433; 4.8%) 

9 y <727 595 2952 1 Refe

727-862 595 2952 0.97 0.87863-980 592 2952 0.95 0.84

980-1125 571 2952 0.93 0.83

>1125 599 2952 0.97 0.87

Lin J 2007167

WHS [17533208] 

Pre-menopausal 

women 

Invasive breast 

cancer (878/31,487; 

2.8%) 

10 y <617 70 10,578 HR 1 Refe

617-789 65 10,578 0.84 0.59

789-1026 44 10,578 0.60 0.41

1026-1366 59 10,578 0.79 0.55

≥1366 38 10,578 0.61 0.40

Post-menopausal 

women 

<617 104 20,909 HR 1 Refe

617-789 116 20,909 1.21 0.95

789-1026 112 20,909 1.09 0.85

1026-1366 119 20,909 1.21 0.95

≥1366 151 20,909 1.17 0.92

Kesse-Guyot 2007166

SU.VI.MAX trial [17536191] 

Pre- and Postmenopausal Breast cancer (92/3627; 2.5%) 8 y <807 32 3627 1 Refe

807-960 24 3627 0.73 0.42

961-1144 20 3627 0.65 0.37

>1144 16 3627 0.50 0.27

Post-menopausal <807 14 nd 1 Refe

807-960 13 nd 0.71 0.33

961-1144 10 nd 0.67 0.30

>1144 11 nd 0.76 0.34

continued 

214 
215 

Author Year Study Name [PMID] 

Life Stage Outcome (n/N; Incidence) 

Followup 

Duration 

(Time to 

Dx) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Adjusted 

RR 95

Pre-menopausal <807 18 nd 1 Refe

807-960 11 nd 0.77 0.36

961-1144 10 nd 0.63 0.29

>1144 5 nd 0.26 0.10

HR: hazard ratio *Statistically significant (P<0.05) 
Figure 20. Breast cancer risk stratified by calcium intake 

 

216 
217 

Breast Mammographic Density. 

Synopsis. 

 No systematic reviews evaluated the association between dietary and supplemental calcium 

intake and breast mammographic density. No RCTs of calcium intake evaluated breast 

mammography density. One prospective cohort study evaluated the association of calcium intake 

and breast mammographic density.171 Both premenopausal and postmenopausal women with 

calcium intakes in the range of 523 mg/d to greater than 1021 mg/d were followed for almost 40 

years, and there was no association between calcium intake and breast mammographic density. 

The methodological quality of this study was rated B. 

Detailed presentation (Tables 71 & 72). 

 One prospective cohort study followed from birth of a British national representative sample 

of 2547 women and followed them for a period of 53 years.171 Women had an average age of 

51.5 years. Dietary calcium intake was evaluated using 5-day food records. The breast density in 

women was assessed through mammography at the ages 36, 43, and 53 years. Since the 

measurement at the age of 53 years was cross-sectional, this has been excluded from our 

analyses. There was no linear association between dietary calcium intakes in the range of 523 

mg/d to greater than 1021 mg/d and breast mammographic density. 

Findings by age and sex. 

 In subgroup analysis by age categories, there was no linear association between calcium 

intake and breast mammography density. 

Findings by life stage. 

• 0 – 6 mo Not applicable 

• 7 mo – 2 y Not applicable 

• 3 – 8 y Not applicable 

• 9 – 18 y Not applicable 

• 19 – 50 y There was no linear association between calcium intake in the range of 

523 mg/d to greater than 1021 mg/d and breast mammographic density 

• 51 – 70 y No data 

• ≥71 y No data 

• Postmenopause No data 

• Pregnant & lactating women Not reviewed 
Table 71. Calcium and breast mammography density: Characteristics of cohort studies 

Confounders/Effect Modifiers A

Author Year Study Name Location Population Dietary Calcium intake 

(Latitude) [PMID] 

Comparisons 

Nutrients 

Demograph 

Anthrop 

Medical 

UV exposure 

Cohort 

• Health status No breast 

cancer 

• Mean age (range/SD), y 

52 

• Dietary assessment method 

5-day food diaries McCance and Widdowson's food table 

Mishra 2008171

Medical MRC NSHD UK 54o N [18827811] • Internal validation? (y/n) ND 

At age 36 y: <523, 524-648, 652-784, 785-940, >941 At age 43 y: <611, 612-735, 736-859, 860-1020, >1021 

x x x x 

Table 72. Calcium and breast cancer: Results of cohort studies Author Year Study Name [PMID] 

Life Stage Outcome (n/N; Incidence) Followup Duration (Time to Dx) Total Ca Intake, mg/day No. of Cases No. in Category Adjusted RR 95% 

Mishra 2008171

Medical MRC NSHD [18827811 

Premenopausal 

women 

Breast cancer 

density 

(nd; median 

21.9%) 

~32 y 

≤523 133 766 

β coefficient 

1 Refer

~32 y 524 – 648 143 766 -0.11 -0.3

0.1

~32 y 652 – 784 156 766 -0.05 -0.2

0.1

~32 y 785 – 940 160 766 -0.04 -0.2

0.1

~32 y ≥941 174 766 -0.08 -0.3

0.1

~39 y ≤611 145 755 β coefficient 

1 Refer

~39 y 612-735 156 755 -0.13 -0.3

0.0

~39 y 736-859 145 755 -0.06 -0.2

0.1

~39 y 860-1020 156 755 -0.11 -0.3

0.1

~39 y ≥1021 153 755 -0.16 -0.4

0.0

218 
Pancreatic cancer. 

 We reviewed primary studies that evaluated associations between calcium intake and 

incidence of pancreatic cancer. 

Synopsis. 

 Two studies analyzed three US cohorts and found that total daily calcium intake was not 

associated with the risk of pancreatic cancer in men and women. No RCTs of calcium intake or 

supplement have evaluated this outcome. 

Detailed presentation (Tables 73 & 74). 

 One study analyzed data from Nurses’ Health Study (NHS) and the Health Professionals 

Follow-up Study (HPFS).172 The study identified a total of 365 cases of pancreatic cancer 

(178/75,427 women aged 38 to 65 years from NHS; 178/46,771 men aged 40 to 75 years from 

HPFS). Comparing the group with at least 1000 mg/d of calcium intake to the group with less 

than 500 mg/d, there was no significant difference in the relative risk of pancreatic cancer (RR 

0.94; 95 percent CI 0.62, 1.41 for overall; 0.75; 95 percent CI 0.43, 1.30 for NHS; 1.23; 95 

percent CI 0.67, 2.25 for HPFS). The result was adjusted for age, categories of total vitamin D 

intake, smoking, diabetes, BMI, height, region of residence, use of multivitamin, and parity (for 

women). The pancreatic cancer was not stratified into endocrine versus exocrine tumors. 

Methodological quality of this study was rated A. 

 Another study analyzed data from AARP (the American Association of Retired Persons) 

members, aged 50 to 71 years old, living in six specific states in the US.125 The study identified a 

total of 717 and 384 cases of pancreatic cancer in men and women over 7 years of followup 

period, respectively. Pancreatic cancer was one of many other cancer outcomes evaluated in this 

study. The results showed that that total calcium intake was not associated with the risk of 

pancreatic cancer after controlling for potential risk factors pertinent to individual cancers. The 

methodological quality of this study was rated B. 

Findings by life stage. 

• 0 – 6 mo Not reviewed

• 7 mo – 2 y Not reviewed

• 3 – 8 y Not reviewed

• 9 – 18 y Not reviewed

• 19 – 50 y One study analyzed two US cohorts (NHS [women 38 - 65 y] and HPFS 

[men 40 -75 y]) and found that total daily calcium intake was not associated with the risk 

of pancreatic cancer.

• 51 – 70 y One study analyzed two US cohorts (NHS [women 38 - 65 y] and HPFS 

[men 40 -75 y]) and found that total daily calcium intake was not associated with the risk 

of pancreatic cancer. Another study analyzed US AARP cohort with men and women in 

this life stage found similar result.

• ≥71 y One study that analyzed HPFS included males up to 75 years old and 

found that total daily calcium intake was not associated with the risk of pancreatic cancer. 

• Postmenopause No data

• Pregnant & lactating women Not reviewed

219 
Table 73. Calcium and pancreatic cancer: Characteristics of cohort studies 

Confounders/Effect Modifiers 

Adjusted Author, 

Year Study Name Location (Latitude) [PMID] 

Population Dietary calcium intake Comparisons 

Nutrients 

Demographic 

Anthrop 

UV exposure 

Life styles 

Comments 

Medical 

Health status 

DM: NHS 3%; HPFS 1% 

Mean age (range/SD), y 

NHS 51; HPFS 55 

Dietary assessment method 

131-item FFQ (Willet, 1990) 

Skinner 2006172

NHS, HPFS US (multiple latitudes) [16985031] 

Male (%) NHS 0; 

HPFS 100 

Internal validation? (y/n) 

y 

Pancreatic cancer risk stratified by different intakes of calcium (dietary and supplement combined) 

X X X X X X current 

smoker ~23% 

• Health status 

No cancer 

• Mean age (range/), y 

50-71 

• Dietary assessment method 

FFQ (NCIDHQ) USDA Nutrient Database 

Park 2009125

NIH-AARP US 38o N [19237724] 

• Male (%) 60 • Internal 

validation? (y/n) 

y 

Pancreatic cancer risk stratified by quintile of total calcium intake 

X X X X X Total 

calcium intake from diet and supplement 

Table 74. Calcium and pancreatic cancer: Results of cohort studies Author Year Study Name [PMID] 

Life 

Stage, y 

Outcome 

(n/N; Incidence) 

Followup 

Duration, y 

Total Ca 

intake in 

mg/d 

No. of 

Cases 

Total no. in 

Category 

Adjusted 

RR 

95% CI 

Skinner 2006172

19-50 51-70 

Pancreatic cancer 

(365/122,198; 0.003) 

overall 

<500 41 nd 1 Referenc

NHS, HPFS 14.5 

500-999 228 nd 1.17 0.83, 1.6

US ≥71 ≥1000 96 nd 0.94 0.62, 1.4(multiple latitudes) <500 24 nd 1 Referenc

500-999 109 nd 1.09 0.69, 1.7

19-50 51-70 

women 

Pancreatic cancer 

(178/75,427; 0.002) 

NHS 

[16985031] 15.4 

45 nd 0.75 0.43, 1.3

≥1000 

19-50 <500 17 nd 1 Referenc51-70 

Pancreatic cancer 

(187/46,771; 0.004) 

13.1 

0.76, 2.1

500-999 119 nd 1.28 

220 
221 

Author Year Study Name [PMID] 

Life 

Stage, y 

Outcome 

(n/N; Incidence) 

Followup 

Duration, y 

Total Ca 

intake in 

mg/d 

No. of 

Cases 

Total no. in 

Category 

Adjusted 

RR 95% CI 

≥71 men HPFS ≥1000 51 nd 1.23 0.67, 2.2

526 717 

(total) 

293,907 

(total) 1 (HR) Referenc

498 0.93 0.74, 1.1857 0.9 0.72,1.14 

1073 0.98 0.78, 1.2

Park 2009 NIH-AARP125

[19237724] 

50-71, 

men 

Pancreatic cancer 

(717/293,907; 0.002) 7 

1530 0.87 0.68, 1.1

526 384 

(total) 

198,903 

(total) 1 (HR) Referenc

498 1.03 0.75, 1.4857 0.93 0.67, 1.2

1073 0.97 0.71, 1.3

50-71, 

women 

Pancreatic cancer 

(384/198,903; 0.002) 7 

1530 0.88 0.63, 1.2
Calcium and pregnancy-related outcomes 

Preeclampsia. 

Synopsis. 

This summary is primarily based on a systematic review of 12 RCTs (n=15,528 

women) of calcium supplementation (≥1000 mg/d) during pregnancy versus placebo for 

preventing preeclampsia. In addition, it includes findings from two cohort studies (one of 

which is a reanalysis of one of the 12 RCTs mentioned above). 

Overall, the random effects meta-analysis of the 12 RCTs favored calcium 

supplementation (RR=0.48, 95 percent CI 0.33, 0.69), albeit with substantial betweenstudy heterogeneity. More than 80 percent of the total number of randomized women 

(n=12,914) came from two large trials that found no significant effect of calcium 

supplementation for preventing preeclampsia (RR=0.95, 95 percent CI 0.89, 1.05). Based 

on their confidence interval, the two large studies excluded large effects of calcium for 

preeclampsia prevention. There is no obvious explanation for the observed between-study 

heterogeneity in the aforementioned meta-analysis. The heterogeneity stems from 

differences in the effects between smaller trials (claiming protective effects) and large 

trials (showing no effect). 

The two cohort studies did not detect associations between calcium intake during the 

first or second trimester of pregnancy with preeclampsia. Both cohorts were rated B for 

methodological and reporting quality. 

Based on the above, there is not a clear answer to whether calcium supplementation is 

effective for preeclampsia prevention. 

Detailed presentation (Tables 75, 76 & 77). 

Relevant published systematic reviews of RCTs (with meta-analyses). 

We identified five systematic reviews173-177 (with meta-analyses) of RCTs on calcium 

supplementation in the first or second trimester versus placebo for the prevention of 

preeclampsia (Appendix D). We selected a 2006 Cochrane review as eligible for this 

section.176 All other systematic reviews were covered by the Cochrane review. We did 

not identify any RCTs published after the Cochrane review was conducted. 

Eligible were RCTs comparing at least 1000 mg/d of calcium versus placebo in 

pregnant women. Studies were performed in several countries (both developed and 

developing). The review defined preeclampsia as high gestational blood pressure 

(diastolic blood pressure >90 mmHg, or increase more than 15 mm Hg in diastolic or 

more than 30 mm Hg in systolic blood pressure) with significant proteinuria (at least 300 

mg/d or at least 500 mg).i

 

Table 75 summarizes the findings of the Cochrane review. A random effects metaanalysis of all studies suggests that calcium supplementation reduces the risk for 

preeclampsia (RR=0.48, 95 percent CI 0.33, 0.69). However, there is substantial 

heterogeneity among the included studies (P<0.001). 

 

i Note that a strict definition of preeclampsia requires confirmation of no hypertension or proteinuria outside of pregnancy. 

222 
In subgroup analyses, the effects of calcium appear larger in women at high risk for 

hypertension versus women at low risk for hypertension. The same is observed when 

trials are grouped according to whether women had adequate average calcium intake 

versus low average calcium intake. 

More than 80 percent of the total number of randomized women in this meta-analysis 

(n=12,914) came from two large trials that reported no significant effects of calcium 

supplementation for preeclampsia (RR=0.95, 95 percent CI 0.89, 1.05; by fixed effects 

synthesis). Based on their combined confidence interval, these two studies exclude 

modest and large effects of calcium for preeclampsia prevention. The remaining (smaller) 

trials show a protective effect. One of the large RCTs was performed in populations with 

low background calcium diets178 and the other in populations with adequate background 

calcium diets.179 

Allowing for the above, there is no clear explanation for the observed discrepant 

findings across the trials in the systematic review. The recurrent pattern is that large trials 

showed no effect for calcium supplementation, whereas smaller trials showed large 

effects. Calcium supplementation for preeclampsia prevention is a well known example 

where large trials and smaller trials show systematically different effects. Past 

methodological explorations (before the publication of the WHO trial178) have 

hypothesized that effects may be observed mostly among women with low calcium in 

their background diet.180 However, as mentioned above, this is not supported by the 

subgroup analyses. 

223 
224 

Table 75. Summary table of systematic review on calcium supplementation and 

preeclampsia, small for gestational age, preterm birth 

Author Year [PMID] Hofmeyr 2006176 [16855957] 

Design (Search Years) Randomized controlled trials (1988-2006) 

Population Pregnant women less than 35 weeks of gestation regardless of their risk of hypertensive of 

pregnancy or their previous calcium intake 

Intervention (Exposure) 

and Comparator 

Calcium supplement (at least 1000 mg/d) vs. placebo 

Results 12 trials (n=15,528)A

Preeclampsia (mother): 

• All 12 trials (n=15,528): RR=0.48 (0.33, 0.69)B

; statistically heterogeneous 

• Among 4 trials (n=5022) with adequate Ca in diet: RR=0.62 (0.32, 1.20); statistically 

heterogeneous 

• Among 7 trials (n=10,154) with low Ca in diet: RR=0.36 (0.18, 0.70); statistically 

heterogeneous 

• Among 5 trials (n=587) at high risk for hypertension: RR=0.22 (0.12, 0.42); statistically 

homogeneous 

• Among 6 trials (n=14,619) at low risk for hypertension: RR=0.68 (0.49, 0.94); 

statistically heterogeneous 

High blood pressure with or without proteinuria (mother): 

• Among 11 trials (n=14,946): RR= 0.70 (95% CI 0.57, 0.86); statistically heterogeneous 

• Among 4 trials (n=5022) with adequate Ca in diet: RR=0.90 (0.81, 0.99); statistically 

homogeneous 

• Among 6 trials (n=9684) with low Ca in diet: RR=0.47 (0.29, 0.76); statistically 

heterogeneous 

• Among 4 trials (n=327) at high risk for hypertension: RR=0.47 (0.22, 0.97); statistically 

heterogeneous 

• Among 7 trials (n=14,619) at low risk for hypertension: RR=0.78 (0.64, 0.95); 

statistically heterogeneous 

Preterm birth: 

• Among 10 trials (n=14,751): RR = 0.81 (0.64, 1.03); statistically heterogeneous 

• Among 4 trials (n=5033) with adequate Ca in diet: RR=0.59 (0.26, 1.33); statistically 

heterogeneous 

• Among 6 trials (n=9684) with low Ca in diet: RR=0.90 (0.80, 1.02); statistically 

homogeneous 

• Among 4 trials (n=478) at high risk for hypertension: RR=0.45 (0.24, 0.83); statistically 

homogeneous 

• Among 7 trials (n=14,183) at low risk for hypertension: RR=0.91 (0.74, 1.12); 

statistically heterogeneous 

Small for gestational age (infant): 

• Among 3 trials (n=13,091; fixed effects): RR = 1.10 (0.88, 1.37); statistically 

homogeneous 

Comments About 80% of participants are from two well designed and well conducted RCTs.178,179 The 

two large RCTs show no effects for all four outcomes. 

AMSTAR Criteria 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? Yes 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages 

included? 

Yes Publication bias assessed? No 

Included and excluded studies listed? Yes Conflicts of interest stated? Yes 

Study characteristics provided? Yes A

 RR <1.0 favors calcium supplementation 

B

 95% confidence interval
Cohort studies. 

We identified two eligible prospective cohort studies (Table 76).181,182 Both were 

rated B for methodological and reporting quality. The first was a reanalysis of a large 

RCT and reported no associations of dietary calcium intakes during the first and second 

trimester with preeclampsia.181 The second study was a prospective cohort that again 

reported no association between dietary calcium intake in the first trimester and risk of 

preeclampsia.182 (See Table 77) 

Findings by life stage. 

• 0 – 6 mo Not applicable 

• 7 mo – 2 y Not applicable 

• 3 – 8 y Not applicable 

• 9 – 18 y Not applicable 

• 19 – 50 y Not applicable 

• 51 – 70 y Not applicable 

• ≥71 y Not applicable 

• Postmenopause Not applicable 

• Pregnant & lactating women Based on a Cochrane review that 

synthesized data from 12 RCTs on 15,528 pregnant women, calcium 

supplementation significantly lowered the risk for preeclampsia during 

pregnancy. However, this meta-analysis was heterogeneous; significant effects 

were observed only among small studies, and not in the two largest RCTs that 

comprised more than 80 percent of the women in the meta-analysis. In addition, 

two cohort studies found no association between calcium intake and 

preeclampsia. Overall, the effects of calcium supplementation on preeclampsia 

are unclear. 

225 
226 

Table 76. Calcium and preeclampsia and other pregnancy outcomes: Characteristics of 

cohort studiesA,B

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Dietary Calcium 

intake Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Outcomes and 

Comments 

• Health 

status 

Healthy 

• Mean 

age 

(SD), y 

ND 

• Dietary 

assessment 

method 

Morris FFQ 

2007181

CPEP 

reanalysisC

US 

(various) 

[11262466] • Male 

(%) 

0 • Internal 

validation? 

(y/n) 

No 

Outcome 

stratified by 

total Ca intake 

quintiles 

X X X Total 

Ca 

(both) 

• Health 

status 

Healthy 

• Mean 

age 

(SD), y 

[most 30 

to <40] 

• Dietary 

assessment 

method 

Oken FFQ 

2007182

Project Viva 

US 

(42°N) 

[17521921] • Male 

(%) 

0 • Internal 

validation? 

(y/n) 

No 

Outcome as a 

function of Ca 

intake 

X X Total 

Ca 

(both) 

A

 Both table entries are treated as cohort studies. 

B

 In contrast with most other summary tables of study characteristics, this table is ordered alphabetically by study author. 

C

 Reanalysis of the CPEP trial (calcium versus placebo) for preeclampsia prevention focusing on calcium content in diet 

(and including the intervention dose in the analyses) 
Table 77. Calcium and preeclampsia and other pregnancy outcomes: Results of cohort studies 

Author Year Study Name Location (Latitude) [PMID] 

Age 

Range, 

Sex 

Outcome (n/N; 

Incidence) 

Followup 

Duration 

Total Ca 

Intake, 

mg/d 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95% 

Preeclampsia Morris 2007181

CPEP reanalysis US (various) [11262466] 

30-40 y, 

Women 

Preeclampsia 

(326/4314; 7.6%) 

ND 579 ND ND 1.00 (ref) 

580-845 ND ND 0.90 0.61, 

846-1131 ND ND 0.95 0.65, 

1132-1560 ND ND 0.97 0.65, 

1561 ND ND 0.78 0.49, 

Oken 2007182

Project Viva US (42°N) [17521921] 

Preeclampsia 

(59/1599; 3.7%)A

~1300 59 1599 1.03B 0.84, 

High blood pressure with or without proteinuria Morris 2007181

CPEP reanalysis US (various) [11262466] 

30-40 y, 

Women 

High blood pressure with 

or without proteinuria 

(747/4314; 17.3%) 

ND 579 ND ND 1.00 (ref) 

580-845 ND ND 1.09 0.84, 

846-1131 ND ND 1.10 0.83, 

1132-1560 ND ND 1.14 0.85, 

1561 ND ND 1.35 0.98, 

Oken 2007182

Project Viva US (42°N) [17521921] 

Pregnancy-induced 

hypertension 

(119/1659)C

ND ~1300 119 1659 0.99 0.85, 

A Excludes 119 women with pregnancy-induced hypertension – comparison versus normotensive women B Per 300 mg of Ca intake (from supplement or diet) C Excludes 59 women with preeclampsia – comparison versus normotensive women

227 
High blood pressure with or without proteinuria during pregnancy. 

Synopsis. 

The synopsis of this outcome is based on the same systematic review described under 

preeclampsia. Overall, the meta-analysis of 11 RCTs favored calcium supplementation 

RR = 0.70 (95 percent CI 0.57, 0.86) for the treatment of hypertension during pregnancy, 

with or without proteinuria. However, there was substantial between-study heterogeneity. 

(Included in this meta-analysis are the two large trials mentioned in the preeclampsia 

section, which found no significant effect of calcium supplementation on blood pressure.) 

The systematic review did not offer a clear explanation for the observed heterogeneity. 

Based on the above, there is no clear answer to whether calcium supplementation is 

effective for preventing high blood pressure (with or without proteinuria) in pregnancy. 

Detailed presentation (Tables 75, 76 & 77). 

Relevant published systematic reviews (with meta-analyses). 

The Cochrane review that was selected for preeclampsia was applicable for 

hypertension during pregnancyi

 as well.176 Table 75 summarizes the findings of the 

Cochrane review. 

A meta-analysis of 11 trials (14,946 pregnant women) suggested that calcium 

supplementation reduces the risk for hypertension during pregnancy (RR=0.70, 95 

percent CI 0.57, 0.86). However, there is substantial heterogeneity among the included 

studies (p<0.001). As described in Table 75, the heterogeneity was not explained by 

whether the trials included women with low versus adequate background dietary calcium 

intake. 

In subgroup analyses, the effects of calcium appear larger in women at high risk for 

hypertension versus women at low risk for hypertension. The same is observed when 

trials are grouped according to whether women had adequate average dietary calcium 

intake versus low average calcium intake (see Table 75). 

Cohort studies. 

A single prospective cohort study182 (Table 68) reported no association between 

calcium intake levels and risk for preeclampsia.182 (See Table 69.) 

Findings by life stage. 

• 0 – 6 mo Not applicable 

• 7 mo – 2 y Not applicable 

• 3 – 8 y Not applicable 

• 9 – 18 y Not applicable 

• 19 – 50 y Not applicable 

• 51 – 70 y Not applicable 

• ≥71 y Not applicable 

• Postmenopause Not applicable 

 

i

The Cochrane review does not clarify whether the women were confirmed normotensive outside pregnancy. This is why we do not 

use the term pregnancy-induced hypertension for this outcome. 

228 
• Pregnant & lactating women Based on a Cochrane review that 

synthesized data from 11 RCTs on 14,946 pregnant women, calcium 

supplementation significantly lowered the risk for hypertension with or without 

proteinuria during pregnancy. However, this meta-analysis was very 

heterogeneous; significant effects were observed only among small studies, and 

not in the two largest RCTs that comprised more than 80 percent of the women in 

the meta-analysis. In addition, a cohort study found no association between 

calcium intake and hypertension during pregnancy. Therefore, the effects of 

calcium supplementation on hypertension with or without proteinuria during 

pregnancy are unclear. 

Preterm birth. 

Synopsis. 

The synopsis of this outcome is based on the same systematic review described under 

preeclampsia. Among 10 RCTs (n=14,751), calcium supplementation has no significant 

effect on preterm births RR 0.81 (95 percent CI 0.64, 1.03). (Included in this metaanalysis are the two large trials mentioned in the preeclampsia section, which found no 

significant effects.) 

Based on the above, there is no evidence for an effect of calcium supplementation on 

preterm births. 

Detailed presentation (Table 75). 

Relevant published systematic reviews (with meta-analyses). 

The Cochrane review that was selected for preeclampsia was applicable for preterm 

birth as well.176 Table 67 summarizes the findings of the Cochrane review. 

A meta-analysis of 10 trials suggests that calcium supplementation had no significant 

effect on preterm births. There is evidence for between-study heterogeneity in this metaanalysis. 

In subgroup analyses, the effects of calcium appear larger in women at high risk for 

hypertension versus women at low risk for hypertension. The same is observed when 

trials are grouped according to whether women had low average dietary calcium intake 

versus adequate average dietary calcium intake. 

Findings by life stage. 

• 0 – 6 mo Based on a Cochrane review that synthesized data from ten RCTs 

on 14,751 pregnant women, calcium supplementation had no significant effect on 

whether infants were born prematurely or not. 

• 7 mo – 2 y Not applicable 

• 3 – 8 y Not applicable 

• 9 – 18 y Not applicable 

• 19 – 50 y Not applicable 

• 51 – 70 y Not applicable 

• ≥71 y Not applicable 

• Postmenopause Not applicable 

• Pregnant & lactating women Not applicable 

229 
230 

Small for gestational age infant. 

Synopsis. 

The synopsis of this outcome is based on the same systematic review described under 

preeclampsia. The overall effects of calcium supplementation were not significant 

(among three RCTs in 13,091 randomized women RR = 1.10, 95 percent CI 0.88, 1.37). 

(Included in this meta-analysis are the two large trials mentioned in the preeclampsia 

section, which found no significant effects.) 

Based on the above, there is no evidence for an effect of calcium supplementation on 

preterm births. 

Detailed presentation (Table 75). 

Relevant published systematic reviews (with meta-analyses). 

The Cochrane review that was selected for preeclampsia was applicable for this 

outcome as well.176 Table 75 shows that among three trials with pertinent information 

there was no significant effect of calcium supplementation on the proportion of infants 

who were small for gestational age.178,179

Findings by life stage. 

• 0 – 6 mo Based on a Cochrane review that synthesized data from three 

RCTs on 13,091 pregnant women, calcium supplementation has no significant 

effect on whether born infants were small for gestational age or not. 

• 7 mo – 2 y Not applicable 

• 3 – 8 y Not applicable 

• 9 – 18 y Not applicable 

• 19 – 50 y Not applicable 

• 51 – 70 y Not applicable 

• ≥71 y Not applicable 

• Postmenopause Not applicable 

• Pregnant & lactating women Not applicable 
Calcium and all-cause Mortality 

Synopsis. 

One cohort study (rated B for methodological and reporting quality) reported no 

significant associations between calcium intakes and all-cause mortality in men or 

women aged between 40-65 years. No RCTs of calcium intake evaluated all-cause 

mortality. 

Detailed presentation (Tables 78 & 79). 

One cohort study from Amsterdam, Netherlands (52°N), reported in two 

publications105,126 evaluated associations between calcium intake and all-cause mortality. 

The cohort was based on a general population health survey and enrolled civil servants or 

their spouses (aged 40-65 years). The reports received grade “B” for methodological and 

reporting quality (Table 70). 

The publications reported no association between calcium intake and all-cause 

mortality among men or women. Table 71 shows the results of the various analyses 

conducted in the two publications.105,126

Findings by life stage. 

• 0 – 6 mo No data 

• 7 mo – 2 y No data 

• 3 – 8 y No data 

• 9 – 18 y No data 

• 19 – 50 y One cohort study found no associations between calcium intakes 

and all-cause mortality in men or women aged between 40-65 y. 

• 51 – 70 y The above (19-50 y) may be applicable here as well, based on the 

age range of cohort participants. 

• ≥71 y No data 

• Postmenopause No data 

• Pregnant & lactating women No data 

231 
232 

Table 78. Calcium intake and all-cause mortality: Characteristics of cohort studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Calcium intake Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Comments 

• Health 

status 

General 

population 

• Age 

range, y 

40-65y 

• Dietary 

assessment 

method 

Van der FFQ 

Vijver 

1992105 & 

Slob 1993126

Netherlands 

(52°N) 

[1544755 & 

8478144] 

• Male 

(%) 

51 • Internal 

validation? 

(y/n) 

No 

Outcome 

stratified by 

total Ca intake 

quintiles 

X X X X Total 

Ca 

(food) 
Table 79. Calcium intake and all-cause mortality: Results of cohort studies 

Author Year Study Name Location (Latitude) [PMID] 

Age 

Range, 

Sex 

Outcome (n/N; 

Incidence) 

Followup 

Duration 

Total Ca 

Intake, 

mg/d 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95% 

Van der Vijver 1992105 & Slob 

1993126

Netherlands (52°N) [1544755 & 8478144] 

40-65 y, 

men 

All cause 

mortality 

(nd) 

336 mo (28 

y) 

≤585 nd nd 1.1 0.7

585 - 725 nd nd 1.1 0.7725 - 935 nd nd 0.8 0.5

935 - 1245 nd nd 0.9 0.6

>1245 nd nd 1.0 Refe

Van der Vijver 1992105 & Slob 

1993126

Netherlands (52°N) [1544755 & 8478144] 

40-65 y, 

women 

All cause 

mortality 

(nd) 

336 mo (28 

y) 

≤445 nd nd 1.2 0.8

445 - 540 nd nd 1.1 0.7540 - 640 nd nd 1.3 0.9640 - 850 nd nd 1.1 0.7

>850 nd nd 1.0 Refe

233 
Calcium and Hypertension and Blood Pressure 

 We searched for systematic reviews and primary studies that evaluated associations between 

calcium intake or body stores and incidence of hypertension and change in blood pressure. For 

the outcome incidence of hypertension, we reviewed randomized controlled trials and other 

longitudinal studies. For the outcome change in blood pressure, we reviewed only randomized 

controlled trials. The EPC and the TEP agreed that due to the large volume of literature, the 

limited resources would not be expended on reviewing observational studies for the surrogate 

outcome blood pressure. We included only studies of adults. Studies of pregnancy-related 

hypertension and blood pressure control are included in the pregnancy section. 

Calcium and hypertension. 

Synopsis. 

 No systematic reviews evaluated the association between calcium intake and incidence of 

hypertension. The association has been analyzed in five large studies (6 articles/analyses). No 

RCTs of calcium intake evaluated hypertension incidence. In analyses of men and women 

together and of men alone, there was no evidence of an association between calcium intake and 

risk of hypertension. In the Women’s Health Study (WHS), a highly significant trend was found 

across quintiles of calcium intake and risk of hypertension, with significantly lower rates of 

hypertension found among women consuming at least 679 mg calcium per day compared to less 

than 558 mg calcium per day. The two articles that reported subgroup analyses based on age 

found associations between lower calcium intake and hypertension among younger adults (below 

40 or 50 years of age), but no significant associations in older adults. 

Detailed presentation (Tables 80 & 81 and Figure 21). 

 The six articles, reporting investigations of five studies, included two analyses of combined 

men and women in the NHANES I study and Navarra, Spain (both methodological quality 

C),183,184 two analyses of men alone in the Health Professionals Follow-up Study (HPFS) and 

NHANES I (of methodological quality B and C, respectively), 185,186 and three analyses of 

women alone in the WHS, the Nurses Health Study (NHS), and NHANES I (of methodological 

quality A, B, and C, respectively).186-188 All studies included only people without hypertension at 

baseline. Only the A quality analysis, WHS, included elevated blood pressure in their outcome 

definition of hypertension; all other analyses used self-reported hypertension (generally based on 

a physician’s diagnosis or treatment). The mean ages of the participants varied widely across 

studies (36-54 years) among those that reported mean data; the range of ages within studies 

varied from broad (20-90 years) to narrow (30-55 years) among those that reported ranges. All 

studies reported adjusted analyses; though each adjusted for different factors. Most of the studies 

were limited by such factors as reliance on self-reported hypertension (without assessment of 

blood pressure), exclusion of numerous participants due to lack of data, inadequate reporting of 

results data, and lack of reporting of definitions (ranges or averages of calcium quintiles). 

 Two studies reported analyses for combined men and women. These are discussed here. The 

remaining analyses of men or women separately are discussed below. In analyses of combined 

men and women (each with almost 7000 participants), neither study reported a significant 

association. No significant trend or individual analyses of quintiles was found in the short 

duration (2 years) Spanish cohort study. A poorly reported analysis from NHANES I concluded 

that there was progressively higher incidence of hypertension in lower quartiles of calcium 

234 
intake after 10 years, but no statistical analysis was performed and the definitions of the quartiles 

were not provided. 

Findings per calcium intake level. 

 Among the studies that provided definitions of the compared categories of calcium intake, 

consistent significant associations were found for calcium intakes below 500 mg/day in men 

under age 50 years (compared to over 1100 mg/day) and below 558 mg/day in women 

(compared to over 678 mg/day). 

Findings per age and sex. 

 Men alone were analyzed from the PHFS (about 31,000 men) and NHANES I (about 2000 

men, split by race). Neither analysis found a significant trend or any significant differences 

among different calcium intake categories at 4 and 10 years, respectively for the two studies. 

 Women alone were analyzed from three studies. The studies had heterogeneous findings. The 

A quality analysis of the WHS (about 29,000 women) found a highly significant trend across 

quintiles (P<0.0001) at 10 years with a significantly higher rate of hypertension in women in the 

lowest calcium intake quintile (189-557 mg/day) compared to all quintiles with intakes above 

679 mg/day. However, the B quality analysis of the NHS (about 41,500 women) found no 

significant association by calcium intake at 14 years and the C quality analysis of NHANES I 

(about 3500 women, split by race) found no consistent association at 10 years. 

 One C quality analysis of NHANES I assessed subgroups of combined men and women by 

age (divided at 40 years old). Among people under age 40 years, those in the lowest quartile of 

calcium intake had significantly higher rates of being treated for hypertension after 10 years; 

however, the article failed to define the calcium intake quartiles. No significant association was 

found among older participants. In the HPFS, in men under age 50 years, a higher rate of 

hypertension at 4 years was found in those with calcium intake less than 500 mg/d compared to 

over 1100 mg/d; but no association was found in older men. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y Five of the six studies included mostly people within this life stage.183-

186,188 Overall, there was no evidence of a significant association between calcium intake 

and risk of hypertension. However, as described in detail in the Findings per age and sex 

section above, in two subgroup analyses, significant associations were found between the 

lowest category of calcium intake and increased risk of hypertension in younger people 

(under age 40 – calcium intake range not reported, or age 50 years – less than 500 mg/d 

compared to over 1100 mg/d. 

• 51 – 70 y Four of the six studies included people largely within this life 

stage.184,185,187,188 The studies mostly found no significant associations between calcium 

intake and risk of hypertension, including within the 2 subgroups of adults above 40 or 50 

years of age. However, the WHS, which included women mostly within this life stage, 

found a highly significant trend across quintiles (P<0.0001) at 10 years with a 

significantly higher rate of hypertension in women in the lowest calcium intake quintile 

(189-557 mg/d) compared to all quintiles with intakes above 679 mg/d. 

235 
• ≥71 y Few of the people in the studies appear to have been in this life stage. No 

unique conclusions are possible for this life stage separate from those for people 51 to 70 

years. 

• Postmenopause Only the WHS appeared to have included (or analyzed) primarily 

postmenopausal women. The study found a highly significant trend across quintiles 

(P<0.0001) at 10 years with a significantly higher rate of hypertension in women in the 

lowest calcium intake quintile (189-557 mg/d) compared to all quintiles with intakes 

above 679 mg/d. 

• Pregnant & lactating women Not reviewed 

236 
237 

Table 80. Calcium and hypertension incidence: Characteristics of cohort studies 

Confounders/Effect Modifiers 

Adjusted 

Author Year 

Study Name 

Location 

[PMID] 

Population Dietary Calcium 

intake Comparisons 

Nutrients Demograph Anthrop Medical UV exposure Lifestyle 

Comments 

• Health 

status 

Normotensive 

• Mean 

age 

(range), y 

36 

(20-90) 

• Dietary 

assessment 

method 

Alonso 2005 FFQ 183

U Navarra 

Follow-up 

Navarra Spain 

(43°N) 

[16280427] • Male 

(%) 

39 • Internal 

validation? 

(y/n) 

No 

Hypertension 

incidence 

stratified by 

total Ca intake 

quintiles 

X X X X X Total 

Ca 

(both) 

• Health 

status 

Normotensive 

• Mean 

age 

(range), y 

46 (25-

74) 

• Dietary 

assessment 

method 

24 hr 

recall 

Dwyer 1996184A 

NHANES I 

US 

(various) 

[8890661] 

• Male 

(%) 

63 • Internal 

validation? 

(y/n) 

nd 

Hypertension 

incidence 

stratified by 

total Ca intake 

quartiles 

X X X X Total 

Ca 

(both) 

• Health 

status 

Normotensive 

• Median 

age 

(range), y 

50 (40-

75) 

• Dietary 

assessment 

method 

Ascherio 1992 FFQ 185

HPFS 

US 

(various) 

[1330360] 

• Male 

(%) 

100 • Internal 

validation? 

(y/n) 

Yes 

Hypertension 

incidence 

stratified by 

total Ca intake 

categories 

X X X Total 

Ca 

(both) 

• Health 

status 

Normotensive 

• Mean 

age 

(range), y 

nd 

(≥25) 

• Dietary 

assessment 

method 

Ford 1991 nd 186B 

NHANES I 

US 

(various) 

[1937662] 

• Male 

(%) 

35 • Internal 

validation? 

(y/n) 

nd 

Hypertension 

incidence 

stratified by 

total Ca intake 

quartiles 

X X Total 

Ca 

(both) 

• Health 

status 

Normotensive 

• Mean 

age (SD, 

range), y 

54 (6.5; 

≥45) 

• Dietary 

assessment 

method 

Wang 2008 FFQ 187

WHS 

US 

(various) 

[18259007] 

• Male 

(%) 

0 • Internal 

validation? 

(y/n) 

No 

Hypertension 

incidence 

stratified by 

total Ca intake 

quintiles 

X X X X X Total 

Ca 

(both) 

• Health 

status 

Normotensive 

• Mean 

age 

(range), y 

nd (30-

55) 

• Dietary 

assessment 

method 

Ascherio 1996 FFQ 188

NHS 

US 

(various) 

[8621198] 

• Male 

(%) 

0 • Internal 

validation? 

(y/n) 

Yes 

Hypertension 

incidence 

stratified by 

total Ca intake 

categories 

X X X Total 

Ca 

(both) 

A

 Overall and age subgroup analyses from NHANES I reported in this study. However, different samples selected; 63% male. B

 Sex and race subgroup analyses from NHANES I reported in this study. However, different samples selected; 35% male. 
Table 81. Calcium and hypertension incidence: Results of cohort studies 

Author Year Study Name [PMID] 

Age Range, 

Sex 

Outcome (n/N, 

Incidence) 

Followup 

Duration 

(Time to Dx) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95% 

Both Sexes Alonso 2005183

U Navarra Follow-up [16280427] 

20-90 y, 

Both 

Hypertension 

(180/6686, 0.027) 

2 y Mean (SD) 

900 (200) 

39 ~1337 1 Refere

1000 (200) 39 ~1337 0.98 0.62, 1200 (200) 35 ~1337 0.82 0.51, 

1400 (300) 30 ~1337 0.73 0.45, 

1700 (400) 37 ~1337 0.97 0.61, 

Dwyer 1996184A NHANES I [8890661] 

25-74 y, Both Hypertension, treated 

(1704/6634, 0.257) 

10 y nd nd ~1658 29.8% 

nd nd ~1658 ~27% nd nd ~1658 ~25% nd nd ~1658 21.3% 

≤40 y Hypertension, treated 

(nd/nd) 

10 y nd nd nd 1 Refere

nd nd nd 0.70 0.54, 0nd nd nd 0.79 0.66, 0nd nd nd 0.89 0.81, 0

>40 y Hypertension, treated 

(nd/nd) 

10 y nd nd nd 1 Refere

nd nd nd 1.01 0.94, nd nd nd 1.02 0.89, nd nd nd 1.04 0.84, 

Men Ascherio 1992185

HPFS [1330360] 

40-75 y, 

Men 

Hypertension 

(1248/30,681, 0.041) 

4 y <500 85 1677 1.17 0.91, 

500-700 297 7504 0.91 0.77, 700-900 333 8576 0.89 0.76, 

900-1100 195 5038 0.91 0.76, 

≥1100 338 7890 1 Refere

≤50 y Hypertension 

(nd/14,354) 

4 y <500 nd nd 1.52 nd

500-1100 nd nd 0.86 nd 

≥1100 nd nd 1 Refere

>50 y Hypertension 

(nd/16,314) 

4 y <500 nd nd 0.98 nd 

500-1100 nd nd 0.91 nd 

≥1100 nd nd 1 Refere

continued 

238 
239 

Author Year Study Name [PMID] 

Age Range, 

Sex 

Outcome (n/N, 

Incidence) 

Followup 

Duration 

(Time to Dx) 

Total Ca 

Intake, 

mg/day 

No. of 

Cases 

No. in 

Category 

Adjusted 

OR 

95% 

Ford 1991186B NHANES I [937662] 

≥25 y, 

Men (White) 

Hypertension 

(360/1707, 0.211) 

10 y <344 47 ~215 1 Refere

344-591 78 ~382 0.91 0.60, 591-954 104 ~448 1.09 0.73, 

>954 131 ~662 0.96 0.64, 

≥25 y, 

Men (Black) 

Hypertension 

(64/183, 0.350) 

10 y <344 20 ~34 1 Refere

344-591 17 ~45 0.68 0.28, 591-954 18 ~56 0.54 0.22, 

>954 9 ~34 0.35 0.11, 

Women Wang 2008187

WHS [8259007] 

≥45 y, 

Women 

Hypertension 

(8529/28,886, 0.295) 

10 y 189-557 1860 5777 1 Refere

558-678 1778 5777 0.96 0.90, 679-801 1626 5777 0.89 0.83, 0802-999 1634 5777 0.89 0.83, 0

1000-2559 1631 5777 0.87 0.81, 0

Ascherio 1996188

NHS [621198] 

30-55 y, 

Women 

Hypertension 

(2526/41,541, 0.061) 

14 y <400 87 5581 

person-y 

1 Refere

400-600 608 36,605 1.07 0.85, 600-800 712 42,544 1.05 0.83, 

800-1000 407 24,240 1.03 0.82, 

≥1000 712 41,325 1.04 0.83, 

Ford 1991186B NHANES I [937662] 

≥25 y, 

Women (White) 

Hypertension 

(645/3065, 0.210) 

10 y <344 186 ~865 1 Refere

344-591 183 ~806 1.11 0.87, 591-954 172 ~775 1.17 0.90, 

>954 104 ~619 1.01 0.74, 

≥25 y, 

Women (Black) 

Hypertension 

(171/456, 0.375) 

10 y <344 94 ~225 1 Refere

344-591 35 ~120 0.61 0.37, 591-954 31 ~74 1.11 0.62, 

>954 11 ~37 0.77 0.33, 

* Statistically significant (P<0.05) A Overall and age subgroup analyses from NHANES I reported in this study. However, different samples selected; 63% male. B Sex and race subgroup analyses from NHANES I reported in this study. However, different samples selected; 35% male. C Estimated from available data
Figure 21. Hypertension risk stratified by calcium intake 

240 
Calcium and blood pressure. 

Synopsis. 

 We identified six systematic reviews that evaluated RCTs of calcium intake and changes in 

blood pressure. Five additional trials not identified by these systematic reviews met eligibility 

criteria for this report and are summarized together with the systematic reviews. Altogether, 69 

trials have been identified. The range of intervention calcium doses were approximately 400 to 

2000 mg/d, with most studies using 1000 to 1500 mg/d. The systematic reviews followed the 

patterns of the primary studies in that they were divided among those that focused on studies of 

people without hypertension, people with hypertension, and general populations (with or without 

hypertension, without subgroup analyses). Because the systematic reviews all used somewhat 

different eligibility criteria, they included overlapping groups of trials. No one or two systematic 

reviews captured most of the relevant trials; therefore, all systematic reviews are included here. 

 Two overlapping systematic reviews evaluated trials of normotensive individuals. Both 

found no significant effect of calcium supplementation and blood pressure. The two additional, 

more recent primary studies of normotensive participants were consistent with this finding. 

 Four overlapping systematic reviews of the effect of calcium on blood pressure in 

hypertensive individuals mostly found significant effects on systolic blood pressure (ranging 

from about -2 to -4 mm Hg). An older, highly selective systematic review found no significant 

effect. The systematic review that found the largest effect of calcium on systolic blood pressure 

also found a significant effect on diastolic blood pressure (-1.5 mm Hg), but the other systematic 

reviews found no significant effect. None of the more recent primary studies were in people 

exclusively with hypertension. 

 Four of the systematic reviews performed meta-analyses of all people regardless of 

hypertension diagnosis. Except for the oldest, highly selective systematic review, they found 

significant effects on systolic blood pressure (ranging from -1.9 to –0.9 mm Hg). The summary 

estimates of the effect on diastolic blood pressure ranged from -1.0 to +0.03 mm Hg, which were 

mostly nonsignificant. The individual, recent primary studies of mixed populations (in terms of 

hypertension) found larger, though statistically nonsignificant, effects. 

 The systematic reviews that evaluated factors including age, sex, calcium dose, background 

dietary calcium, supplement versus dietary source, and other factors found no significant 

associations (or differences). The five additional primary studies did not provide further insights 

into these subgroup analyses. 

Detailed presentation (Tables 82, 83, & 84). 

 The six systematic reviews explicitly or implicitly used generally different eligibility criteria, 

resulting in large overlaps in the trials included.169,189-193. The systematic reviews included a total 

of 64 trials. The largest systematic review189 included trials up to 1997 and was an update of a 

previous review191 that reported more analyses. The next largest systematic review190 was one of 

the more recent systematic reviews (including trials through 2003). The most recent systematic 

review169 was restricted to trials of people with hypertension. Five more recent trials, not 

included in any of the systematic reviews were found.120,194-197 Two of the trials were restricted 

to normotensive individuals; none included only people with hypertension. 

241 
Normotensive individuals. 

 The systematic reviews by Bucher et al. (1996)191 and Allender et al. (1996)192 evaluated 

trials of normotensive individuals. The range of intervention calcium doses were approximately 

400 to 2000 mg/d, with most studies using 1000 to 1500 mg/d. Both found no significant effect 

of calcium supplementation on blood pressure (net effect on systolic blood pressure of -0.27 and 

-0.53 mm Hg, respectively, and on diastolic blood pressure of -0.33 and -0.28 mm Hg, 

respectively). The two additional, more recent primary studies of normotensive participants were 

consistent with this finding. The TOHP trial compared calcium supplement to placebo in people 

without hypertension but high normal diastolic blood pressure (80-89 mm Hg) and found a 

nonsignificant net change in blood pressure of approximately -0.5/+0.35 mm Hg 

(systolic/diastolic) after 18 months.195 Lijnen 1995 also compared calcium supplement to 

placebo, but in men who had been put on a low calcium run-in diet, and found a nonsignificant 

net change in blood pressure of approximately -2/-1 mm Hg after 4 months.197 Both trials had 

methodological quality C due to inadequate reporting of this outcome or of the background 

calcium intakes of the participants. Bucher et al. (1996) reported a wide range of study quality; 

Allender et al. (1996) did not evaluate study quality. 

Findings per calcium intake level. 

 Neither systematic review performed subgroup analyses of the normotensive individuals to 

evaluate a dose (calcium intake) effect. Qualitative examination of the data provided in the 

systematic review tables and the two additional trials did not indicate any dose effect. 

Findings per age and sex. 

 Neither systematic review performed subgroup analyses of the normotensive individuals to 

evaluate age or sex. The trials in the Allender et al. (1996) systematic review and the two 

additional trials represented a wide range of ages, though apparently all participants were under 

age 70 years. Studies were of all men, all women, and both sexes. There were no apparent 

differences based on age or sex. 

Hypertensive individuals. 

 Four systematic reviews evaluated trials of hypertensive individuals (Bucher et al. 1996191, 

Allender et al. 1996192, Cappuccio et al. 1989193, and Dickinson 2006198). Dickinson et al. (2006) 

included only studies of people with hypertension. The range of supplemental calcium was 

approximately 400 to 2000 mg/d in most systematic reviews, with most studies using 1000 to 

1500 mg/d. The systematic reviews generally found significant effects on systolic blood pressure 

of about -2 to -4 mm Hg, but no (or small) effects on diastolic blood pressure. The one 

systematic review that found no effect of calcium supplementation on systolic blood pressure 

(Cappuccio et al. 1989) was the oldest systematic review (including trials up to only 1988). In 

addition, the reviewers were highly selective in their eligibility criteria, having excluded trials 

that did not report various types of baseline data. The one systematic review that found a 

significant effect of calcium supplementation on diastolic blood pressure (Bucher et al. 1996) 

meta-analyzed only 6 trial subgroups of people with hypertension, compared to 10 to 16 trials in 

the other systematic reviews. None of the more recent trials provided analyses in only people 

with hypertension. 

242 
Findings per calcium intake level. 

 Only Dickinson et al. (2006), the systematic review of only trials of people with 

hypertension, evaluated calcium intake (or dose) as a predictor of effect. They found essentially 

the same overall effects on systolic and diastolic blood pressures in studies that used less than 

1200 mg/d or 1200 to 2000 mg/d of calcium. Qualitative examination of the data provided in the 

tables of the remaining systematic reviews did not indicate any dose effect. 

Findings per age and sex. 

 No systematic review evaluated the association between age or sex and treatment effect in 

trials of people with hypertension. Overall, the range of ages of participants was about 20 to 75 

years. Studies were of all men, all women, and both sexes. There were no apparent differences 

based on age or sex. 

All trials (combined normotensive and hypertensive individuals). 

 Five systematic reviews (including one which is an update of a second) combined trials of 

hypertensive, normotensive, or mixed groups of people (Griffith et al. 1999189, van Mierlo et al. 

2006190, Bucher et al. 1996191, Allender et al. 1996192, and Cappuccio et al. 1989193). The range 

of calcium supplementation was approximately 400 to 2000 mg/d in most systematic reviews, 

with most studies using 1000 to 1500 mg/d. The systematic reviews generally found a significant 

effect of calcium supplementation on systolic blood pressure of -0.9 to -1.9 mm Hg (excluding 

the earliest, highly selective systematic review by Cappuccio et al. (1989)193, as discussed 

above). The two systematic reviews that included the most studies (Griffith et al. 1999189 and van 

Mierlo et al. 2006190) found a significant effect on diastolic blood pressure (-0.8 and -1.0 mm Hg, 

respectively). The smaller, older systematic reviews found no significant effect (Allender et al. 

1996192 and Cappuccio et al. 1989193). The reason for the difference in conclusions of the 

systematic reviews may relate to greater statistical power in the more recent meta-analyses or 

differences in study eligibility criteria. The systematic reviews that reported on study 

heterogeneity found significant heterogeneity. Three of the systematic reviews reported data on 

subgroup or regression analyses to explain the heterogeneity. The only factor that explained a 

significant amount of the heterogeneity was the difference in effect between studies of people 

with or without hypertension. (The age, sex, and calcium dose analyses are described below.) 

 Two recent randomized trials included postmenopausal women (over 50 or 55 years) 

regardless of their blood pressure;120,194 a third trial enrolled pregnant women and evaluated 

long-term postpartum blood pressures.196 The trials each compared different interventions: 

calcium citrate 1000 mg versus placebo; dairy product intake (with a mean of 1242 mg/d 

calcium) versus nondairy product intake (377 mg/d calcium); and calcium carbonate 2000 mg/d 

versus placebo in women all taking prenatal vitamins that included 400 IU/d vitamin D2. The 

calcium citrate trial was of methodological quality B; the other two trials C. The recent trials 

found broadly similar conclusions to that of the systematic reviews, with women with greater 

calcium intake having lower systolic blood pressure (-2.2 to -5.4 mm Hg) and smaller decreases 

in diastolic blood pressure (-0.7 to -2.2 mm Hg); though none of the effects was statistically 

significant. 

Findings per calcium intake. 

 Three systematic reviews190-192 evaluated calcium dose (or intake) as a source of 

heterogeneity. None found a significant association. Specifically, van Mierlo et al. (2006) found 

similar (though smaller) effects in studies of over 1000 mg/d of calcium (SBP/DBP -1.75/-0.56) 

compared to studies of 1000 mg/d of calcium or less (-2.17/-1.41). 

243 
Findings per age and sex. 

 Age and sex were evaluated as potential explanations of heterogeneity in two systematic 

reviews.190,192 Neither found that age or sex were significantly associated with the effect of 

calcium on blood pressure. However, these analyses are subject to ecological fallacy, as they 

used the mean ages and the percent of study participants who were male as proxies for the effects 

of calcium intake in people of a particular age or sex. Most studies included participants under 

age 70 years. Studies were of all men, all women, and both sexes. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y The majority of studies are applicable to people within this life stage; 

though people under approximately 40 years are less well represented. The evidence 

suggests no significant effect of calcium supplementation on blood pressure in 

normotensive individuals. In people with hypertension, the evidence suggests that 

calcium supplementation lowers systolic blood pressure by about -2 to -4 mm Hg, but 

does not change diastolic blood pressure. The effect appears to be consistent across 

calcium supplement doses (specifically above or below 1200 mg/d). 

• 51 – 70 y The majority of studies are applicable to people within this life stage. The 

conclusions are the same as for those in the 19-50 years life stage. 

• ≥71 y The evidence is scant for this life stage. Few of the studies appear to have 

included people over age 70 years. 

• Postmenopause Our review of the evidence does not allow for a definitive 

conclusion for this life stage. None of the systematic reviews evaluated menopausal 

status as an explanatory variable for heterogeneity. 

• Pregnant & lactating women Not reviewed 

244 
Table 82. Summary of systematic reviews of calcium and blood pressure 

Author Year [PMID] Griffith 1999189 [10075392] 

Design (Search Years) Randomized controlled trials (1966-1997) 

Population Both hypertensive and normotensive participants 

Intervention and Comparator Dietary and nondietary calcium supplementation versus placebo (no supplement) 

Dose range 600-2000 mg (36% 1000 mg; 26% 1500-1600 mg; 12% 2000 mg) 

Results 42 trials 

SBP: -1.44 (-2.20, -0.68)A; statistically heterogeneous 

DBP: -0.84 (-1.44, -0.24); statistically heterogeneous 

 Subgroup analyses did not find that heterogeneity could be explained by age, sex, baseline 

calcium, dietary versus nondietary calcium, or quality. 

 Subgroups with hypertensive versus normotensive people were significantly different (no 

further details). 

 Conclusions similar to previous systematic review (Bucher 1996191) 

Comments Update of Bucher 1996191 (see below). 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? No 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? Yes Publication bias assessed? No 

Included and excluded studies listed? Yes Conflicts of interest stated? No 

Study characteristics provided? Yes Study quality not discussed in conclusions. Funding 

source reported, but not conflict of interest. 

Author Year [PMID] van Mierlo 2006190 [16673011] 

Design (Search Years) Randomized controlled trials (1966-2003) 

Population Both hypertensive and normotensive participants 

Intervention and Comparator Calcium supplementation versus placebo (no supplement) 

Dose range 355-2000 mg (40% 1000 mg; 32% 1500-1600 mg; 6% 2000 mg) 

Results 40 trials 

SBP: -1.86 (95% CI -2.91, -0.81); statistically heterogeneous 

DBP: -0.99 (95% CI -1.61, -0.37); statistically heterogeneous 

 In multivariable analysis including age, sex, initial calcium intake, calcium dose, and initial 

blood pressure: 

 SBP DBP 

 Age <45 y -1.45 (-2.99, +0.09) -1.26 (-2.20, -0.33) 

 ≥45 y -2.33 (-3.69, -0.96) -0.80 (-1.62, +0.02) 

 Male ≤50% -2.20 (-3.68, -0.72) -1.12 (-1.98, -0.26) 

 >50% -1.77 (-3.13, -0.42) -0.84 (-1.65, -0.04) 

 Initial BP <140/90 mm Hg -2.04 (-3.40, -0.68) -1.04 (-1.86, -0.22) 

 ≥140/90 mm Hg -1.85 (-3.45, -0.32) -0.89 (-1.79, +0.01) 

 Ca dose ≤1000 mg -2.17 (-3.59, -0.75) -1.41 (-2.24, -0.59) 

 >1000 mg -1.75 (-3.20, -0.31) -0.56 (-1.40, +0.29) 

Blood pressures not statistically significantly different between any strata. 

Comments 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? No 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? Unclear Publication bias assessed? Yes 

Included and excluded studies listed? Partial Conflicts of interest stated? Yes 

Study characteristics provided? Yes No data on inclusion of unpublished data. Excluded 

studies available from authors 

245 
Table 82. continued 

Author Year [PMID] Bucher 1996191 [8596234] 

Design (Search Years) Randomized controlled trials (1966-1994) 

Population Both hypertensive and normotensive participants 

Intervention and Comparator Dietary and nondietary calcium supplementation vs. placebo (no supplement) 

Dose range 406-2000 mg (41% 1000 mg; 31% 1500-1600 mg; 8% 2000 mg) 

Results 33 trials 

[Overall summary results were updated in Griffith 1999189, above] 

Studies with specified subgroups of hypertensive and normotensive participants (6 trials): 

 Hypertensives SBP -4.30 (-6.47, -2.13) DBP -1.50 (-2.77, -0.23) 

 Normotensives SBP -0.27 (-1.80, +1.27) DBP -0.33 (-1.56, +0.90) 

Regression analyses: 

 BP (continuous scale) SBP OR = 0.99 (0.96, 1.01) DBP OR = 0.99 (0.96, 1.03) 

Dose of calcium, duration of supplementation, dietary vs. nondietary calcium supplementation, 

methodological quality did not demonstrate a relationship with the magnitude of treatment effect. 

Comments Updated in Griffith 1999189 (see above) 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? Yes 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? Yes Publication bias assessed? No 

Included and excluded studies listed? Yes Conflicts of interest stated? No 

Study characteristics provided? Yes Funding source reported, but not conflict of interest. 

Author Year [PMID] Allender 1996192 [8610952] 

Design (Search Years) Randomized controlled trials (1982-1993) 

Population Both hypertensive and normotensive participants 

Intervention and Comparator Dietary and nondietary calcium supplementation vs. placebo (no supplement) 

Dose range 400-2160 mg (35% 1000 mg; 29% 1500-1600 mg; 10% 2000 mg) 

Results 26 trials (22 trials included in meta-analyses) 

SBP: -0.89 (-1.74, -0.05) 

DBP: -0.18 (-0.75, +0.40) 

 Hypertensives SBP -1.68 (-3.18, -0.18) DBP +0.02 (-0.96, +1.00) 

 Normotensives SBP -0.53 (-1.56, +0.49) DBP -0.28 (-0.99, +0.42) 

By weighted linear regression analyses, age, sex, calcium dose, trial duration were not 

associated with treatment effect (P>0.10) 

Comments 

AMSTAR 

A priori design? Yes Study quality assessment performed? No 

Two independent reviewers? Yes Study quality appropriately used in analysis? No 

Comprehensive literature search? Yes Appropriate statistical synthesis? No 

All publication types and languages included? Yes Publication bias assessed? No 

Included and excluded studies listed? No Conflicts of interest stated? No 

Study characteristics provided? Yes Excluded studies not enumerated or listed. Fixed effects 

models used. 

Author Year [PMID] Cappuccio 1989193 [2697729] 

Design (Search Years) Randomized controlled trials (1983-1988) 

Population Both hypertensive and normotensive participants 

Intervention and Comparator Nondietary calcium supplementation versus placebo (no supplement) or low calcium intake 

Dose range 800-1600 mg (60% 1000 mg; 27% 1500-1600 mg) 

Results 15 trials 

SBP (supine): -0.13 (-0.46, +0.19) 

DBP (supine): +0.03 (-0.17, +0.22) 

 Hypertensives SBP +0.06 (-0.59, +0.72) DBP +0.03 (-0.21, +0.27) 

Comments 

AMSTAR 

A priori design? Yes Study quality assessment performed? No 

Two independent reviewers? nd Study quality appropriately used in analysis? NA 

Comprehensive literature search? Yes Appropriate statistical synthesis? No 

All publication types and languages included? nd Publication bias assessed? No 

Included and excluded studies listed? No Conflicts of interest stated? No 

Study characteristics provided? Yes Excluded studies not enumerated or listed. Fixed effects 

models used. 

246 
Table 82. continued 

Author Year [PMID] Dickinson 2006198 [16625609]B 

Design (Search Years) Randomized controlled trials (1982-2003/2005C) 

Population Hypertensive participants 

Intervention and Comparator Dietary and nondietary calcium supplementation versus placebo (no supplement) 

Dose range 400-2000 mg (50% 1000 mg; 25% 1500-1600 mg; 6% 2000 mg) 

Results 13 trials 

SBP: -2.53 (-4.45, -0.60); statistically heterogeneous 

DBP: -0.81 (-2.07, +0.44); statistically heterogeneous 

 Ca dose <1200 mg SBP -2.67 (-5.15, -0.18) DBP -0.75 (-2.13, +0.63) 

 Ca dose 1200-2000 mg SBP -2.69 (-5.86, +0.47) DBP -0.78 (-3.82, +2.25) 

 Not statistically significantly different by calcium dose 

Comments 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? Yes 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? Yes Publication bias assessed? Yes 

Included and excluded studies listed? Yes Conflicts of interest stated? Yes 

Study characteristics provided? Yes A Numbers in parentheses are 95% confidence intervals 

B

 A technical update, with no further studies added was published in the Cochrane database in 2008. 

C

 Different dates for different databases. 

247 
248 

Table 83. Calcium and blood pressure: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium 

Intake & 

Vitamin D 

Data 

Comparisons Compliance Comments 

• Health 

status 

No HTN (DBP 

80-89 mm Hg) 

• Mean age 

(range), y 

43 (30-54) 

Whelton 1997195

TOHP 

US 

(various) 

[9022561] • Male (%) 68 

nd Calcium 

supplement vs. 

Placebo 

nd 

• Health 

status 

Normotensive 

• Mean age 

(range), y 

24 (20-44) 

Lijnen 1995197

Leuven, Belgium 

(51°N) 

[8557965] 

• Male (%) 100 

“Low calcium 

diet” run-in 

Calcium 

supplement vs. 

Placebo 

nd With low 

dairy intake 

• Health 

status 

Healthy 

• Mean age 

(range), y 

75 (≥55) 

Reid 2005194

Auckland, New 

Zealand 

(36.5°S) 

[15827103] • Male (%) 0 

Ca 857 mg/day Calcium 

supplement vs. 

Placebo 

Calcium group: 

55%, Placebo 

group: 58% 

• Health 

status 

Healthy 

• Mean age 

(range), y 

~80 (≥50) 

Ghadirian 1995120

Montreal, Canada 

(46°N) 

[7493659] 

• Male (%) 0 

Ca 776 mg/day Dairy vs. Dairy-free 

intake 

Non-compliant and 

those who 

provided 

incomplete data 

were excluded. 

• Health 

status 

Pregnant 

during trial 

• Mean age 

(range/SD), 

y 

nd 

Hatton 2003196

CPEP 

Portland, Oregon 

(45.5°N) 

[14553957] 

• Male (%) 0 

nd Calcium 

supplement vs. 

Placebo (both on 

prenatal vitamins 

including Vit D2

400 IU) 

nd (but all had to 

meet a compliance 

test prior to 

randomization) 

Oregon site 

only. Postpregnancy 

followup 
Table 84. Calcium and blood pressure: Results of RCTs 

Author Year Study Name [PMID] 

Age 

Range, 

Sex; 

Population 

Outcome 1°/2° 

Mean 

Followup, 

unit 

Interventions, 

Daily Dose 

No. 

Analyzed Unit Baseline Change Change 95% CI Net Diff 

SYSTOLIC BLOOD PRESSURENormotensive 

Ca carbonate 

1000 mg 

mm 

Hg ~-0.5A Whelton 221 126.0 nd nd 

1997195

TOHP [9022561] 

30-54 y, 

Both; 

No HTN 

(DBP 80-

89 mm Hg) 

SBP 1° 18 mo 

Placebo 224 125.4 nd nd 

Ca gluconate 

2000 mg (low 

dairy intake) 

mm 

Hg ~-4A Lijnen 1995 16 114 nd ~-2 

197 Belgium 

[8557965] 

20-44 y, 

Men 

No HTN 

SBP, 

supine 2° 4 mo Placebo (low 

dairy intake) 16 114 ~-2 nd 

All women 

Ca citrate 

1000 mg 

mm 

Hg 732 134.9 0.0 -0.1, 0.1 -2.4 

Reid 2005194 New Zealand 

[15827103] 

≥55 y, 

Women; 

All BP 

SBP 2° 30 mo 

Placebo 739 133.9 +2.4 2.3, 2.5 

Dairy intake 

(1242 mg Ca) 

mm 

Hg 81 140.34 -2.69 -7.3, 2.0* -5.4 

Ghadirian 1995120

Canada [7493659] 

≥50 y, 

Women; 

All BP 

SBP 2° 1 mo Dairy-free 

(377 mg Ca) 77 131.71 +2.75 -2.3, 7.8* 

Ca carbonate 

2000 mg (+Vit 

D2 400 IU) 

37 mm Hg nd Final Differenc

101.9 -2.2 

Hatton 2003 

196 CPEP 

[14553957] 

Pregnant, 

WomenB; 

All BP 

SBP 2° 2 y post- partum Placebo (+Vit 

D2 400 IU) 25 nd 104.1 

DIASTOLIC BLOOD PRESSURENormotensive 

Ca carbonate 

1000 mg 

mm 

Hg ~+0.35A Whelton 221 84.1 nd nd 

1997195

TOHP [9022561] 

30-54 y, 

Both; 

No HTN 

(DBP 80-

89 mm Hg) 

DBP 1° 18 mo 

Placebo 224 83.9 nd nd 

Ca gluconate 

2000 mg (low 

dairy intake) 

mm 

Hg ~-1A Lijnen 1995 16 74 nd ~-1 

197 Belgium 

[8557965] 

20-44 y, 

Men 

No HTN 

DBP, 

supine 2° 4 mo Placebo (low 

dairy intake) 16 72 ~0 nd 

All women 

Ca citrate 

1000 mg 

mm 

Hg 732 70.1 -0.2 -0.2, -0.2 -1.0 

Reid 2005194 New Zealand 

[15827103] 

≥55 y, 

Women; 

All BP 

DBP 2° 30 mo 

Placebo 739 69.6 +0.8 0.8, 0.8 

continued 

249 
250 

Author Year Study Name [PMID] 

Age 

Range, 

Sex; 

Population 

Outcome 1°/2° 

Mean 

Followup, 

unit 

Interventions, 

Daily Dose 

No. 

Analyzed Unit Baseline Change Change 95% CI Net Diff 

Dairy intake 

(1242 mg Ca) 81 mm Hg 81.17 -7.78 -10.0, -5.5* -2.2 

Ghadirian 1995120

Canada [7493659] 

≥50 y, 

Women; 

All BP 

DBP 2° 1 mo 

Dairy-free 

(377 mg Ca) 77 79.09 -5.59 -7.9, -3.3* 

Ca carbonate 

2000 mg (+Vit 

D2 400 IU) 

37 mm Hg nd Final 67.1 Differenc

-0.7 

Hatton 2003 

196 CPEP 

[14553957] 

Pregnant, 

WomenB; 

All BP 

DBP 2° 2 y post- partum Placebo (+Vit 

D2 400 IU) 25 nd 67.8 

A From figure B Blood pressure outcomes are 1 year post-partum C Estimated from available data
Combined Vitamin D and Calcium and Health Outcomes 

Women’s Health Initiative (WHI) trial. 

 The WHI trial provided data for numerous health outcomes of interest. For this reason and 

because of some methodological issues unique to this trial, the study is discussed here. The trial 

compared combined vitamin D3 400 IU and calcium carbonate 1000 mg daily versus placebo in a 

7 year trial in 36,282 postmenopausal women (age 50-79 y). The Tufts EPC, members of the 

Technical Expert Panel, and reviewers of the draft report debated about the quality of this trial. It 

was generally agreed that the overall methodological rigor and analyses were of good quality for 

most outcomes. However, there was not complete consensus on how to regard the fact that the 

women in both groups of this 7 year trial were allowed to take additional vitamin D supplements 

up to 600 IU and later 1000 IU per day and calcium supplements up to 1000 mg per day. At 

baseline, about one-third of women in both supplement and placebo groups were taking vitamin 

D supplements of at least 400 IU/d and 29 percent were taking at least 500 mg/d of supplemental 

calcium; by the end of the trial 69 percent of women were taking any additional supplemental 

calcium. During the 7 years, only about 60 percent of women (in any given year) were taking at 

least 80 percent of the study pills; at the end of the trial, only 76 percent were still taking any 

study medications. Regarding the overall quality of the study, arguments were put forward that 

this was a high quality effectiveness trial (in contrast with a more standardized efficacy trial) and 

thus had increased relevance to the actual use of supplements, that the crossover of interventions 

affects the applicability more than the methodological quality, and that the trial should not be 

downgraded because data reporting was more complete than for most trials. However, it was the 

consensus among the Tufts EPC that overall, the methodological quality of the trial was B, 

particularly when the trial is being used to guide decisions about DRI, as opposed to decisions 

about whether to actively recommend supplementation for an individual woman. 

Combined Vitamin D Calcium and Growth 

 We reviewed primary studies that evaluated relationships between vitamin D and growth 

parameters in infants and children. 

Synopsis. 

One C-rated nonrandomized study compared combined vitamin D (1200 IU/d) and calcium 

(375 mg/d) to no supplementation in women in their third trimester of pregnancy. Infants of 

women who received supplementation were significantly heavier at birth. 

Detailed presentation (Tables 4 & 6). 

Infant 0 - 6 months; 7 months - 2 years; pregnant or lactating women. 

We identified a study from India that included a nonrandomized comparison between 

combined vitamin D (1200 IU/d) and calcium (375 mg/d) for the expectant mothers versus no 

supplementation. The outcome was infant birth weight.41 This study has already been described 

in the “Vitamin D and growth” section, as it also included a vitamin D only intervention arm. 

The study included expectant mothers with daily milk intake less than 500 mL and estimated 

daily vitamin D intake less than 30 IU. It was rated C for methodological quality, because of the 

lack of randomization and incomplete reporting of analyses. According to the reported analysis, 

251 
252 

infants of women who received supplementation were significantly heavier at birth by 160 g on 

average (95 percent CI 0, 320). 

 Findings by life stage 

• 0 – 6 mo One C-rated nonrandomized study from India compared combined vitamin 

D (1200 IU/d) and calcium (375 mg/d) to no supplementation in women in their third 

trimester of pregnancy. Infants of women who received supplementation were 

significantly heavier at birth by 160 g on average (95 percent CI 0, 320). (See also the 

Pregnant & lactating women.) 

• 7 mo – 2 y No identified study covered this life stage. 

• 3 – 8 y No identified study covered this life stage.

• 9 – 18 y No identified study covered this life stage. 

• 19 – 50 y Not reviewed

• 51 – 70 y Not reviewed

• ≥71 y Not reviewed

• Postmenopause Not reviewed

• Pregnant & lactating women One C-rated nonrandomized study from India 

compared combined vitamin D (1200 IU/d) and calcium (375 mg/d) to no 

supplementation in women in their third trimester of pregnancy. Infants of women who 

received supplementation were significantly heavier at birth by 160 g on average (95 

percent CI 0, 320). (See also the 0 – 6 mo category.)
Combined Vitamin D and Calcium and Cardiovascular Disease 

Synopsis. 

 No qualified systematic reviews evaluated the association between combined vitamin D and 

calcium, body stores, or serum concentrations, and cardiovascular events. A variety of 

cardiovascular events after 7 years were evaluated in the Women’s Health Initiative (WHI) trial 

of combined daily vitamin D3 400 IU and calcium carbonate 1000 mg versus placebo in 50 to 79 

year old women. No statistically significant effect was found with combined vitamin D and 

calcium supplementation on any cardiovascular outcome. However, near significant associations 

were found for three outcomes, suggesting increased risk with supplementation for a composite 

cardiac outcome that included invasive cardiac interventions, invasive cardiac interventions, and 

transient ischemic attacks. No significant associations were found for cardiovascular death, a 

composite cardiac outcome (myocardial infarction or cardiac death), coronary heart disease 

death, myocardial infarction, hospitalization for heart failure, angina, combined stroke or 

transient ischemic attack, stroke alone, or cerebrovascular death. 

Detailed presentation (Tables 85 & 86). 

 In the WHI trial, discussed above, the evaluated cardiovascular outcomes were all 

prespecified secondary outcomes.199,200 On average, the women had normal blood pressure. 

There were no significant effects of the supplementation on any of the outcomes, though three of 

the outcomes did approach statistical significance suggesting increased events with 

supplementation: composite cardiac events (HR = 1.08 [95 percent CI 0.99, 1.19]), coronary 

artery bypass grafting or percutaneous coronary interventions (HR=1.09 [95 percent CI 0.98, 

1.22]), and transient ischemic attacks (HR=1.16 [95 percent CI 0.95, 1.42]). The authors, 

however, concluded that calcium and vitamin D supplementation neither increased nor decreased 

coronary or cerebrovascular risk in generally healthy postmenopausal women. The outcomes 

cardiac death and stroke were evaluated by age decade. No interaction was found with age (no 

significant difference across age groups). A similar analysis based on total calcium intake 

(dietary plus supplemental) also found no interaction. 

Findings per intake level. 

 No conclusions are possible about a dose effect from this single study, especially since the 

women were allowed to take additional concurrent calcium and vitamin D supplements. 

However, no interaction was found with total reported calcium intake. 

Findings by age and sex. 

 The study investigated postmenopausal women 50 to 79 years old. No interaction of effects 

with decade of age was found. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y No data available 

253 
254 

• 51 – 70 y One large trial that included women mostly within this life stage (WHI) 

found no significant effect of combined vitamin D3 (400 IU) and calcium carbonate 

(1000 mg) on cardiovascular outcomes after 7 years. 

• ≥71 y Inadequate available data. 

• Postmenopause All women in the WHI trial were postmenopausal. See 51-71 y life 

stage. 

• Pregnant & lactating women Not reviewed 

Table 85. Combined vitamin D and calcium and cardiovascular outcomes: Characteristics of 

RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population Background Calcium 

Intake & Vitamin D Data Comparisons Compliance Comments 

• Health 

status 

Any 

• Mean age 

(range), y 

62 

(50-79) 

Hsia 2007199

LaCroix 2009200

WHI 

US 

(various) 

[17309935 

19221190] 

• Male (%) 0 

Ca: 1148 (654) mg/d in 

treatment group; 1154 (658) 

in placebo group 

Low Ca intake (<800 

mg/day): 34% 

Combined Vit D & Ca 

supplement vs. 

Placebo 

See page 

242 
Table 86. Combined vitamin D and calcium and cardiovascular outcomes: Results of RCTs 

Author Year Study Name [PMID] 

Life 

Stage Outcome 1°/2° Mean Followup, y Interventions, Daily Dose n Event N Total Outcome Metric (Comparison) Result 

Vit D + Ca 226 18,176 HR (Suppl/Placebo) Cardiovascular 0.92* 

death 2° Placebo 244 18,106 

Vit D3 400 IU + Ca 

carbonate 1000 mg 920 18,176 HR 1.08 

Cardiac composite (MI, CHD death, CABG, or PCI) 

2° 

Placebo 841 18,106 

Cardiac composite Vit D + Ca 499 18,176 HR 1.04 (MI or CHD death) 2° Placebo 475 18,106 

Vit D + Ca 130 18,176 HR 1.01* 

CHD death 2° Placebo 128 18,106 

Vit D + Ca 411 18,176 HR 1.05 

MI 2° Placebo 390 18,106 

Vit D + Ca 674 18,176 HR 1.09 

CABG or PCI 2° Placebo 607 18,106 Hospitalized for Vit D + Ca 394 18,176 HR 0.95 heart failure 2° Placebo 407 18,106 

Vit D + Ca 404 18,176 HR 1.08 

Angina 2° Placebo 377 18,106 Cerebrovascular Vit D + Ca 563 18,176 HR 1.02 composite (Stroke or TIA) 

2° Placebo 547 18,106 

Vit D + Ca 362 18,176 HR 0.95 

Stroke 2° Placebo 377 18,106 

Vit D + Ca 213 18,176 HR 1.16 

TIA 2° Placebo 182 18,106 

Vit D + Ca 213 18,176 HR 0.89* 

Hsia 2007199

LaCroix 2009200

WHI [17309935 19221190] 

50-79 y, 

Women 

Cerebrovascular death 

7 

2° Placebo 182 18,106 

255 
Combined Vitamin D and Calcium and Body Weight 

 We searched for systematic reviews and primary studies that evaluated associations between 

combined vitamin D and calcium and incidence of overweight or obesity; no such studies were 

found. For the outcome weight change (in kilograms or body mass index units), we included 

only randomized controlled trials. The EPC and the TEP agreed that the limited resources would 

not be expended on reviewing observational studies for the surrogate outcome body weight 

(where overweight or obesity are considered to be the clinical outcomes). We included only 

studies of adults. Studies of weight gain in children are included in the “Growth” section. 

Synopsis. 

 No qualified systematic reviews evaluated the association between combined vitamin D and 

calcium, body stores, or serum concentrations, and body weight in adults. One RCT each tested 

the effect of combined vitamin D and calcium in the setting of either an isocaloric diet or an 

energy restricted diet. Both used vitamin D2 400 IU/d and calcium carbonate (one 1000 mg/d, 

one 1200 mg/d) and were restricted to women. In the WHI trial of postmenopausal women on an 

isocaloric diet after 7 years, there was a statistically significant 0.1 kg smaller weight gain in 

those assigned to the supplement. The effect was statistically similar across age groups. In a 

Quebec study of 63 overweight premenopausal women, the apparent effect of supplementation in 

the setting of an energy restricted diet was greater than the WHI trial (net change -1.0 kg), but 

this was not a significant difference between the supplement and placebo groups. 

Detailed presentation (Tables 87 & 88). 

Isocaloric diet. 

 The WHI trial was analyzed for the effect of daily combined vitamin D2 400 IU and calcium 

carbonate 1000 mg on weight.201 The trial included about 36,000 postmenopausal women aged 

50 to 79 years. The methodological quality of the study was B. At 7 year followup, the net 

change in body weight (supplemented minus control) was -0.13 kg (95 percent CI -0.21, -0.05; 

less weight gained in supplement group). This was of questionable clinical significance, but was 

statistically significant. The investigators performed numerous subgroup analyses including 

those based on age. There were no substantive or statistically significant differences among the 

evaluated age subgroups. 

Energy restricted diet. 

 A trial performed in Quebec City analyzed 63 premenopausal overweight or obese women 

(mean age 43) comparing daily vitamin D2 400 IU and calcium carbonate 1200 mg versus 

placebo.202 Women in both study groups were placed on a weight-loss intervention which 

consisted of a 700 Kcal/day decrease in energy intake for 15 weeks; the women met biweekly 

with a nutritionist. The trial was rated methodological quality C due to a high drop out rate (25 

percent) and poor description of the methodology. Women in both study groups on average lost 

weight, with those in the supplement group losing 1.0 kg more (4 vs. 3 kg). However, this effect 

was not statistically significant (P=0.19). 

Findings per vitamin D and calcium dose. 

 No conclusion could be reached about a possible effect of vitamin D and calcium dose. 

256 
257 

Findings per age and sex. 

 The trials included only women. The effect of supplementation on postmenopausal women 

not on an energy restricted diet was of questionable clinical significance after 7 years. The effect 

of supplementation for 15 weeks on overweight and obese premenopausal women (in an 

approximate age range of 32 to 54 years) on an energy restricted diet was relatively large (-4 vs. 

-3 kg), but this difference between the supplemented and control groups was not statistically 

significant. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y A single trial of women on an energy restricted diet found a nonsignificant 

difference in weight loss between that those assigned to vitamin D 300 IU and calcium 

1200 mg supplementation for 15 weeks. 

• 51 – 70 y The WHI trial found no clinically significant effect on weight of vitamin 

D 300 IU and calcium 1000 mg after 7 years. 

• ≥71 y The subgroup of women in the WHI trial in this life stage had a similar net 

weight change as all the study participants as a whole, but the effect was not statistically 

significant. 

• Postmenopause All the women in the WHI trial were postmenopausal. 

• Pregnant & lactating women Not reviewed 

Table 87. Combined vitamin D and calcium and weight: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake & 

Vitamin D Data 

Comparisons Compliance Comments 

• Health 

status 

All, postmenopause 

• Mean age 

(range), y 

62 (50-79) 

Caan 2007201

WHI 

US 

(various) 

[17502530] • Male (%) 0 

Ca: 1148 (654) mg/d 

in treatment group; 

1154 (658) in placebo 

group 

Vit D & Ca 

carbonate vs. 

Placebo 

See page 

242 

Factorial 

design with HT 

vs. Placebo 

• Health 

status 

Overweight, 

healthy, premenopause 

• Mean age 

(range/SD), y 

43 (5.5) 

Major 2007202

Quebec City, 

Canada 

(47°N) 

[17209177] 

• Male (%) 0 

Ca 704 mg/d Vit D + Ca 

carbonate vs. 

Placebo 

nd Energy 

restriction 
Table 88. Combined vitamin D and calcium and weight: Results of RCTs 

Author Year Study Name [PMID] 

Age 

Range, 

Sex 

(Subgp) 

Outcome 1°/2° Mean Followup Interventions, Daily Dose No. Analyzed Unit Baseline Change Change 95% CI Net Diff Ne

95

Isocaloric Diet 

Vit D2 400 IU + 

Ca carbonate 1000 mg 

18,129 kg 76.0 nd nd -0.13 -0.21

Caan 2007 

201 WHI 

[17502530] 

50-79 y, Women Weight 2° 7 y 

Placebo 18,055 75.9 nd nd 

Vit D3 + Ca 2592 kg nd nd -0.24 -0.45

(50-54 y) Placebo 2561 nd nd 

Vit D3 + Ca 4134 kg nd nd -0.08 -0.24

(55-59 y) Placebo 4135 nd nd 

Vit D3 + Ca 8276 kg nd nd -0.15 -0.27

(60-69 y) Placebo 8243 nd nd 

Vit D3 + Ca 3174 kg nd nd -0.10 -0.27

(70-79 y) Placebo 2561 nd nd 

Vit D3 + Ca 15,047 kg nd nd -0.13 -0.22

(White) Placebo 15,106 nd nd 

Vit D3 + Ca 1682 kg nd nd -0.32 -0.59

(Black) Placebo 1635 nd nd 

Vit D3 + Ca 789 kg nd nd -0.08 -0.48

(Hispanic) Placebo 718 nd nd (Asian / Vit D3 + Ca 369 kg nd nd +0.19 -0.37Pacific Islander) Placebo 353 nd nd 

Energy Restricted Diet 

Vit D2 400 IU + 

Ca carbonate 1200 mg 

30 kg 81.5 -4.0 +-9.0 -1.0 -2.31

Major 2007202

Quebec City, Canada [17209177] 

43 (SD) Weight 2° 15 wk 

Placebo 33 83.6 -3.0 +-11.7 A In addition, subgroup analyses by baseline BMI and baseline dietary calcium intake are reported. B No statistically significant interaction with age. 

C No statistically significant interaction with ethnicity.

258 
Combined Vitamin D and Calcium and Cancer 

Cancer from all causes and total cancer mortality. 

Synopsis. 

No qualified systematic reviews evaluated the association between combined vitamin D and 

calcium, body stores, or serum concentrations, and total cancer incidence or mortality. Two 

RCTs reported different effects of combined vitamin D3 and calcium supplementation on the risk 

of total cancer. The WHI showed no effects,71 while the trial conducted in Nebraska (latitude 

41°N) reported significant reduction of risk of total cancer.52 However, both vitamin D doses and 

baseline vitamin D status were substantially different between these two RCTs. Therefore, the 

effects from these two RCTs were not comparable. 

Detailed presentation (Tables 89 & 90). 

 The 7-year WHI trial that enrolled 36,282 postmenopausal women across the US compared a 

daily supplement of vitamin D3 (400 IU) and elemental calcium (1000 mg) with placebo and 

evaluated incidence of total cancer and total cancer mortality as part of multiple secondary 

analyses.71 The median serum 25(OH)D level of the study population was 42 nmol/L. The trial 

did not find significant effect of combined vitamin D3 and calcium supplementation on either the 

risk of total cancer (adjusted HR: 0.98, 95 percent CI 0.91, 1.05) or total cancer mortality 

(adjusted HR: 0.89, 95 percent CI 0.77, 1.03). The methodological quality of this study was rated 

B. 

A 4-year population based RCT,52 sampled from a 9-county, largely rural area in eastern 

Nebraska (latitude 41°N), aimed to determine the efficacy of vitamin D3 (1000 IU/d) plus 

calcium (either calcium citrate 1400 mg/d or calcium carbonate 1500 mg/d), or calcium alone 

(either calcium citrate 1400 mg/d or calcium carbonate 1500 mg/d), compared to placebo in 

reducing the incidence of fracture. Incidence of cancer was a secondary outcome in this trial. A 

total of 734 postmenopausal women, aged more than 55 years old, were analyzed for the effect 

of vitamin D3 (1000 IU/d) plus calcium (either calcium citrate 1400 mg/d or calcium carbonate 

1500 mg/d). The mean 25(OH)D concentration at baseline was 72 nmol/L. Compared to the 

placebo group, the relative risk of developing cancer at the end of study was 0.40 (95 percent CI 

0.20, 0.82; P=0.013) for the vitamin D3 plus calcium group. On the hypothesis that cancers 

diagnosed early in the study would have been present, although unrecognized at entry, the 

analyses were restricted to women who were free of cancer at 1 year intervention. The relative 

risk of developing cancer at the end of study for the vitamin D3 plus calcium group changed to 

0.23 (95 percent CI 0.09, 0.60; P= 0.005). The methodological quality of this study was rated B. 

Findings by life stage. 

• 0 – 6 mo No data 

• 7 mo – 2 y No data 

• 3 – 8 y No data 

• 9 – 18 y No data 

• 19 – 50 y No data 

• 51 – 70 y No data 

• ≥71 y No data 

259 
260 

• Postmenopause The WHI trial using vitamin D3 400 IU/d plus calcium carbonate 

1000 mg/d showed no effects, while the trial in Nebraska using vitamin D3 1000 IU/d 

plus calcium citrate or carbonate 1500 mg/d showed significant reduction of risk of total 

cancer. 

• Pregnant & lactating women No Data 

Table 89. Combined vitamin D and calcium and total cancer incidence: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake 

& Vitamin D 

Data 

Comparisons Compliance Comments 

• Health 

status 

Postmenopausal 

women 

• Mean age 

(range/SD), y 

nd (50-79) 

Wactawski-Wende 

200671

WHI 

US 

(various) 

[16481636] 

Ca intake 

(mg/d): 

<800, 34%; 

800-200, 26%; 

≥1200, 40% 

Median 

25(OH)D: 42 

nmol/L 

Vit D3 400 IU/d + 

Ca 1000 mg/d 

vs. 

Placebo 

See page 

242 

• Health 

status 

Mentally and 

physically fit; 

postmenopause 

• Mean age 

(range/SD), y 

67 (7.3) 

Lappe 

200752

Nebraska, US (41o 

N) 

[17556697] 

 

25(OH)D: 71.8 

nmol/L 

Vit D3 1000 IU/d + Ca 

(citrate 1400 mg/d or 

carbonate 1500 mg/d) 

vs. Ca (citrate 1400 

mg/d or carbonate 1500 

mg/d) vs. placebo 

nd 
Table 90. Combined vitamin D and calcium and total cancer incidence: Results of RCTs 

Author Year Study Name [PMID] 

Life Stage Outcome 1°/2° Followup, year n Event N Total Outcome Metric (Comparison) Result 

Interventions, Daily Dose 

Vit D3 400 IU + 

Ca carbonate 1000 mg 

1634 18176 Adjusted HR 

(Vit 

D+Ca)/placebo 

Wactawski-Wende 0.98 0.200671

WHI [16481636] 

Postmenopausal women 

Incident cancer (all causes) 2° 7 

Placebo 1655 18106 

Vit D3 400 IU + 

Ca carbonate 1000 mg 

344 18176 Adjusted HR 

(Vit 

D+Ca)/placebo 

0.89 0.

Postmenopausal women 

Total cancer mortality 2° 7 

Placebo 382 18106 

Vit D3 1000 IU + 

Ca (citrate 1400 mg or carbonate 1500 mg) 

0.40 

13 446 RR (Vit D+Ca)/placebo 

0.

Lappe 200752

[17556697] 

Postmenopausal women 

Incident cancer (all causes) 2° 4 

Placebo 20 288 

Vit D3 1000 IU + 

Ca (citrate 1400 mg or carbonate 1500 mg) 

0.23 

8 403 RR (Vit D+Ca)/placebo 

0.

Postmenopausal women 

Incident cancer (restrict to subjects who were free of cancer at 1 y intervention) 

2° 4 

Placebo 20 288 

261 
Colorectal cancer. 

Synopsis. 

 No qualified systematic reviews evaluated the association between combined vitamin D and 

calcium, body stores, or serum concentrations, and colorectal cancer mortality or incidence. One 

B quality RCT of postmenopausal women reported no significant association between 

supplemental vitamin D3 and calcium and, colorectal cancer mortality or incidence. 

Detailed presentation (Table 91 & 92). 

 The WHI compared daily supplemental vitamin D3 (400 IU) and elemental calcium (1000 

mg) with placebo in 36,282 postmenopausal women. Colorectal cancer was evaluated as a 

secondary endpoint.71 The primary endpoint was the prevention of hip fracture. At 7 years 

vitamin D3 and calcium supplementation had no significant effect on colorectal cancer mortality 

(P=0.39) or incidence (P=0.51). In a subgroup analysis, risks of colon cancer and rectal cancer 

were also not significantly different between the supplemented and unsupplemented groups 

(P=0.99 and P=0.11, respectively). This trial was rated B because it did not restrict the 

participants from taking calcium or vitamin D supplements; they had mean daily total calcium 

intake of 1151 mg and vitamin D intake of 367 IU at enrollment. 

Findings per special populations. 

 The WHI performed 18 subgroup analyses based on baseline participant characteristics 

including ethnic groups, body mass index, smoking status, and geographic regions according to 

solar irradiance.71 No significant interactions were found with these baseline characteristics. The 

same RCT with multifactorial design reported an interaction between estrogen alone or 

combined estrogen and progestin therapy, and combined vitamin D and calcium supplementation 

for colorectal cancer risk in a post hoc analysis.203 Among women concurrently assigned to 

hormone replacement therapies, colorectal cancer incidence was increased in the combined 

supplemental vitamin D and calcium arm compared to placebo (HR 1.50, 95 percent CI 0.96, 

2.33), whereas among those concurrently assigned to placebo in the estrogen trials, colorectal 

cancer risk was reduced in the vitamin D plus calcium arm compared to placebo (HR 0.71, 95 

percent CI 0.46, 1.09) (P for interaction = 0.02). 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y No data 

• 51 – 70 y One trial that included women mostly within this life stage (WHI) found 

no significant association between combined vitamin D3 (400 IU) and calcium carbonate 

(1000 mg) and colorectal cancer mortality or incidence. 

• 71+ The WHI included some people within this life stage, but no study 

adequately evaluated this life stage. 

262 
263 

• Postmenopause The WHI exclusively focused on postmenopausal women. The 

study found no association between vitamin D and calcium intake and colorectal cancer 

mortality or incidence. 

• Pregnant & lactating women Not reviewed 

Table 91. Combined vitamin D with calcium and colorectal cancer: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake 

& Vitamin D 

Data 

Comparisons Compliance Comments 

• Health 

status 

Postmenopausal 

women 

• Mean 

age 

(range), 

y 

nd (50-79) 

Wactawski-Wende 

200671

WHI 

US 

(various) 

[16481636] 

• Male 

(%) 

0 

Total Ca intake 

(mg/d) 

(Mean for both 

groups: 1151) 

 Ca + Vit D 

arm: 1148 

• <800: 34% 

• 800-<1200: 26% 

• ≥1200: 39% 

 Placebo arm: 

1154 

• <800: 33% 

• 800-<1200: 26% 

• ≥1200: 40% 

Total Vit D intake 

(IU/d) 

(Mean for both 

groups: 367) 

 Ca + Vit D 

arm: nd 

• <200: 38% 

• 200-<400: 19% 

• 400-<600: 23% 

• 600: 19% 

 Placebo arm: 

nd 

• <200: 37% 

• 200-<400: 19% 

• 400-<600: 24% 

• 600: 19% 

Ca 1000 mg/d 

+ Vit D3 400 

IU/d vs.

Placebo 

See page 

242 

The outcomes were based 

on self-reported 

questionnaires. Only 

colorectal cancers were 

verified centrally. 

Colorectal cancer 

screening was not 

mandated in the protocol.

Lost to followup: 

• Ca + Vit D arm: 0.8% 

• Placebo arm: 0.8% 

Withdrawn: 

• Ca + Vit D arm: 1.9% 

• Placebo arm: 1.8% 
Table 92. Combined vitamin D with calcium and colorectal cancer: Results of RCTs 

Author Year Study Name [PMID] 

Life Stage Outcome 1°/2° 

Mean 

Followup, 

y 

Interventions, 

Daily Dose 

n 

Event 

N 

Total 

Outcome Metric 

(Comparison) Result 

Vit D3 400 IU + Ca carbonate 1000 mg 

34 18,176 HR (Suppl/Placebo) 0.82 

Wactawski-Wende 200671 WHI 

[16481636] 

Postmenopausal women 

Colorectal cancer mortality 

2° 7 

Placebo 41 18,106 

Colorectal Vit D + Ca 168 18,176 HR 1.08 cancer 

2° Placebo 154 18,106 

Colon Vit D + Ca 128 18,176 HR 1.00 cancer 

2° Placebo 126 18,106 

Rectal Vit D + Ca 44 18,176 HR 1.46 cancer 

2° Placebo 30 18,106 

264 
Colorectal adenoma. Synopsis. 

 No qualified systematic reviews evaluated the association between combined vitamin D and 

calcium, body stores, or serum concentrations, and incidence of intestinal adenoma. One B 

quality RCT of postmenopausal women found no significant effect of combined vitamin D3 and 

calcium supplements on the incidence of colorectal adenoma. Another B quality post hoc 

subgroup analysis of a secondary prevention trial of adenomatous adenoma reported that calcium 

supplemented patients with higher baseline 25(OH)D concentrations had significantly lower risk 

of relapse compared to placebo (interaction P = 0.01 between subgroups). In contrast, no 

significant difference in relapse rates was found in calcium supplemented patients with lower 

baseline 25(OH)D concentrations compared to placebo. 

Detailed presentation (Table 91 & 92). 

 The WHI compared a daily supplement of vitamin D3 (400 IU) and elemental calcium (1000 

mg) with placebo and evaluated incidence of self-reported colorectal adenoma as part of multiple 

secondary analyses.71 At 7 years, the incidence of adenoma was not significantly different 

between the supplement and placebo groups (p=0.71). All the adenoma cases were based on selfreported data, not verified by medical record review or histopathology report. 

A post hoc subgroup analysis of the CPP trial of secondary adenoma prevention on the basis 

of calcium supplementation (1200 mg of elemental calcium) evaluated the risk of colorectal 

adenoma stratified by baseline 25(OH)D concentrations.204 The primary endpoint of the original 

trial was the risk of recurrent adenoma. After 4 years, in the subgroup with 25(OH)D 

concentrations greater than 72.6 nmol/L at baseline, subjects who received supplemental calcium 

had a significantly lower incidence of recurrent adenoma compared to placebo (HR=0.71 [95 

percent CI 0.57,0.89] versus HR=1.05 [95 percent CI 0.85, 1.29]; interaction P=0.01). In the 

subgroup with 25(OH)D concentrations lower than 72.6 nmol/L, the risk of recurrence was not 

significantly different between supplemental calcium and placebo. No subgroup data were 

available regarding sex, separate life stages, or other special populations (e.g., obese, smokers, 

ethnic groups, or users of contraceptives). 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y The CPP included some people within this life stage, but no study 

adequately evaluated this life stage. 

• 51 – 70 y The analysis of the CPP with a mean age of 61 years included participants 

mostly within this life stage. The study found a significant association between 

supplemental calcium and reduced risk of colorectal adenoma in a subgroup with 

25(OH)D concentrations higher than 72.6 nmol/L. 

• 71+ The CPP included some people within this life stage, but no study adequately 

evaluated this life stage. 

• Postmenopause The WHI found no association between combined vitamin D3 and 

calcium supplements and the incidence of colorectal adenoma. 

• Pregnant & lactating women Not reviewed 

265 
Breast cancer 

Synopsis 

 No qualified systematic reviews evaluated the association between vitamin D and calcium 

intake, body stores, or serum concentrations, and breast cancer. Breast cancer incidence and 

breast cancer related mortality after 7 years were evaluated in the Women’s Health Initiative 

(WHI) trial of combined daily vitamin D3 400 IU and calcium carbonate 1000 mg versus placebo 

in 50 to 79 year old women without a prior history of breast cancer.205 No statistically significant 

effect was found with combined vitamin D and calcium supplementation on incident breast 

cancer outcome. No significant associations were found for breast cancer related mortality. 

Detailed presentation (Tables 93 & 94) 

 In the WHI trial, the evaluated breast cancer incidence and breast cancer related mortality 

outcomes were secondary outcomes.205 There were no significant effects of combined vitamin D 

and calcium supplementation on both outcomes. The authors concluded that invasive breast 

cancer incidence was similar in the two groups of healthy postmenopausal women: calcium and 

vitamin D supplementation and placebo groups. The relationship of 25(OH)D serum 

concentrations and the risk of breast cancer was examined in a nested case-control design. The 

study found no relationship between total vitamin D intake and 25(OH)D serum concentrations 

with the risk of breast cancer. 

Findings per intake level 

 No conclusions are possible regarding a dose effect from this single study, especially since 

the women in the intervention and placebo groups were allowed to take additional concurrent 

calcium and vitamin D supplements. 

Findings by age and sex 

 The study investigated postmenopausal women 50 to 79 years old. 

Findings by life stage 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y No data available 

• 51 – 70 y The WHI trial that included women mostly within this life stage found no 

significant effect of combined vitamin D3 (400 IU) and calcium carbonate (1000 mg) on 

incident breast cancer and mortality from breast cancer after 7 years. 

• ≥71 y Inadequate available data. 

• Postmenopause All women in the WHI trial were postmenopausal. 

• Pregnant & lactating women Not reviewed 

266 
267 

Table 93. Combined vitamin D and calcium and breast cancer outcomes: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake & 

Vitamin D Data 

Comparisons Compliance Comments 

• Health 

status 

No 

breast 

cancer 

• Mean 

age 

(range), y 

50-79 

Chebowski 

2008205

WHI 

US 

(various) 

[19001601] 

• Male 

(%) 

0 

Baseline Ca 

supplementation: 

Vit D & Ca arm 

<800: 34.3% 

800-<1200: 26.5% 

≥1200: 39.3% 

Placebo arm 

<800: 33.8% 

800-<1200: 26.2% 

≥1200: 40.0% 

Baseline Vit D 

supplementation: 

Vit D & Ca arm 

Yes: 47.1% 

No: 52.9% 

Placebo arm 

Yes 47. 6% 

No 52.4%

Combined Vit D & 

Ca supplement 

vs. Placebo 

See page 

242 

Intervention and placebo 

groups were allowed to 

take additional 

concurrent calcium and 

vitamin D supplements. 
Table 94. Combined vitamin D and calcium and breast cancer outcomes: Results of RCTs 

Author Year Study Name [PMID] 

Life 

Stage 

Outcome 1°/2° Mean 

Followup, y 

Interventions, Daily 

Dose 

n 

Event 

N 

Total 

Outcome Metric 

(Comparison) 

Result 

Vit D3 400 IU + Ca 

carbonate 1000 mg 

668 18176 HR 

(Suppl/Placebo) 

Breast cancer incidence 2° 7 0.96 

Placebo 693 18106 

Vit D3 400 IU + Ca 

carbonate 1000 mg 

23 18176 HR 0.99 

Chebowski 2008205

WHI [19001601] 

50-79 y, 

Women 

Death from breast cancer 

2° 7 

Placebo 23 18106 

Vit D3 400 IU + Ca 

carbonate 1000 mg 

Invasive breast cancer 86 195 Adj OR 0.89 – subgroup >67.6 baseline 25(OH)D 

2° 7 

Placebo 76 185 

Invasive breast cancer Vit D3 + Ca 95 171 Adj OR 1.25 – subgroup 55.4-<67.6 baseline 25(OH)D 

2° 7 

Placebo 86 171 

Invasive breast cancer Vit D3 + Ca 102 176 Adj OR 1.07 – subgroup 43.9- <55.4 baseline 25(OH)D 

2° 7 

Placebo 92 195 

Invasive breast cancer Vit D3 + Ca 71 185 Adj OR 0.69 – subgroup 32.4-<43.9 baseline 25(OH)D 

2° 7 

Placebo 102 171 

Invasive breast cancer Vit D3 + Ca 94 171 Adj OR 0.91 – subgroup <32.4 baseline 25(OH)D 

2° 7 

Placebo 91 176 

268 
Combined Vitamin D and Calcium and Pregnancy-related Outcomes 

Preeclampsia. 

Synopsis. 

Based on data from a single RCT, there is no significant effect of combined vitamin D and 

calcium supplementation on the prevention of preeclampsia. 

Detailed presentation (Tables 95 & 96.) 

One RCT from India used a combination of vitamin D (1200 IU/d) and calcium (375 mg/d) 

for the prevention of preeclampsia.206 Table 85 describes the characteristics of the trial. The trial 

found no significant difference between the compared arms (Table 86). Note that this RCT was 

excluded from the meta-analysis of trials for preeclampsia in the calcium section. 

Findings by life stage. 

• 0 – 6 mo No data 

• 7 mo – 2 y Not applicable 

• 3 – 8 y Not applicable

• 9 – 18 y Not applicable 

• 19 – 50 y [see pregnant and lactating women]

• 51 – 70 y Not applicable

• 71+ Not applicable

• Postmenopause Not applicable

• Pregnant & lactating women Based on data from a single RCT, there is no 

significant effect of combined vitamin D (1200 IU/d) and calcium (375 mg/d) 

supplementation on the prevention of preeclampsia.

Other pregnancy-related outcomes. 

Synopsis. 

We did not identify any eligible studies on the relationship of vitamin D with or without 

calcium and high blood pressure, preterm birth, or small for gestational age infant. 

Table 95. Combined vitamin D and calcium and preeclampsia: Characteristics of RCTs 

Author Year 

Study Name Background Calcium Intake Location Population Comparisons Compliance & Vitamin D Data (Latitude) 

[PMID] 

Comments 

• Health 

status 

Marya 1987 Any 206 

India 

Ca: 500 mg/d in in diet; Combined Vit D (1200 

IU/d) & Ca (375 mg/d) 

supplement vs. no 

supplement 

nd 

Vit D: ~40 IU/d (unclear how it 

(29°N) • Age was quantified) 

range, y 

20-35 

[3623260] 

269 
Table 96. Combined vitamin D and calcium and preeclampsia: Results of RCTs 

Author Year Study Name Location (Latitude) [PMID] 

Life Stage Outcome 1°/2° 

Mean Followup, y 

n Event 

N Total 

Outcome Metric (Comparison) Result 95% 

Interventions, Daily Dose Vit D (1200 IU) & calcium (375 mg) 12 200 0.67 0.3

Marya 1987206

India (29°N) [3623260] 

Pregnancy Toxemia (preeclampsia) 1° 

RR (combined Vit D & Ca vs. nothing) 

ND 

No supplement 18 200 

270 
Combined Vitamin D and Calcium and Clinical Outcomes of Bone 

Health 

 Rickets, fractures, falls, or performance measures. 

 For bone health outcomes (e.g., bone mineral density, fracture, fall or muscle strength), we 

relied on a recent comprehensive systematic review performed by the Ottawa EPC (Table 34).

6

Because the Ottawa’s EPC report did not have separate analyses for the effect of vitamin D 

supplementation alone, the results for the effect of vitamin D alone or in combination with 

calcium supplementation are presented in this section. 

 The Ottawa EPC report was updated with literature published between January 2006 and 

April 2009, selected according to our eligibility criteria. Only RCTs qualified for inclusion. 

Synopsis. 

The Ottawa EPC report concluded that supplementation with vitamin D (most studies used 

D3) plus calcium is effective in reducing fractures in institutionalized populations, but there is 

inconsistent evidence that supplemental vitamin D reduces falls in postmenopausal women and 

older men. Our update search did not identify new RCT examining the combined effect of 

vitamin D plus calcium supplementation on rickets, fractures, or falls in postmenopausal women 

and older men. 

One study published after the Ottawa EPC report analyzed the performance measure 

outcomes in a small sample of postmenopausal women from WHI trial showed generally no 

differences in performance measures between vitamin D (400 IU/d) plus calcium (1000 mg/d) 

supplementation or placebo groups after 5 years of followup.207 One RCT of premenopausal 

women, aged 17 to 35 years old, showed that 800 IU/d of vitamin D in combination with 2000 

mg/d of calcium supplementation can reduce the risk of stress fracture from military training 

compared to placebo.208

Detailed presentation (Table 34, 97, 98 & 99). 

One RCT of female Navy recruits, aged 17 to 35 years, aimed to determine whether 

supplementation with vitamin D (800 IU/d) plus calcium (2000 mg/d) can reduce the risk of 

stress fractures from military training near the Great Lakes (41°N).208 The median dairy intake 

was <1 serving/day, which provided less than 300 mg of calcium. The combined 

supplementation significantly reduced the risk of stress fractures by 20 percent compared to 

placebo. The methodological quality of this study was rated B. 

One study analyzed the performance measure outcomes in a sample of 2928 postmenopausal 

women from the WHI trial who had objective physical function measures.207 The results showed 

that physical function, measured by grip strength, chair stands, and walking time, had generally 

declined in postmenopausal women who were assigned to either vitamin D (400 IU/d) plus 

calcium (1000 mg/d) supplementation or placebo group. However, women who had received 

vitamin D plus calcium supplementation showed less declines in walking time than those who 

had received placebo. The methodological quality of this study was rated C because only a small 

proportion of women from the WHI trial were in the analyses and their baseline characteristics 

were unclear. 

271 
From the Ottawa EPC Report: Fractures - Postmenopausal women and older men. 

Fifteen RCTs examined the effect of either vitamin D2 or D3 alone or in combination with 

calcium on total, nonvertebral and hip fractures in postmenopausal women or older men. Few 

trials evaluated vertebral fractures. Most trials used vitamin D3. There were no trials identified in 

premenopausal women. 

 Meta-analysis results from 13 RCTs of vitamin D2 or D3 with or without calcium showed a 

nonsignificant reduction in the risk of total fractures that persisted when only trials of higher 

quality were combined. Most trials used vitamin D3. When combining seven RCTs of vitamin D3 

(400-800 IU) plus calcium, there was a reduction in the risk of total and hip fractures. However, 

in a subgroup analysis (800 IU vitamin D3), this benefit was only evident in trials of 

institutionalized elderly subjects. One possible explanation for the discrepancy is that the mean 

serum 25(OH)D concentration achieved in trials of institutionalized participants was higher than 

in the trials on community dwellers. The combined estimate from trials with higher end-of-study 

serum 25(OH)D concentrations (>74 nmol/L) was consistent with a significant reduction in the 

risk of fractures. 

In Ottawa EPC report: Falls - Postmenopausal women and older men. 

Meta-analysis results from 12 RCTs demonstrated a small reduction in the risk of falls with 

supplemental vitamin D2 or D3 (oral or injectable) with or without calcium (OR 0.89, 95 percent 

CI 0.80, 0.99). The individual treatment effects ranged from OR 0.28 (95 percent CI 0.12, 0.67) 

to 1.16 (95 percent CI 0.70, 1.92). In the two cluster RCTs, one demonstrated a significant 

reduction in the risk of falls in postmenopausal women taking vitamin D3 plus calcium (RR 0.88, 

95 percent CI 0.79, 0.98), whereas the other trial did not show a significant reduction in the risk 

of falls in elderly individuals taking vitamin D2 (RR 1.09, 95 percent CI 0.95, 1.25). Metaanalysis of eight RCTs of oral vitamin D2/D3 supplementation with calcium showed a reduction 

in the risk of falls, whereas four RCTs of oral vitamin D3 alone did not. Subgroup analyses 

showed a significant reduction in the risk of falls when only trials of postmenopausal women 

were combined. Sensitivity analyses showed a significant reduction in the risk of falls when 

combining (1) RCTs that explicitly defined falls and the method of fall ascertainment and (2) 

those in which the allocation concealment was unclear. However, combining trials by degree of 

compliance and loss to followup did not. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y The Ottawa EPC report concluded that supplementation with vitamin D 

(most studies used D3) plus calcium is effective in reducing the risk of fractures in 

institutionalized populations, but there is inconsistent evidence that supplemental vitamin 

D reduces the risk of falls in postmenopausal women and older men. One RCT of female 

Navy recruit, aged 17 to 35 years old, showed that vitamin D (800 IU/d) in combination 

of calcium (2000 mg/d) supplementation can reduce the risk of stress fractures from 

military training compared to placebo. 

• 51 – 70 y No new data since the Ottawa report 

• 71+ No new data since the Ottawa report 

272 
273 

• Postmenopause One study analyzed the performance measure outcomes in a small 

sample of postmenopausal women from the WHI trial showed generally no differences in 

performance measures between vitamin D (400 IU/d) plus calcium (1000 mg/d) 

supplementation and placebo groups after 5 years of followup. 

• Pregnant & lactating women No data 

Table 97. Combined vitamin D and calcium and bone health: Characteristics of RCTs published 

after the Ottawa EPC report 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake 

& Vitamin D 

Data 

Comparisons Compliance Comments 

• Health 

status 

Assumed 

healthy 

(Navy 

recruits) 

• Mean 

age 

(range), y 

19 (17-35) 

Lappe 

2008208

Great Lakes, 

IL, US 

(41°N) 

[18433305] 

• Male 

(%) 

0 

Mean dairy 

servings/wk = 6 

(ranged 1-26) 

Vit D 800 IU/d + 

Ca 2000 mg/d 

vs. Placebo 

Monitor pill taking: project 

staff observed the galley 

food lines, visited recruits 

in their quarters, and 

conducted an exit 

interview. 

• Health 

status 

nd (for the 

sub sample 

from WHI 

trial) 

• Mean 

age 

(range), y 

50-79 

Brunner 

2008207

WHI 

US 

(various) 

[18755319] 

• Male 

(%) 

0 

nd Vit D 400 IU/d + 

Ca 1000 mg/d 

vs. Placebo 

nd (however, adherence 

was assessed at least 

annually from the weight 

of remaining pills along 

with a structured interview 

in WHI trial) 

A sub sample 

from WHI trial. 

Post hoc 

analyses of a 

RCT. 
Table 98. Combined vitamin D and calcium and bone health: Results of RCTs published after the Ottawa EPC repo

Author Year Study Name [PMID] 

Life 

Stage Outcome 1°/2° 

Mean 

Followup, 

mo 

Interventions, 

Daily Dose 

n 

Event 

N 

Total 

Outcome Metric 

(Comparison) Result 

Vit D 800 IU + Ca 200 mg 

139 2626 RR (Vit 

D+Ca)/placebo 

Lappe 0.8 02008208

[18433305] 

17-35 y 

women 

Stress fracture from Navy training (ITT) 1° 2 Placebo 170 2575 

Vit D 800 IU + Ca 200 mg 

126 1852 Adjusted OR (Vit 

D+Ca)/placebo 

Stress fracture from 0.79 0Navy training (per protocol) 1° 2 Placebo 160 1848 

Table 99. Combined vitamin D and calcium and bone health: Results of RCTs published after the Ottawa EPC repomeasures) Author Year Study Name PMID 

Life Stage Outcome 1°/2° 

Mean 

Followup, 

mo 

Interventions, 

Daily Dose 

No. 

Analyzed Unit Baseline Change Change SD Net Diff 

Vit D 400 IU + Ca carbonate 1000 mg 

1185 22.81 -2.49 5.81 0.15 

kg 

Brunner 2008207

[18755319] 

Postmenopause 

Grip strength 2° 60 

Placebo 1162 22.96 -2.64 5.69 

Vit D 400 IU + Ca carbonate 1000 mg 

1065 -0.38 1.81 0.04 

counts 6.52 

Chair stands 2° 60 

Placebo 1053 6.63 -0.43 1.81 

Vit D 400 IU + Ca carbonate 1000 mg 

1160 seconds +0.26 6.28 -

0.54 

Walking time 2° 60 

Placebo 1141 +0.81 6.43 

274 
Combined Vitamin D and Calcium and all-cause Mortality 

Synopsis. 

This synopsis is based on a meta-analysis of RCTs of combined vitamin D and 

calcium supplementation evaluating mortality. Numerical data were extracted from 

previous systematic reviews. Most trials used daily regimens; in these trials, vitamin D 

doses ranged between 300 and 880 IU per day. Most trials combined vitamin D and 

calcium supplementation; when used, calcium doses ranged between 500 and 1200 mg 

per day. 

Our meta-analysis of 11 RCTs (44,688 participants) suggests no significant 

relationship between combined supplementation of vitamin D and calcium all-cause 

mortality (RR=0.93, 95 percent CI 0.86, 1.01; random effects model). There is little 

evidence for between-study heterogeneity in these analyses. Among 8 RCTs on 44,281 

postmenopausal women, the summary random effects RR was 0.93 (95 percent CI 0.86, 

1.00), again with little evidence for between-study heterogeneity. 

Although the meta-analyses suggest decreased risk for all-cause mortality with 

combined vitamin D and calcium supplementation, the relationship is not statistically 

significant in the performed analyses. 

Detailed presentation (Table 37; Figure 22). 

As mentioned in the Methods section, we updated and reanalyzed published metaanalyses of mortality outcomes. We drew our own conclusions based on our analyses. 

We also comment on the concordance of our conclusions with those of the published 

meta-analyses. 

Relevant published systematic reviews of RCTs (with meta-analyses). 

As described in the vitamin D and all-cause mortality section, we identified two 

potentially eligible systematic reviews,83,84 and selected one as the basis for our 

reanalysis (Autier 2007).83 Table 37 in the “Vitamin D” section summarizes the findings 

of the Autier 2007 systematic review. 

As detailed below, we identified one additional trial of combined vitamin D and 

calcium supplementation reporting all-cause mortality.209 

Eligible studies published after the systematic reviews. 

The literature searches in Autier 2007 extended up to November 2006. We identified 

two additional RCT reports published after November 2006.71,209 One publication71

reported on the same trial as another publication210 in the Autier 2007 meta-analysis, and 

was therefore excluded from our reanalysis. The other RCT (Bjorkman 2008209) was 

included in our meta-analysis. 

One three-arm RCT (Bjorkman 2008209, n=218) compared no supplementation versus 

daily supplementation with 400 IU and 1200 IU of vitamin D3 and 500 mg of calcium. 

Mortality was assessed at 6 months. It included people older than 65 years, with 

chronically impaired mobility and stable general condition. The Bjorkman 2008 RCT was 

assigned grade “A” for overall reporting quality. 

275 
276 

Reanalysis. 

We excluded 5 of 18 trials in the Autier 2007 meta-analysis: One trial was on patients 

with congestive heart failure,85 one was published only in abstract form,86 and in the last 

trial the controls also received supplementation with vitamin D, albeit with a smaller 

dose,87 and two used injections of vitamin D.88,89 Altogether, 11 RCTs were included in 

the reanalysis of combined vitamin D and calcium supplementation and all-cause 

mortality (i.e., 10 out of 18 in the Autier 2007 meta-analysis, and a subsequently 

published one209). 

Among the 12 trials, sample sizes ranged from 55 to 36,282 participants, with 7 

studies including more than 500 participants. Followup periods ranged from 6 to 84 

months (median 24 months). Vitamin D doses in most trials ranged between 300 and 880 

IU per day. One trial used 100,000 IU orally every 4 months. Calcium supplementation 

doses ranged between 500 to 1200 mg per day. 

Overall, a meta-analysis of the 11 RCTs (44,688 participants; Figure 22) found no 

statistically significant relationship between vitamin D and all-cause mortality (RR=0.93, 

95 percent CI 0.86, 1.01). There is little evidence for between-study heterogeneity in 

these analyses (P=0.58, I

2

=0 percent). Among 8 RCTs on 44,281 postmenopausal 

women, the summary random effects RR was 0.93 (95 percent CI 0.86, 1.00), again with 

little evidence for between-study heterogeneity (P=0.46, I

2

=0 percent). There are no 

RCTs with mean participant age below 50 years. It is unclear whether these findings are 

directly applicable to other life stages. In addition, in a subgroup analysis among 8 RCTs 

(n=8109) where the mean participant age was above 70 years, the summary random 

effects RR=0.98 (95 percent CI 0.84, 1.15), with little evidence for between study 

heterogeneity (P=0.33, I

2

=13 percent). 

Findings by life stage. 

• 0 – 6 mo No data 

• 7 mo – 2 y No data 

• 3 – 8 y No data 

• 9 – 18 y No data 

• 19 – 50 y No data 

• 51 – 70 y Our meta-analysis of 12 RCTs (44,838 participants) suggests no 

significant relationship between combined supplementation of vitamin D and 

calcium all-cause mortality (RR=0.94, 95 percent CI 0.87, 1.01; random effects 

model). There is little evidence for between-study heterogeneity in these analyses. 

• 71+ The above are likely applicable here. In addition, in a subgroup 

analysis among 8 RCTs (n=8109) where the mean participant age was above 70 

years, the summary random effects RR=0.98 (95 percent CI 0.84, 1.15), with little 

evidence for between study heterogeneity. 

• Postmenopause Among 8 RCTs on 44,281 postmenopausal women, the 

summary random effects RR was 0.93 (95 percent CI 0.86, 1.00), again with little 

evidence for between-study heterogeneity. 

• Pregnant & lactating women No data 
Figure 22. Forest plot of trials of combined vitamin D and calcium supplementation and 

effects on all-cause mortality. 

277 
Combined Vitamin D and Calcium and Hypertension and Blood 

Pressure. 

 We reviewed systematic reviews and primary studies that evaluated associations between 

combined vitamin D and calcium intake and incidence of hypertension or change in blood 

pressure. For the outcome incidence of hypertension, we included RCTs and other longitudinal 

studies. For the outcome change in blood pressure, we included only RCTs. We included only 

studies of adults. Studies of pregnancy-related hypertension and blood pressure control are 

included in the “Pregnancy-related outcomes” section. 

Combined vitamin D and calcium and hypertension. 

Synopsis. 

 No qualified systematic reviews evaluated the association between combined vitamin D and 

calcium intake, body stores, or serum concentrations and incidence of hypertension. The WHI 

trial reported an analysis of the risk of developing hypertension among the subset of women 

without hypertension at baseline. Over 7 years, combined vitamin D and calcium 

supplementation had no effect on the risk of hypertension. 

Detailed presentation (Tables 100 & 101). 

 The WHI trial of a combined vitamin D3 400 IU and calcium carbonate 1000 mg supplement 

daily versus placebo had methodological quality B for the blood pressure outcome. The 36,282 

women were postmenopausal (age 50-79 y) with a background calcium intake on average of 

about 1150 mg/day (from diet and supplements).211 The women were allowed to take additional 

concurrent calcium and vitamin D supplements. The analysis of incident hypertension was 

reported briefly in a larger analysis of the blood pressure outcome (see Combined vitamin D and 

calcium and blood pressure, below). Among 17,122 initially nonhypertensive women, 39 

percent either were prescribed medication for hypertension or developed blood pressure above 

140/90 mm Hg. The adjusted HR of developing hypertension over 7 years was 1.01 (95 percent 

CI 0.96, 1.06). Among 377 women with available data, there was a statistically significant trend 

across subgroups based on serum 25(OH)D concentration such that combined vitamin D and 

calcium supplementation increased the risk of developing hypertension more in those women 

with progressively lower baseline 25(OH)D (P<0.01 for trend). Other subgroup analyses based 

on age, race or ethnicity, weight, or baseline total calcium intake did not find any interactions 

with the effect of the supplement intervention. 

Findings per intake level. 

 This single trial did not analyze different actual intake levels. 

Findings by age and sex. 

 This trial found no difference in (lack of) effect by age among postmenopausal women. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y No data. 

278 
279 

• 51 – 70 y One large trial that included women mostly within this life stage found no 

significant effect of combined vitamin D and calcium supplementation. 

• ≥71 y The WHI trial included some women within the life stage, but no study 

adequately evaluated this life stage. 

• Postmenopause All women in the WHI trial were postmenopausal. See 51-71 y life 

stage. 

• Pregnant & lactating women Not reviewed 

Table 100. Combined vitamin D and calcium and incident hypertension: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake & 

Vitamin D Data 

Comparisons Compliance Comments 

• Health 

status 

No 

HTN 

• Mean 

age 

(range), y 

62 

(50-79) 

Margolis 

2008211

WHI 

US 

(various) 

[18824662] • Male 

(%) 

0 

Ca: 1148 (654) mg/d 

in treatment group; 

1154 (658) in 

placebo group 

52% used Ca 

supplements 

40% had intake 

≥1200 mg/d 

(based on all 

subjects, including 

those with 

hypertension) 

Combined Vit D + 

Ca supplement vs. 

Placebo 

See page 

242 

Mean dose of open label 

supplemental Ca increased 

by <100 mg/d from 325 

mg/d at enrollment; similar 

in both groups 

(based on all subjects, 

including those with 

hypertension) 
Table 101. Combined vitamin D and calcium and incident hypertension: Results of RCTs 

Author Year Study Name [PMID] 

Life Stage 

[Subgp] Outcome 1°/2° Mean Followup, y Interventions, Daily Dose n Event N Total Outcome Metric (Comparison) Result 

Vit D3 400 IU + Ca 

carbonate 1000 mg 3377 ~8578 HR (Suppl/Placebo) 1.01 0

Margolis 2008211

WHI [18824662] 

50-79 y, Women HTN 2° 7 Placebo 3315 ~8544 

[25(OH)D Vit D + Ca 53 1.52 0<34.4 nmol/L] Placebo 38 [25(OH)D Vit D + Ca 39 1.48 034.4-47.6 nmol/L] Placebo 48 [25(OH)D Vit D + Ca 45 1.15 047.7-64.6 nmol/L] Placebo 45 [25(OH)D Vit D + Ca 48 0.79 0≥64.7 nmol/L] Placebo 61 

280 
Combined vitamin D and calcium and blood pressure. 

Synopsis. 

 No qualified systematic reviews evaluated the association between vitamin D and calcium 

intake, body stores, or serum concentrations, and changes in blood pressure. Two RCTs 

compared combined vitamin D and calcium supplementation with placebo. Both the small trial 

of a combined vitamin D3 400 IU and calcium carbonate 1200 mg supplement daily and the WHI 

trial found no significant effect of supplementation on blood pressure after 15 weeks or 6.1 

years, respectively. The WHI trial analyzed blood pressure changes in a variety of subgroups, 

including by age, ethnicity, baseline total calcium intake, and baseline diagnosis of hypertension, 

but found no significant differences in effect across any subgroup. 

Detailed presentation (Tables 102 & 103). 

 The WHI trial of a combined vitamin D3 400 IU and calcium carbonate 1000 mg supplement 

daily versus placebo had methodological quality B for the blood pressure outcome. The 36,282 

women were postmenopausal (age 50-79 y) with a background calcium intake on average of 

about 1150 mg/day (from diet and supplements).211 On average, the women had normal blood 

pressure and were allowed to take additional concurrent calcium and vitamin D supplements. At 

74 months, the women’s mean systolic blood pressure had risen and diastolic blood pressure had 

fallen in both trial arms (by less than about 2 mm Hg each at 2 years199). The absolute changes 

were not significantly different in the women assigned to the supplement than placebo (net 

difference 0.2 mm Hg systolic and 0.1 mm Hg diastolic). In subgroup analyses there was no 

differences in results by age, ethnicity, baseline total calcium intake, baseline diagnosis of 

hypertension, or a variety of other factors. 

 The C quality trial of combined vitamin D and calcium, performed in Quebec City, recruited 

premenopausal women (mean age 43 y) with low calcium intake (800 mg calcium per day) who 

did not have severe hypertension (blood pressure over 160/95 mm Hg).202 The mean baseline 

calcium intake was 704 mg/day. On average, the 63 women had normal blood pressure. They 

were given either combined vitamin D3 400 IU and calcium carbonate 1200 mg daily or placebo. 

All women were on an energy restriction diet with a 700 kcal/day deficit. At 15 weeks, systolic 

and diastolic blood pressures were reduced in both study groups; systolic blood pressure was 

reduced by 2.5 mm Hg more in women on vitamin D and calcium than placebo, but this 

difference was not statistically significant. Diastolic blood pressure was reduced by the same 

amount in both groups. No subgroup analyses were reported. The study was limited by a 25 

percent dropout rate due to lack of compliance with the diet and exercise portion of the trial, 

without performing an intention to treat analysis, an adequate description of the study methods, 

or a complete statistical analysis. 

Findings per intake level. 

 Both trials used similar doses, vitamin D3 400 IU and calcium carbonate 1000 or 1200 mg 

daily. The background calcium intake was lower in the study of premenopausal women (800 

mg/day) than the WHI trial (1150 mg/day). The WHI trial found no significant difference in 

(lack of) effect in subgroups with different baseline total calcium intake. 

281 
Findings by age and sex. 

 Both the one small, short term, C quality trial of premenopausal women and the 6 year WHI 

trial of postmenopausal women found no effect. The WHI trial also found no difference in effect 

in subgroups of women based on age. No trials of men were found. 

Findings by life stage. 

• 0 – 6 mo Not reviewed 

• 7 mo – 2 y Not reviewed 

• 3 – 8 y Not reviewed 

• 9 – 18 y Not reviewed 

• 19 – 50 y One small trial that included women mostly within this life stage found no 

significant effect of combined vitamin D and calcium supplementation. 

• 51 – 70 y One large trial that included women mostly within this life stage found no 

significant effect of combined vitamin D and calcium supplementation. 

• ≥71 y The WHI trial included some women within the life stage, but no study 

adequately evaluated this life stage. 

• Postmenopause All women in the WHI trial were postmenopausal. See 51-71 y life 

stage. 

• Pregnant & lactating women Not reviewed 

282 
283 

Table 102. Combined vitamin D and calcium and blood pressure: Characteristics of RCTs 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium Intake & 

Vitamin D Data 

Comparisons Compliance Comments 

• Health 

status 

Any 

• Mean 

age 

(range), y 

62 (50-79) 

Margolis 

2008211

WHI 

US 

(various) 

[18824662] • Male 

(%) 

0

Ca: 1148 (654) 

mg/d in treatment 

group; 1154 (658) 

in placebo group 

52% used Ca 

supplements 

40% had intake 

≥1200 mg/d 

Combined Vit D + 

Ca supplement 

vs. Placebo 

See page 

242 

Mean dose of open label 

supplemental Ca 

increased by <100 mg/d 

from 325 mg/d at 

enrollment; similar in 

both groups 

• Health 

status 

Healthy, 

Overweight, 

low Ca intake 

• Mean 

age (SD), 

y 

43 (5.5) 

Major 2007202

Quebec City, 

Canada 

(47°N) 

[17209177] 

• Male 

(%) 

0 

Ca: ~704 mg/d; all 

<800 mg/d 

Combined Vit D + 

Ca supplement 

vs. Placebo 

nd 
Table 103. Combined vitamin D and calcium and blood pressure: Results of RCTs 

Author Year Study Name [PMID] 

Age 

Range, 

Sex 

Outcome 1°/2° Mean Followup Interventions, Daily Dose No. Analyzed Unit Baseline Change Change 95% CI Net Diff 

SYSTOLIC BLOOD PRESSURE

Vit D3 400 IU + 

Ca carbonate 1000 mg 

mm 

Hg 127A +1.1%A 18,176 0.9, 1.3 +0.22 

Margolis 2008211 WHI 

[18824662] 

50-79, 

Women SBP 2° 6.1 y 

18,106 128A +0.7%A 0.5, 0.9 

Placebo 

Vit D3 400 IU + 

Ca carbonate 1200 mg (energy restriction diet) 

mm 

Hg Major 30 112.4 -4.1 -6.5, -1.7 -2.5 

2007202

Quebec City [17209177] 

43 (5.5), 

Women SBP 2° 15 wk 

Placebo (energy restriction diet) 

33 109.5 -1.6 -4.2, 1.0 

DIASTOLIC BLOOD PRESSURE

Vit D3 400 IU + 

Ca carbonate 1000 mg 

-0.4, -

0.02 

mm 

Hg 76A -0.2%A 18,176 +0.11 

Margolis 2008211 WHI 

[18824662] 

50-79, 

Women DBP 2° 6.1 y 

18,106 76A -0.6%A -0.8, -0.4 

Placebo 

Vit D3 400 IU + 

Ca carbonate 1200 mg (energy restriction diet) 

mm 

Hg Major 30 74.9 -3.0 -4.8, -1.2 0 

2007202

Quebec City [17209177] 

43 (5.5), 

Women DBP 2° 15 wk 

Placebo (energy restriction diet) 

33 75.2 -3.0 -5.0, -1.0 

A Hsia 2007199 [17309935]

284 
Combined Vitamin D and Calcium and Bone Mineral Density or Bone 

Mineral Content. 

 For bone health outcomes (e.g., bone mineral density, fracture, fall or muscle strength), we 

relied on a recent comprehensive systematic review performed by the Ottawa EPC (Table 34).

6

Because the Ottawa’s EPC report did not have separate analyses on the effect of vitamin D 

supplementation alone, the results for the effect of vitamin D alone or in combination with 

calcium supplementation were presented in this section. 

 The Ottawa EPC report was updated with literature published between January 2006 and 

April 2009, selected according to our eligibility criteria. For adults, we included only BMD 

indices. For children, we included only BMC indices. Only RCTs with duration more than 1 year 

qualified for inclusion. 

Synopsis 

One RCT found that, compared to placebo, there was no significant effect of 

supplementation with vitamin D3 (200 IU/d) plus calcium (1000 mg/d) on BMC changes in 

healthy girls, between 10 and 12 years. 

Overall, findings from the Ottawa EPC report showed that vitamin D3 (≤ 800 IU/d) plus 

calcium (~500 mg/d) supplementation resulted in small increases in BMD of the spine, total 

body, femoral neck and total hip in predominantly populations of late menopausal women.6 Two 

of the three new RCTs showed consistent findings in postmenopausal women, comparing 

vitamin D3 or D2 (300 or 1000 IU/d, respectively) plus calcium (1200 mg/d) to placebo. 

Detailed presentation (Table 34, 104 & 105). 

One RCT compared the effect of vitamin D3 (200 IU/d) plus calcium (1000 mg/d) 

supplementation to placebo on bone indices in healthy girls, aged 10 and 12 years.212 The mean 

background dietary calcium intake was 670 mg/d. The intention-to-treat analyses showed that 

after 2 years of supplementation, there was no significant difference in the BMC changes 

between girls who received vitamin D plus calcium supplement or placebo. The methodological 

quality of this study was rated C, due to underpower and low compliance rate. 

Three RCTs (two were rated B and one was rated C) examined the effect of vitamin D plus 

calcium supplementation on BMD changes. All three trials were conducted in postmenopausal 

women. However, the doses of vitamin D and calcium combinations varied. One RCT used daily 

dose of 400 IU vitamin D3 plus 100 mg elemental calcium for 2 years 213 The second RCT used 

daily dose of 1000 IU vitamin D2 plus 1200 mg calcium citrate for 5 years.214 The third RCT 

used a daily dose of vitamin D3 300 IU plus calcium citrate 1200 mg from calcium supplemented 

low-fat dairy products for 1 year.215 The latter two RCTs resulted in a significant increase in hip 

or total BMD comparing vitamin D plus calcium supplementation to placebo.214,215 The one RCT 

that did not show significant change in femoral neck BMD comparing vitamin D plus calcium 

supplementation to placebo used a substantially lower dose of calcium (100 mg/d) than the other 

two RCTs. 

In Ottawa EPC report - Bone Mineral Density and women of reproductive age, postmenopausal 

women, and older men. 

Overall, there is good evidence that vitamin D3 plus calcium supplementation resulted in 

small increases in BMD of the spine, total body, femoral neck and total hip. Based on included 

285 
trials, it was less certain whether vitamin D3 supplementation alone has a significant effect on 

BMD. 

Seventeen RCTs evaluated the effect of supplemental vitamin D2 or D3 on BMD, 

predominantly in populations of late menopausal women. Only one small RCT included 

premenopausal women, and two trials included older men (> 60 years). Most trials were two to 

three years in duration and used vitamin D doses of ≤ 800 IU daily. Most trials used vitamin D3 

and also included calcium 500 mg as a cointervention. 

Meta-analysis results of 17 RCTs of vitamin D3 plus calcium versus placebo were consistent 

with a small effect on lumbar spine, femoral neck, and total body BMD. The WHI trial found a 

significant benefit of 400 IU vitamin D3 plus 1000 mg calcium supplementation on total hip 

BMD. However, when the effect of vitamin D3 plus calcium versus calcium alone 

supplementation is assessed, no significant increase in BMD was observed with either 

intervention, suggesting vitamin D3 may be of less benefit in calcium replete postmenopausal 

women. Vitamin D3 alone versus placebo did not result in a significant increase in BMD in 

postmenopausal women, except in one trial that noted an increase in femoral neck BMD. Only a 

few trials reported the impact of baseline serum 25(OH)D concentrations on BMD and in all of 

these trials, baseline 25(OH)D concentration was not associated with increased BMD. 

Findings by life stage. 

• 0 – 6 mo No data 

• 7 mo – 2 y No data 

• 3 – 8 y No data 

• 9 – 18 y One RCT showed that, compared to placebo, there was no significant 

effect of vitamin D3 (200 IU/d) plus calcium (1000 mg/d) on BMC changes in healthy 

girls, aged between 10 and 12 years old. 

• 19 – 50 y No data 

• 51 – 70 y No new data since the Ottawa EPC report 

• ≥71 y No new data since the Ottawa EPC report 

• Postmenopause Findings from the Ottawa EPC report showed that vitamin D3 (≤

800 IU/d) plus calcium (~500 mg/d) supplementation resulted in small increases in BMD 

of the spine, total body, femoral neck, and total hip in predominantly populations of late 

menopausal women. Two of the three new RCTs showed a significant increase in hip or 

total BMD in postmenopausal women, comparing D3 or D2 (300 or 1000 IU/d, 

respectively) plus calcium (1200 mg/d) to placebo. 

• Pregnant & lactating women No new data since the Ottawa EPC report 

286 
287 

Table 104. Combined vitamin D and calcium and bone mineral density/content: Characteristics of 

RCTs published after the Ottawa EPC report 

Author Year 

Study Name 

Location 

(Latitude) 

[PMID] 

Population 

Background 

Calcium 

Intake & 

Vitamin D 

Data 

Comparisons Compliance Comments 

• Health 

status 

Healthy 

• Mean 

age 

(range), 

y 

11.2 (10-12) 

Cheng 

2005212

Jyvaskyla, 

Finland 

(62°24'N) 

[16280447] 

• Male 

(%) 

0 

Diet Vit D: 

100 IU/d 

Ca: 670 

mg/d 

Vit D3 200 

IU/d + Ca 

carbonate 

1000 mg/d vs. 

placebo 

65% 

completed 

intervention 

with >50% 

compliance 

• Health 

status 

Healthy (assumed 

postmenopausal) 

• Mean 

age 

(range), 

y 

68 (≥60) 

Bolton-Smith 

2007213

(UK 54oN) 

[17243866] 

• Male 

(%) 

0

25(OH)D: 

59.4 nmol/L 

Ca: 1548 

mg/d 

Vit D3 400 

IU/d + 

Elemental Ca 

100 mg/d vs. 

placebo 

Good 

supplement 

adherence 

based on pill 

count 

(median, 99; 

IQE 97.3-

99.8%). 

Noncompliant 

women were 

excluded. 

• Health 

status 

nd (assumed postmenopausal) 

• Mean 

age 

(SD), y 

74.8 (2.6) 

Zhu 2008214

CIFOS 

Western 

Australia 

[18089701] 

• Male 

(%) 

0 

25(OH)D: 

68.0 nmol/L 

Ca: 1010 

mg/d 

Vit D2 1000 

IU/d + Ca 

citrate 1200 

mg/d vs. 

placebo 

No 

differences 

in 

adherence 

among 

groups (81-

89% by 

tablet 

counting) 

• Health 

status 

Postmenopausal 

• Mean 

age 

(range), 

y 

61 (55-65) 

Moschonis 

2006215

Greece 

(31oN) 

[17181890] 

• Male 

(%) 

0 

Diet Vit D: 

23.6 IU/d 

Ca 680 mg/d 

Vit D3 300 

IU/d + Ca 

1200 mg/d 

(from low fat 

dairy 

products) vs. 

control (usual 

diet) 

Dairy group 

93% 

(assessed 

via 

information 

obtained at 

the biweekly 

sessions 

Control group 

had no 

intervention ( 

or usual diet ) 

so 

compliance 

issue not 

applicable 
Table 105. Combined vitamin D and calcium and bone mineral density/content: Results of RCTs published after th

Author Year Study Name PMID 

Life Stage Outcome 1°/2° 

Mean 

Followup, 

mo 

Interventions, 

Daily Dose 

No. 

Analyzed Unit Baseline Change Change 95% CI 

Vit D 200 IU + Ca carbonate 1000 mg 

46 kg 1.3 34.7% 34.3%, 35.1% 

Cheng 2005212

[16280447] 

10-12 y girls BMC 1° 24 

39 1.3 35.0% 34.6%, 35.4% 

Placebo 

Vit D3 400 IU 

+ Elemental Ca 100 mg 

mg/cm2 50 nd +1.9 -6.5, 10.3 

Bolton-Smith 2007213

[17243866] 

Postmenopausal women 

Femoral neck BMD 

nd 24 

56 nd +0.7 -10.2, 11.6 

Placebo 

Vit D2 1000 IU 

+ Ca citrate 1200 mg 

39/33B mg/cm2 783 nd 

Zhu 2008214

Australia CIFOS [18089701] 

Postmenopausal women Hip BMD 1° 60 

41/36B 828 nd 

Placebo 

Vit D3 300 IU 

+ Ca 1200 mg (from low fat dairy products) 

mg/cm2 39 1.13 1.5% 0.9%, 2.2% 

Moschonis 2006215

[17181890] 

Postmenopausal women 

Total body BMD 

1° 12 

Control (usual diet) 36 1.12 -0.7% -1.4%, -0.1% 

A Estimated from reported data. B Baseline/follow-up number of subjects analyzed 

288 
How does dietary intake of vitamin D from fortified foods 

and vitamin D supplementation affect serum 25(OH)D 

concentrations (arrow 4)? 

 The evidence for this question comes from studies identified in our literature search 

that crossed vitamin D terms with various outcomes terms. Studies that addressed this 

question but do not report any of the outcomes of interest would not have been identified 

in this manner. Because the availability of serum 25(OH)D concentration is unlikely to be 

adequately indexed in the Medline citation, it would be difficult to comprehensively 

search the literature for this question. To do so would require retrieving all vitamin D 

supplements full text articles (in excess of 10,000) to look for serum 25(OH)D 

concentration data. Given that there is no plausible reason for a systematic bias of studies 

of a specific outcome choosing to report serum 25(OH)D concentration, we believe that 

the evidence found, while not comprehensive, is a small but representative random 

sample. Only RCTs were included for this question. RCTs of different regimens but with 

the same dose of vitamin D supplementation were excluded (e.g., comparison of daily, 

weekly versus monthly dose). 

 This question was also addressed in the Ottawa EPC report.6

 When appropriate, we 

extracted relevant data from the Ottawa EPC report to be incorporated into our analyses. 

RCTs on Dietary Intakes of Vitamin D From Fortified Foods and 

Serum 25(OH)D Concentrations. 

Synopsis. 

 Our updated search did not identify new RCT evaluating the effect of food 

fortification on serum 25(OH)D concentrations since the Ottawa EPC report.6 The 

Ottawa EPC report concluded that there is “good” evidence that dietary intake of vitamin 

D increases serum 25(OH)D concentrations among adults. 

Detailed presentation. 

Ottawa EPC report –Adults. 

 There were eleven RCTs (n=1281) of which seven (n=668) permitted a quantitative 

analysis. Ten of eleven trials found a significant effect of dietary intake from foods 

fortified with vitamin D on serum 25(OH)D concentrations. There was significant 

heterogeneity of the treatment effect. Potential sources of heterogeneity are the different 

25(OH)D assays used (two studies each used HPLC, RIA or CPBA, and one study did 

not report the assay), the dietary vehicles used, and study populations. The increase in 

serum vitamin D concentration in the seven trials ranged from 15 (95 percent CI 11, 18) 

to 40 (95 percent CI 25, 55) nmol/L (fortification consisting of 100 - 1000 IU of vitamin 

D). 

 There can be a potential confounding of the data by the food source, the assay used to 

measure 25(OH)D and potential differences in the bioavailability and/or metabolism of 

vitamin D2 versus vitamin D3. Most studies in this review used dairy products as the 

289 
source of fortified food. It is important to note that there is potential for study 

contamination through altered intake of other nutrients such as calcium, phosphate and 

acid load that can affect the study outcomes. 

RCTs on Vitamin D Supplementation and Serum 25(OH)D 

Concentrations. 

Synopsis. 

 Because the availability of serum 25(OH)D concentration is unlikely to be adequately 

indexed in the Medline citation, it would be difficult to comprehensively search the 

literature for this question. We believe that studies summarized here is a small but 

representative random sample of all available data. 

 We plot the net changes in serum 25(OH)D concentration against the doses of 

vitamin D supplementation using data from 26 RCTs with 28 comparisons in adults. Only 

RCTs of daily vitamin D3 supplementation (doses ranged from 200 to 5000 IU/d) alone 

or in combination with calcium supplementation (doses ranged from 500 to 1550 mg/d) 

that provided sufficient data for the calculations were included in the plot. It is important 

to note that the studies had varied compliance rates in the vitamin D intake; limited or no 

adjustment for skin pigmentations, calcium intake, or background sun exposure; different 

vitamin D assay methodologies and measurement (both intra- and interassay) variability. 

All these factors increase the heterogeneity and limit the usefulness of an overall 

summary estimate for an intake dose response in serum 25(OH)D concentration. 

Nonetheless, the relationship between increasing doses of vitamin D3 with increasing net 

change in 25(OH)D concentration was evident in both adults and children (Figure 23). It 

was also apparent that the dose-response relationships differ depending on study 

participants’ serum 25(OH)D status (≤40 vs. >40 nmol/L) at baseline (Figure 24), and 

depending on duration of supplementation (≤3 vs. >3 months) (Figure 25). 

 Vitamin D2 supplementation was more commonly used in RCTs of infants and 

pregnant or lactating women, than vitamin D3 supplementation. Results showed that 

supplementation of vitamin D2 significantly increased 25(OH)D concentrations in infants, 

lactating mothers and in cord blood. 

Detailed presentation (Table 106; Figures 23, 24 & 25). 

 The results from 26 RCTs with 28 comparisons in adults and two RCTs with three 

comparisons in children evaluating the effect of vitamin D3 supplementation alone or in 

combination with calcium supplementation on serum 25(OH)D concentrations were 

shown in Table 106. Most of the data were extracted directly from the Ottawa EPC 

report. In adults, the doses of vitamin D3 ranged from 200 to 5000 IU/d, and the doses of 

calcium supplementation ranged from 500 to 1550 mg/d across the 25 comparisons. In 

children, the doses of vitamin D3 ranged from 200 to 2000 IU/d across the three 

comparisons. Duration of supplementation ranged from 0.5 to 60 months. Study 

populations and baseline vitamin D concentrations varied across these comparisons. 

Ottawa EPC report – Infants. 

 Seven RCTs included infants and few trials used vitamin D3 supplementation. One 

RCT concluded that 200 IU of vitamin D2 may not be enough to prevent vitamin D 

deficiency in those infants residing at northern latitudes. A dose-response relationship 

290 
was noted in this trial (100, 200, 400 IU/day). Consistent responses to vitamin D 

supplementation were noted across the seven trials, and some trials suggested that infants 

who are vitamin D deficient may respond differently and require higher doses of vitamin 

D to achieve serum 25(OH)D concentrations within the normal range. 

Ottawa EPC report - Pregnant or lactating women. 

 There were six small RCTs of vitamin D supplementation in pregnant or lactating 

women. No randomized trials studied the effect of 400 IU vitamin D3/d. Three trials used 

1000 IU vitamin D2/d and one trial used 1000 IU/d of vitamin D3. Supplementation of 

vitamin D2 1000-3600 IU/d and vitamin D3 1000 IU/d resulted in significant increases in 

serum 25(OH)D concentrations in lactating mothers and in cord blood. One trial found 

that supplementation of lactating mothers with 1000 IU vitamin D2/d during winter 

months did not significantly increase serum 25(OH)D concentrations in the infants. 

Ottawa EPC report - Children and adolescents. 

There were four trials that examined the effect of vitamin D on serum 25(OH)D 

concentrations in children or adolescents with doses ranging from 200 to 2000 IU of 

vitamin D3 per day and 400 IU of vitamin D2. There were consistent increases in serum 

25(OH)D concentrations ranging from 8 nmol/L (200 IU/d), 16.5 (with 600 IU D3/d) to 

60 nmol/L (2000 IU of vitamin D3/d). 

Ottawa EPC report - Premenopausal women and younger men. 

Ten small trials included premenopausal women and younger males. Three trials 

compared vitamin D2 to vitamin D3 in healthy young adults. Two of the three trials used 

RIA, and one used HPLC to measure serum 25(OH)D concentrations The doses of 

vitamin D3 ranged from 600 to 10,000 IU/day and vitamin D2 (4000 IU/d or 50,000 to 

100,000 for single dose). 

Three trials found that supplementation with vitamin D2 and D3 in healthy adults may 

have different effects on serum 25(OH)D concentrations. One trial compared 100,000 IU 

vitamin D2 given orally versus injection and found a greater variability in response with 

the intramuscular preparation. There appeared to be dose-response effect in those trials 

that used multiple doses of vitamin D3, although there were insufficient data to perform a 

meta-analysis. 

Ottawa EPC report - Postmenopausal women and older men. 

Forty-four trials were conducted exclusively in postmenopausal women and older 

men, with 14 of these in elderly populations living in long-term care or nursing homes. 

One trial enrolled only women in early menopause (n=129). Doses of vitamin D3 ranged 

from 100 to 4000 IU/day and vitamin D2 was 9000 IU/day. One trial was conducted in 

African American women. 

One trial found that wintertime declines in serum 25(OH)D concentrations were 

prevented with 500 IU vitamin D3 per day. A dose response with increasing doses of 

vitamin D3 was noted for serum 25(OH)D concentrations. There was variability in 

response to similar doses across trials that may have been due to differences in serum 

25(OH)D assays or baseline 25(OH)D concentrations. Similarly, although some trials 

reported a greater response to vitamin D in populations that were vitamin D deficient at 

baseline compared to those who were not, there were insufficient data on which to base a 

definitive conclusion on this point. 

291 
Figure 23. Relationship between doses of Vitamin D3 supplementation and net changes in 

serum 25(OH)D concentrations in RCTs 

Adults

0

20

40

60

80

100

Net change in 25(OH)D, mnol/L

0 1000 2000 3000 4000 5000

Vit D3 daily dose(IU)

Children

0

20

40

60

80

100

Net change in 25(OH)D, mnol/L

0 1000 2000 3000 4000 5000

Vit D3 daily dose(IU)

Legends: Each empty circle represents one study. The area of the circle is proportional to the inverse of the within-study 

variances. Typically, the larger the bubble, the larger the sample size and the smaller the standard error of the changes in 

25(OH)D. 

292 
Figure 24. Relationship between doses of Vitamin D3 supplementation and net changes in 

serum 25(OH)D concentrations in RCTs by baseline vitamin D status among adults 

Adults with low 25(OH)D concentrations

0

20

40

60

80

100

Net change in 25(OH)D, mnol/L

0 1000 2000 3000 4000 5000

Vit D3 daily dose(IU)

Adults with normal/high 25(OH)D concentrations

0

20

40

60

80

100

Net change in 25(OH)D, mnol/L

0 1000 2000 3000 4000 5000

Vit D3 daily dose(IU)

Legends: Each empty circle represents one study. The area of the circle is proportional to the inverse of the within-study 

variances. Typically, the larger the bubble, the larger the sample size and the smaller the standard error of the changes in 

25(OH)D. 

293 
294 

Figure 25. Relationship between doses of Vitamin D3 supplementation and net changes in 

serum 25(OH)D concentrations in RCTs by duration of supplementation among adults 

Duration of supplementation <=3 mo

0

20

40

60

80

100

Net change in 25(OH)D, mnol/L

0 1000 2000 3000 4000 5000

Vit D3 daily dose(IU)

Duration of supplementation >3 mo

0

20

40

60

80

100

Net change in 25(OH)D, mnol/L

0 1000 2000 3000 4000 5000

Vit D3 daily dose(IU)

Legends: Each empty circle represents one study. The area of the circle is proportional to the inverse of the within-study 

variances. Typically, the larger the bubble, the larger the sample size and the smaller the standard error of the changes in 

25(OH)D.
Table 106. The relationship between vitamin D3 daily doses and changes in 25(OH)D concentrations in RCTs 

Vit D3 ± Ca Group P

Vit D3 dose 

(IU/d) 

Ca dose 

(mg/d) 

Duration 

(mo) Author Year Life stage Base 25(OH)D, nmol/L 

n 

Mean 

change 

from 

baseline 

SD n 

Bjorkman 2008209 71+ 23 400 0 6 60 26.5 11.8 59 Bjorkman 2008209 71+ 23 1200 0 6 63 49.1 19.5 59 Blum 2008216 71+ 73 700 500A 12 132 48.5 35.3 125 Bunout 2006 80 71+ 40 400 800A 9 46 33.4 14.3 46 Chapuy 1992 217 71+ 36 800 1200 18 73 65.0 16.5 69 Chel 2008218 71+ 23 600 0 4 46 46.9 15.4 45 Deroisy 2002 219 71+ 28 200 500A 3 50 14.7 10.0 50 Himmelstein 1990 220 71+ 45 2000 0 1.5 15 39.7 15.7 15 Kenny 2003 221 71+ 62 1000 500A 6 29 22.3 10.1 31 Krieg 1999 222 71+ 29 880 500 24 34 36.5 14.0 38 Pfeifer 2000 223 71+ 25 880 1200A 2 74 40.5 27.0 74 Pfeifer 2001 97 71+ 25 800 1200 2 73 39.2 22.4 72 Sorva 1991 224 71+ 11 1000 1000 10 5 44.6 28.9 10 Zhu 2008 214 71+ 68 1000 1200A 60 29 36.2 27.5 34 Barnes 2006 225 adults 52 600 1500A 2 12 38.6 15.1 15 Bolton-Smith 2007 213 adults 60 400 100 24 50 12.0 15.1 56 DawsonHughes 1997226 adults 74 700 500 36 145 35.2 32.6 167 Harris 2002 227 adults 55 800 0 2 27 22.3 14.0 23 Heaney 2003 228 adults 71 1000 0 5 16 12.0 16.0 16 Heaney 2003 228 adults 71 5000 0 5 17 91.9 37.6 16 Heikkinen 1998 229 adults 26 300 500A 12 18 9.4 10.9 18 Honkanen 1990 230 adults 31 1800 1550 2.75 55 39.5 12.1 60 Jensen 2002 231 adults 41 400 1450 36 33 34.6 23.2 33 Nelson 2009232 adults 62 800 0 12 55 35.3 23.2 31 Orwoll 1988 233 adults 58 1000 1000 12 46 25.0 19.1 46 Patel 2001 234 adults 72 800 0 12 35 8.4 13.1 35 Riis 1984 235 adults 41 2000 500 12 8 87.5 14.1 7 continued 

295 
296 

Vit D3 ± Ca Group P

Author Year Life stage Base 25(OH)D, nmol/L Vit D3 dose (IU/d) Ca dose (mg/d) Duration (mo) 

n 

Mean 

change 

from 

baseline 

SD n 

Trang 1998 236 adults 42 4000 0 0.5 24 23.3 17.5 24 Chan 1982 237 children 43 400 0 6 30 22.5 6.6 30 El-Hajj (Fuleihan) 2006 35 children 35 200 0 12 58 7.5 19.8 55 El-Hajj (Fuleihan) 2006 35 children 35 2000 0 12 55 59.9 67.1 55 

A Calcium supplement was given to all patients 

The format of this table has been slightly modifies to fit each RCT in one line. 
Outcomes for Tolerable Upper Intake Levels 

 We included only clinical outcomes of tolerable upper intake levels, such as all-cause 

mortality, cancer (incidence and mortality), soft tissue calcification, renal outcomes, and 

adverse events reported in RCTs. 

 Results of all-cause mortality and cancer have been described in previous sections. In 

brief, we did not find vitamin D and/or calcium associated with an increased risk of 

mortality. For cancer risk, there were some observational studies reporting high calcium 

intake may be associated with an increased risk of prostate cancer (see “Prostate cancer” 

in “Calcium and cancer” section). We did not identify any studies on soft tissue 

calcification and tolerable upper intake levels. 

Renal Outcomes 

 The WHI trial on women aged 50 to 79 years, examined the effect of vitamin D3 400 

IU (the Recommended Dietary Allowance for women aged 50 to 70 years and below the 

600 IU recommended intake for women > 70 years) in combination with 1000 mg 

calcium carbonate versus placebo and found an increase in the risk of renal stones 

(Hazard Ratio 1.17 95 percent CI 1.02, 1.34), corresponding to 5.7 events per 10,000 

person years of exposure.71 It should be noted that women in both groups were allowed to 

take additional vitamin D supplements up to 600 IU and later 1000 IU per day and 

calcium supplements up to 1000 mg per day. The baseline total calcium intakes (from 

foods and supplements) were high: 34 percent consumed less than 800 mg/d, 26 percent 

consumed 800 to 1200 mg/d, and 40 percent consumed more than 1200 mg/d. A prior 

publication from WHI trial provided the same data on the risk of renal stones was also 

included in the Ottawa EPC report. 

No studies were identified that evaluated the effect of vitamin D, calcium, or 

combined vitamin D and calcium on other renal outcomes. 

Adverse Events Reported in RCTs. 

The reporting of adverse events in RCTs was generally inadequate, and most trials 

were not adequately powered to detect adverse events. Among the 63 RCTs included in 

this report, 47 did not report information on adverse events. 

Five RCTs (in 6 publications) that enrolled a total of 444 subjects reported no adverse 

events during the trial periods.35,51,227,238,239 Of these, one RCT administered combination 

of vitamin D2 (1600 or 3600 IU/d) and vitamin D3 (400 IU/d) supplements for 3 months, 

two RCTs administered vitamin D supplements (type of vitamin D not reported) with 

doses ranging from 200 to 2000 IU/d for 3 weeks or 1 year, one RCT used high-dose 

intermittent vitamin D3 supplement (120,000 IU sachets given 3 times, every 2 weeks, for 

6 weeks), and one RCT administered 1200 IU/d vitamin D2 supplement for 5 years. 

Eleven RCTs reported at least one adverse event (Table 107). Excessive gas, bloating, 

and gastrointestinal discomforts were reported to be associated with calcium 

supplementation (doses ranged from 600 to 1000 mg/d). Other RCTs of vitamin D (doses 

ranged from 400 to 5714 IU/d vitamin D3 or ranged from 5000 to 10,000 vitamin D2) 

and/or calcium supplementations (doses ranged from 200 to 1500 mg/d) reported few 

297 
298 

cases of gastrointestinal disruption such as constipation, diarrhea, upset stomach, 

musculoskeletal soreness, primary hyperparathyroidism, hypercalcemia, renal calculi and 

craniotabes. One RCT reported some adverse events that required hospital admission, 

including retrosternal pain, a non-ST elevation myocardial infarction and a transient 

ischemic attack (all 3 cases in vitamin D 400 IU/d plus exercise training group) and one 

case of acute cholecystitis (in calcium, vitamin D plus exercise training group).80 Another 

RCT reported that “there were no significant differences between the vitamin D and the 

control groups in the rate of incident cancer and vascular disease (ischemic heart disease 

and stroke)” (actual data not provided), and one participant died during the study.98

However, these adverse events may or may not be associated with vitamin D and/or 

calcium supplementation in this study. Also described earlier in the “Renal outcomes” 

section, the WHI trial examined the effect of vitamin D3 400 IU in combination with 

1000 mg calcium carbonate versus placebo and found an increase in the risk of renal 

stones (Hazard Ratio 1.17 95 percent CI 1.02, 1.34), corresponding to 5.7 events per 

10,000 person years of exposure.71 

Ottawa EPC report: 

A total of 22 trials reported data on toxicity-related outcomes, 21 of which used doses 

above 400 IU/d. Toxicity results from trials with intakes of vitamin D above current 

reference intakes varied and this may have been related to different doses, baseline 

characteristics of populations or exposure times. Most trials excluded subjects with renal 

insufficiency or hypercalcemia, were of small sample sizes and had short durations of 

exposure to vitamin D. Event rates were low across trials in both the treatment and 

placebo arms. 
Table 107. Adverse events reported in RCTs 

Author Year N enrolled Vit D dose (IU/d) Ca dose (mg/d) Duration Adverse Event data (n=casYamamoto 1995 117 471 0 1000 6 mo Comparing calcium group to the placebo group, ex

were more frequently reported by white women at in general, at 6 months, and white men reported mmonths. 

Moschonis 2006 215 112 300 D3 600 or 1200 12 mo Bloating, constipation and intestinal discomfort app

calcium supplement 

Bunout 2006 80 96 400 800 9 mo Adverse events that required hospital admission: 

 Vit D plus exercise training group (n=3): retrosteelevation myocardial infarction and a transient isch Calcium, Vit D plus exercise training group (n=1

Wactawski-Wende 2006 71

36282 400 1000 7 y The WHI trial found an increase in the risk of renal 

1.17 95% CI 1.02, 1.34), corresponding to 5.7 evenyears of exposure. 

Burleigh 2007 81 205 800 D3 1200 Median 1 

mo 

Hypercalcemia (n=2) 

Lappe 2008 208 5201 800 200 8 wks GI disruption such as constipation, diarrhea, upset 

musculoskeletal soreness (0.9%) 

Brooke 1980 34 126 1000 0 3rd

trimester 

only 

Vit D group (craniotabes, n=2), placebo group (hypcraniotabes, n=6) 

Lappe 2007 52 1180 1000 D3 1400-1500 4 y Renal calculi in placebo (n=1), renal calculi in calci

calculi in calcium plus vit D (n=1) 

Mastaglia 2006 240 65 5000 or 10,000 D2 500 3 mo Hypercalciuria (n=1) in control group Zhu200898 256 1000 D2 1200 12 mo There were no significant differences between the 

groups in the rate of incident cancer and vascular ddisease and stroke). There were 8 and 5 adverse events in vitamin D an

respectively. One participant in the vitamin D group hypercalcemia one occasion. No case of renal calc1 participant was deceased during the study. 

Sneve 200850 445 Group 1: 2 capsules of 

vitamin D3 each 

20,000 IU taken twice 

a week (Monday and 

Thursday): ~5714 IU/d 

500 12 mo Primary hyperparathyroidism (n=2), increase in se

mmol/L (n=1), transient increases in serum calcium 317 other adverse events were recorded, most of tdiscomfort. There were no significant differences b

Group 2: 1 capsules of groups regarding adverse events. vitamin D3 each 

20,000 IU taken twice 

a week (Monday and 

Thursday): ~2857 IU/d 

299 
300 
Chapter 4. Discussion 

 This evidence report on vitamin D and calcium in relation to health outcomes was prepared 

for consideration by the Committee on Dietary Reference Intakes for Vitamin D and Calcium at 

the request of AHRQ on behalf of the various sponsors. This report does not make nor was it 

intended to make recommendations for DRI values concerning vitamin D or calcium. 

Responsibility for setting DRI values lies with the Committee. Evidence from systematic reviews 

is one of several types of information available to the Committee for use in its deliberations to 

establish DRI values. This is the first time that an independent systematic review is being 

commissioned to support the DRI process. Thus, it is important for users of this report to fully 

appreciate the nuances of the methodologies employed, as well as the strengths and limitations of 

this approach. In particular, it should be noted that total vitamin D exposure was not evaluated in 

this report because there is no valid method to quantify the contribution of endogenous vitamin 

D synthesis resulting from sun exposure and it is also the TEP’s consensus that vitamin D intake, 

as estimated by current food frequency questionnaires, is too inaccurate to be of value. 

 For this report, we identified 165 primary articles that met the eligibility criteria established 

by the TEP. In addition, we included 11 published systematic reviews that incorporated over 200 

additional primary articles. Despite the relatively large number of studies included, with the 

following few exceptions, it is difficult to make any substantive and concise statements on the 

basis of the available evidence concerning the association of serum 25(OH)D concentration, 

supplemental vitamin D, dietary calcium intake, or the combination of both nutrients with the 

various health outcomes. It proved challenging because many of the studies contained substantial 

heterogeneity and their findings were inconsistent for the health outcomes examined. 

 In general, among RCTs of hypertensive adults, calcium supplementation (400 to 2000 mg/d) 

lowered systolic, but not diastolic, blood pressure by a small but statistically significant amount 

(2 to 4 mm Hg). 

 For body weight, despite a wide range of calcium intakes (from supplements or from dairy 

and nondairy sources) across the calcium trials, the RCTs were fairly consistent in finding no 

significant effect of increased calcium intake on body weight. 

 For growth, a meta-analysis of 17 RCTs did not find a significant effect on weight and height 

gain attributable to calcium supplement in children ranged from 3 to 18 years of age. 

 For bone health, one well-conducted systematic review of RCTs found that vitamin D3 (up to 

800 IU/d) plus calcium (~500 mg/d) supplementation resulted in small increases in BMD of the 

spine, total body, femoral neck, and total hip in populations consisting predominantly of women 

in late menopause. 

 For breast cancer, subgroup analyses in four cohort studies consistently found that calcium 

intake in the range of 780 to 1750 mg/d in premenopausal women was associated with a 

decreased risk for breast cancer. However, no RCTs of calcium supplementation to prevent 

breast cancer in premenopausal women have been published. In contrast, cohort studies of 

postmenopausal women are consistent in showing no association of calcium intake with the risk 

of breast cancer. 

For prostate cancer, three of four cohort studies found significant associations between 

higher calcium intake (>1500 or >2000 mg/day) and increased risk of prostate cancer, compared 

to men consuming lower amount of calcium (500-1000 mg/day). 

 For cardiovascular events, a cohort study and a nested case-control study found associations 

between lower serum 25(OH)D concentrations (less than either about 50 or 75 nmol/L) and 

311
increased risk of total cardiovascular events; however an RCT found no effect of 

supplementation and studies of specific cardiovascular events were too sparse to reach 

conclusions. Taken together, six cohort studies of calcium intake suggest that in populations at 

relatively increased risk of stroke and with relatively low dietary calcium intake (i.e., in East 

Asia), lower levels of calcium intake under about 700 mg/day are associated with higher risk of 

stroke. This association, however, was not replicated in Europe or the US, and one Finnish study 

found a possible association of increased risk of stroke in men with calcium intakes above 1000 

mg. 

 Studies on the association between either serum 25(OH)D concentration or calcium intake 

and other forms of cancer (colorectum, pancreas, prostate, all-cause); incidence of hypertension 

or specific cardiovascular disease events; immunologic disorders; and pregnancy-related 

outcomes including preeclampsia were either few in number or reported inconsistent findings. 

Too few studies of combined vitamin D and calcium supplementation have been conducted to 

allow adequate conclusions about its possible effects on health. The WHI trial was commonly 

the only evidence available for a given outcome.

Strengths of This Report 

 The strengths of this report lie in the wide range of topics covered, critical appraisal, detailed 

documentation, transparent methods to assess the scientific literature, and an unbiased selection 

of studies. A team of evidence-based methodologists not previously directly involved in research 

related to vitamin D and calcium worked with nutrient experts to refine the key questions 

(initially defined by AHRQ with input from various sponsors), analytic framework, and review 

criteria for the systematic review. After defining the questions and eligibility criteria with input 

from content experts and the sponsoring agencies, the Tufts EPC reviewed the published 

evidence on the topic. The intent was to perform a thorough and unbiased systematic review of 

the literature base on available evidence as defined by prespecified criteria. Once the review 

process began, input from experts in the field was sought to clarify technical questions during the 

literature review process. These individuals did not participate in study selection or detailed data 

extraction from the included studies nor were any members serving on the IOM committee on 

vitamin D and calcium involved in the review of this document. A quality rating as detailed in 

Chapter 2 (Methods section) was assigned for each primary study and systematic review, and 

incorporated into the data summaries section of the report. On the basis of this work, a sound 

foundation has been created which will facilitate rapid and efficient future updates as needed. 

 Details concerning the process of question formulation, selection of health outcomes of 

interest, justification for study selection criteria, methods used for critical appraisals of studies 

and quality rating, and summary of results are described fully in the Methods chapter. This 

approach is critical to the establishment of a transparent and reproducible process. Furthermore, 

important variables that affect vitamin D status such as life stages, latitude of the study locale, 

background diet and skin pigmentation are documented in this review. 

 This evidence report was carried out under the AHRQ EPC program, which has a 12-year 

history of producing over 175 evidence reports and numerous technology assessments for 

various users including many federal agencies. EPCs are staffed by experienced methodologists 

who continuously refine approaches to conducting systematic reviews and develop new methods 

on the basis of accumulated experience encompassing a wide range of topics. In addition, the 

Tufts EPC has conducted a number of nutrition-related evidence reports19-22,241, as well as 

312
conducted the mock exercise on vitamin A panel.3

 This report drew on these experiences, the 

expertise of the TEP, and the support of federal agencies. 

DRI and the Literature on Vitamin D and Calcium 

 It should be emphasized that none of the studies reviewed were designed to address issues 

specifically relevant for establishing DRI values (i.e., to ascertain the optimal dose in a particular 

life stage to promote growth and tissue maintenance, and prevent chronic disease throughout the 

lifecycle). In general, the studies did not enroll subjects with ages that could be easily mapped to 

specific life stages as defined within the DRI framework (with the exception of postmenopausal 

women and pregnant or lactating women) and did not evaluate health outcomes on the basis of 

what doses will lower risk for a particular disease in prespecified life stages. Therefore, data will 

need to be extrapolated from these studies to craft a set of DRI values for vitamin D and calcium. 

This extrapolation may prove challenging. 

 Certain issues concerning the studies of vitamin D must be noted. As mentioned previously, 

it is difficult to evaluate nutritional adequacy because there are no methods currently available to 

quantify the contribution of endogenous vitamin D synthesis resulting from sun exposure on an 

individual or group level. In addition, it is generally accepted that estimating intake by dietary 

assessments is not a valid indicator of vitamin D status, because there are limitations in the 

completeness of nutrient databases for both food and dietary supplements vitamin D content and 

the rapidly changing landscape of vitamin D food fortification has not yet been captured in either 

instruments used to assess intake and the databases used to analyze the data. For example, 

vitamin D values are available for only about 600 out of 1400 foods in the USDA National 

Nutrient Database for Standard Reference (http://www.ars.usda.gov/nutrientdata) and notably 

missing are foods recently fortified with vitamin D.25 Given the recent trend towards increased 

nutrient fortification of the North American food supply, the lag in updating food composition 

tables, and the inability to distinguish between fortified and unfortified foods when using most 

dietary assessment tools, it is difficult to accurately estimate dietary intakes of vitamin D, 

especially for a given year. Shifts in methodological approaches to measure serum 25(OH)D 

concentrations, the heterogeneous nature of the data available with respect to study locations 

(i.e., latitude) and times during the year (i.e., season) hamper our ability to succinctly summarize 

dose-response relationships. We did not perform a dose-response meta-analysis of the 

relationship between serum 25(OH)D concentrations and health outcomes because limited and 

inconsistent data would result in a meta-analysis that is difficult to interpret and results that may 

be misleading. Furthermore, many of the large cohorts analyzed for associations of vitamin D 

with health outcomes enrolled mostly white participants aged approximately 40 to 70 years old 

and much of the data on intake dose-response and serum 25(OH)D concentration were derived 

from studies designed to measure bone health in postmenopausal women. These factors limit the 

applicability of the findings to other life stages and other racial groups. 

 Unlike serum 25(OH)D concentrations for vitamin D, there is no equivalent serum biomarker 

to indicate calcium status. Relying on dietary assessment to gauge calcium intake is limited by 

the confounding effect of vitamin D status on the efficiency of calcium absorption and 

uncertainties in the calcium content of many foods due to the recent trend in nutrient fortification 

of food, limited ability of current dietary assessment tools to distinguish among fortified and 

unfortified foods and the lag in updating nutrient databases with current nutrient information. 

313
Limitations of our Methodological Approach 

 The number of potentially relevant (English language articles on humans and not reviews) 

vitamin D studies indexed in MEDLINE is very large (~15,000) and the number of calcium 

studies is even larger (~110,000). Without unlimited time and resources, the systematic review 

conducted in this report had to focus on selected key questions predefined by our federal 

sponsors with input from the IOM, and capitalize on existing systematic reviews. Using previous 

systematic reviews risks propagating deficiencies and errors242 introduced in those reviews (e.g., 

errors in data abstraction, flawed assumptions in quantitative synthesis). Although we have 

assessed the quality of these systematic reviews using AMSTAR26 checklist, we cannot reliably 

know the validity of the reported summary data without knowing the details of the primary 

studies. It should also be stressed that a well-performed systematic review does not necessarily 

imply that the body of evidence for a particular outcome of interest is of high quality. While 

some systematic reviews assessed the quality of the individual studies, the methods used varied. 

Any systematic review is limited by the quality of the primary studies included in the review. 

Unless the methods used to assess the quality of the primary studies is transparent and the details 

made available for examination, it would be difficult to reliably determine the validity of the 

conclusions. Also, relying on existing systematic reviews alone could have potentially precluded 

us from identifying all relevant studies because those systematic reviews might have addressed 

somewhat different questions and had a different scope from this review. For example, for 

growth outcome in children, we principally relied on the findings from a meta-analysis of RCTs 

of calcium originally designed to evaluate bone density outcomes. If there were RCTs of calcium 

intake specifically designed to measure growth outcomes such as weight and height gain, but not 

bone density, then those studies would not have been identified. In addition, as per the task order 

from AHRQ, we relied on the Ottawa report for bone health outcomes and we did not examine 

specific studies included in that report. As a consequence, if those studies had reported other 

(than bone health) outcomes that were of interest, those studies would not have been included in 

this review. 

 As there is no consensus on how to assess the quality of the nutrition observational studies, 

we created a quality checklist based on a newly published reporting standard for observational 

studies32 and nutrition reporting items that we believe should be considered in quality 

assessment. This checklist, however, has not been calibrated and the intra- and interrater 

variability have not been assessed. We should also remind the readers that impeccable study 

reporting does not equate study validity. However, transparent, comprehensive, and accurate 

reporting does help in evaluating a study’s validity. 

 Also, studies on vitamin D and calcium were not specifically targeted at life stages (except 

for children, pregnant, and postmenopausal women) specified for the determination of DRI. We, 

therefore, were unable to structure our report strictly according to prespecified life stages. When 

a study enrolled populations that spanned across multiple life stages, we provided our best 

estimates as to which life stage(s) the study’s findings would be of most relevance. 

Comments on the Observational Studies 

 All the included observational studies were designed to generate hypotheses of potential 

associations of multiple factors with vitamin D or calcium. Therefore, a finding of a significant 

association in these studies, after exploratory analyses, should not be considered equivalent to 

314
the result of studies that were designed to confirm this relationship. Many of the nested casecontrol studies typically excluded a substantial portion of participants (some as high as 60 to 70 

percent) in the original cohorts because blood samples, or completed dietary questionnaires were 

not available. How this selection bias would affect the reported association is unclear. In 

addition, several of the studies might have suffered from outcome misclassification; for example, 

when cancer cases were identified from registries without histopathology verification. The effect 

of outcome misclassification is unpredictable. Furthermore, many of the studies did not report a 

power calculation. Even though many of the studies included cohorts with relatively large 

numbers of subjects (tens of thousands), it is plausible that, in fact, the included studies may 

have been underpowered to detect the true effect sizes. If that were the case, the significant effect 

reported may, in fact, be spurious. Furthermore, many of the reported effect sizes were small to 

moderate (with OR ranged from 1.03 to 2.0). When the effect size is small, the possibility of 

residual confounding by unmeasured variables must be considered. 

Sources of Heterogeneity and Potential Biases 

 As have been mentioned previously, most of the findings reported in this review were 

inconsistent for each of the outcomes of interest. Many studies showed substantial heterogeneity. 

Some studies adjusted the serum 25(OH)D concentration by season of serum collection, some 

did not. While the majority of the studies used some forms of RIA to measure the serum 

25(OH)D concentration, a minority used competitive protein-binding assay. Some studies 

reported a substantial proportion of the frozen serums were accidentally thawed and limited the 

analyses that could be performed. It is unclear how this would alter the overall results. Many 

studies suffered from potentially inadequate outcome ascertainment (e.g., reliance on selfreported calcium intake and hypertension diagnosis). Time between measurement of serum 

25(OH)D concentration and the diagnosis of interest varied. For prostate and colorectal cancer, it 

ranged from 1 to more than 16 years. Factors potentially relevant to the outcomes of interest like 

family history (in colorectal cancer) were not consistently reported and accounted for in the 

studies. Also, the blinding of case assessors to the risk factor of interest (e.g., serum 25(OH)D 

concentrations) as well as that of investigators who measured the risk factor per se to outcomes 

were rarely reported. 

 For studies on calcium supplementation, intake compliance, information on the 

bioavailability of the calcium source, the role of background sun exposure, and associated 

vitamin D effects were not consistently available across all studies. Thus, it is difficult to 

interpret those findings on an absolute level and among studies. 

 Finally, all systematic reviews, including this report, may suffer from potential publication 

and reporting biases since currently there is no reliable way to detect and correct these biases. 

However, there is an underlying suspicion of publication bias against studies having either null 

or negative outcomes and reporting bias toward “significant” outcomes in the literature.243,244

Thus, it is important to consider these biases when reviewing the overall findings of any 

systematic review. 

Vitamin D Intake and Response in Serum 25(OH)D Concentration 

 The findings of this review on the association between vitamin D intake dose and change in 

serum 25(OH)D concentration was primarily derived from RCTs reviewed in a systematic 

review of bone health in postmenopausal women. This limits the applicability of the findings to 

315
316

other life stages. Though, we did not find any reason to consider these trials to be biased, they 

are nonetheless an arbitrary sample of all studies that have reported the association between 

vitamin D intake dose and change in serum 25(OH)D concentration. We did not perform a 

quantitative synthesis (e.g., meta-regression) to examine the relationship between vitamin D 

intake dose and serum 25(OH)D concentration due to the heterogeneity across studies. Studies 

had varied compliance rates in the vitamin D intake; limited or no adjustment for skin 

pigmentations, calcium intake, or background sun exposure; different vitamin D assay 

methodologies and measurement (both intra- and interassay) variability. All these factors 

increase the heterogeneity and limit the usefulness of an overall summary estimate for an intake 

dose response in serum 25(OH)D concentration. Nonetheless, overall, there appeared to be a 

trend for higher vitamin D supplementation dose resulting in higher net change in serum 

25(OH)D concentration. 

Considerations for Future DRI Committees 

 Formulating the appropriate key questions is the most important aspect of conducting a 

systematic review to ensure the final product will meet the intended purpose. Ideally, this should 

be an iterative process involving the sponsors, EPC, TEP and targeted end-users. The questions 

should be reviewed and potentially refined once the “state” of the literature has been 

systematically appraised, with the understanding that any modifications to the key questions after 

the review process has started will likely extend the literature review and synthesis processes. In 

addition, developing relevant study selection criteria for the systematic review is critical to 

finding pertinent data to answer the key questions; the TEP should be engaged early in this 

process. Crafting a framework of the entire review process depicting the explicit roles of the 

sponsors, TEP, and targeted end-users could also be helpful for future reviews. 

 While the process of conducting the actual systematic review of a nutrient or group of 

nutrients on an agreed upon set of key questions concerning specific health outcomes is carefully 

laid out and could be replicated without undue difficulty, the process of selecting which health 

outcomes would be important for inclusion in a systematic review could not be easily replicated. 

The health outcomes selected were decided after much deliberation by the TEP with input from 

the various partners. As the nature of the deliberation hinged much on the expertise reflected by 

the particular composition of the TEP, it is conceivable that a different TEP composed of 

members with different expertise may have recommended a different set of health outcomes for 

inclusion. To minimize this variability, an a priori designed set of instructions to weigh each 

outcome (taking into account such factors like population attributable risk, morbidity, and others) 

for possible inclusion would be valuable. 
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Abbreviations 

25(OH)D 25-hydroxyvitamin D 

AHRQ Agency for Healthcare Research and Quality 

AMSTAR Assessment of multiple systematic reviews 

Anthrop Anthropometric measures 

ASA Acetyl-salicylic acid (aspirin) 

ATBC Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study 

BCDDP Breast Cancer Detection Demonstration Project 

BMC Bone mineral content 

BMD Bone mineral density 

BMI Body Mass Index 

Ca Calcium 

CABG Coronary artery bypass graft 

CeVD Cerebrovascular disease 

CHD Coronary heart disease 

CHD Coronary Heart Disease

CI Confidence Interval 

CIFOS Calcium Intake Fracture Outcome Study

CONSORT Consolidated Standards of Reporting Trials 

CPBA Competitive protein binding assay 

CPEP Calcium for Prevention of Preeclampsia Trial 

CPP Calcium Polyp Prevention Study 

CPS Cancer Prevention Study 

CRC Colorectal cancer 

CVD Cardiovascular disease 

DBP Diastolic blood pressure 

Demograph Demographics 

DM Diabetes Mellitus 

DRI Dietary Reference Intake 

Dx Diagnosis 

EAR Estimated average requirement 

EPC Evidence-based Practice Center 

337 
FFQ Food frequency questionnaire 

FNB Food and Nutrition Board 

FOS Framingham Offspring Study 

FREE Fracture Risk Epidemiology in the Elderly 

HAH Harvard Alumni Health Study 

HbC Hemoglobin C disease 

HPFS Health Professionals Follow-up Study 

HPLC High pressure liquid chromatography 

HR Hazard ratio 

ht Height 

HT Hormone (replacement) therapy 

HTN Hypertension 

IHD Ischemic heart disease 

IOM Institute of Medicine 

Iowa WHS Iowa Women’s Health Study 

IQR Interquartile range 

IU International unit 

Japan CC Japan Collaborative Cohort 

Japan PHC Japan Public Health Center study 

Kupio ORFPS Kupio Osteoporosis Risk Factor and Prevention Study 

MCS Multiethnic Cohort Study, Hawaii, California 

MI Myocardial infarction 

mil Million 

mo Months(s) 

N Number of subjects 

n Number of subjects had event(s) 

NA Not applicable 

nd No data 

NHANES National Health and Nutrition Examination Survey 

NHEFS NHANES I Epidemiologic Follow-up Study 

NHS Nurses’ Health Study 

338 
NIH National Institutes of Health 

NIH-AARP National Institutes of Health – American Association of Retired Persons

NPC Nutrition Prevention of Cancer trial 

NS Not significant 

ODS Office of Dietary Supplements 

OR Odds Ratio 

PAHSG Princess Anne Hospital Study Group, UK 

PCI Percutaneous coronary intervention 

PHS Physicians’ Health Study 

PI(E)CO Population, Intervention (or Exposure), Comparison and Outcome 

PLCO Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial 

PMID PubMed (unique) identifier 

PSA Prostate specific antigen 

PTH Parathyroid hormone 

RCT Randomized-controlled trial 

RDA Recommended Dietary Allowance 

RIA Radioimmunoassay 

RR Relative risk 

SBP Systolic blood pressure 

SD Standard deviation 

SE Standard error 

STROBE STrengthening the Reporting of OBservational studies in Epidemiology 

Subgp Subgroup 

Suppl Supplement(s) 

TEP Technical Expert Panel 

TIA Transient ischemic attach 

TOHP Trials of Hypertension Prevention 

TOO Task order officer 

UK United Kingdom 

UL Tolerable upper intake levels 

US United States 

USDA United States Department of Agriculture 

339 
340 

UV Ultraviolet rays 

Vit Vitamin 

WCC Washington County Cohort 

WHI Women's Health Initiative 

WHS Women’s Health Study 

wk week(s) 

WMD Weighted mean difference 

wt Weight 

y Year(s) 
Latitudes of Selected Cities 

Latitude Western Hemisphere Eastern Hemisphere 

64° N Reykjavik, Iceland 

Nome, Alaska 

60-61° N Anchorage, Alaska Oslo, Norway 

56° N Copenhagen, Denmark 

52° N Berlin, Germany 

Amsterdam, Netherlands 

51° N Calgary, Alberta London, England 

49° N Vancouver, British Columbia Paris, France 

48° N Seattle, Washington Munich, Germany 

47° N Quebec City, Quebec 

Bismarck, North Dakota Zurich, Switzerland 

45° N Ottawa, Ontario 

Minneapolis, Minnesota Milan, Italy 

44° N Toronto, Ontario 

Portland, Maine 

42° N Boston, Massachusetts 

Chicago, Illinois Rome, Italy 

41° N New York, New York 

Salt Lake City, Utah Barcelona, Spain 

40° N Philadelphia, Pennsylvania 

Columbus, Ohio 

Madrid, Spain 

Beijing, China 

39° N 

Washington, DC 

St Louis, Missouri 

Sacramento, California 

38° N 

Louisville, Kentucky 

Wichita, Kansas 

San Francisco, California 

Athens, Greece 

36° N Raleigh, North Carolina 

Las Vegas, Nevada Tokyo, Japan 

34° N Columbia, South Carolina 

Los Angeles, California Fez, Morocco 

33° N Dallas, Texas 

30° N New Orleans, Louisiana Cairo, Egypt 

29° N San Antonio, Texas New Delhi, India 

26° N Miami, Florida 

22° N Hong Kong, China 

21° N Honolulu, Hawaii 

19° N Mexico City, Mexico Mumbai (Bombay), India 

15° N Guatemala City, Guatemala Manila, Philippines 

10° N Caracas, Venezuela 

4° N Bogota, Columbia 

1° N Singapore 

12° S Lima, Peru 

23° S Rio de Janeiro, Brazil 

26° S Johannesburg, South Africa 

34° S Sydney, Australia 

Cape Town, South Africa 

35° S Buenos Aires, Argentina 

37° S Auckland, New Zealand 

38° S Melbourne, Australia 

41° S Wellington, New Zealand 

341 
342 
Appendix A. Search strategy for primary studies 

a. Overall Search Strategy for Outcomes of Estimated Average 

Requirements 

Database: Ovid MEDLINE(R), CCTR (1969 to April 2009) 

1. exp Vitamin D/ 

2. (25-hydroxy vit D or plasma vit D or 25OHD or 25-OHD).mp. [mp=title, original title, 

abstract, name of substance word, subject heading word] 

3. (25OHD3 or "25(OH)D3" or 25-OHD3 or "25-(OH)D3").tw. 

4. ("25(OH)D" or "25-(OH)D" or "25-OH-D").tw. 

5. 25-hydroxycholecalciferol.tw. 

6. 25-hydroxyergocalciferol.tw. 

7. calcidiol.tw. 

8. Calcifediol/ 

9. (vit adj (d or d2 or d3)).mp. 

10. Ergocalciferols/ 

11. Ergocalciferol$.tw. 

12. Cholecalciferol/ 

13. Cholecalciferol$.tw. 

14. calciferol.tw. 

15. or/1-14 

16. exp Calcium/ 

17. exp Calcium Carbonate/ or exp Calcium Citrate/ or exp Calcium Phosphates/ or exp Calcium 

Malate/ 

18. exp Calcium, Dietary/ 

19. calcium.tw. 

20. or/16-19 

21. (ANIMALS not HUMAN).sh. 

22. *Dialysis/ or *hemodialysis/ or *peritoneal dialysis/ 

23. 15 or 20 

24. 23 not 21 

25. 24 not 22 

26. limit 25 to (addresses or bibliography or biography or comment or congresses or consensus 

development conference or consensus development conference, nih or dictionary or directory or 

duplicate publication or editorial or in vitro or interview or lectures or letter or news or 

newspaper article or "review") 

27. 25 not 26 

28. limit 27 to english language 

29. randomized controlled trial.pt. 

A-1
30. controlled clinical trial.pt. 

31. randomized controlled trials/ 

32. Random Allocation/ 

33. Double-blind Method/ 

34. Single-Blind Method/ 

35. clinical trial.pt. 

36. Clinical Trials.mp. or exp Clinical Trials/ 

37. (clinic$ adj25 trial$).tw. 

38. ((singl$ or doubl$ or trebl$ or tripl$) adj (mask$ or blind$)).tw. 

39. Placebos/ 

40. placebo$.tw. 

41. random$.tw. 

42. trial$.tw. 

43. (latin adj square).tw. 

44. Comparative Study.tw. 

45. exp Evaluation studies/ 

46. Follow-Up Studies/ 

47. Prospective Studies/ 

48. (control$ or prospectiv$ or volunteer$).tw. 

49. Cross-Over Studies/ 

50. or/29-49 

51. 50 and 28 

52. 28 not 51 

53. limit 51 to yr="1969-2008" 

54. limit 52 to yr="1969-2008" 

55. 53 not ("200810$" or "200811$" or "200812$").ed. 

56. 54 not ("200810$" or "200811$" or "200812$").ed. 

57. 55 or 56 

58. exp Vitamin D/ 

59. (25-hydroxy vit D or plasma vit D or 25OHD or 25-OHD).mp. [mp=title, original title, 

abstract, name of substance word, subject heading word] 

60. (25OHD3 or "25(OH)D3" or 25-OHD3 or "25-(OH)D3").tw. 

61. ("25(OH)D" or "25-(OH)D" or "25-OH-D").tw. 

62. 25-hydroxycholecalciferol.tw. 

63. 25-hydroxyergocalciferol.tw. 

64. calcidiol.tw. 

65. Calcifediol/ 

66. (vit adj (d or d2 or d3)).mp. 

A-2
67. Ergocalciferols/ 

68. Ergocalciferol$.tw. 

69. Cholecalciferol/ 

70. Cholecalciferol$.tw. 

71. calciferol.tw. 

72. or/58-71 

73. exp Calcium/ 

74. exp Calcium Carbonate/ or exp Calcium Citrate/ or exp Calcium Phosphates/ or exp Calcium 

Malate/ 

75. exp Calcium, Dietary/ 

76. calcium.tw. 

77. or/73-76 

78. (ANIMALS not HUMAN).sh. 

79. (ANIMALS not HUMAN).sh. 

80. 72 or 77 

81. 80 not 78 

82. 81 not 79 

83. limit 82 to (addresses or bibliography or biography or comment or congresses or consensus 

development conference or consensus development conference, nih or dictionary or directory or 

duplicate publication or editorial or in vitro or interview or lectures or letter or news or 

newspaper article or "review") 

84. 82 not 83 

85. limit 84 to english language 

86. randomized controlled trial.pt. 

87. controlled clinical trial.pt. 

88. randomized controlled trials/ 

89. Random Allocation/ 

90. Double-blind Method/ 

91. Single-Blind Method/ 

92. clinical trial.pt. 

93. Clinical Trials.mp. or exp Clinical Trials/ 

94. (clinic$ adj25 trial$).tw. 

95. ((singl$ or doubl$ or trebl$ or tripl$) adj (mask$ or blind$)).tw. 

96. Placebos/ 

97. placebo$.tw. 

98. random$.tw. 

99. trial$.tw. 

100. (latin adj square).tw. 

101. Comparative Study.tw. 

A-3
102. exp Evaluation studies/ 

103. Follow-Up Studies/ 

104. Prospective Studies/ 

105. (control$ or prospectiv$ or volunteer$).tw. 

106. Cross-Over Studies/ 

107. or/86-106 

108. 107 and 85 

109. 85 not 108 

110. limit 108 to yr="1969-2008" 

111. limit 109 to yr="1969-2008" 

112. 110 not ("200810$" or "200811$" or "200812$").ed. 

113. 111 not ("200810$" or "200811$" or "200812$").ed. 

114. 112 or 113 

115. verapamil.mp. or 52-53-9.rn. 

116. nifedipine.mp. or 21829-25-4.rn. 

117. diltiazem.mp. or 42399-41-7.rn. 

118. Azelnidipine.mp. or 123524-52-7.rn. 

119. nicardipine.mp. or 55985-32-5.rn. 

120. felodipine.mp. or 72509-76-3.rn. 

121. mepirodipine.mp. or 104713-75-9.rn. 

122. Amlodipine.mp. or 88150-42-9.rn. 

123. isradipine.mp. or 75695-93-1.rn. 

124. bepridil.mp. or 64706-54-3.rn. 

125. gallopamil.mp. or 16662-47-8.rn. 

126. aranidipine.mp. or 86780-90-7.rn. 

127. nitrendipine.mp. or 39562-70-4.rn. 

128. Barnidipine.mp. 

129. benidipine.mp. or 105979-17-7.rn. 

130. Cilnidipine.mp. or 132203-70-4.rn. 

131. clevidipine.mp. 

132. efonidipine.mp. or 111011-53-1.rn. 

133. Lacidipine.mp. or 103890-78-4.rn. 

134. Lercanidipine.mp. or 100427-26-7.rn. 

135. Manidipine.mp. or 89226-50-6.rn. 

136. Nilvadipine.mp. or 75530-68-6.rn. 

137. Nimodipine.mp. or 66085-59-4.rn. 

138. Nisoldipine.mp. or 63675-72-9.rn. 

139. Pranidipine.mp. or 99522-79-9.rn. 

A-4
140. ((calcium or Ca) adj3 channel$).mp. 

141. ((calcium or Ca) adj3 agonist$).mp. 

142. (intracellular adj2 (calcium or Ca)).mp. 

143. or/115-142 

144. weight loss.mp. or exp Weight Loss/ 

145. body mass index.mp. or exp Body Mass Index/ or exp Body Mass/ or body mass.mp. or exp 

body weight/ or body weight.mp. 

146. 144 or 145 

147. obesity.mp. or exp OBESITY/pc, di, ep, et 

148. or/144-147 

149. limit 148 to ("all infant (birth to 23 months)" or "newborn infant (birth to 1 month)" or 

"infant (1 to 23 months)" or "preschool child (2 to 5 years)") 

150. limit 149 to ("all adult (19 plus years)" or "child (6 to 12 years)" or "adolescent (13 to 18 

years)" or "adult (19 to 44 years)" or "middle age (45 to 64 years)" or "middle aged (45 plus 

years)" or "all aged (65 and over)" or "aged (80 and over)") 

151. 149 not 150 

152. 148 not 151 

153. exp Body Height/ 

154. exp body size/ 

155. growth velocity.af. 

156. growth retardation.af. 

157. growth delay.af. 

158. growth restriction.af. 

159. (height adj6 restrict$).af. 

160. linear velocity.af. 

161. (height adj6 delay).af. 

162. length delay.af. 

163. (length adj6 retardation).af. 

164. or/153-163 

165. limit 164 to ("all infant (birth to 23 months)" or "all child (0 to 18 years)" or "newborn 

infant (birth to 1 month)" or "infant (1 to 23 months)" or "preschool child (2 to 5 years)" or 

"child (6 to 12 years)" or "adolescent (13 to 18 years)") 

166. 164 not 165 

167. limit 166 to ("all adult (19 plus years)" or "adult (19 to 44 years)" or "middle age (45 to 64 

years)" or "middle aged (45 plus years)" or "all aged (65 and over)" or "aged (80 and over)") 

168. 164 not 167 

169. Bone Density/ 

170. exp Osteoporosis/ 

171. ((bone$ or plate$) adj3 mineral$).tw. 

172. (bone adj2 (loss or turnover or densi$)).tw. 

A-5
173. (Skelet$ adj2 (mineral$ or development$)).tw. 

174. mineralization defect$.tw. 

175. Mineral$ content$.tw. 

176. BMC.tw. 

177. Osteoporo$.tw. 

178. Osteomalac$.tw. 

179. Osteopath$.tw. 

180. Bone Development/ 

181. Osteogenesis/ 

182. fracture$.tw. 

183. Accidental Falls/ 

184. falls.tw. 

185. exp "Bone and Bones"/ 

186. or/169-185 

187. Rickets/ 

188. rachitis.tw. 

189. rickets.tw. 

190. or/187-189 

191. tooth loss.mp. or exp Tooth Loss/ 

192. 190 or 186 or 191 

193. limit 192 to yr="2006-2008" 

194. exp Cardiovascular Diseases/pc, di, ep, et 

195. Cardi$.mp. 

196. 195 

197. Coronary.mp. 

198. heart disease$.mp. 

199. Myocardial infarct$.mp. 

200. exp Cerebrovascular Accident/ 

201. stroke.tw. 

202. Transient Ischemic Attack.tw. 

203. exp Ischemia/ 

204. cardioprotect$.mp. 

205. Pulmonary Embol$.tw. 

206. Heart failure$.tw. 

207. (embol$ or thromb$).tw. 

208. exp Peripheral Vascular Diseases/ or peripheral artery disease.mp. 

209. arterial occlusive diseases/ 

210. or/194-209 

A-6
211. limit 210 to "all adult (19 plus years)" 

212. exp hypertension/pc, di, ep, et 

213. exp hypertension, renal/ 

214. hypertens$.af. 

215. high blood pressure.af. 

216. (eleva$ adj2 blood pressure).tw. 

217. systolic blood pressure/ 

218. diastolic blood pressure/ 

219. mean arterial pressure/ 

220. or/212-219 

221. limit 220 to "all adult (19 plus years)" 

222. exp Neoplasms/dh, pc, et, di, ep [Diet Therapy, Prevention & Control, Etiology, Diagnosis, 

Epidemiology] 

223. ("cancer risk" or "melanoma risk" or "lymphoma risk" or "leukemia risk" or "myeloma risk" 

or "sarcoma risk").tw. 

224. (("risk of" or "occurrence of") and (cancer$ or neoplasm$ or malignan$ or adenocarcinom$ 

or carcinom$ or melanom$ or lymphom$ or leuk?emi$ or myelodysplas$ or myelom$ or 

sarcom$)).tw. 

225. 222 or 224 or 223 

226. colon polyps.mp. or exp adenomatous polyps/ or exp colonic polyps/ 

227. (colon$ or rectum or rectal or colorectum or colorectal).ti,ab. 

228. (adenoma$ or polyps or polyp).ti,ab. 

229. 228 and 227 

230. 229 or 226 

231. mammography.mp. or exp mammography/ 

232. mammog$.ti,ab. 

233. 231 or 232 

234. dens$.ti,ab. 

235. 233 and 234 

236. prostate specific antigen.mp. or exp prostate-specific antigen/ 

237. (aberrant crypt$ foc$ or ACF).ti,ab. 

238. (prostat$ and (intraepitheli$ or intra-epitheli$ or intra epitheli$) and Neoplas$).ab,ti. 

239. 236 or 238 or 235 or 237 or 230 

240. type 1 diabetes mellitus.mp. or exp Diabetes Mellitus, Type 1/ 

241. psoriasis.mp. or exp Psoriasis/ 

242. rheumatoid arthritis.mp. or exp Arthritis, Rheumatoid/ 

243. multiple sclerosis.mp. or exp Multiple Sclerosis/ 

244. inflammatory bowel disease.mp. or exp Inflammatory Bowel Diseases/ 

245. ulcerative colitis.mp. or exp Colitis, Ulcerative/ 

A-7
246. Crohn's disease.mp. or exp Crohn Disease/ 

247. 240 or 241 or 242 or 243 or 244 or 245 or 246 

248. tuberculosis.mp. or exp Tuberculosis/ 

249. influenza.mp. or exp Influenza, Human/ 

250. 248 or 249 

251. exp "Activities of Daily Living"/ 

252. muscle strength.mp. or exp Muscle Strength/ 

253. exp Musculoskeletal Equilibrium/ or exp Walking/ 

254. ("balance test" or "timed walk" or "physical performance" or "hand-grip strength").tw. 

255. exp Hand Strength/ 

256. exp Muscles/ 

257. ("walking time" or "muscle strength").tw. 

258. or/251-257 

259. limit 258 to ("all adult (19 plus years)" or "all aged (65 and over)" or "aged (80 and over)") 

260. exp Pre-eclampsia/ 

261. (pre-eclampsia or preeclampsia).mp. 

262. pregnancy complication$.mp. or exp Pregnancy Complications/ 

263. or/260-262 

264. limit 263 to male 

265. limit 263 to female 

266. 264 not 265 

267. 263 not 266 

268. limit 267 to animal 

269. limit 267 to human 

270. 268 not 269 

271. 267 not 270 

272. limit 271 to english language 

273. exp infant,low birth weight/ 

274. low birth weight.af. 

275. exp infant, premature/ 

276. ("small for gestational age" or sga).af. 

277. ((preterm or prematur$) adj6 (infant or newborn)).af. 

278. or/273-277 

279. exp Milk, Human/ 

280. human milk.mp. 

281. (human adj2 milk).tw. 

282. breast milk.mp. 

283. breastmilk.mp. 

A-8
284. breast feeding.mp. 

285. breastfeed$.mp. 

286. breast fed.mp. 

287. breastfed.mp. 

288. (breast adj2 fed).tw. 

289. exp lactation/ 

290. (lactating or lactation).mp. 

291. or/279-290 

292. Mortality.mp. or exp Mortality/ 

293. Fatal Outcome.mp. or exp Fatal Outcome/ 

294. exp Death/ or exp "Cause of Death"/ or death.mp. 

295. Survival Rate.mp. or exp Survival Rate/ 

296. 295 or 292 or 294 or 293 

297. heterotopic ossification.mp. or exp Ossification, Heterotopic/ 

298. myositis ossificans.mp. or exp Myositis Ossificans/ 

299. calcinosis.mp. or exp Calcinosis/ 

300. extraosseous calcification.mp. 

301. metaplastic calcification.mp. 

302. myo-osteosis.mp. 

303. neurogenic osteoma.mp. 

304. osseous heteroplasia.mp. 

305. ossifying fibromyopathy.mp. 

306. para-articular calcification.mp. 

307. heterotopic calcification.mp. 

308. pathological bone.mp. 

309. pathological calcification.mp. 

310. periarticular calcification.mp. 

311. synostosis.mp. 

312. ectopic bone.mp. 

313. heterotopic bone.mp. 

314. dystrophic ossification.mp. 

315. ectopic ossification.mp. 

316. metaplastic ossification.mp. 

317. para-articular ossification.mp. 

318. periarticular ossification.mp. 

319. pathological ossification.mp. 

320. ectopic calcification.mp. 

321. soft tissue calcification.mp. 

A-9
322. (vascular adj3 calcification).mp. 

323. (aort$ adj3 calcification).mp. 

324. (valv$ adj3 calcification).mp. 

325. or/297-324 

326. limit 325 to animal 

327. limit 325 to human 

328. 326 not 327 

329. 325 not 328 

330. limit 329 to english language 

331. exp kidney disease/ 

332. exp kidney/ 

333. kidney.mp. 

334. renal.af. 

335. nephro$.af. 

336. exp renal replacement therapy/ 

337. exp kidney, artificial/ 

338. (hemodialy$ or haemodialy$ or dialy$).af. 

339. exp Kidney Glomerulus/ 

340. exp Kidney Function Tests/ 

341. ur?emia.tw. 

342. exp Kidney Calculi/ 

343. (kidney stone$ or renal stone$ or renal calcul$ or kidney calcul$ or nephrolith$).af. 

344. 343 not 342 

345. exp nephrolithiasis/ 

346. or/331-345 

347. allerg$.mp. or exp Hypersensitivity/ 

b. Overall Search Strategy for Outcomes of Upper Limits 

Database: Ovid MEDLINE(R), CCTR (from 1966 to December 2008) 

1. exp Vitamin D/ 

2. (25-hydroxy vit D or plasma vit D or 25OHD or 25-OHD).mp. [mp=title, original title, 

abstract, name of substance word, subject heading word] 

3. (25OHD3 or "25(OH)D3" or 25-OHD3 or "25-(OH)D3").tw. 

4. ("25(OH)D" or "25-(OH)D" or "25-OH-D").tw. 

5. 25-hydroxycholecalciferol.tw. 

6. 25-hydroxyergocalciferol.tw. 

7. calcidiol.tw. 

8. Calcifediol/ 

A-10
9. (vit adj (d or d2 or d3)).mp. 

10. Ergocalciferols/ 

11. Ergocalciferol$.tw. 

12. Cholecalciferol/ 

13. Cholecalciferol$.tw. 

14. calciferol.tw. 

15. exp Calcium Carbonate/ or exp Calcium Citrate/ or exp Calcium Phosphates/ or exp Calcium 

Malate/ 

16. or/1-15 

17. supplement$.tw. 

18. exp Dietary Supplements/to, ae, po, ut [Toxicity, Adverse Effects, Poisoning, Utilization] 

19. No-Observed-Adverse-Effect Level/ 

20. upper limit$.tw. 

21. UL.tw. 

22. (excess$ or toxic$).tw. 

23. vit d intox$.tw. 

24. (noael or noel).tw. 

25. (no observed adj2 effect$).tw. 

26. or/17-25 

27. 26 and 16 

28. (ANIMALS not HUMAN).sh. 

29. *Dialysis/ or *hemodialysis/ or *peritoneal dialysis/ 

30. 27 not 28 

31. 30 not 29 

32. limit 31 to (addresses or bibliography or biography or comment or dictionary or directory or 

duplicate publication or editorial or in vitro or interview or lectures or letter or news or "review") 

33. 31 not 32 

34. limit 33 to english language 

35. exp kidney disease/ 

36. exp kidney, artificial/ 

37. exp Kidney Function Tests/ 

38. ur?emia.tw. 

39. (kidney stone$ or renal stone$ or renal calcul$ or kidney calcul$ or nephrolith$).af. 

40. exp nephrolithiasis/ 

41. heterotopic ossification.mp. or exp Ossification, Heterotopic/ 

42. myositis ossificans.mp. or exp Myositis Ossificans/ 

43. calcinosis.mp. or exp Calcinosis/ 

44. extraosseous calcification.mp. 

45. metaplastic calcification.mp. 

A-11
46. myo-osteosis.mp. 

47. neurogenic osteoma.mp. 

48. osseous heteroplasia.mp. 

49. ossifying fibromyopathy.mp. 

50. para-articular calcification.mp. 

51. heterotopic calcification.mp. 

52. pathological bone.mp. 

53. pathological calcification.mp. 

54. periarticular calcification.mp. 

55. synostosis.mp. 

56. ectopic bone.mp. 

57. heterotopic bone.mp. 

58. dystrophic ossification.mp. 

59. ectopic ossification.mp. 

60. metaplastic ossification.mp. 

61. para-articular ossification.mp. 

62. periarticular ossification.mp. 

63. pathological ossification.mp. 

64. ectopic calcification.mp. 

65. soft tissue calcification.mp. 

66. (vascular adj3 calcification).mp. 

67. (aort$ adj3 calcification).mp. 

68. (valv$ adj3 calcification).mp. 

69. or/41-68 

70. Calcification, Physiologic/de [Drug Effects] 

71. Hypercalcemia/ 

72. Kidney Calculi/ 

73. Nephrocalcinosis/ 

74. Urinary Calculi/ 

75. Bladder Calculi/ 

76. Ureteral Calculi/ 

77. Calcinosis/ 

78. Hypercalcemi$.tw. 

79. (Burnett$ adj2 syndrome$).tw. 

80. Hypercalciuri$.tw. 

81. or/70-80 

82. psoriasis.mp. or exp Psoriasis/ 

83. 81 or 69 or 82 

A-12
A-13

84. 34 and 83 

85. limit 84 to case reports 

86. 84 not 85 
Appendix B. Search strategy for systematic reviews 

Databases: MEDLINE(R), the Cochrane Database of Systemic Reviews, and the 

Health Technology Assessments (up to December 2008) 

1. (meta-analys$ or metaanalys$).mp. [mp=title, abstract, full text, keywords, caption text] 

2. (systematic review$ or systematic literature or evidence-based or evidence review$).mp. 

[mp=title, abstract, full text, keywords, caption text] 

3. (EBM or EBR or EBRs).mp. [mp=title, abstract, full text, keywords, caption text] 

4. or/1-3 

5. (vitamin D or cholecalciferol or ergocalciferol or hydroxy vitamin D or calcitriol).mp. 

[mp=title, abstract, full text, keywords, caption text] 

6. Calcium.mp. [mp=title, abstract, full text, keywords, caption text] 

7. 5 or 6 

8. 4 and 7 

1
Appendix D. Evaluation of existing systematic reviews 

and evidence tables of the qualified systematic 

reviews 

1
Evaluation of existing systematic reviews 

Author Year Journal /Source 

Intervention or exposure 

Outcome Study 

design included 

Healthy population at baseline?* 

Only included Ca +- Vit D interventions?** Reported baseline dietary Ca intake with dietary assessment methods?*** 

Clear reporting of comparison and control group? 

Clear reporting of outcome definitions? 

Clear repoof study designs (nseparate reporting itwo or mordifferent designs arincluded)? 

Autier 2007 Arch Intern Med [17846391]1

Vitamin D [+/- Calcium] 

All cause mortality 

RCTs Yes1 Yes Yes Yes Yes 

Avenell 2008 Cochrane Database of Systematic Reviews [16034849]2

Vitamin D [+/- Calcium] 

All cause mortality 

RCTs Yes Yes Yes Yes Yes 

Allender 1996 Ann Intern Med 

Ca supplement 

Blood pressure 

RCT Yes 

(subgroup analysis) 

Yes Yes Yes Yes 

Cappuccio 1995 AJE 

Ca intake Blood 

pressure 

Observational, including crosssectional 

Unclear No NA 

(regressions) 

Yes No 

Dickinson 2008 Cochrane 

Ca supplement 

Blood pressure 

RCT No 

All with HTN 

Yes Yes Yes Yes 

1 We excluded a study on patients with congestive heart failure in our reanalysis of data from this systematic review 

2
Author Year 

Journal /Source 

Intervention or exposure 

Outcome Study 

design included 

Healthy population at baseline?* 

Only included Ca +- Vit D interventions?** Reported baseline dietary Ca intake with dietary assessment methods?*** 

Clear reporting of comparison and control group? 

Clear reporting of outcome definitions? 

Clear repoof study designs (nseparate reporting itwo or mordifferent designs arincluded)? 

Griffith 1999 AJH 

Ca supplement 

Blood pressure 

RCT Yes & No 

HTN & NTN combined See comment 

Yes Yes Yes Yes 

van Mierlo 2006 J Hum Hypert 

Ca supplement 

Blood pressure 

RCT Yes 

Subgroup of HTN & NTN 

Yes Yes Yes Yes 

Trumbo 2007 Nutr Rev 

Ca supplement 

Blood pressure, HTN, Pregnancyinduced HTN 

All Yes 

Subgroup of HTN & NTN 

Yes (interv) No (observ) 

No No No 

Bergsma-Kadijk 1996 Epidemiology 

Ca intake cancer and 

polyp 

Cohort and Casecontrol 

nd (probably healthy population) 

nd on dietary assessment method 

nd on Ca intake (only RR/OR between lowest and highest categories reported) 

nd nd on the 

definition of case-controstudy 

Weigarten 2008 Cochrane Database of Systematic Reviews 

Ca supplement (>1200 mg/d) 

cancer and polyp 

RCT yes (pts with 

prior adenoma) 

yes yes yes yes 

3
Author Year 

Journal /Source 

Intervention or exposure 

Outcome Study 

design included 

Healthy population at baseline?* 

Only included Ca +- Vit D interventions?** Reported baseline dietary Ca intake with dietary assessment methods?*** 

Clear reporting of comparison and control group? 

Clear reporting of outcome definitions? 

Clear repoof study designs (nseparate reporting itwo or mordifferent designs arincluded)? 

Davies 2006 J Natl Cancer Inst 

Nutritional RCTs, including Ca supplement 

Cancer, recurrence of preinvasive lesions 

RCT No (both pts 

with cancer and preinvasive lesions) 

nd no no yes 

Bergel 2007 BMC Pediatrics 

maternal calcium intake 

offspring BP RCTs & 

cohort 

y (RCT) no 

yes 

yes yes no 

Carroli 1994 Brit J Obstet Gynecol 

Ca supplement 

Preeclampsia RCT Yes Yes Yes Yes Yes 

Hofmeyer 2003 S African J 

Ca Supplement 

Preeclampsia RCT Yes Yes Yes Yes Yes 

Hofmeyer 2007 S African J 

Ca Supplement 

Preeclampsia (and summary of the outcomes mentioned above) 

RCT Yes Yes Yes Yes Yes 

4
Author Year 

Journal /Source 

Intervention or exposure 

Outcome Study 

design included 

Healthy population at baseline?* 

Only included Ca +- Vit D interventions?** Reported baseline dietary Ca intake with dietary assessment methods?*** 

Clear reporting of comparison and control group? 

Clear reporting of outcome definitions? 

Clear repoof study designs (nseparate reporting itwo or mordifferent designs arincluded)? 

Hoffmeyr 2006 Cochrane Database of Systematic Reviews 

Ca supplement 

Preeclampsia, pregnancy induced hypertension with and without proteinuria, maternal death or serious morbidity, other maternal outcomes, stillbirth, neonatal mortality  or morbidity, preterm birth, small  gestational age, and other outcomes for  the child 

RCT Yes Yes Yes Yes Yes 

Bucher 1996 JAMA 

Ca supplement 

Preeclampsia, pregnancyinduced hypertension 

RCT Yes Yes Yes Yes Yes 

Gao 2005 NCI 

calcium intake or dairy product 

prostate cancer 

prospective cohort 

yes (assumed from study design) 

yes yes yes yes 

Shaukat 2005 Am J Gastroenterol 

Ca supplement 

recurrent polyp 

RCT yes (pts with 

prior adenoma) 

no (1/3 included Ca+Vit A/C/E+selenium) 

yes yes? 

"recurrence of adenoma" 

yes? "RCT" 

5
6

Author Year Journal /Source 

Intervention or exposure 

Outcome Study 

design included 

Healthy population at baseline?* 

Only included Ca +- Vit D interventions?** Reported baseline dietary Ca intake with dietary assessment methods?*** 

Clear reporting of comparison and control group? 

Clear reporting of outcome definitions? 

Clear repoof study designs (nseparate reporting itwo or mordifferent designs arincluded)? 

Barr 2003 J Nutr 

Increased dairy product or calcium intake (from supplements) 

Weight RCTs Yes 

“healthy” 

Yes (separate studies of increased dairy product and those of calcium supplements) 

yes yes yes 

Trowman 2006 Br J Nutr 

Calcium supplements or increased provision of dairy products 

Weight RCTs Yes 

(excluded populations with severe comorbidities, such as renal problems or cancer) 

Yes (Separate meta-analyses for calcium supplement and increased provision of dairy products) 

yes yes yes 

Winzenberg 2007 Obesity 

calcium supplementation food or chemical 

weight RCTs yes yes yes yes yes 

Lanou 2008 Nutr Rev 

Calcium or dairy supplementation with or without energy restriction 

Weight, body fat 

RCTs nd yes no yes yes 

*Either included only healthy population at baseline or SR had separate analyses for population with diseases and without diseases **For SR of interventional studies ***For SR of observational studies ****Please comment on issues such as update of previous SRs or specific reasons for using or not using the SR, other than not fulfilling the screening crit
Evidence table of systematic review of the effect of vitamin D on bone health

Author Year [PMID] Cranney 2007 [18088161] 

Design Systematic review of RCTs and observational studies 

Population • Include all ages 

• Exclude secondary causes of osteoporosis (e.g., glucocorticoid-induced, renal or liver 

disease) 

• Exclude studies on the treatment of vitamin D-dependent rickets (to minimize clinical 

heterogeneity as treatments is often non-dietary sources of vitamin D) 

Intervention (Exposure) and 

Comparator 

Intervention (Exposure): 

• Include vitamin D2 or D3 with or without calcium. 

• Exclude vitamin D preparations, calcitriol, alphacalcidol (because they are not nutritional 

supplements, and have different safety profile) 

Comparator: 

• No vitamin D or lower doses/levels of vitamin D 

Results See text for summary results for the following outcomes in both vitamin D and combined vitamin 

D and calcium sections of the report: 

• Rickets 

• Fractures, falls, or performance measures 

• Bone mineral density or bone mineral contents 

• How does dietary intake of vitamin D from fortified foods and vitamin D 

supplementation affect serum 25(OH)D Concentrations 

• Adverse events 

Comments Case-control studies were included but always summarized separately from cohort studies and 

RCTs. Meta-analyses were performed to pool results from RCTs only. 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? Yes 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? No Publication bias assessed? No 

Included and excluded studies listed? Yes Conflicts of interest stated? Yes 

Study characteristics provided? Yes 

Evidence table of systematic review on vitamin D supplementation and all-cause mortality 

Author Year [PMID] Autier 2007 [17846391] 

Design (Search Years) Randomized controlled trials (1992-2006) 

Population Community dwelling or institutionalized adults 

Intervention (Exposure) 

and Comparator 

Supplementary vitamin D (at least 1000 mg/d) without calcium vs. placebo or no treatment 

Results 18 trials of combined vitamin D and vitamin D + calcium 

RR: 0.93 (95% CI 0.87, 0.99); favoring vitamin D (± calcium) supplementation 

Statistically homogeneous 

In our reanalysis we and excluded 3 of 18 trials and separated studies with vitamin D only from 

those with vitamin D and calcium combination. 

For details and results of our reanalysis, see text. 

Comments See text in vitamin D and vitamin D + calcium sections for reanalyses of the separated trials. 

Study participants, vitamin D assays, and vitamin D status are not described in detail. 

AMSTAR Criteria 

A priori design? Yes Study quality assessment performed? No 

Two independent reviewers? No Study quality appropriately used in analysis? NA 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? Yes Publication bias assessed? No 

Included and excluded studies listed? No Conflicts of interest stated? Yes 

Study characteristics provided? Yes The meta-analysis did not perform quality assessment 

(neither using individual quality items nor using quality 

scores) 

Evidence table of systematic review of calcium on growth in children 

Author Year [PMID] Winzenberg 2007 [17636098] 

Design (Search Years) Randomized controlled trials (1966-2005) 

Population Children <18 y 

Intervention (Exposure) and 

Comparator 

Supplemental and dietary calcium 300-1200 mg/d vs. placebo 

Results 17 trials (2088 participants) 

Weighted mean difference: +0.14 (95% CI -0.28, +0.57) Kg; favors control 

Weighted mean difference: +0.22 (95% CI -0.30, +0.74) cm; favors control 

 No significant statistical heterogeneity 

7
Comments Post hoc analysis performed on trials identified for a metaanalysis of randomized controlled trials 

of calcium on bone outcomes 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? No 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? No Publication bias assessed? Yes 

Included and excluded studies listed? No Conflicts of interest stated? No 

Study characteristics provided? Yes Unclear if all languages included; study quality assessed but not 

factored into the M-A 

Evidence table of systematic review s of calcium and blood pressure 

Author Year [PMID] Griffith 1999 [10075392] 

Design (Search Years) Randomized controlled trials (1966-1997) 

Population Both hypertensive and normotensive participants 

Intervention and Comparator Dietary and nondietary calcium supplementation versus placebo (no supplement) 

Dose range 600-2000 mg (36% 1000 mg; 26% 1500-1600 mg; 12% 2000 mg) 

Results 42 trials 

SBP: -1.44 (-2.20, -0.68)2

; statistically heterogeneous 

DBP: -0.84 (-1.44, -0.24); statistically heterogeneous 

 Subgroup analyses did not find that heterogeneity could be explained by age, sex, baseline 

calcium, dietary versus nondietary calcium, or quality. 

 Subgroups with hypertensive versus normotensive people were significantly different (no 

further details). 

 Conclusions similar to previous systematic review (Bucher 1996{2263 /id}) 

Comments Update of Bucher 1996{2263 /id} (see below). 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? No 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? Yes Publication bias assessed? No 

Included and excluded studies listed? Yes Conflicts of interest stated? No 

Study characteristics provided? Yes Study quality not discussed in conclusions. Funding 

source reported, but not conflict of interest. 

Author Year [PMID] van Mierlo 2006 [16673011] 

Design (Search Years) Randomized controlled trials (1966-2003) 

Population Both hypertensive and normotensive participants 

Intervention and Comparator Calcium supplementation versus placebo (no supplement) 

Dose range 355-2000 mg (40% 1000 mg; 32% 1500-1600 mg; 6% 2000 mg) 

Results 40 trials 

SBP: -1.86 (95% CI -2.91, -0.81); statistically heterogeneous 

DBP: -0.99 (95% CI -1.61, -0.37); statistically heterogeneous 

 In multivariable analysis including age, sex, initial calcium intake, calcium dose, and initial 

blood pressure: 

 SBP DBP 

 Age <45 y -1.45 (-2.99, +0.09) -1.26 (-2.20, -0.33) 

 ≥45 y -2.33 (-3.69, -0.96) -0.80 (-1.62, +0.02) 

 Male ≤50% -2.20 (-3.68, -0.72) -1.12 (-1.98, -0.26) 

 >50% -1.77 (-3.13, -0.42) -0.84 (-1.65, -0.04) 

 Initial BP <140/90 mm Hg -2.04 (-3.40, -0.68) -1.04 (-1.86, -0.22) 

 ≥140/90 mm Hg -1.85 (-3.45, -0.32) -0.89 (-1.79, +0.01) 

 Ca dose ≤1000 mg -2.17 (-3.59, -0.75) -1.41 (-2.24, -0.59) 

 >1000 mg -1.75 (-3.20, -0.31) -0.56 (-1.40, +0.29) 

 Blood pressures not statistically significantly different between any strata. 

Comments 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? No 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? Unclear Publication bias assessed? Yes 

Included and excluded studies listed? Partial Conflicts of interest stated? Yes 

Study characteristics provided? Yes No data on inclusion of unpublished data. Excluded 

studies available from authors 

 

2

 Numbers in parentheses are 95% confidence intervals 

8
Evidence table of systematic review s of calcium and blood pressure. continued 

Author Year [PMID] Bucher 1996 [8596234] 

Design (Search Years) Randomized controlled trials (1966-1994) 

Population Both hypertensive and normotensive participants 

Intervention and Comparator Dietary and nondietary calcium supplementation versus placebo (no supplement) 

Dose range 406-2000 mg (41% 1000 mg; 31% 1500-1600 mg; 8% 2000 mg) 

Results 33 trials 

[Overall summary results were updated in Griffith 1999{1927 /id}, above] 

Studies with specified subgroups of hypertensive and normotensive participants (6 trials): 

 Hypertensives SBP -4.30 (-6.47, -2.13) DBP -1.50 (-2.77, -0.23) 

 Normotensives SBP -0.27 (-1.80, +1.27) DBP -0.33 (-1.56, +0.90) 

Regression analyses: 

 BP (continuous scale) SBP OR = 0.99 (0.96, 1.01) DBP OR = 0.99 (0.96, 1.03) 

Dose of calcium, duration of supplementation, dietary vs nondietary calcium supplementation, 

methodological quality did not demonstrate a relationship with the magnitude of treatment effect. 

Comments Updated in Griffith 1999{1927 /id} (see above) 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? Yes 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? Yes Publication bias assessed? No 

Included and excluded studies listed? Yes Conflicts of interest stated? No 

Study characteristics provided? Yes Funding source reported, but not conflict of interest. 

Author Year [PMID] Allender 1996 [8610952] 

Design (Search Years) Randomized controlled trials (1982-1993) 

Population Both hypertensive and normotensive participants 

Intervention and Comparator Dietary and nondietary calcium supplementation versus placebo (no supplement) 

Dose range 400-2160 mg (35% 1000 mg; 29% 1500-1600 mg; 10% 2000 mg) 

Results 26 trials (22 trials included in metaanalyses) 

SBP: -0.89 (-1.74, -0.05) 

DBP: -0.18 (-0.75, +0.40) 

 Hypertensives SBP -1.68 (-3.18, -0.18) DBP +0.02 (-0.96, +1.00) 

 Normotensives SBP -0.53 (-1.56, +0.49) DBP -0.28 (-0.99, +0.42) 

By weighted linear regression analyses, age, sex, calcium dose, trial duration were not 

associated with treatment effect (P>0.10) 

Comments 

AMSTAR 

A priori design? Yes Study quality assessment performed? No 

Two independent reviewers? Yes Study quality appropriately used in analysis? No 

Comprehensive literature search? Yes Appropriate statistical synthesis? No 

All publication types and languages included? Yes Publication bias assessed? No 

Included and excluded studies listed? No Conflicts of interest stated? No 

Study characteristics provided? Yes Excluded studies not enumerated or listed. Fixed effects 

models used. 

Author Year [PMID] Cappuccio 1989 [2697729] 

Design (Search Years) Randomized controlled trials (1983-1988) 

Population Both hypertensive and normotensive participants 

Intervention and Comparator Nondietary calcium supplementation versus placebo (no supplement) or low calcium intake 

Dose range 800-1600 mg (60% 1000 mg; 27% 1500-1600 mg) 

Results 15 trials 

SBP (supine): -0.13 (-0.46, +0.19) 

DBP (supine): +0.03 (-0.17, +0.22) 

 Hypertensives SBP +0.06 (-0.59, +0.72) DBP +0.03 (-0.21, +0.27) 

Comments 

AMSTAR 

A priori design? Yes Study quality assessment performed? No 

Two independent reviewers? nd Study quality appropriately used in analysis? NA 

Comprehensive literature search? Yes Appropriate statistical synthesis? No 

All publication types and languages included? nd Publication bias assessed? No 

Included and excluded studies listed? No Conflicts of interest stated? No 

Study characteristics provided? Yes Excluded studies not enumerated or listed. Fixed effects 

models used. 

9
Evidence table of systematic review s of calcium and blood pressure. continued 

Author Year [PMID] Dickinson 2006 [16625609]3

Design (Search Years) Randomized controlled trials (1982-2003/20054) 

Population Hypertensive participants 

Intervention and Comparator Dietary and nondietary calcium supplementation versus placebo (no supplement) 

Dose range 400-2000 mg (50% 1000 mg; 25% 1500-1600 mg; 6% 2000 mg) 

Results 13 trials 

SBP: -2.53 (-4.45, -0.60); statistically heterogeneous 

DBP: -0.81 (-2.07, +0.44); statistically heterogeneous 

 Ca dose <1200 mg SBP -2.67 (-5.15, -0.18) DBP -0.75 (-2.13, +0.63) 

 Ca dose 1200-2000 mg SBP -2.69 (-5.86, +0.47) DBP -0.78 (-3.82, +2.25) 

 Not statistically significantly different by calcium dose 

Comments 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? Yes 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? Yes Publication bias assessed? Yes 

Included and excluded studies listed? Yes Conflicts of interest stated? Yes 

Study characteristics provided? Yes 

Evidence table of systematic review of calcium on growth in children 

Author Year [PMID] Winzenberg 2007 [17636098] 

Design (Search Years) Randomized controlled trials (1966-2005) 

Population Children <18 y 

Intervention (Exposure) and 

Comparator 

Supplemental and dietary calcium 300-1200 mg/d vs. placebo 

Results 17 trials (2088 participants) 

Weighted mean difference: +0.14 (95% CI -0.28, +0.57) Kg; favors control 

Weighted mean difference: +0.22 (95% CI -0.30, +0.74) cm; favors control 

 No significant statistical heterogeneity 

Comments Post hoc analysis performed on trials identified for a metaanalysis of randomized controlled trials 

of calcium on bone outcomes 

AMSTAR 

A priori design? Yes Study quality assessment performed? Yes 

Two independent reviewers? Yes Study quality appropriately used in analysis? No 

Comprehensive literature search? Yes Appropriate statistical synthesis? Yes 

All publication types and languages included? No Publication bias assessed? Yes 

Included and excluded studies listed? No Conflicts of interest stated? No 

Study characteristics provided? Yes Unclear if all languages included; study quality assessed but not 

factored into the M-A 

 

3

 A technical update, with no further studies added was published in the Cochrane database in 2008. 

4

 Different dates for different databases. 

10
11

 Evidence table of systematic review on calcium intake and adenoma recurrence 

Author Year [UI] Weingarten, 2008 [18254022] 

Design Randomized controlled trials: Cochrane Library Issue 2, 2007, the Cochrane Colorectal Cancer 

Group (CCCG) specialized register, MEDLINE (1966 to July 2007 ), Cancerlit (1963 to April 

2002), Embase (1980 to July 2007) 

Population Healthy adults and studies of adults at higher risk of colon cancer due to family history, previous 

adenomatous polyps, or inflammatory bowel disease 

Intervention (Exposure) and 

Comparator 

Calcium (>1200 mg/d) vs. placebo 

Results Calcium vs. placebo 

colorectal adenoma recurrence: OR 0.74, CI 0.58-0.95, P=0.02 

CRC: OR 0.34, CI 0.05-2.15, P=0.20 

at least one adverse event requiring discontinuation: OR 0.93, CI 0.42-2.05, P=0.80 

Comments Based only on two RCTs (1346 participants). Heterogeneity due to different dose of 

supplementation (one RCT supplemented with 1200 mg/d and the other RCT with 2000 mg/d). 

Analysis based on fixed effects model; however, considering there are only two studies, random 

effects model might have been more appropriate. Analysis on adverse events is based only on 

reported data of one out of the two RCTs (Barron 1999). Only participants with high risk due to 

previous adenomas were recruited in these two RCTs; therefore, applicability of the results can 

only be considered for high risk population. Insufficient evidence to recommend the general use 

of calcium supplements to prevent colorectal adenoma or colorectal cancer 

AMSTAR 

A priori design? X Study quality assessment performed? X 

Two independent reviewers? X Study quality appropriately used in analysis? X 

Comprehensive literature search? X Appropriate statistical synthesis? X 

All publication types and languages included? Publication bias assessed? 

Included and excluded studies listed? X Conflicts of interest stated? X 

Study characteristics provided? X 
Appendix E. Blank Data Extraction Form and Quality 

Assessment Checklists 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author 

Year 

Study Design* Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor 

RCT RCT-post hoc**

Other intervention study Cohort study Case-cohort study 

*Leave appropriate choice of study design and delete all others **Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCTPOPULATION (BASELINE)**UI Author Year Study Design*

Location 

(e.g., City and 

Country, 

latitude) 

N 

enrolled***

N 

analyzed 

Mean 

(SD) 

Age, yr 

Age 

Range / 

IQR 

Male, 

% 

Race / 

Ethnicity 

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc) 

Heal

Statu

*Please copy from above**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. ***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (egassessment), number of subjects had outcome data ...etc. Background Diet*UI Author Year Exposure Dietary Assessment Method** Food Composition Database***

Internal Calibration 

(or Validity) of 

Dietary 

Assessment? (y/n) 

If Yes, Provide Data 

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data 

Time between 

Biomarker 

Sampling and 

Analysis 

Sea

w

bi

sam

25(OH)D and/or 1,25(OH)2D Dietary calcium intake 

* Write “nd” if there was no data reported. Please do not leave blank **Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief ***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Countnutrient analysis (please specify) ****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author Year Intervention(s) Source (e.g., brand name, foods, or formulation) Vit D and/or Ca Total Daily Dose Intervention Duration Intervention Frequ

taken 

Co-intervention(s) *: Compliance/Adherence: Duplicate one row per intervention, including control intervention. *Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitam

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. LIST OF ALL OUTCOMES UI Author Year Primary / Secondary Outcome** Outcome Definition 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. **Must have been explicitly stated in the original paper. Otherwise, please enter “nd” UI Author 

Year Comments 

-----Confounders: Please report all confounders controlled in the analyses reported in the follow

(adjusted results) 

UI Author 

Year Confounder Groups Please List Name of Confounder (including matching factors) 

Other nutrients or dietary factors (e.g., certain food consumption), including supplement use and total energy intake Demographics (e.g., age, gender, race, education)? Yes/no*Anthropometrics (e.g., BMI, body weight, % body fat)? Yes/no*Medical conditions Medication Sunlight exposure and its proxy variables (e.g., seasonal variation of 25(OH)D, UV exposure, location) Smoking and other life styles variables (e.g., physical activity, occupation, alcohol consumption) 

Yes/no*

Other 

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLEC

ALL OUTCOMES OF INTEREST -----Main Analyses (For analyses that adjusted for confounders, choose the “best” model) 2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

Unadjusted 

UI Author Year Outcome Exposure / Intervention Mean Follow-up, 

mo 

N 

Event 

N 

Total 

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison* Result 95% CI 

b

*Example: OR Ca/placebo 2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) UI Author Year Outcome Unit Exposure / Intervention Mean Follow-up, 

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD* Final or Delta** Final or Delta CI / SE / SD* Net difference 

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas *Enter outcome metric reported in the unadjusted or adjusted result section **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 ≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) UI Author Year Outcome 

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups 

Mean 

Vit D 

level / 

dose 

Mean 

Ca 

level / 

dose 

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean 

Follow-up, 

mo 

Crude or 

Adjusted 

analysis? 

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%) 

Outcome 

effect 

size 

Duplicate one row per exposure category or intervention group. *Number of subjects with outcome **Please choose one and delete the others ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 ****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author Year Outcome Unit 

Exposure 

Category / 

Intervention 

Group 

Crude or 

Adjusted 

analysis? Mean Follow-up 

(months) 

No. 

Analyzed Baseline 

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / SD*

Net 

difference**

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. *Please choose one and delete the others **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH 

CONTROLS (WITHOUT DISEASE) UI Author Year Outcome Group 

Time between 

Baseline Exposure 

and Outcome 

Assessments 

Crude or 

Adjusted 

analysis? 

No. 

Analyzed 

Mean 

25(OH)D 

Level 

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance 

Ca CI 

/ SE / 

SD*

P 

between 

groups 

Cases: Control: 

Duplicate one table per outcome OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE UI Author Year Outcome Results UI Author 

Year Comments for Results 

-----Subgroup Analyses Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA) 

Allocation 

Concealment 

(y/n/nd/NA) 

Appropriate 

Washout 

Period 

(y/n/nd/NA) 

Dropout 

Rate 

<20% 

Blinded 

Outcome 

Assessment 

(y/n/nd) 

Intention 

to Treat 

Analysis 

(y/n/nd) 

Appropriate 

Statistical 

Analysis**

(y/n) 

Assessment 

for 

Confounding 

(y/n/nd/NA) 

Adverse Event(s): **Explanation for Overall Quality Grade (if not Grade A):NA=not applicable *Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) **Please do not leave blank. Type nd if there was no data on adverse events. QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES UI Author Year Population Exposure (All) Dietary assessment* Biomarkers* Comparator Statistical Analysis Outco

a) Eligibility criteria clear? (y/n) 

a) Exposure assessor blinded to outcome info? (y/n) 

a) Method reported? (y/n) 

a) One of the prespecified methods***was used? (y/n) 

a) Clear 

definition of outcome, including timascertainme(y/n) 

b) Sampling of population random or consecutive? (y/n) 

b) Outcome assessor blinded to exposure measurement? (y/n) 

b) Food composition database or suppl composition reported? (y/n) 

Time from 

sample collection to sample analysis reported? (y/n) 

a) Level of the exposure in comparative categories (eg quartiles) is given (ranges)? (y/n) applicable for categorical analyses only 

a) Adjusted or matched for ANY confounders (other than age and sex)?** (y/n) 

b) Loss to follow-up <2(y/n) 

c) Internal calibration of method perform (if FFQ)? (y/n/NA) 

b) Justification of final adjusted model selection? (y/n) 

c) Do the authors spea primary outcome? (y

OVERALL Grade (A/B/C): Explanation for Overall Quality Grade (if not Grade A):*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers **We will judge in the end if the set of confounders is adequate ***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
Appendix F. Excluded Studies 

Excluded Study Reason 

Aalberts JS, Weegels PL, van der HL et al. Calcium supplementation: 

effect on blood pressure and urinary mineral excretion in normotensive 

male lactoovovegetarians and omnivores. American Journal of Clinical 

Nutrition 48 (1):131-8, 1988. 

No outcomes of interest 

Abbasi AA, Chemplavil JK, Farah S, Muller BF, Arnstein AR. 

Hypercalcemia in active pulmonary tuberculosis. Annals of Internal 

Medicine 90 (3):324-8, 1979. 

No UL outcomes 

Abrams SA, Griffin IJ, Hawthorne KM, Ellis KJ. Effect of prebiotic 

supplementation and calcium intake on body mass index. Journal of 

Pediatrics 2007; 151(3):293-298. 

Not a calcium intervention trial 

Adams JS, Lee G. Gains in bone mineral density with resolution of 

Vitamin D intoxication. Annals of Internal Medicine 127 (3):203-6, 

1997. 

Case report 

Akcakus M, Koklu E, Budak N, Kula M, Kurtoglu S, Koklu S. The 

relationship between birthweight, 25-hydroxyVitamin D concentrations 

and bone mineral status in neonates. Annals of Tropical Paediatrics 

2006; 26(4):267-275. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Ala-Houhala M, Koskinen T, Terho A, Koivula T, Visakorpi J. Maternal 

compared with infant Vitamin D supplementation. Archives of Disease 

in Childhood 61 (12):1159-63, 1986. 

Not RCT arrow 4 study 

Ala-Houhala M. 25-HydroxyVitamin D levels during breast-feeding 

with or without maternal or infantile supplementation of Vitamin D. 

Journal of Pediatric Gastroenterology & Nutrition 4(2):220-6, 1985. 

In Ottawa EPC report 

Almendingen K, Hofstad B, Vatn MH. Dietary habits and growth and 

recurrence of colorectal adenomas: results from a three-year endoscopic 

follow-up study. Nutrition & Cancer 49 (2):131-8, 2004. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Almendingen K, Hofstad B, Vatn MH. Lifestyle-related factors and 

colorectal polyps: preliminary results from a Norwegian follow-up and 

intervention study. European Journal of Cancer Prevention 11(2):153-8, 

2002. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Almendingen K, Trygg K, Hofstad B, Veierod MB, Vatn MH. Results 

from two repeated 5 day dietary records with a 1 y interval among 

patients with colorectal polyps. European Journal of Clinical Nutrition 

55 (5):374-9, 2001. 

No outcomes of interest 

Al-oanzi ZH, Tuck SP, Raj N et al. Assessment of Vitamin D status in 

male osteoporosis. Clinical Chemistry 52 (2):248-54, 2006. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Aloia JF, Talwar SA, Pollack S, Feuerman M, Yeh JK. Optimal Vitamin 

D status and serum parathyroid hormone concentrations in African 

American women. American Journal of Clinical Nutrition 84 (3):602-9, 

2006. 

No outcomes of interest 

Anonymous. Calcium supplementation during pregnancy reduces the 

risk of developing preeclampsia in nulliparous women. Canadian Family 

Physician 45:614, 618-20, 1999. 

Editorial-like brief review 

1
Excluded Study Reason 

Anonymous. Vitamin D supplementation for northern native 

communities. Indian and Inuit Health Committee, Canadian Paediatric 

Society. CMAJ Canadian Medical Association Journal 138 (3):229-30, 

1988. 

Review paper 

Armitage NC, Rooney PS, Gifford KA, Clarke PA, Hardcastle JD. The 

effect of calcium supplements on rectal mucosal proliferation. British 

Journal of Cancer 71 (1):186-90, 1995. 

No outcomes of interest 

Armstrong AL, Oborne J, Coupland CA, Macpherson MB, Bassey EJ, 

Wallace WA. Effects of hormone replacement therapy on muscle 

performance and balance in post-menopausal women. Clinical Science 

91 (6):685 -90, 1996. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Arunabh S, Pollack S, Yeh J, Aloia JF. Body fat content and 25-

hydroxyVitamin D levels in healthy women. Journal of Clinical 

Endocrinology & Metabolism 88 (1):157-61, 2003. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

August P, Helseth G, Cook EF, Sison C. A prediction model for 

superimposed preeclampsia in women with chronic hypertension during 

pregnancy. American Journal of Obstetrics & Gynecology. 191(5):1666-

72, 2004 Nov. 

>=20% subjects with diseases 

August P, Marcaccio B, Gertner JM, Druzin ML, Resnick LM, Laragh 

JH. Abnormal 1,25-dihydroxyVitamin D metabolism in preeclampsia. 

American Journal of Obstetrics & Gynecology 166 (4):1295-9, 1992. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Back O, Blomquist HK, Hernell O, Stenberg B. Does vitamin D intake 

during infancy promote the development of atopic allergy? Acta 

Dermato -Venereologica 89 (1):28 -32 , 2009. 

combination of vit D/Ca and other 

treatment w/o analysis of independent 

effect 

Bailey BW, Sullivan DK, Kirk EP, Hall S, Donnelly JE. The influence 

of calcium consumption on weight and fat following 9 months of 

exercise in men and women. Journal of the American College of 

Nutrition 2007; 26(4):350-355. 

No outcomes of interest 

Bakker R, Rifas-Shiman SL, Kleinman KP, Lipshultz SE, Gillman MW. 

Maternal calcium intake during pregnancy and blood pressure in the 

offspring at age 3 years: a follow-up analysis of the Project Viva cohort. 

American Journal of Epidemiology 168 (12 ):1374 -80 , 2008. 

age <18 (BP outcome) 

Baron JA, Beach M, Mandel JS et al. Calcium supplements and 

colorectal adenomas. Polyp Prevention Study Group. Annals of the New 

York Academy of Sciences 889:138-45, 1999. 

Duplicate publication (see Baron 1999 

NEJM) 

Baron JA, Beach M, Mandel JS et al. Calcium supplements for the 

prevention of colorectal adenomas. Calcium Polyp Prevention Study 

Group. . New England Journal of Medicine 340 (2):101-7, 1999. 

In Weigarten 2008 systematic review 

Baron JA, Tosteson TD, Wargovich MJ et al. Calcium supplementation 

and rectal mucosal proliferation: a randomized controlled trial. . Journal 

of the National Cancer Institute 87 (17):1303-7, 1995. 

No outcomes of interest 

Barr SI. Calcium and body fat in peripubertal girls: cross-sectional and 

longitudinal observations. Obesity 2007; 15(5):1302-1310. 

Not RCT growth study 

Barsoum GH, Hendrickse C, Winslet MC et al. Reduction of mucosal 

crypt cell proliferation in patients with colorectal adenomatous polyps b

dietary calcium supplementation. British Journal of Surgery 79 (6):

3, 1992. 

y 

581-

No outcomes of interest 

2
Excluded Study Reason 

Basile LA, Taylor SN, Wagner CL, Horst RL, Hollis BW. The effect of 

high-dose Vitamin D supplementation on serum Vitamin D levels and 

milk calcium concentration in lactating women and their infants. 

Breastfeeding Medicine: The Official Journal of the Academy of 

Breastfeeding Medicine 2006; 1(1):27-35. 

In Ottawa EPC report 

Belizan JM, Villar J, Bergel E et al. Long-term effect of calcium 

supplementation during pregnancy on the blood pressure of offspring: 

follow up of a randomised controlled trial.. BMJ 315 (7103):281-5, 

1997. 

In Hofmeyer 2007 systematic review 

Belizan JM, Villar J, Gonzalez L, Campodonico L, Bergel E. Calcium 

supplementation to prevent hypertensive disorders of pregnancy.. New 

England Journal of Medicine 325 (20):1399 -405, 1991. 

In Hofmeyer 2007 systematic review 

Belizan JM, Villar J, Pineda O et al. Reduction of blood pressure with 

calcium supplementation in young adults. JAMA 249 (9):1161 -5, 1983. 

In systematic review 

Belizan JM, Villar J, Zalazar A, Rojas L, Chan D, Bryce GF. 

Preliminary evidence of the effect of calcium supplementation on blood 

pressure in normal pregnant women. American Journal of Obstetrics & 

Gynecology 146 (2):175 -80, 1983. 

In Hofmeyer 2007 systematic review 

Bell NH, Epstein S, Greene A, Shary J, Oexmann MJ, Shaw S. Evidence 

for alteration of the Vitamin D-endocrine system in obese subjects. 

Journal of Clinical Investigation 76 (1):370-3, 1985. 

Not RCT arrow 4 study 

Bell NH, Epstein S, Shary J, Greene V, Oexmann MJ, Shaw S. Evidence 

of a probable role for 25-hydroxyVitamin D in the regulation of human 

calcium metabolism. Journal of Bone & Mineral Research 3(5):489-95, 

1988. 

Not RCT arrow 4 study 

Bell NH, Godsen RN, Henry DP, Shary J, Epstein S. The effects of 

muscle-building exercise on Vitamin D and mineral metabolism. Journal 

of Bone & Mineral Research 3(4):369-73, 1988. 

No outcomes of interest 

Bell NH. Hypercalcemic and hypocalcemic disorders: diagnosis and 

treatment. Nephron 23(2-3):147-51, 1979. 

Review paper 

Berggren M, Stenvall M, Olofsson B, Gustafson Y. Evaluation of a fallprevention program in older people after femoral neck fracture: a oneyear follow-up. Osteoporosis International 1919;801-9. 

100% patients with femoral neck 

fracture who admitted to the hospital 

Berkey CS, Rockett HR, Willett WC, Colditz GA. Milk, dairy fat, 

dietary calcium, and weight gain: a longitudinal study of adolescents.. 

Archives of Pediatrics & Adolescent Medicine 159 (6):543 -50, 2005. 

Not RCT growth study 

Berube S, Diorio C, Masse B et al. Vitamin D and calcium intakes from 

food or supplements and mammographic breast density. Cancer 

Epidemiology, Biomarkers & Prevention 14(7):1653-9, 2005. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Bierenbaum ML, Fleischman AI, Raichelson RI. Long term human 

studies on the lipid effects of oral calcium. Lipids 7 (3):202-6, 1972. 

No outcomes of interest 

Bierenbaum ML, Wolf E, Bisgeier G, Maginnis WP. Dietary calcium. A 

method of lowering blood pressure. American Journal of Hypertension 

1(3 Pt 3):149S -152S, 1988. 

In systematic review 

3
Excluded Study Reason 

Bischoff HA, Stahelin HB, Dick W et al. Effects of Vitamin D and 

calcium supplementation on falls: a randomized controlled trial.. Journal 

of Bone & Mineral Research 18 (2):343-51, 2003. 

In Ottawa EPC report 

Bischoff-Ferrari HA, Conzelmann M, Stahelin HB et al. Is fall 

prevention by Vitamin D mediated by a change in postural or dynamic 

balance? Osteoporosis International 2006; 17(5):656-663. 

Secondary analysis of an original RCT 

by Bischoff-Ferrari 2003, which is 

already in Ottawa's report 

Bischoff-Ferrari HA, Orav EJ, wson-Hughes B. Effect of cholecalciferol 

plus calcium on falling in ambulatory older men and women: a 3-year 

randomized controlled trial. Archives of Internal Medicine 166 (4):424-

30, 2006. 

In Ottawa EPC report 

Blum M, Kirsten M, Worth MH, Jr. Reversible hypertension. Caused by 

the hypercalcemia of hyperparathyroidism, Vitamin D toxicity, and 

calcium infusion. JAMA 237 (3):262 -3, 1977. 

No 25(OH)D or dietary Ca 

Boggess KA, Samuel L, Schmucker BC, Waters J, Easterling TR. A 

randomized controlled trial of the effect of third-trimester calcium 

supplementation on maternal hemodynamic function. Obstetrics & 

Gynecology 90 (2):157-61, 1997. 

In Hofmeyer 2007 systematic review 

Bonithon-Kopp C, Kronborg O, Giacosa A, Rath U, Faivre J. Calcium 

and fibre supplementation in prevention of colorectal adenoma 

recurrence: a randomised intervention trial. European Cancer Prevention 

Organisation Study Group. . Lancet 356 (9238):1300-6, 2000. 

In Weigarten 2008 systematic review 

Bonithon-Kopp C, Piard F, Fenger C et al. Colorectal adenoma 

characteristics as predictors of recurrence. Diseases of the Colon & 

Rectum 47 (3):323-33, 2004. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Boon N, Koppes LL, Saris WH, Van MW. The relation between calcium 

intake and body composition in a Dutch population: The Amsterdam 

Growth and Health Longitudinal Study. American Journal of 

Epidemiology 162 (1):27-32, 2005. 

No outcomes of interest 

Bostick RM, Fosdick L, Grandits GA, Grambsch P, Gross M, Louis TA. 

Effect of calcium supplementation on serum cholesterol and blood 

pressure. A randomized, double-blind, placebo-controlled, clinical trial. 

Archives of Family Medicine 9(1):31-8 2000. 

>=20% subjects with diseases 

Bostick RM, Fosdick L, Wood JR et al. Calcium and colorectal 

epithelial cell proliferation in sporadic adenoma patients: a randomized, 

double-blinded, placebo-controlled clinical trial.. Journal of the National 

Cancer Institute 87 (17):1307-15, 1995. 

No outcomes of interest 

Bostick RM, Potter JD, Fosdick L et al. Calcium and colorectal 

epithelial cell proliferation: a preliminary randomized, double-blinded, 

placebo-controlled clinical trial. Journal of the National Cancer Institute. 

85(2):132-41, 1993 Jan 20. 

No outcomes of interest 

Boutron MC, Faivre J, Marteau P, Couillault C, Senesse P, Quipourt V. 

Calcium, phosphorus, Vitamin D, dairy products and colorectal 

carcinogenesis: a French case--control study.. British Journal of Cancer 

74 (1):145-51, 1996. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

4
Excluded Study Reason 

Bowen J, Noakes M, Clifton PM. Effect of calcium and dairy foods in 

high protein, energy-restricted diets on weight loss and metabolic 

parameters in overweight adults. International Journal of Obesity 29 

(8):957-65, 2005. 

In systematic review 

Braverman AS. Evidence that high calcium and Vitamin D intake 

decrease the risk of breast cancer in premenopausal women: implications 

for breast cancer prevention and screening. Southern Medical Journal 

100 (11):1061-2, 2007. 

Review paper 

Brekke HK, Ludvigsson J. Vitamin D supplementation and diabetesrelated autoimmunity in the ABIS study. Pediatric Diabetes 2007; 

8(1):11-14. 

No 25(OH)D or dietary Ca 

Broe KE, Chen TC, Weinberg J, Bischoff-Ferrari HA, Holick MF, Kiel 

DP. A higher dose of Vitamin d reduces the risk of falls in nursing home 

residents: a randomized, multiple-dose study. Journal of the American 

Geriatrics Society 2007; 55(2):234-239. 

In Ottawa EPC report 

Brooke OG, Butters F, Wood C. Intrauterine Vitamin D nutrition and 

postnatal growth in Asian infants. British Medical Journal Clinical 

Research Ed 283 (6298):1024, 1981. 

No 25(OH)D or dietary Ca 

Brooke OG. Supplementary Vitamin D in infancy and childhood. 

Archives of Disease in Childhood 1983; 58(8):573-574. 

Review paper 

Brunvand L, Quigstad E, Urdal P, Haug E. Vitamin D deficiency and 

fetal growth. Early Human Development 45 (1-2):27-33, 1996. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Brunvand L, Shah SS, Bergstrom S, Haug E. Vitamin D deficiency in 

pregnancy is not associated with obstructed labor. A study among 

Pakistani women in Karachi. Acta Obstetricia et Gynecologica 

Scandinavica 77 (3):303-6, 1998. 

No outcomes of interest 

Campbell CG, Chew BP, Luedecke LO, Shultz TD. Yogurt consumption 

does not enhance immune function in healthy premenopausal women. 

Nutrition & Cancer 37 (1):27-35, 2000. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Cancela L, Le BN, Miravet L. Relationship between the Vitamin D 

content of maternal milk and the Vitamin D status of nursing women and 

breast-fed infants. Journal of Endocrinology 110 (1):43-50, 1986. 

Not RCT arrow 4 study 

Canto-Costa MH, Kunii I, Hauache OM. Body fat and cholecalciferol 

supplementation in elderly homebound individuals. Brazilian Journal of 

Medical & Biological Research 39 (1):91-8, 2006. 

Not RCT arrow 4 study 

Caplan RH, Miller CD, Silva PD. Severe hypercalcemia in a lactating 

woman in association with moderate calcium carbonate 

supplementation: a case report. Journal of Reproductive Medicine 49 

(3):214-7, 2004. 

Case report 

Cappuccio FP, Elliott P, Allender PS, Pryer J, Follman DA, Cutler JA. 

Epidemiologic association between dietary calcium intake and blood 

pressure: a meta-analysis of published data. . American Journal of 

Epidemiology 142 (9):935-45, 1995. 

Meta-analysis 

Carlon GC, Howland WS, Goldiner PL, Kahn RC, Bertoni G, Turnbull 

AD. Adverse effects of calcium administration. Report of two cases. 

Archives of Surgery 113 (7):882-5, 1978. 

Case report 

5
Excluded Study Reason 

Carlson LA, Derblom H, Lanner A. Effect of different doses of Vitamin 

D on serum cholesterol and triglyceride levels in healthy men. 

Atherosclerosis 12 (2):313-7, 1970. 

Multiple antioxidant trials analyses 

Caruso JB, Patel RM, Julka K, Parish DC. Health-behavior induced 

disease: return of the milk-alkali syndrome. Journal of General Internal 

Medicine 2007; 22(7):1053-1055. 

Case report 

Cats A, Kleibeuker JH, van der MR et al. Randomized, double-blinded, 

placebo-controlled intervention study with supplemental calcium in 

families with hereditary nonpolyposis colorectal cancer. Journal of the 

National Cancer Institute 87 (8):598-603, 1995. 

No outcomes of interest 

Cervellin G, Bonino P, Palummeri E, Passeri M. Calcium phosphate and 

blood pressure: their relationships in a geriatric population. American 

Journal of Nephrology 6 Suppl 1:16-8, 1986. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Chan GM, Roberts CC, Folland D, Jackson R. Growth and bone 

mineralization of normal breast-fed infants and the effects of lactation on 

maternal bone mineral status. American Journal of Clinical Nutrition 36 

(3):438-43, 1982. 

In Ottawa EPC report 

Chan GM. Growth and bone mineral status of discharged very low birth 

weight infants fed different formulas or human milk. Journal of 

Pediatrics 123 (3):439-43, 1993. 

>=20% subjects with diseases 

Chan JM, Pietinen P, Virtanen M et al. Diet and prostate cancer risk in a 

cohort of smokers, with a specific focus on calcium and phosphorus 

(Finland). Cancer Causes & Control 11(9):859-67, 2000. 

Superseded by Mitrou 2007 

Chen W, Dawsey SM, Qiao YL et al. Prospective study of serum 

25(OH)-Vitamin D concentration and risk of oesophageal and gastric 

cancers. British Journal of Cancer 2007; 97(1):123-128. 

No outcomes of interest 

Chyou PH, Nomura AM, Stemmermann GN. Diet, alcohol, smoking and 

cancer of the upper aerodigestive tract: a prospective study among 

Hawaii Japanese men. International Journal of Cancer 60 (5):616-21, 

1995. 

No outcomes of interest 

Cleghorn GJ, Tudehope DI. Neonatal intestinal obstruction associated 

with oral calcium supplementation. Australian Paediatric Journal 

17(4):298-9, 1981. 

Case report 

Cockburn F, Belton NR, Purvis RJ et al. Maternal Vitamin D intake and 

mineral metabolism in mothers and their newborn infants. British 

Medical Journal 281 (6232):11-4, 1980. 

Not RCT arrow 4 study 

Cohen GR, Curet LB, Levine RJ et al. Ethnicity, nutrition, and birth 

outcomes in nulliparous women. American Journal of Obstetrics & 

Gynecology 2001; 185(3):660-667. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Colditz GA, Manson JE, Stampfer MJ, Rosner B, Willett WC, Speizer 

FE. Diet and risk of clinical diabetes in women. American Journal of 

Clinical Nutrition 55 (5):1018 -23, 1992. 

No outcomes of interest 

Combs GF, Jr., Hassan N, Dellagana N et al. Apparent efficacy of foodbased calcium supplementation in preventing rickets in Bangladesh. 

Biological Trace Element Research 121 (3):193 -204, 2008. 

>=20% subjects with diseases 

6
Excluded Study Reason 

Cong K, Chi S, Liu G. Calcium supplementation during pregnancy for 

reducing pregnancy induced hypertension. Chinese Medical Journal 108 

(1):57-9, 1995. 

In Hofmeyer 2007 systematic review 

Corless D, Dawson E, Fraser F et al. Do Vitamin D supplements 

improve the physical capabilities of elderly hospital patients? Age & 

Ageing 14(2):76-84, 1985. 

In Ottawa EPC report 

Cosman F, Nieves J, Shen V, Lindsay R. Oral 1,25-dihydroxyVitamin D 

administration in osteoporotic women: effects of estrogen therapy. 

Journal of Bone & Mineral Research 10(4):594-600, 1995. 

Not RCT arrow 4 study 

Costenbader KH, Feskanich D, Holmes M, Karlson EW, ito-Garcia E. 

Vitamin D intake and risks of systemic lupus erythematosus and 

rheumatoid arthritis in women. Annals of the Rheumatic Diseases 67 

(4):530-5, 2008. 

Observational study estimated Vitamin 

D supplement doses 

Crowther CA, Hiller JE, Pridmore B et al. Calcium supplementation in 

nulliparous women for the prevention of pregnancy-induced 

hypertension, preeclampsia and preterm birth: an Australian randomized 

trial. FRACOG and the ACT Study Group. Australian & New Zealand 

Journal of Obstetrics & Gynaecology 39 (1):12-8, 1999. 

In Hofmeyer 2007 systematic review 

Dahifar H, Faraji A, Yassobi S, Ghorbani A. Asymptomatic rickets in 

adolescent girls. Indian Journal of Pediatrics 2007; 74(6):571-575. 

Not RCT arrow 4 study 

Dattani JT, Exton-Smith AN, Stephen JM. Vitamin D status of the 

elderly in relation to age and exposure to sunlight. Human Nutrition - 

Clinical Nutrition 38 (2):131-7, 1984. 

Not RCT arrow 4 study 

Dauchet L, Kesse-Guyot E, Czernichow S et al. Dietary patterns and 

blood pressure change over 5-y follow-up in the SU.VI.MAX cohort. 

American Journal of Clinical Nutrition 2007; 85(6):1650-1656. 

No 25(OH)D or dietary Ca 

Davie MW, Abraham RR, Hewins B, Wynn V. Changes in bone and 

muscle constituents during dieting for obesity. Clinical Science 70 

(3):285-93, 1986. 

No outcomes of interest 

Davies KM, Heaney RP, Recker RR et al. Calcium intake and body 

weight. Journal of Clinical Endocrinology & Metabolism 85 (12):4635-

8, 2000. 

Meta-analysis; five clinical studies 

Deheeger M, Bellisle F, Rolland-Cachera MF. The French longitudinal 

study of growth and nutrition: data in adolescent males and females. 

Journal of Human Nutrition & Dietetics 15 (6):429-38, 2002. 

Analysis did not relate exposure to 

outcome 

DeJongh ED, Binkley TL, Specker BL. Fat mass gain is lower in 

calcium-supplemented than in unsupplemented preschool children with 

low dietary calcium intakes. American Journal of Clinical Nutrition 84 

(5):1123-7, 2006. 

<9y (a study on BMI) 

Dent CE, Gupta MM. Plasma 25-hydroxyVitamin-D-levels during 

pregnancy in Caucasians and in vegetarian and non-vegetarian Asians. 

Lancet 2(7944):1057-60, 1975. 

No outcomes of interest 

DeSantiago S, Alonso L, Halhali A, Larrea F, Isoard F, Bourges H. 

Negative calcium balance during lactation in rural Mexican women. 

American Journal of Clinical Nutrition 76 (4):845-51, 2002. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

7
Excluded Study Reason 

Devereux G, Litonjua AA, Turner SW et al. Maternal Vitamin D intake 

during pregnancy and early childhood wheezing. American Journal of 

Clinical Nutrition 2007; 85(3):853-859. 

No 25(OH)D or dietary Ca 

Dewey KG, Lonnerdal B. Milk and nutrient intake of breast-fed infants 

from 1 to 6 months: relation to growth and fatness. Journal of Pediatric 

Gastroenterology & Nutrition 2(3):497 -506, 1983. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Dhesi JK, Bearne LM, Moniz C et al. Neuromuscular and psychomotor 

function in elderly subjects who fall and the relationship with Vitamin D 

status. Journal of Bone & Mineral Research 17(5):891-7, 2002. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Dhesi JK, Jackson SH, Bearne LM et al. Vitamin D supplementation 

improves neuromuscular function in older people who fall. Age & 

Ageing 33 (6):589-95, 2004. 

Intramuscular injection of high dose 

ergocalciferol 

Dijkstra SH, van BA, Janssen JW, de Vleeschouwer LH, Huysman WA, 

van den Akker EL. High prevalence of Vitamin D deficiency in newborn 

infants of high-risk mothers.[erratum appears in Arch Dis Child. 2007 

Nov;92(11):1049]. Archives of Disease in Childhood 2007; 92(9):750-

753. 

Relationship betweem mother's 

25(OH)D and infant's 25(OH)D levels 

Dixon LB, Pellizzon MA, Jawad AF, Tershakovec AM. Calcium and 

dairy intake and measures of obesity in hyper- and 

normocholesterolemic children. Obesity Research 13(10):1727-38, 2005. 

Outcome is BW but participants age is 

from 4 to 10y (mostly <9y) 

Dobnig H, Pilz S, Scharnagl H et al. Independent association of low 

serum 25-hydroxyvitamin d and 1,25-dihydroxyvitamin d levels with 

all-cause and cardiovascular mortality. Archives of Internal Medicine 

168 (12 ):1340 -9 , 2008. 

>=20% subjects with diseases 

Doege C, Bauer J. Effect of high volume intake of mother's milk with an 

individualized supplementation of minerals and protein on early growth 

of preterm infants <28 weeks of gestation. Clinical Nutrition 26 (5):581-

8, 2007. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Domrongkitchaiporn S, Ongphiphadhanakul B, Stitchantrakul W et al. 

Risk of calcium oxalate nephrolithiasis after calcium or combined 

calcium and calcitriol supplementation in postmenopausal women. 

Osteoporosis International 11(6):486-92, 2000. 

No outcomes of interest, no UL 

outcomes 

Drinka PJ, Nolten WE. Hazards of treating osteoporosis and 

hypertension concurrently with calcium, Vitamin D, and distal diuretics. 

Journal of the American Geriatrics Society 32 (5):405-7, 1984. 

Case report 

Drouillet P, Balkau B, Charles MA et al. Calcium consumption and 

insulin resistance syndrome parameters. Data from the Epidemiological 

Study on the Insulin Resistance Syndrome (DESIR). Nutrition 

Metabolism & Cardiovascular Diseases 2007; 17(7):486-492. 

No outcomes of interest 

Ehrenberg A. Non-medical prevention of pre-eclampsia. Acta 

Obstetricia et Gynecologica Scandinavica - Supplement 164:108-10, 

1997. 

Review paper 

Epstein S, Bell NH, Shary J, Shaw S, Greene A, Oexmann MJ. Evidence 

that obesity does not influence the Vitamin D-endocrine system in 

blacks. Journal of Bone & Mineral Research 1(2):181-4, 1986. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

8
Excluded Study Reason 

Epstein S, Stern PH, Bell NH, Dowdeswell I, Turner RT. Evidence for 

abnormal regulation of circulating 1 alpha, 25-dihydroxyVitamin D in 

patients with pulmonary tuberculosis and normal calcium metabolism. 

Calcified Tissue International 36 (5):541-4, 1984. 

Not RCT arrow 4 study 

Ertbeg P, Norgaard P, Bang L, Nyholm H, Rudnicki M. Ionized 

magnesium in gestational diabetes. Magnesium Research 17(1):35-8, 

2004. 

No 25(OH)D or dietary Ca 

Faivre J, Couillault C, Kronborg O et al. Chemoprevention of 

metachronous adenomas of the large bowel: design and interim results of 

a randomized trial of calcium and fibre. ECP Colon Group. European 

Journal of Cancer Prevention 6(2):132-8, 1997. 

Design and interim results article 

Farrerons J, Barnadas M, Rodriguez J et al. Clinically prescribed 

sunscreen (sun protection factor 15) does not decrease serum Vitamin D 

concentration sufficiently either to induce changes in parathyroid 

function or in metabolic markers. British Journal of Dermatology 139 

(3):422-7, 1998. 

No outcomes of interest 

Faulkner KA, Cauley JA, Zmuda JM et al. Higher 1,25-

dihydroxyVitamin D3 concentrations associated with lower fall rates in 

older community-dwelling women. Osteoporosis International 2006; 

17(9):1318-1328. 

In Ottawa EPC report 

Feeley RM, Eitenmiller RR, Jones JB, Jr., Barnhart H. Calcium, 

phosphorus, and magnesium contents of human milk during early 

lactation. Journal of Pediatric Gastroenterology & Nutrition 2(2):262-7, 

1983. 

No outcomes of interest 

Felson DT, Niu J, Clancy M et al. Low levels of Vitamin D and 

worsening of knee osteoarthritis: results of two longitudinal studies. 

Arthritis & Rheumatism 2007; 56(1):129-136. 

No outcomes of interest 

Fleischman AR, Rosen JF, Cole J, Smith CM, DeLuca HF. Maternal and 

fetal serum 1,25-dihydroxyVitamin D levels at term. Journal of 

Pediatrics 1980; 97(4):640-642. 

No outcomes of interest 

Fleischman AR, Rosen JF, Nathenson G. 25-hydroxyVitamin D. Serum 

levels and oral administration of calcifediol in neonates. Archives of 

Internal Medicine 138 Spec No: 869-73, 1978. 

Premature infants 

Forman JP, Bischoff-Ferrari HA, Willett WC, Stampfer MJ, Curhan GC. 

Vitamin D intake and risk of incident hypertension: results from three 

large prospective cohort studies. Hypertension 46 (4):676-82, 2005. 

No 25(OH)D or dietary Ca 

Franco A, Sikalidis AK, Solis Herruzo JA. Colorectal cancer: influence 

of diet and lifestyle factors. Revista Espanola de Enfermedades 

Digestivas 97 (6):432-48, 2005. 

Review paper 

Freedman DM, Tangrea JA, Virtamo J, Albanes D. The effect of betacarotene supplementation on serum Vitamin D metabolite 

concentrations. Cancer Epidemiology, Biomarkers & Prevention 8 

(12):1115-6, 1999. 

No outcomes of interest 

Fronczak CM, Baron AE, Chase HP et al. In utero dietary exposures and 

risk of islet autoimmunity in children. Diabetes Care 26 (12):3237 -42 , 

2003. 

Observational study estimated Vitamin 

D supplement doses 

9
Excluded Study Reason 

Galloe AM, Graudal N, Moller J, Bro H, Jorgensen M, Christensen HR. 

Effect of oral calcium supplementation on blood pressure in patients 

with previously untreated hypertension: a randomised, double-blind, 

placebo-controlled, crossover study. Journal of Human Hypertension 7 

(1):43-5, 1993. 

In systematic review 

Gambacciani M, Ciaponi M, Cappagli B et al. Body weight, body fat 

distribution, and hormonal replacement therapy in early postmenopausal 

women.[erratum appears in J Clin Endocrinol Metab 1997 

Dec;82(12):4074]. Journal of Clinical Endocrinology & Metabolism 82 

(2):414-7, 1997. 

No outcomes of interest 

Garland CF, Garland FC. Do sunlight and Vitamin D reduce the 

likelihood of colon cancer? [reprint in Int J Epidemiol. 2006 

Apr;35(2):217-20; PMID: 16303809]. International Journal of 

Epidemiology 9 (3):227-31, 1980. 

Ecological study 

Garland CF, Mohr SB, Gorham ED, Grant WB, Garland FC. Role of 

ultraviolet B irradiance and Vitamin D in prevention of ovarian cancer. 

American Journal of Preventive Medicine 2006; 31(6):512-514. 

No 25(OH)D or dietary Ca 

Genkinger JM, Hunter DJ, Spiegelman D et al. Dairy products and 

ovarian cancer: a pooled analysis of 12 cohort studies. Cancer 

Epidemiology, Biomarkers & Prevention 15 (2):364-72, 2006. 

Pooled analysis 

Gertner JM, Domenech M. 25-HydroxyVitamin D levels in patients 

treated with high-dosage ergo- and cholecalciferol. Journal of Clinical 

Pathology 30(2):144-50, 1977. 

>=20% subjects with diseases 

Gillies DR, Hay A, Sheltawy MJ, Congdon PJ. Effect of phototherapy 

on plasma 25(OH)-Vitamin D in neonates. Biology of the Neonate 1984; 

45(5):225-227. 

Not RCT arrow 4 study 

Gillman MW, Oliveria SA, Moore LL, Ellison RC. Inverse association 

of dietary calcium with systolic blood pressure in young children. JAMA 

267 (17):2340-3, 1992. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Gillman MW, Rifas-Shiman SL, Kleinman KP, Rich-Edwards JW, 

Lipshultz SE. Maternal calcium intake and offspring blood pressure. 

Circulation 110 (14):1990-5, 2004. 

Relationship between maternal intake 

and offspring blood pressure 

Giovannucci E, Liu Y, Rimm EB et al. Prospective study of predictors 

of Vitamin D status and cancer incidence and mortality in men.. Journal 

of the National Cancer Institute 98 (7):451-9, 2006. 

Superseded by Giovannucci 2007 

Giovannucci E, Rimm EB, Wolk A et al. Calcium and fructose intake in 

relation to risk of prostate cancer. Cancer Research 58 (3):442-7, 1998. 

Predictive model was used to predict 

25(OH)D levels of whole cohort 

Giovannucci E, Stampfer MJ, Colditz GA et al. MultiVitamin use, 

folate, and colon cancer in women in the Nurses' Health Study.. Annals 

of Internal Medicine 129 (7):517 -24, 1998. 

No 25(OH)D or dietary Ca 

Gonzalez AJ, White E, Kristal A, Littman AJ. Calcium intake and 10-

year weight change in middle-aged adults. Journal of the American 

Dietetic Association 106 (7):1066-73 2006. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

10
Excluded Study Reason 

Goswami R, Gupta N, Ray D, Singh N, Tomar N. Pattern of 25-hydroxy 

vitamin D response at short (2 month) and long (1 year) interval after 8 

weeks of oral supplementation with cholecalciferol in Asian Indians 

with chronic hypovitaminosis D. British Journal of Nutrition 100 (3):526 

-9 , 2008. 

not RCT curve 4 study 

Grady D, Halloran B, Cummings S et al. 1,25-DihydroxyVitamin D3 

and muscle strength in the elderly: a randomized controlled trial. Journal 

of Clinical Endocrinology & Metabolism 73 (5):1111-7, 1991. 

1,25(OH)2D supplement 

Grant WB. The likely role of Vitamin D from solar ultraviolet-B 

irradiance in increasing cancer survival. Anticancer Research 26 (4A 

):2605-14, 2006. 

Ecological study 

Grau MV, Baron JA, Barry EL et al. Interaction of calcium 

supplementation and nonsteroidal anti-inflammatory drugs and the risk 

of colorectal adenomas. Cancer Epidemiology, Biomarkers & 

Prevention 14(10):2353-8, 2005. 

In Weigarten 2008 systematic review 

Greene MF. Trial of calcium to prevent preeclampsia. Journal of 

Women's Health 6(4):485-6, 1997. 

Commentary 

Greer FR, Ho M, Dodson D, Tsang RC. Lack of 25-hydroxyVitamin D 

and 1,25-dihydroxyVitamin D in human milk. Journal of Pediatrics 99 

(2):233-5, 1981. 

No 25(OH)D or dietary Ca 

Greer FR, Hollis BW, Cripps DJ, Tsang RC. Effects of maternal 

ultraviolet B irradiation on Vitamin D content of human milk. Journal of 

Pediatrics 105 (3):431-3, 1984. 

No 25(OH)D or dietary Ca 

Greer FR, Marshall S. Bone mineral content, serum Vitamin D 

metabolite concentrations, and ultraviolet B light exposure in infants fed 

human milk with and without Vitamin D2 supplements. Journal of 

Pediatrics 114 (2):204-12, 1989. 

In Ottawa EPC report 

Greer FR, Searcy JE, Levin RS, Steichen JJ, Asch PS, Tsang RC. Bone 

mineral content and serum 25-hydroxyVitamin D concentration in 

breast-fed infants with and without supplemental Vitamin D. Journal of 

Pediatrics 98 (5):696-701, 1981. 

In Ottawa EPC report 

Gruson M, Cancela L, Denne MA, Miravet L. Relationship between 

bone GLA-protein (BGP) and calcidiol (25-hydroxycalciferol) in serum 

of breast-fed infants. Endocrinologia Experimentalis. 20(2-3):329-34, 

1986 Aug. 

25(OH)D supplement 

Gunther CW, Legowski PA, Lyle RM et al. Dairy products do not lead 

to alterations in body weight or fat mass in young women in a 1-y 

intervention. American Journal of Clinical Nutrition 81 (4):751-6, 2005. 

In systematic review 

Gunther CW, Legowski PA, Lyle RM et al. Parathyroid hormone is 

associated with decreased fat mass in young healthy women. 

International Journal of Obesity 30 (1):94-9, 2006. 

Ca intake and BW measured but not 

assessed ==> no relevant results 

reported 

Haddad JG, Jr., Rojanasathit S. Acute administration of 25-

hydroxycholecalciferol in man. Journal of Clinical Endocrinology & 

Metabolism 42 (2):284 -90, 1976. 

Not RCT arrow 4 study 

Hakala P, Karvetti RL. Weight reduction on lactovegetarian and mixed 

diets. Changes in weight, nutrient intake, skinfold thicknesses and blood 

pressure. European Journal of Clinical Nutrition 43 (6):421-30, 1989. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

11
Excluded Study Reason 

Halhali A, Villa AR, Madrazo E et al. Longitudinal changes in maternal 

serum 1,25-dihydroxyVitamin D and insulin like growth factor I levels 

in pregnant women who developed preeclampsia: comparison with 

normotensive pregnant women. Journal of Steroid Biochemistry & 

Molecular Biology 89 -90 (1-5):553-6, 2004. 

No outcomes of interest 

Hamet P, Mongeau E, Lambert J et al. Interactions among calcium, 

sodium, and alcohol intake as determinants of blood pressure. 

Hypertension 17(1 Suppl):I150-4, 1991. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Hamid Z, Riggs A, Spencer T, Redman C, Bodenner D. Vitamin D 

deficiency in residents of academic long-term care facilities despite 

having been prescribed Vitamin D.. Journal of the American Medical 

Directors Association 2007; 8(2):71-75. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Hansen KE, Jones AN, Lindstrom MJ, Davis LA, Engelke JA, Shafer 

MM. Vitamin D insufficiency: disease or no disease? Journal of Bone & 

Mineral Research 23(7):1052-60, 2008. 

Not RCT arrow 4 study 

Haub MD, Simons TR, Cook CM, Remig VM, Al-Tamimi EK, 

Holcomb CA. Calcium-fortified beverage supplementation on body 

composition in postmenopausal women. Nutrition Journal 4:21, 2005. 

In systematic review 

Heilbrun LK, Hankin JH, Nomura AM, Stemmermann GN. Colon 

cancer and dietary fat, phosphorus, and calcium in Hawaiian-Japanese 

men. American Journal of Clinical Nutrition 43 (2):306-9, 1986. 

Letter to the editor 

Heilbrun LK, Nomura A, Hankin JH, Stemmermann GN. Dietary 

Vitamin D and calcium and risk of colorectal cancer. Lancet 1985; 

1(8434):925. 

Superceded by Stemmermann, 1990 

RefID 1691 

Herrera JA, revalo-Herrera M, Herrera S. Prevention of preeclampsia by 

linoleic acid and calcium supplementation: a randomized controlled trial. 

Obstetrics & Gynecology 91 (4):585 -90, 1998. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Herrmann U, Schwille PO, Schmiedl A, Fan J, Manoharan M. Acute 

effects of calcium sodium citrate supplementation of a test meal on 

mineral homeostasis, oxalate, and calcium oxalate crystallization in the 

urine of healthy humans--preliminary results in patients with idiopathic 

calcium urolithiasis. Biomedicine & Pharmacotherapy 53 (5-6):264-73, 

1999. 

No UL outcomes: CaOx crystallization; 

saturation of CaOx 

Hill KM, Braun M, Kern M et al. Predictors of calcium retention in 

adolescent boys. Journal of Clinical Endocrinology & Metabolism 93 

(12 ):4743 -8 , 2008. 

no outcomes of interest 

Hiller JE, Crowther CA, Moore VA, Willson K, Robinson JS. Calcium 

supplementation in pregnancy and its impact on blood pressure in 

children and women: follow up of a randomised controlled trial. 

Australian & New Zealand Journal of Obstetrics & Gynaecology 2007; 

47(2):115-121. 

No outcomes of interest 

Hillman LS, Haddad JG. Perinatal Vitamin D metabolism. II. Serial 25-

hydroxyVitamin D concentrations in sera of term and premature infants. 

Journal of Pediatrics 1975; 86(6):928-935. 

No clear Vitamin D dose for term 

infants 

12
Excluded Study Reason 

Hillman LS, Johnson LS, Lee DZ, Vieira NE, Yergey AL. Measurement 

of true absorption, endogenous fecal excretion, urinary excretion, and 

retention of calcium in term infants by using a dual-tracer, stable-isotope 

method. Journal of Pediatrics 1993; 123(3):444-456. 

All neonates included weighed < 1500 

gm 

Hintzpeter B, Mensink GB, Thierfelder W, Muller MJ, Scheidt-Nave C. 

Vitamin D status and health correlates among German adults. European 

Journal of Clinical Nutrition 62 (9 ):1079 -89 , 2008. 

cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Hofmeyr GJ, Mlokoti Z, Nikodem VC et al. Calcium supplementation 

during pregnancy for preventing hypertensive disorders is not associated 

with changes in platelet count, urate, and urinary protein: a randomized 

control trial. Hypertension in Pregnancy 27 (3):299 -304 , 2008. 

ancillary study (small sample) of WHO 

trial. The preeclampsia data of WHO 

trial was already included in the 

previous SR (Hofmeyer2007). 

Hofstad B, Almendingen K, Vatn M et al. Growth and recurrence of 

colorectal polyps: a double-blind 3-year intervention with calcium and 

antioxidants. Digestion 59 (2):148-56, 1998. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Hofstad B, Vatn MH, Andersen SN, Owen RW, Larsen S, Osnes M. The 

relationship between faecal bile acid profile with or without 

supplementation with calcium and antioxidants on recurrence and 

growth of colorectal polyps. European Journal of Cancer Prevention 7 

(4):287-94, 1998. 

No independent Ca effect 

Hollis BW, Wagner CL. Vitamin D requirements during lactation: highdose maternal supplementation as therapy to prevent hypoVitaminosis D 

for both the mother and the nursing infant. Am J Clin Nutr 2004; 80(6 

Suppl):1752S-1758S. 

In Ottawa EPC report 

Hollis JH, Mattes RD. Effect of increased dairy consumption on 

appetitive ratings and food intake. [erratum appears in Obesity (Silver 

Spring). 2007 Oct;15(10):2520]. Obesity 2007; 15(6):1520-1526. 

No outcomes of interest 

Holt PR, Atillasoy EO, Gilman J et al. Modulation of abnormal colonic 

epithelial cell proliferation and differentiation by low-fat dairy foods: a 

randomized controlled trial. . JAMA 280 (12):1074-9, 1998. 

No outcomes of interest 

Holt PR, Bresalier RS, Ma CK et al. Calcium plus Vitamin D alters 

preneoplastic features of colorectal adenomas and rectal mucosa. Cancer 

106 (2):287-96, 2006. 

No outcomes of interest 

Holt PR, Wolper C, Moss SF, Yang K, Lipkin M. Comparison of 

calcium supplementation or low-fat dairy foods on epithelial cell 

proliferation and differentiation. Nutrition & Cancer 41 (1-2):150-5, 

2001. 

No outcomes of interest 

Hunt CD, Johnson LK. Calcium requirements: new estimations for men 

and women by cross-sectional statistical analyses of calcium balance 

data from metabolic studies. American Journal of Clinical Nutrition 

2007; 86(4):1054-1063. 

Arrow 4: calcium balance 

Hvarfner A, Ljunghall S, Morlin C, Wide L. Calcium metabolism and 

arterial blood pressure in a healthy population sample and in 

hypertensive men. American Journal of Nephrology 6 Suppl 1:14-5, 

1986. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Hyman J, Baron JA, Dain BJ et al. Dietary and supplemental calcium 

and the recurrence of colorectal adenomas. Cancer Epidemiology, 

Biomarkers & Prevention 7 (4):291-5, 1998. 

Multiple antioxidant trials analyses 

13
Excluded Study Reason 

Hypponen E, Hartikainen AL, Sovio U, Jarvelin MR, Pouta A. Does 

Vitamin D supplementation in infancy reduce the risk of pre-eclampsia? 

European Journal of Clinical Nutrition 2007; 61(9):1136-1139. 

Observational study estimated Vitamin 

D supplement doses 

Hypponen E, Laara E, Reunanen A, Jarvelin MR, Virtanen SM. Intake 

of Vitamin D and risk of type 1 diabetes: a birth-cohort study.. Lancet 

358 (9292):1500-3, 2001. 

Observational study estimated Vitamin 

D supplement doses 

Hypponen E, Sovio U, Wjst M et al. Infant Vitamin d supplementation 

and allergic conditions in adulthood: northern Finland birth cohort 1966. 

Annals of the New York Academy of Sciences 1037:84-95, 2004. 

Observational study estimated Vitamin 

D supplement doses 

Ilich-Ernst JZ, McKenna AA, Badenhop NE et al. Iron status, menarche, 

and calcium supplementation in adolescent girls.[erratum appears in Am 

J Clin Nutr 1999 Mar;69(3):577]. American Journal of Clinical Nutrition 

68 (4):880-7, 1998. 

Ca intake, BMI, LBM and BW 

measured, but the analyses on the 

relationship among these were not 

performed. 

Ish-Shalom S, Segal E, Salganik T, Raz B, Bromberg IL, Vieth R. 

Comparison of daily, weekly, and monthly vitamin D3 in ethanol dosing 

protocols for two months in elderly hip fracture patients. Journal of 

Clinical Endocrinology & Metabolism 93 (9 ):3430 -5, 2008. 

arrow 4 RCT but daily doses were the 

same in the comparison groups 

(comparison of daily, weekly versus 

monthly dose) 

Ito M, Koyama H, Ohshige A, Maeda T, Yoshimura T, Okamura H. 

Prevention of preeclampsia with calcium supplementation and Vitamin 

D3 in an antenatal protocol. International Journal of Gynaecology & 

Obstetrics 47 (2):115 -20, 1994. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Jackson RD, Donepudi S, Mysiw WJ. Epidemiology of fracture risk in 

the Women's Health Initiative. Current Osteoporosis Reports 6 (4):155 -

61 , 2008. 

review paper 

Jackson RD, Lacroix AZ, Cauley JA, McGowan J. The Women's Health 

Initiative calcium-Vitamin D trial: overview and baseline characteristics 

of participants. Annals of Epidemiology 13(9 Suppl):S98-106, 2003. 

Overview of trial participants 

Jackson RD, Lacroix AZ, Gass M et al. Calcium plus Vitamin D 

supplementation and the risk of fractures.[erratum appears in N Engl J 

Med. 2006 Mar 9;354(10):1102]. New England Journal of Medicine 354 

(7):669-83, 2006. 

Same as Wactawski-Wende 2006 RefID 

1967 in which longer f/up data reported 

Jacobs D. Calcium and myocardial infarction. South African Medical 

Journal Suid -Afrikaanse Tydskrif Vir Geneeskunde 48 (13):523-7, 

1974. 

No 25(OH)D or dietary Ca 

Jacobs ET, Alberts DS, Benuzillo J, Hollis BW, Thompson PA, 

Martinez ME. Serum 25(OH)D levels, dietary intake of Vitamin D, and 

colorectal adenoma recurrence. Journal of Steroid Biochemistry & 

Molecular Biology 2007; 103(3-5):752-756. 

Analyses include 25(OH)D 

measurements taken after outcome 

(colorectal polyps) occurred. 

Jacques PF, Felson DT, Tucker KL et al. Plasma 25-hydroxyVitamin D 

and its determinants in an elderly population sample. American Journal 

of Clinical Nutrition 66 (4):929-36, 1997. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Joffe GM, Esterlitz JR, Levine RJ et al. The relationship between 

abnormal glucose tolerance and hypertensive disorders of pregnancy in 

healthy nulliparous women. Calcium for Preeclampsia Prevention 

(CPEP) Study Group.. American Journal of Obstetrics & Gynecology 

179 (4):1032-7, 1998. 

No 25(OH)D or dietary Ca 

14
Excluded Study Reason 

John EM, Dreon DM, Koo J, Schwartz GG. Residential sunlight 

exposure is associated with a decreased risk of prostate cancer. . Journal 

of Steroid Biochemistry & Molecular Biology 89 -90 (1-5):549 -52, 

2004. 

No 25(OH)D or dietary Ca 

John WG, Noonan K, Mannan N, Boucher BJ. HypoVitaminosis D is 

associated with reductions in serum apolipoprotein A-I but not with 

fasting lipids in British Bangladeshis. American Journal of Clinical 

Nutrition 82 (3):517-22, 2005. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Johnson MA, Fischer JG, Park S. Vitamin D deficiency and 

insufficiency in the Georgia Older Americans Nutrition Program. 

Journal of Nutrition for the Elderly 27 (1-2):29 -46 , 2008. 

combination of vit D/Ca and other 

treatment w/o analysis of independent 

effect 

Johnson NE, Smith EL, Freudenheim JL. Effects on blood pressure of 

calcium supplementation of women. American Journal of Clinical 

Nutrition 42 (1):12-7, 1985. 

In systematic review 

Jones G, Scott F. Low bone mass in premenopausal parous women: 

identification and the effect of an information and bone density feedback 

program. . Journal of Clinical Densitometry 2(2):109-15, 1999. 

No outcomes of interest 

Jorde R, Bonaa KH. Calcium from dairy products, Vitamin D intake, 

and blood pressure: the Tromso Study.. American Journal of Clinical 

Nutrition 71 (6):1530-5, 2000. 

No outcomes of interest 

Kampman E, Giovannucci E, van ', V et al. Calcium, Vitamin D, dairy 

foods, and the occurrence of colorectal adenomas among men and 

women in two prospective studies. Am J Epidemiol 1994; 139(1):16-29. 

Same cohorts as Wu 2002 RefID 529 

(HPFS & NHS) and same exposureoutcome relationship but shorter followup 

Karanja N, Morris CD, Illingworth DR, McCarron DA. Plasma lipids 

and hypertension: response to calcium supplementation. American 

Journal of Clinical Nutrition 45 (1):60-5, 1987. 

No outcomes of interest 

Karanja N, Morris CD, Rufolo P, Snyder G, Illingworth DR, McCarron 

DA. Impact of increasing calcium in the diet on nutrient consumption, 

plasma lipids, and lipoproteins in humans. . American Journal of 

Clinical Nutrition 59 (4):900-7, 1994. 

No outcomes of interest 

Kawano Y. Role of blood pressure monitoring in non-pharmacological 

management of hypertension. Blood Pressure Monitoring 7 (1):51-4, 

2002. 

Review paper 

Kearney J, Giovannucci E, Rimm EB et al. Calcium, Vitamin D, and 

dairy foods and the occurrence of colon cancer in men. American 

Journal of Epidemiology 143 (9):907-17, 1996. 

Longer followup data were published in 

Wu 2002 

Kemi VE, Karkkainen MU, Karp HJ, Laitinen KA, Lamberg-Allardt CJ. 

Increased calcium intake does not completely counteract the effects of 

increased phosphorus intake on bone: an acute dose-response study in 

healthy females. British Journal of Nutrition 99 (4):832-9, 2008. 

No outcomes of interest 

Kenny AM, Bellantonio S, Gruman CA, Acosta RD, Prestwood KM. 

Effects of transdermal testosterone on cognitive function and health 

perception in older men with low bioavailable testosterone levels. 

Journals of Gerontology Series A-Biological Sciences & Medical 

Sciences 57 (5):M321-5, 2002. 

No 25(OH)D or dietary Ca 

15
Excluded Study Reason 

Kenny AM, Biskup B, Robbins B, Marcella G, Burleson JA. Effects of 

Vitamin D supplementation on strength, physical function, and health 

perception in older, community-dwelling men. Journal of the American 

Geriatrics Society 51 (12):1762-7, 2003. 

In Ottawa EPC report 

Kesteloot H, Geboers J. Calcium and blood pressure. Lancet 

1(8276):813 -5, 1982. 

No 25(OH)D or dietary Ca 

Khaw KT, Barrett-Connor E. Dietary potassium and stroke-associated 

mortality. A 12-year prospective population study. New England Journal 

of Medicine 316 (5):235-40, 1987. 

Continuous Ca intake analysis only 

Kigutha HN, van Staveren WA, Wijnhoven TM, Hautvast JG. Maternal 

nutritional status may be stressed by seasonal fluctuations in food 

availability: evidence from rural women in Kenya. International Journal 

of Food Sciences & Nutrition 46 (3):247-55, 1995. 

Ca intake, BMI and BW measured, but 

analysis did not relate Ca intake to 

BMI/BW. 

Knekt P, Laaksonen M, Mattila C et al. Serum Vitamin D and 

subsequent occurrence of type 2 diabetes. Epidemiology. 19(5):666-71, 

2008 Sep. 

No outcomes of interest 

Knight KB, Keith RE. Calcium supplementation on normotensive and 

hypertensive pregnant women. American Journal of Clinical Nutrition 

55 (4):891-5, 1992. 

No outcomes of interest 

Knox EG. Ischaemic-heart-disease mortality and dietary intake of 

calcium. Lancet 1(7818):1465-7, 1973. 

Analysis @ region level, not individual 

level 

Kobayashi E, Okubo Y, Suwazono Y et al. Association between urinary 

calcium excretion level and mortality in inhabitants of the Jinzu River 

basin area of Japan. Biological Trace Element Research 89(2):145-53, 

2002. 

No 25(OH)D or dietary Ca 

Koh-Banerjee PK, Ferreira MP, Greenwood M et al. Effects of calcium 

pyruvate supplementation during training on body composition, exercise 

capacity, and metabolic responses to exercise. Nutrition 21(3):312-9, 

2005. 

No 25(OH)D or dietary Ca 

Kokot F, Pietrek J, Srokowska S et al. 25-hydroxyVitamin D in patients 

with essential hypertension. Clinical Nephrology 16 (4):188-92, 1981. 

On drug Rx for hypertension 

Koralek DO, Bertone-Johnson ER, Leitzmann MF et al. Relationship 

between calcium, lactose, Vitamin D, and dairy products and ovarian 

cancer. Nutrition & Cancer 2006; 56(1):22-30. 

No outcomes of interest 

Kristal AR, Chi C, Tangen CM, Goodman PJ, Etzioni R, Thompson IM. 

Associations of demographic and lifestyle characteristics with prostatespecific antigen (PSA) concentration and rate of PSA increase. Cancer 

106 (2):320-8, 2006. 

No outcomes of interest 

Kromhout D, Bosschieter EB, Coulander CD. Potassium, calcium, 

alcohol intake and blood pressure: the Zutphen Study. American Journal 

of Clinical Nutrition 41 (6):1299-304, 1985. 

No outcomes of interest 

Kulier R, de OM, Gulmezoglu AM, Villar J. Nutritional interventions 

for the prevention of maternal morbidity. International Journal of 

Gynaecology & Obstetrics 63 (3):231-46, 1998. 

SR of prevention of maternal morbidity 

16
Excluded Study Reason 

Kumar R, Cohen WR, Silva P, Epstein FH. Elevated 1,25-

dihydroxyVitamin D plasma levels in normal human pregnancy and 

lactation. Journal of Clinical Investigation 63 (2):342-4, 1979. 

No outcomes of interest 

Kuroda T, Shiraki M, Tanaka S, Ohta H. Contributions of 25-

hydroxyvitamin D, co-morbidities and bone mass to mortality in 

Japanese postmenopausal women. Bone 44 (1):168 -72 , 2009. 

>=20% subjects with diseases 

Kynast-Gales SA, Massey LK. Effects of dietary calcium from dairy 

products on ambulatory blood pressure in hypertensive men.. Journal of 

the American Dietetic Association 92 (12):1497-501, 1992. 

In systematic review 

Laaksi I, Ruohola JP, Tuohimaa P et al. An association of serum 

Vitamin D concentrations < 40 nmol/L with acute respiratory tract 

infection in young Finnish men. American Journal of Clinical Nutrition 

86 (3):714-7, 2007. 

No outcomes of interest 

Lakdawala DR, Widdowson EM. Vitamin-D in human milk. Lancet 

1(8004):167-8, 1977. 

No outcomes of interest 

Lamberg-Allardt C, Larjosto M, Schultz E. 25-HydroxyVitamin D 

concentrations in maternal and cord blood at delivery and in maternal 

blood during lactation in Finland. Human Nutrition - Clinical Nutrition 

38 (4):261-8, 1984. 

Not RCT arrow 4 study 

Lancia B, Tedesco M, Sergio G, Tenna M. Anthropometric and 

nutritional assessment in Italian elderly subjects. Journal of Nutrition, 

Health & Aging 1(3):174-80, 1997. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Lappe JM, Davies KM, Travers-Gustafson D, Heaney RP. Vitamin D 

status in a rural postmenopausal female population. Journal of the 

American College of Nutrition 2006; 25(5):395-402. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Laraia BA, Bodnar LM, Siega-Riz AM. Pregravid body mass index is 

negatively associated with diet quality during pregnancy. Public Health 

Nutrition 2007; 10(9):920-926. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Lasco A, Gaudio A, Morini E et al. Effect of long-term treatment with 

raloxifene on mammary density in postmenopausal women. Menopause 

2006; 13(5):787-792. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Latham NK, Anderson CS, Lee A et al. A randomized, controlled trial of 

quadriceps resistance exercise and Vitamin D in frail older people: the 

Frailty Interventions Trial in Elderly Subjects (FITNESS). . Journal of 

the American Geriatrics Society 51 (3):291-9, 2003. 

In Ottawa EPC report 

Le BN, Cancela L, Miravet L. Calcidiol in human milk. The effect of 

prohormone on Vitamin D status of breast fed unsupplemented infants. 

Endocrinologia Experimentalis. 20(2-3):325-8, 1986. 

Correlation b/tw breastmilk 25(OH)D 

with infant's serum 25(OH)D 

Lee DC, Lee GY. The use of pamidronate for hypercalcemia secondary 

to acute Vitamin D intoxication. Journal of Toxicology - Clinical 

Toxicology 36 (7):719-21, 1998. 

Case report 

Lee WT, Leung SS, Wang SH et al. Double-blind, controlled calcium 

supplementation and bone mineral accretion in children accustomed to a 

low-calcium diet.. American Journal of Clinical Nutrition 60 (5):744 -

50, 1994. 

In Winzenberg 2007 systematic review, 

no outcomes of interest 

17
Excluded Study Reason 

Levine AJ, Harper JM, Ervin CM et al. Serum 25-hydroxyVitamin D, 

dietary calcium intake, and distal colorectal adenoma risk. Nutrition & 

Cancer 2001; 39(1):35-41. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Levine RJ, Esterlitz JR, Raymond EG et al. Trial of Calcium for 

Preeclampsia Prevention (CPEP): rationale, design, and methods. 

Controlled Clinical Trials 17(5):442-69, 1996. 

Methods for trial 

Levine RJ, Hauth JC, Curet LB et al. Trial of calcium to prevent 

preeclampsia.. New England Journal of Medicine 337 (2):69-76, 1997. 

In Hofmeyer 2007 systematic review 

Lewandowski S, Rodgers AL. Renal response to lithogenic and antilithogenic supplement challenges in a stone-free population group. 

Journal of Renal Nutrition 14(3):170-9, 2004. 

No UL outcomes: saturation of CaOx 

Liebman M, Chopin LF, Carter E et al. Factors related to blood pressure 

in a biracial adolescent female population. Hypertension 8(10):843-50, 

1986. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Lin PH, Appel LJ, Funk K et al. The PREMIER intervention helps 

participants follow the Dietary Approaches to Stop Hypertension dietary 

pattern and the current Dietary Reference Intakes recommendations. 

Journal of the American Dietetic Association 2007; 107(9):1541-1551. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Lin YC, Lyle RM, McCabe LD, McCabe GP, Weaver CM, Teegarden 

D. Dairy calcium is related to changes in body composition during a 

two-year exercise intervention in young women. Journal of the 

American College of Nutrition. 19(6):754-60, 2000 Nov-Dec. 

No outcomes of interest 

Lind L, Lithell H, Skarfors E, Wide L, Ljunghall S. Reduction of blood 

pressure by treatment with alphacalcidol. A double-blind, placebocontrolled study in subjects with impaired glucose tolerance. Acta 

Medica Scandinavica 223 (3):211-7, 1988. 

>=20% subjects with diseases 

Lipkin M, Friedman E, Winawer SJ, Newmark H. Colonic epithelial cell 

proliferation in responders and nonresponders to supplemental dietary 

calcium. Cancer Research 49 (1):248 -54, 1989. 

>=20% subjects with diseases 

Lipkin M, Newmark H. Effect of added dietary calcium on colonic 

epithelial-cell proliferation in subjects at high risk for familial colonic 

cancer. New England Journal of Medicine 313 (22):1381-4, 1985. 

No outcomes of interest 

Liu LS. Epidemiology of hypertension and cardiovascular disease--

China experience. Clinical & Experimental Hypertension - Part A, 

Theory & Practice 12 (5):831-44, 1990. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Liu S, Choi HK, Ford E et al. A prospective study of dairy intake and the 

risk of type 2 diabetes in women. Diabetes Care 29 (7):1579-84, 2006. 

No 25(OH)D or dietary Ca 

Ljunghall S, Lind L, Lithell H et al. Treatment with one-alphahydroxycholecalciferol in middle-aged men with impaired glucose 

tolerance--a prospective randomized double-blind study. Acta Medica 

Scandinavica 222 (4):361-7, 1987. 

>=20% subjects with diseases 

Lonzer MD, Imrie R, Rogers D, Worley D, Licata A, Secic M. Effects of 

heredity, age, weight, puberty, actiVitaminy, and calcium intake on bone 

mineral density in children. Clinical Pediatrics 35 (4):185-9, 1996. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

18
Excluded Study Reason 

Lopez-Jaramillo P, Delgado F, Jacome P, Teran E, Ruano C, Rivera J. 

Calcium supplementation and the risk of preeclampsia in Ecuadorian 

pregnant teenagers. Obstetrics & Gynecology 90 (2):162-7, 1997. 

In Hofmeyer 2007 systematic review 

Lopez-Jaramillo P, Narvaez M, Weigel RM, Yepez R. Calcium 

supplementation reduces the risk of pregnancy-induced hypertension in 

an Andes population. British Journal of Obstetrics & Gynaecology 96 

(6):648 -55, 1989. 

In Hofmeyer 2007 systematic review 

Luft FC, Aronoff GR, Sloan RS, Fineberg NS, Weinberger MH. Shortterm augmented calcium intake has no effect on sodium homeostasis. 

Clinical Pharmacology & Therapeutics 39 (4):414-9, 1986. 

No outcomes of interest 

Lutter CK, Rodriguez A, Fuenmayor G, Avila L, Sempertegui F, 

Escobar J. Growth and micronutrient status in children receiving a 

fortified complementary food. Journal of Nutrition 138 (2):379-88, 

2008. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Lyle RM. Does baseline serum total calcium level influence the blood 

pressure response to calcium supplementation? A double-blind study. 

Netherlands Journal of Medicine 41 (1-2):48-55, 1992. 

In systematic review 

Lynch MF, Griffin IJ, Hawthorne KM, Chen Z, Hamzo M, Abrams SA. 

Calcium balance in 1-4-y-old children. American Journal of Clinical 

Nutrition 2007; 85(3):750-754. 

Arrow 4: calcium balance 

Ma J, Stampfer MJ, Gann PH et al. Vitamin D receptor polymorphisms, 

circulating Vitamin D metabolites, and risk of prostate cancer in United 

States physicians. Cancer Epidemiology, Biomarkers & Prevention 7 

(5):385-90, 1998. 

Main results had been previous 

published (Gann 1996, RefID 3783), and 

no additional usable data 

Macdonald HM, New SA, Campbell MK, Reid DM. Longitudinal 

changes in weight in perimenopausal and early postmenopausal women: 

effects of dietary energy intake, energy expenditure, dietary calcium 

intake and hormone replacement therapy. International Journal of 

Obesity & Related Metabolic Disorders: Journal of the International 

Association for the Study of Obesity 27 (6):669-76, 2003. 

No outcomes of interest 

Madore F, Stampfer MJ, Rimm EB, Curhan GC. Nephrolithiasis and risk 

of hypertension. American Journal of Hypertension 11(1 Pt 1):46-53, 

1998. 

No outcomes of interest 

Malila N, Virtanen M, Pietinen P et al. A comparison of prospective and 

retrospective assessments of diet in a study of colorectal cancer. 

Nutrition & Cancer 32 (3):146 -53, 1998. 

Superseded by Pietinen 1999 

Mandic-Puljek M, Mandic ML, Perl A, Kenjeric D. Calcium intake, 

food sources and seasonal variations in eastern Croatia. Collegium 

Antropologicum 29 (2):503-7, 2005. 

No outcomes of interest 

Manios Y, Moschonis G, Grammatikaki E, Katsaroli I, Kanelou P, 

Tanagra S. Nutrition education in postmenopausal women: changes in 

dietary and cardiovascular indices. Maturitas 2006; 55(4):338-347. 

Nutrition education intervention study 

Marangella M, Vitaminale C, Petrarulo M, Rovera L, Dutto F. Effects of 

mineral composition of drinking water on risk for stone formation and 

bone metabolism in idiopathic calcium nephrolithiasis. Clinical Science 

91 (3):313-8, 1996. 

No UL outcomes: saturation of CaOx 

19
Excluded Study Reason 

Markestad T, Kolmannskog S, Arntzen E, Toftegaard L, Haneberg B, 

Aksnes L. Serum concentrations of Vitamin D metabolites in exclusively 

breast-fed infants at 70 degrees north. Acta Paediatrica Scandinavica 73 

(1):29-32, 1984. 

No relation with 25(OH)D to growth 

outcome 

Markestad T. Effect of season and Vitamin D supplementation on 

plasma concentrations of 25-hydroxyVitamin D in Norwegian infants. 

Acta Paediatrica Scandinavica 72 (6):817-21, 1983. 

Not RCT arrow 4 study 

Markestad T. Plasma concentrations of Vitamin D metabolites in 

unsupplemented breast-fed infants. European Journal of Pediatrics 141 

(2):77-80, 1983. 

No outcomes of interest 

Marniemi J, Jarvisalo J, Toikka T, Raiha I, Ahotupa M, Sourander L. 

Blood Vitamins, mineral elements and inflammation markers as risk 

factors of vascular and non-vascular disease mortality in an elderly 

population. International Journal of Epidemiology 27 (5):799-807, 1998. 

No 25(OH)D or dietary Ca 

Martinez ME, Giovannucci EL, Colditz GA et al. Calcium, Vitamin D, 

and the occurrence of colorectal cancer among women. Journal of the 

National Cancer Institute 88 (19):1375-82, 1996. 

Longer followup data were published in 

Wu 2002 

Marx SJ, Swart EG, Jr., Hamstra AJ, DeLuca HF. Normal intrauterine 

development of the fetus of a woman receiving extraordinarily high 

doses of 1,25-dihydroxyVitamin D3. Journal of Clinical Endocrinology 

& Metabolism 51 (5):1138 -42, 1980. 

Case report 

Masse PG, Tranchant CC, Jougleux JL, Coburn SP, Cole DE. 

Cardiovascular disease-risk factors in middle-aged osteopaenic women 

treated with calcium alone or combined to three nutrients essential to 

artery and bone collagen. Journal of Human Nutrition & Dietetics 

21(2):117-28, 2008. 

No outcomes of interest 

Matheson NA. Letter: Multiple sclerosis and diet. Lancet 2 (7884):831, 

1974. 

Letter to the editor 

Matsumoto T, Kubodera N. ED-71, a new active Vitamin D3, increases 

bone mineral density regardless of serum 25(OH)D levels in 

osteoporotic subjects. Journal of Steroid Biochemistry & Molecular 

Biology 2007; 103(3-5):584-586. 

Vitamin D analog 

Mawer EB, Berry JL, Sommer-Tsilenis E, Beykirch W, Kuhlwein A, 

Rohde BT. Ultraviolet irradiation increases serum 1,25-

dihydroxyVitamin D in Vitamin-D-replete adults. Mineral & Electrolyte 

Metabolism 10(2):117-21, 1984. 

Not RCT arrow 4 study 

Mazess RB, Peppler WW, Chesnut CH, III, Nelp WB, Cohn SH, Zanzi 

I. Total body bone mineral and lean body mass by dual-photon 

absorptiometry. II. Comparison with total body calcium by neutron 

activation analysis. Calcified Tissue International 33 (4):361-3, 1981. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Mazess RB, Peppler WW, Harrison JE, McNeill KG. Total body bone 

mineral and lean body mass by dual-photon absorptiometry. III. 

Comparison with trunk calcium by neutron activation analysis. Calcified 

Tissue International 33 (4):365-8, 1981. 

No 25(OH)D or dietary Ca 

20
Excluded Study Reason 

McCarron DA, Morris CD. Blood pressure response to oral calcium in 

persons with mild to moderate hypertension. A randomized, doubleblind, placebo-controlled, crossover trial. Annals of Internal Medicine 

103 (6 (Pt 1)):825 -31, 1985. 

In systematic review 

Merlino LA, Curtis J, Mikuls TR et al. Vitamin D intake is inversely 

associated with rheumatoid arthritis: results from the Iowa Women's 

Health Study.. Arthritis & Rheumatism 50(1):72-7, 2004. 

Observational study estimated Vitamin 

D supplement doses 

Methy N, Binquet C, Boutron-Ruault MC, Paillot B, Faivre J, BonithonKopp C. Dietary fatty acids and recurrence of colorectal adenomas in a 

European intervention trial. Nutrition & Cancer 60 (5):560 -7 , 2008. 

no 25(OH)D or dietary Ca 

Michaud DS, Spiegelman D, Clinton SK, Rimm EB, Willett WC, 

Giovannucci E. Prospective study of dietary supplements, 

macronutrients, micronutrients, and risk of bladder cancer in US men. 

American Journal of Epidemiology 152 (12):1145-53, 2000. 

No outcomes of interest 

Misselwitz J, Hesse V, Markestad T. Nephrocalcinosis, hypercalciuria 

and elevated serum levels of 1,25-dihydroxyVitamin D in children. 

Possible link to Vitamin D toxicity. Acta Paediatrica Scandinavica 79 

(6-7):637-43, 1990. 

Case report 

Moerman CJ, Smeets FW, Kromhout D. Dietary risk factors for 

clinically diagnosed gallstones in middle-aged men. A 25-year follow-up 

study (the Zutphen Study). Annals of Epidemiology 4(3):248-54, 1994. 

No outcomes of interest 

Mohr SB, Garland CF, Gorham ED, Garland FC. The association 

between ultraviolet B irradiance, vitamin D status and incidence rates of 

type 1 diabetes in 51 regions worldwide. Diabetologia 51 (8 ):1391 -8 , 

2008. 

ecological study 

Moller UK, Ramlau-Hansen CH, Rejnmark L, Heickendorff L, 

Henriksen TB, Mosekilde L. Postpartum Vitamin D insufficiency and 

secondary hyperparathyroidism in healthy Danish women. European 

Journal of Clinical Nutrition 2006; 60(10):1214-1221. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Morley R, Carlin JB, Dwyer T. Maternal calcium supplementation and 

cardiovascular risk factors in twin offspring.. International Journal of 

Epidemiology 33 (6):1304-9, 2004. 

No 25(OH)D or dietary Ca 

Morosetti M, Jankovic L, Palombo G et al. High-dose calcitriol therapy 

and progression of cardiac vascular calcifications. Journal of 

Nephrology 21(4):603 -8 , 2008;-Aug. 

i.v. calcitriol 

Morris CD, McCarron DA. Effect of calcium supplementation in an 

older population with mildly increased blood pressure. American Journal 

of Hypertension 5(4 Pt 1):230-7, 1992. 

No outcomes of interest 

Munger KL, Levin LI, Hollis BW, Howard NS, Ascherio A. Serum 25-

hydroxyVitamin D levels and risk of multiple sclerosis. JAMA. 

296(23):2832-8, 2006 Dec 20. 

No outcomes of interest 

Muray S, Marco MP, Craver L, Rue M, Valdivielso JM, Fernandez E. 

Influence of mineral metabolism parameters on pulse pressure in healthy 

subjects.. Clinical Nephrology 2006; 66(6):411-417. 

No 25(OH)D or dietary Ca 

21
Excluded Study Reason 

Nakamura K, Nishiwaki T, Ueno K, Yamamoto M. Age-related decrease 

in serum 25-hydroxyVitamin D concentrations in the frail elderly: a 

longitudinal study. Journal of Bone & Mineral Metabolism 2007; 

25(4):232-236. 

Effect of aging on 25(OH) D 

Nakamura R, Saruta T. Effect of calcium supplementation on blood 

pressure in essential hypertensive subjects. Japanese Journal of Medicine 

26 (2):203-6, 1987. 

No outcomes of interest 

Nako Y, Fukushima N, Tomomasa T, Nagashima K, Kuroume T. 

HyperVitaminosis D after prolonged feeding with a premature formula. 

Pediatrics 1993; 92(6):862-864. 

Case report 

Narang NK, Gupta RC, Jain MK. Role of Vitamin D in pulmonary 

tuberculosis. Journal of the Association of Physicians of India 32 

(2):185-8, 1984. 

No outcomes of interest 

Nayir A, Kadioglu A, Sirin A, Emre S, Tonguc E, Bilge I. Causes of 

increased renal medullary echogenicity in Turkish children. Pediatric 

Nephrology 9 (6):729 -33, 1995. 

Case report 

Need AG, O'Loughlin PD, Horowitz M, Nordin BE. Relationship 

between fasting serum glucose, age, body mass index and serum 25 

hydroxyVitamin D in postmenopausal women. Clinical Endocrinology 

62 (6):738-41, 2005. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Nieves JW, Barrett-Connor E, Siris ES, Zion M, Barlas S, Chen YT. 

Calcium and vitamin D intake influence bone mass, but not short-term 

fracture risk, in Caucasian postmenopausal women from the National 

Osteoporosis Risk Assessment (NORA) study. Osteoporosis 

International 1919;673-9. 

not RCT bone study (postmenepausal 

women) 

Nilas L, Christiansen C. Treatment with Vitamin D or its analogues does 

not change body weight or blood glucose level in postmenopausal 

women. International Journal of Obesity 8(5):407-11, 1984. 

Review paper 

Niromanesh S, Laghaii S, Mosavi-Jarrahi A. Supplementary calcium in 

prevention of pre-eclampsia. International Journal of Gynaecology & 

Obstetrics 74 (1):17-21, 2001. 

In Hofmeyer 2007 systematic review 

Nishimura K, Shima M, Tsugawa N et al. Long-term hospitalization 

during pregnancy is a risk factor for Vitamin D deficiency in 

neonates.[erratum appears in J Bone Miner Metab. 2003;21(4):253]. 

Journal of Bone & Mineral Metabolism 21(2):103-8, 2003. 

No outcomes of interest 

Nishiyama T. Effects of calcium on muscular training. Journal of 

Nutritional Science & Vitaminology 31 Suppl: S45-7, 1985. 

Calcium only and bone/muscle 

outcomes 

Nowak A, Pachocka L, Targosz U, Klosiewicz-Latoszek L. Dietary 

calcium and obesity in men. Roczniki Panstwowego Zakladu Higieny 58 

(1):301-5, 2007. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Nowson C, Morgan T. Effect of calcium carbonate on blood pressure in 

normotensive and hypertensive people. Hypertension 13(6 Pt 1):630-9, 

1989. 

In systematic review 

Obarzanek E, Hunsberger SA, Van HL et al. Safety of a fat-reduced diet: 

the Dietary Intervention Study in Children (DISC). Pediatrics 100 

(1):51-9, 1997. 

No outcomes of interest 

22
Excluded Study Reason 

Ochner CN, Lowe MR. Self-reported changes in dietary calcium and 

energy intake predict weight regain following a weight loss diet in obese 

women. Journal of Nutrition 2007; 137(10):2324-2328. 

No outcomes of interest 

Olafsdottir AS, Wagner KH, Thorsdottir I, Elmadfa I. Fat-soluble 

Vitamins in the maternal diet, influence of cod liver oil supplementation 

and impact of the maternal diet on human milk composition. Annals of 

Nutrition & Metabolism 45 (6):265-72, 2001. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Paganus A, Juntunen-Backman K, Savilahti E. Follow-up of nutritional 

status and dietary survey in children with cow's milk allergy. Acta 

Paediatrica 81 (6-7 ):518 -21, 1992. 

>=20% subjects with diseases 

Palacios C, Benedetti P, Fonseca S. Impact of calcium intake on body 

mass index in Venezuelan adolescents. Puerto Rico Health Sciences 

Journal 26 (3):199-204, 2007. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Park SB, Suh DH, Youn JI. A pilot study to assess the safety and 

efficacy of topical calcipotriol treatment in childhood psoriasis. Pediatric 

Dermatology 16 (4):321-5, 1999. 

No 25(OH)D or dietary Ca 

Pasch A, Frey FJ, Eisenberger U, Mohaupt MG, Bonny O. PTH and 1.25 

vitamin D response to a low-calcium diet is associated with bone 

mineral density in renal stone formers. Nephrology Dialysis 

Transplantation 23(8 ):2563 -70 , 2008. 

no outcomes of interest 

Pehlivan I, Hatun S, Aydogan M, Babaoglu K, Gokalp AS. Maternal 

Vitamin D deficiency and Vitamin D supplementation in healthy infants. 

Turkish Journal of Pediatrics 45 (4):315-20, 2003;-Dec. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Peters U, Hayes RB, Chatterjee N et al. Circulating Vitamin D 

metabolites, polymorphism in Vitamin D receptor, and colorectal 

adenoma risk. Cancer Epidemiology, Biomarkers & Prevention 2004; 

13(4):546-552. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Peters U, McGlynn KA, Chatterjee N et al. Vitamin D, calcium, and 

Vitamin D receptor polymorphism in colorectal adenomas. Cancer 

Epidemiology, Biomarkers & Prevention 2001; 10(12):1267-1274. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Pettifor JM, Bikle DD, Cavaleros M, Zachen D, Kamdar MC, Ross FP. 

Serum levels of free 1,25-dihydroxyVitamin D in Vitamin D toxicity. 

Annals of Internal Medicine 122 (7):511-3, 1995. 

Case report 

Phillips SM, Bandini LG, Cyr H, Colclough-Douglas S, Naumova E, 

Must A. Dairy food consumption and body weight and fatness studied 

longitudinally over the adolescent period. . International Journal of 

Obesity & Related Metabolic Disorders: Journal of the International 

Association for the Study of Obesity 27 (9):1106-13, 2003. 

Not RCT growth study 

Pilz S, Dobnig H, Fischer JE et al. Low Vitamin d levels predict stroke 

in patients referred to coronary angiography. Stroke 39 (9):2611-3, 2008. 

>=20% subjects with diseases 

Pilz S, Dobnig H, Winklhofer-Roob B et al. Low serum levels of 25-

hydroxyVitamin D predict fatal cancer in patients referred to coronary 

angiography. Cancer Epidemiology, Biomarkers & Prevention 

17(5):1228-33, 2008. 

>=20% subjects with diseases 

Pittard WB, III, Geddes KM, Hulsey TC, Hollis BW. How much 

Vitamin D for neonates? American Journal of Diseases of Children 145 

(10):1147-9, 1991. 

Not RCT arrow 4 study 

23
Excluded Study Reason 

Pittard WB, III, Geddes KM, Sutherland SE, Miller MC, Hollis BW. 

Longitudinal changes in the bone mineral content of term and premature 

infants. . American Journal of Diseases of Children 1990; 144(1):36-40. 

Changes in 25(OH)D status of term and 

premature infants 

Pittas AG, Harris SS, Stark PC, wson-Hughes B. The effects of calcium 

and Vitamin D supplementation on blood glucose and markers of 

inflammation in nondiabetic adults.. Diabetes Care 2007; 30(4):980-986. 

No outcomes of interest 

Porojnicu AC, Robsahm TE, Dahlback A et al. Seasonal and 

geographical variations in lung cancer prognosis in Norway. Does 

Vitamin D from the sun play a role? Lung Cancer 2007; 55(3):263-270. 

Ecological study 

Prentice A, Ginty F, Stear SJ, Jones SC, Laskey MA, Cole TJ. Calcium 

supplementation increases stature and bone mineral mass of 16- to 18-

year-old boys. Journal of Clinical Endocrinology & Metabolism 90 

(6):3153-61, 2005. 

In Winzenberg 2007 systematic review 

Prineas RJ, Folsom AR, Zhang ZM, Sellers TA, Potter J. Nutrition and 

other risk factors for renal cell carcinoma in postmenopausal women. 

Epidemiology 8 (1):31-6, 1997. 

No outcomes of interest 

Purwar M, Kulkarni H, Motghare V, Dhole S. Calcium supplementation 

and prevention of pregnancy induced hypertension. Journal of Obstetrics 

& Gynaecology Research 22 (5):425-30, 1996. 

In Hofmeyer 2007 systematic review 

Rajalakshmi R, Sail SS, Shah DG, Ambady SK. The effects of 

supplements varying in carotene and calcium content on the physical, 

biochemical and skeletal status of preschool children. British Journal of 

Nutrition 30 (1):77-86, 1973. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Rajpathak SN, Rimm EB, Rosner B, Willett WC, Hu FB. Calcium and 

dairy intakes in relation to long-term weight gain in US men. American 

Journal of Clinical Nutrition 83 (3):559-66, 2006. 

No outcomes of interest 

Rees GA, Doyle W, Srivastava A, Brooke ZM, Crawford MA, Costeloe 

KL. The nutrient intakes of mothers of low birth weight babies - a 

comparison of ethnic groups in East London, UK. Maternal & Child 

Nutrition 1(2):91-9, 2005. 

No outcomes of interest 

Repke JT, Villar J, Anderson C, Pareja G, Dubin N, Belizan JM. 

Biochemical changes associated with blood pressure reduction induced 

by calcium supplementation during pregnancy. American Journal of 

Obstetrics & Gynecology 160 (3):684-90, 1989. 

In Hofmeyer 2007 systematic review 

Repke JT, Villar J. Pregnancy-induced hypertension and low birth 

weight: the role of calcium. American Journal of Clinical Nutrition 

1991; 54(1:Suppl): Suppl-241S. 

Review paper 

Resnick LM, Oparil S, Chait A et al. Factors affecting blood pressure 

responses to diet: the Vanguard study. American Journal of 

Hypertension 13(9):956-65, 2000. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Reunanen A, Knekt P, Marniemi J, Maki J, Maatela J, Aromaa A. Serum 

calcium, magnesium, copper and zinc and risk of cardiovascular death. 

European Journal of Clinical Nutrition 50 (7):431-7, 1996. 

No 25(OH)D or dietary Ca 

Rich GM, McCullough M, Olmedo A, Malarick C, Moore TJ. Blood 

pressure and renal blood flow responses to dietary calcium and sodium 

intake in humans. American Journal of Hypertension 4(11):642S-645S, 

1991. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

24
Excluded Study Reason 

Roberts CC, Chan GM, Folland D, Rayburn C, Jackson R. Adequate 

bone mineralization in breast-fed infants. Journal of Pediatrics 99 

(2):192-6, 1981. 

In Ottawa EPC report 

Robien K, Cutler GJ, Lazovich D. Vitamin D intake and breast cancer 

risk in postmenopausal women: the Iowa Women's Health Study. Cancer 

Causes & Control 2007; 18(7):775-782. 

Observational study estimated Vitamin 

D supplement doses 

Rogers MS, Fung HY, Hung CY. Calcium and low-dose aspirin 

prophylaxis in women at high risk of pregnancy-induced hypertension. 

Hypertension in Pregnancy 18 (2):165-72, 1999. 

In Hofmeyer 2007 systematic review 

Roongpisuthipong C, Kantawan R, Roongpisuthipong W. Reduction of 

adipose tissue and body weight: effect of water soluble calcium 

hydroxycitrate in Garcinia atroviridis on the short term treatment of 

obese women in Thailand. Asia Pacific Journal of Clinical Nutrition 

2007; 16(1):25-29. 

No 25(OH)D or dietary Ca 

Rosell M, Hakansson NN, Wolk A. Association between dairy food 

consumption and weight change over 9 y in 19,352 perimenopausal 

women. American Journal of Clinical Nutrition 2006; 84(6):1481-1488. 

Ca intake and BW measured but not 

assessed ==> no relevant results 

reported 

Rothberg AD, Pettifor JM, Cohen DF, Sonnendecker EW, Ross FP. 

Maternal-infant Vitamin D relationships during breast-feeding. Journal 

of Pediatrics 101 (4):500-3, 1982. 

In Ottawa EPC report 

Rourke KM, Brehm BJ, Cassell C, Sethuraman G. Effect of weight 

change on bone mass in female adolescents. Journal of the American 

Dietetic Association 103 (3):369-72, 2003. 

No 25(OH)D or dietary Ca 

Rozen P, Fireman Z, Fine N, Wax Y, Ron E. Oral calcium suppresses 

increased rectal epithelial proliferation of persons at risk of colorectal 

cancer. Gut 30(5):650-5, 1989. 

No outcomes of interest 

Rozen P, Lubin F, Papo N et al. Calcium supplements interact 

significantly with long-term diet while suppressing rectal epithelial 

proliferation of adenoma patients. Cancer 91 (4):833-40, 2001. 

No outcomes of interest 

Rumiris D, Purwosunu Y, Wibowo N, Farina A, Sekizawa A. Lower rate 

of preeclampsia after antioxidant supplementation in pregnant women 

with low antioxidant status. Hypertension in Pregnancy 2006; 25(3):241-

253. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Rush D, Sloan NL, Leighton J et al. The National WIC Evaluation: 

evaluation of the Special Supplemental Food Program for Women, 

Infants, and Children. V. Longitudinal study of pregnant women. 

American Journal of Clinical Nutrition 48 (2 Suppl):439-83, 1988. 

No exposure of interest 

Saadi HF, Dawodu A, Afandi B et al. Effect of combined maternal and 

infant vitamin D supplementation on vitamin D status of exclusively 

breastfed infants. Maternal & Child Nutrition 5(1):25 -32 , 2009. 

arrow 4 RCT but daily doses were the 

same in the comparison groups 

(comparison of daily vs. monthly doses) 

Sacks FM, Brown LE, Appel L, Borhani NO, Evans D, Whelton P. 

Combinations of potassium, calcium, and magnesium supplements in 

hypertension. Hypertension 26 (6 Pt 1):950-6, 1995. 

Combinations of minerals 

Sacks FM, Obarzanek E, Windhauser MM et al. Rationale and design of 

the Dietary Approaches to Stop Hypertension trial (DASH). A 

multicenter controlled-feeding study of dietary patterns to lower blood 

pressure. Annals of Epidemiology 5(2):108-18, 1995. 

No outcomes of interest 

25
Excluded Study Reason 

Sacks FM, Willett WC, Smith A, Brown LE, Rosner B, Moore TJ. 

Effect on blood pressure of potassium, calcium, and magnesium in 

women with low habitual intake. Hypertension 31 (1):131-8, 1998. 

In systematic review 

Saito K, Sano H, Kawahara J, Yokoyama M. Calcium supplementation 

attenuates an enhanced platelet function in salt-loaded mildly 

hypertensive patients. Hypertension 26 (1):156-63, 1995. 

Data too incomplete 

Sakhaee K, Baker S, Zerwekh J, Poindexter J, Garcia-Hernandez PA, 

Pak CY. Limited risk of kidney stone formation during long-term 

calcium citrate supplementation in nonstone forming subjects. Journal of 

Urology 152 (2 Pt 1):324-7, 1994. 

No UL outcomes 

Sakhaee K, Poindexter JR, Griffith CS, Pak CY. Stone forming risk of 

calcium citrate supplementation in healthy postmenopausal women. 

Journal of Urology 172 (3):958-61, 2004. 

No UL outcomes: saturation of CaOx 

Salazar-Martinez E, Lazcano-Ponce E, Sanchez-Zamorano LM, 

Gonzalez-Lira G, Escudero-DE Los RP, Hernandez-Avila M. Dietary 

factors and endometrial cancer risk. Results of a case-control study in 

Mexico. International Journal of Gynecological Cancer 15 (5):938-45 , 

2005. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Sampath V, Havel PJ, King JC. Calcium supplementation does not alter 

lipid oxidation or lipolysis in overweight/obese women. Obesity 16 

(11):2400 -4, 2008. 

not RCT wt study 

Sanchez-Ramos L, Adair CD, Kaunitz AM, Briones DK, Del Valle GO, 

Delke I. Calcium supplementation in mild preeclampsia remote from 

term: a randomized double-blind clinical trial. Obstetrics & Gynecology 

85 (6):915-8, 1995. 

100% patients with already diagnosed 

"mild" preeclampsia 

Sanchez-Ramos L, Briones DK, Kaunitz AM, Delvalle GO, Gaudier FL, 

Walker CD. Prevention of pregnancy-induced hypertension by calcium 

supplementation in angiotensin II-sensitive patients. Obstetrics & 

Gynecology 84 (3):349-53, 1994. 

In Hofmeyer 2007 systematic review 

Sanders TA, Purves R. An anthropometric and dietary assessment of the 

nutritional status of vegan preschool children. Journal of Human 

Nutrition 35 (5):349-57, 1981. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Sato K, Emoto N, Toraya S et al. Progressively increased serum 1,25-

dihydroxyVitamin D2 concentration in a hypoparathyroid patient with 

protracted hypercalcemia due to Vitamin D2 intoxication. Endocrine 

Journal 41 (4):329-37, 1994. 

Case report 

Satterfield S, Cutler JA, Langford HG et al. Trials of hypertension 

prevention. Phase I design. Annals of Epidemiology 1(5):455-71, 1991. 

Shows research design, but no result 

Schleithoff SS, Zittermann A, Tenderich G, Berthold HK, Stehle P, 

Koerfer R. Vitamin D supplementation improves cytokine profiles in 

patients with congestive heart failure: a double-blind, randomized, 

placebo-controlled trial.[see comment]. American Journal of Clinical 

Nutrition 83 (4):754 -9 , 2006. 

>=20% subjects with diseases 

Schumann SA, Ewigman B. Double-dose Vitamin D lowers cancer risk 

in women over 55. Journal of Family Practice 2007; 56(11):907-910. 

Editorial-like brief review 

26
Excluded Study Reason 

Sellers TA, Bazyk AE, Bostick RM et al. Diet and risk of colon cancer 

in a large prospective study of older women: an analysis stratified on 

family history (Iowa, United States). Cancer Causes & Control 9(4):357-

67, 1998. 

Same cohort as Zheng 1998 (RefID 

2924) only difference is that taking into 

consideration the family history of colon 

cancer in the analysis 

Shahar DR, Abel R, Elhayany A, Vardi H, Fraser D. Does dairy calcium 

intake enhance weight loss among overweight diabetic patients? 

Diabetes Care 2007; 30(3):485-489. 

>=20% subjects with diseases 

Shapses SA, Heshka S, Heymsfield SB. Effect of calcium 

supplementation on weight and fat loss in women. Journal of Clinical 

Endocrinology & Metabolism 89 (2):632-7, 2004. 

In systematic review 

Sharkey JR, Giuliani C, Haines PS, Branch LG, Busby-Whitehead J, 

Zohoori N. Summary measure of dietary musculoskeletal nutrient 

(calcium, Vitamin D, magnesium, and phosphorus) intakes is associated 

with lower-extremity physical performance in homebound elderly men 

and women. American Journal of Clinical Nutrition 77 (4):847-56, 2003. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Shaunak S, Ang L, Colston K, Patel S, Bland M, Maxwell JD. Muscle 

strength in healthy white and Asian subjects: the relationship of 

quadriceps maximum voluntary contraction to age, sex, body build and 

Vitamin D. Clinical Science 73 (5):541-6, 1987. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Sibai BM, Ewell M, Levine RJ et al. Risk factors associated with 

preeclampsia in healthy nulliparous women. The Calcium for 

Preeclampsia Prevention (CPEP) Study Group. . American Journal of 

Obstetrics & Gynecology 177 (5):1003-10, 1997. 

No Ca dose 

Sieg J, Sieg A, Dreyhaupt J, Schmidt-Gayk H. Insufficient Vitamin D 

supply as a possible co-factor in colorectal carcinogenesis. Anticancer 

Research 26 (4A):2729 -33, 2006. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Silverman SL, Delmas PD, Kulkarni PM, Stock JL, Wong M, Plouffe L, 

Jr. Comparison of fracture, cardiovascular event, and breast cancer rates 

at 3 years in postmenopausal women with osteoporosis. Journal of the 

American Geriatrics Society 52 (9):1543-8, 2004. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Sita-Lumsden A, Lapthorn G, Swaminathan R, Milburn HJ. Reactivation 

of tuberculosis and Vitamin D deficiency: the contribution of diet and 

exposure to sunlight. Thorax 62 (11):1003-7, 2007. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Siwek RA, Burkinshaw L, Oxby CB, Robinson PA. Multi-element 

analysis of the obese subject by in vivo neutron activation analysis. 

Physics in Medicine & Biology 29 (6):687-701, 1984. 

Not relevant 

Skinner JD, Bounds W, Carruth BR, Ziegler P. Longitudinal calcium 

intake is negatively related to children's body fat indexes.. Journal of the 

American Dietetic Association 103 (12):1626-31, 2003. 

Not RCT growth study 

Slemenda CW, Reister TK, Hui SL, Miller JZ, Christian JC, Johnston 

CC, Jr. Influences on skeletal mineralization in children and adolescents: 

evidence for varying effects of sexual maturation and physical 

actiVitaminy. Journal of Pediatrics 125 (2):201-7, 1994. 

No 25(OH)D or dietary Ca 

Specker BL, Beck A, Kalkwarf H, Ho M. Randomized trial of varying 

mineral intake on total body bone mineral accretion during the first year 

of life. Pediatrics 99(6): E12, 1997. 

No independent Ca effect 

27
Excluded Study Reason 

Specker BL, Tsang RC, Ho M, Miller D. Effect of vegetarian diet on 

serum 1,25-dihydroxyVitamin D concentrations during lactation. 

Obstetrics & Gynecology 70 (6):870-4, 1987. 

No 25(OH)D or dietary Ca 

Specker BL, Valanis B, Hertzberg V, Edwards N, Tsang RC. Sunshine 

exposure and serum 25-hydroxyVitamin D concentrations in exclusively 

breast-fed infants. Journal of Pediatrics 107 (3):372-6, 1985. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Stamler J, Liu K, Ruth KJ, Pryer J, Greenland P. Eight-year blood 

pressure change in middle-aged men: relationship to multiple nutrients. 

Hypertension 39 (5):1000-6, 2002. 

No outcomes of interest 

Stern HS, Gregoire RC, Kashtan H, Stadler J, Bruce RW. Long-term 

effects of dietary calcium on risk markers for colon cancer in patients 

with familial polyposis. Surgery 108 (3):528-33, 1990. 

No outcomes of interest 

Sugden JA, Davies JI, Witham MD, Morris AD, Struthers AD. Vitamin 

D improves endothelial function in patients with Type 2 diabetes 

mellitus and low vitamin D levels. Diabetic Medicine 2008;25:320-5. 

>=20% subjects with diseases 

Swanenburg J, de Bruin ED, Stauffacher M, Mulder T, Uebelhart D. 

Effects of exercise and nutrition on postural balance and risk of falling in 

elderly people with decreased bone mineral density: randomized 

controlled trial pilot study. Clinical Rehabilitation 2007; 21(6):523-534. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Takeuchi A, Okano T, Tsugawa N et al. Effects of ergocalciferol 

supplementation on the concentration of Vitamin D and its metabolites 

in human milk. Journal of Nutrition 119 (11):1639-46, 1989. 

Not RCT arrow 4 study 

Tanji JL, Lew EY, Wong GY, Treguboff C, Ward JA, Amsterdam EA. 

Dietary calcium supplementation as a treatment for mild hypertension.. 

Journal of the American Board of Family Practice 4(3):145-50, 1991. 

In systematic review 

Taylor EN, Stampfer MJ, Curhan GC. Dietary factors and the risk of 

incident kidney stones in men: new insights after 14 years of follow-up. 

Journal of the American Society of Nephrology 15 (12):3225-32, 2004. 

No outcomes of interest 

Teegarden D, White KM, Lyle RM et al. Calcium and dairy product 

modulation of lipid utilization and energy expenditure. Obesity 16 

(7):1566-72, 2008. 

No outcomes of interest 

Thompson IM, Coltman CA, Jr., Crowley J. Chemoprevention of 

prostate cancer: the Prostate Cancer Prevention Trial. Prostate 33 

(3):217-21, 1997. 

Commentary 

Thompson WG, Rostad HN, Janzow DJ, Slezak JM, Morris KL, Zemel 

MB. Effect of energy-reduced diets high in dairy products and fiber on 

weight loss in obese adults. . Obesity Research 13(8):1344-53, 2005. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Thomson K, Morley R, Grover SR, Zacharin MR. Postnatal evaluation 

of Vitamin D and bone health in women who were Vitamin D-deficient 

in pregnancy, and in their infants.[erratum appears in Med J Aust. 2005 

Jan 3;182(1):48 Note: Thompson, Katherine [corrected to Thomson, 

Katherine]]. Medical Journal of Australia 181 (9):486-8, 2004. 

No analysis of association between 

25(OH)D and outcomes 

Tomoda S, Kitanaka T, Ogita S, Hidaka A. Prevention of pregnancyinduced hypertension by calcium dietary supplement: a preliminary 

report. Journal of Obstetrics & Gynaecology 21(3):281-8, 1995. 

No outcomes of interest 

28
Excluded Study Reason 

Tretli S, Hernes E, Berg JP, Hestvik UE, Robsahm TE. Association 

between serum 25(OH)D and death from prostate cancer. British Journal 

of Cancer 100 (3):450 -4, 2009. 

>=20% subjects with diseases 

Tsang RC, Gigger M, Oh W, Brown DR. Studies in calcium metabolism 

in infants with intrauterine growth retardation. Journal of Pediatrics 86 

(6):936-41, 1975. 

No 25(OH)D or dietary Ca 

Tworoger SS, Lee IM, Buring JE, Rosner B, Hollis BW, Hankinson SE. 

Plasma 25-hydroxyVitamin D and 1,25-dihydroxyVitamin D and risk of 

incident ovarian cancer. Cancer Epidemiology, Biomarkers & 

Prevention 2007; 16(4):783-788. 

No outcomes of interest 

van Beresteijn EC, Riedstra M, van der WA, Schouten EG, Burema J, 

Kok FJ. Habitual dietary calcium intake and blood pressure change 

around the menopause: a longitudinal study. International Journal of 

Epidemiology 21(4):683-9, 1992. 

No outcomes of interest 

van Buul BJ, Steegers EA, Jongsma HW et al. Dietary sodium restriction 

in the prophylaxis of hypertensive disorders of pregnancy: effects on the 

intake of other nutrients. American Journal of Clinical Nutrition 62 

(1):49-57, 1995. 

Ca intake and BM (mothers and 

neonates) measured but not assessed 

==> no relevant results reported 

Vatanparast H, Baxter-Jones A, Faulkner RA, Bailey DA, Whiting SJ. 

Positive effects of vegetable and fruit consumption and calcium intake 

on bone mineral accrual in boys during growth from childhood to 

adolescence: the University of Saskatchewan Pediatric Bone Mineral 

Accrual Study. American Journal of Clinical Nutrition 82 (3):700-6, 

2005. 

No 25(OH)D or dietary Ca 

Vergnaud AC, Peneau S, Chat-Yung S et al. Dairy consumption and 6-y 

changes in body weight and waist circumference in middle-aged French 

adults. American Journal of Clinical Nutrition 88 (5):1248 -55 , 2008. 

not RCT (weight outcome) 

Verhaar HJ, Samson MM, Jansen PA, de Vreede PL, Manten JW, 

Duursma SA. Muscle strength, functional mobility and Vitamin D in 

older women.. Aging-Clinical & Experimental Research 12 (6):455-60, 

2000. 

In Ottawa EPC report 

Verreault R, Semba RD, Volpato S, Ferrucci L, Fried LP, Guralnik JM. 

Low serum Vitamin d does not predict new disability or loss of muscle 

strength in older women. . Journal of the American Geriatrics Society 50 

(5):912-7, 2002. 

In Ottawa EPC report 

Verreault R, Semba RD, Volpato S, Ferrucci L, Fried LP, Guralnik JM. 

Low serum Vitamin d does not predict new disability or loss of muscle 

strength in older women. . Journal of the American Geriatrics Society 

50(5):912-7, 2002. 

In Ottawa EPC report 

Villar J, bdel-Aleem H, Merialdi M et al. World Health Organization 

randomized trial of calcium supplementation among low calcium intake 

pregnant women. American Journal of Obstetrics & Gynecology. 

194(3):639-49, 2006 Mar. 

In Hofmeyer 2007 systematic review, 

systematic review 

Villar J, Gulmezoglu AM, de OM. Nutritional and antimicrobial 

interventions to prevent preterm birth: an overview of randomized 

controlled trials. Obstetrical & Gynecological Survey 53 (9):575-85 , 

1998 Sep. 

Not relevant systematic review 

29
Excluded Study Reason 

Villar J, Repke JT. Calcium supplementation during pregnancy may 

reduce preterm delivery in high-risk populations. American Journal of 

Obstetrics & Gynecology 163 (4 Pt 1):1124 -31, 1990. 

In Hofmeyer 2007 systematic review 

Visser M, Deeg DJ, Lips P, Longitudinal Aging SA. Low Vitamin D and 

high parathyroid hormone levels as determinants of loss of muscle 

strength and muscle mass (sarcopenia): the Longitudinal Aging Study 

Amsterdam. Journal of Clinical Endocrinology & Metabolism 88 

(12):5766-72, 2003. 

In Ottawa EPC report 

von Hurst PR, Stonehouse W, Matthys C, Conlon C, Kruger MC, Coad 

J. Study protocol--metabolic syndrome, vitamin D and bone status in 

South Asian women living in Auckland, New Zealand: a randomised, 

placebo-controlled, double-blind vitamin D intervention. BMC Public 

Health 8 :267 , 2008. 

RCT protocol only 

Wallace K, Baron JA, Cole BF et al. Effect of calcium supplementation 

on the risk of large bowel polyps.[see comment]. Journal of the National 

Cancer Institute 96 (12 ):921 -5, 2004.

In Weigarten 2008 SR 

Wallace K, Baron JA, Karagas MR et al. The association of physical 

actiVitaminy and body mass index with the risk of large bowel polyps. 

Cancer Epidemiology, Biomarkers & Prevention 14(9):2082-6, 2005. 

No outcomes of interest 

Waltman NL, Twiss JJ, Ott CD et al. Testing an intervention for 

preventing osteoporosis in postmenopausal breast cancer survivors. 

Journal of Nursing Scholarship 35 (4):333-8, 2003. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Wanchu M, Malhotra S, Khullar M. Calcium supplementation in preeclampsia. Journal of the Association of Physicians of India 49:795-8, 

2001. 

In Hofmeyer 2007 systematic review 

Wang LD, Qiu SL, Yang GR, Lipkin M, Newmark HL, Yang CS. A 

randomized double-blind intervention study on the effect of calcium 

supplementation on esophageal precancerous lesions in a high-risk 

population in China. Cancer Epidemiology, Biomarkers & Prevention 

2(1):71-8, 1993. 

>=20% subjects with diseases 

Wargovich MJ, Isbell G, Shabot M et al. Calcium supplementation 

decreases rectal epithelial cell proliferation in subjects with sporadic 

adenoma. . Gastroenterology 103 (1):92-7, 1992. 

No outcomes of interest 

Webb AR, Pilbeam C, Hanafin N, Holick MF. An evaluation of the 

relative contributions of exposure to sunlight and of diet to the 

circulating concentrations of 25-hydroxyVitamin D in an elderly nursing 

home population in Boston. American Journal of Clinical Nutrition 51 

(6):1075-81, 1990. 

Not RCT arrow 4 study 

Webber CE, Blake JM, Chambers LF, Roberts JG. Effects of 2 years of 

hormone replacement upon bone mass, serum lipids and lipoproteins. 

Maturitas. 19(1):13-23, 1994 May. 

No 25(OH)D or dietary Ca 

Wei EK, Giovannucci E, Fuchs CS, Willett WC, Mantzoros CS. Low 

plasma adiponectin levels and risk of colorectal cancer in men: a 

prospective study. Journal of the National Cancer Institute 97 (22):1688-

94, 2005. 

No 25(OH)D or dietary Ca 

30
Excluded Study Reason 

Weinberger MH, Wagner UL, Fineberg NS. The blood pressure effects 

of calcium supplementation in humans of known sodium responsiveness. 

American Journal of Hypertension 6 (9):799-805, 1993. 

In systematic review 

Weisgerber UM, Boeing H, Owen RW, Waldherr R, Raedsch R, 

Wahrendorf J. Effect of longterm placebo controlled calcium 

supplementation on sigmoidal cell proliferation in patients with sporadic 

adenomatous polyps. Gut 38 (3):396-402, 1996. 

No outcomes of interest 

Weisman Y, Bawnik JC, Eisenberg Z, Spirer Z. Vitamin D metabolites 

in human milk. Journal of Pediatrics 100 (5):745-8, 1982. 

Cross-sectional or retrospective 

assessment of diet after disease 

diagnosis 

Weston TL, Aronson KJ, Siemiatycki J, Howe GR, Nadon L. Cancer 

mortality among males in relation to exposures assessed through a jobexposure matrix. International Journal of Occupational & Environmental 

Health 6(3):194-202, 2000. 

No 25(OH)D or dietary Ca 

Widga AC, Lewis NM. Defined, in-home, prenatal nutrition intervention 

for low-income women. Journal of the American Dietetic Association 

99(9):1058-62, 1999. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Willett WC, Stampfer MJ, Colditz GA, Rosner BA, Speizer FE. Relation 

of meat, fat, and fiber intake to the risk of colon cancer in a prospective 

study among women. N Engl J Med 1990; 323(24):1664-1672. 

No 25(OH)D or dietary Ca 

Williams CP, Child DF, Hudson PR et al. Why oral calcium 

supplements may reduce renal stone disease: report of a clinical pilot 

study. Journal of Clinical Pathology 54 (1):54-62, 2001. 

No UL outcomes 

Wimalawansa SJ. Antihypertensive effects of oral calcium 

supplementation may be mediated through the potent vasodilator CGRP. 

American Journal of Hypertension 6 (12):996-1002, 1993. 

n=8, Ca to Rx HTN 

Witteman JC, Willett WC, Stampfer MJ et al. A prospective study of 

nutritional factors and hypertension among US women. Circulation 80 

(5):1320-7, 1989. 

Superceded by Ascherio (4022) 

Wortsman J, Matsuoka LY, Chen TC, Lu Z, Holick MF. Decreased 

bioavailability of Vitamin D in obesity. [erratum appears in Am J Clin 

Nutr. 2003 May;77(5):1342]. American Journal of Clinical Nutrition 72 

(3):690-3, 2000. 

Not RCT arrow 4 study 

Wosje KS, Kalkwarf HJ. Lactation, weaning, and calcium 

supplementation: effects on body composition in postpartum women. 

American Journal of Clinical Nutrition 80 (2):423-9, 2004. 

No outcomes of interest 

Wyatt HR, Jortberg BT, Babbel C et al. Weight loss in a community 

initiative that promotes decreased energy intake and increased physical 

actiVitaminy and dairy consumption: Calcium Weighs-In. Journal of 

Physical ActiVitaminy & Health 5(1):28-44, 2008. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Yang YX, Han JH, Shao XP et al. Effect of micronutrient 

supplementation on the growth of preschool children in China. 

Biomedical & Environmental Sciences 15 (3):196-202, 2002. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

31
32

Excluded Study Reason 

Yesudian PD, Berry JL, Wiles S et al. The effect of ultraviolet Binduced Vitamin D levels on host resistance to Mycobacterium 

tuberculosis: a pilot study in immigrant Asian adults living in the United 

Kingdom. Photodermatology, Photoimmunology & Photomedicine 24 

(2):97-8, 2008. 

No outcomes of interest 

Zemel MB, Richards J, Milstead A, Campbell P. Effects of calcium and 

dairy on body composition and weight loss in African-American adults. 

Obesity Research 13(7):1218 -25, 2005. 

In systematic review 

Zemel MB, Thompson W, Milstead A, Morris K, Campbell P. Calcium 

and dairy acceleration of weight and fat loss during energy restriction in 

obese adults. . Obesity Research 12 (4):582-90, 2004. 

In systematic review 

Zhang Y, Kiel DP, Ellison RC et al. Bone mass and the risk of prostate 

cancer: the Framingham Study. American Journal of Medicine 113 

(9):734 -9, 2002. 

No 25(OH)D or dietary Ca 

Zhou C, Fan S, Zhou L, Ni Y, Huang T, Shi Y. Clinical observation of 

treatment of hypertension with calcium. American Journal of 

Hypertension 7 (4 Pt 1):363-7, 1994. 

In systematic review 

Zofkova I, Hill M. Long-term 1,25(OH)2 Vitamin D therapy increases 

bone mineral density in osteopenic women. Comparison with the effect 

of plain Vitamin D. Aging-Clinical & Experimental Research. 

19(6):472-7, 2007 Dec. 

Combination of Vitamin D/Ca and other 

treatment w/o analysis of independent 

effect 

Zorbas YG, Petrov KL, Kakurin VJ et al. Calcium supplementation 

effect on calcium balance in endurance-trained athletes during prolonged 

hypokinesia and ambulatory conditions. Biological Trace Element 

Research 73 (3):231-50, 2000. 

Arrow 4: calcium balance 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author 

Year 

Study 

Design* Inclusion Exclusion Enrollment Years Trial or Cohort Name F

18505967 Ahn 2008 Case- cohort study 

Non-Hispanic white males, at least one prostate cancer screen before end of follow-up. All eligible patients with aggressive cancer selected, and a randomly selected subset of those with non-aggressive prostate cancer. 

No prior history of prostate cancer before first year of follow-up. 

1993-2001 Prostate, Lung, 

Colorectal, and Ovarian Cancer Screening Trial (PLCO) 

NCInR

*Leave appropriate choice of study design and delete all others **Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCTPOPULATION (BASELINE)**

UI Author Year Study Design* Location (e.g., City and Country, latitude) N enrolled N analyzed Mean (SD) Age, yr Age Range / IQR Male, % Race / Ethnicity Anthropometry data (e.g., BMI, weight, or %body fat ...etc) Hea

18505967 Ahn 2008 Case- cohort study 

United States (various): Birmingham, AL; Denver, CO; Detroit, MI; Honolulu, HI; Marshfield, WI; Minneapolis, MN; Pittsburgh, PA; Salt Lake City, UT; St. Louis, MO; Washington DC 

1530 749 cases; 781 controls 

1530 

Case: 67.8 (5.3); Control: 67.6 (5.3) 

nd 100% 

NonHispanic white 

BMI case 27.3 (3.6); BMI control 27.5 (3.9) 

No pof cabeforand

*Please copy from above**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 
Background Diet*

UI Author Year Exposure Dietary Assessment Method** Food Composition Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data 

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data 

Time 

between 

Biomarker 

Sampling 

and 

Analysis 

S

sa

18505967 Ahn 2008 25(OH)D 

25(OH)D 

determined by 

radioimmunoassay 

(Heartland Assays) 

y, coefficient 

of variation in 

subset of 80 

patients was 

5.9% 

nd 

18505967 Ahn 2008 Dietary calcium intake FFQ US Department of Agriculture n nd n * Write “nd” if there was no data reported. Please do not leave blank **Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief ***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Countnutrient analysis (please specify) ****ONLY biomarker of interest for calcium is calcium balance INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY UI Author Year Vit D and/or Ca Intervention(s) Source (e.g., brand name, foods, or formulation) Vit D and/or Ca Dose Intervention Duration Intervention Freq

taken 

Co-intervention(s) *: Duplicate one row per intervention, including control intervention. *Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitam

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. LIST OF ALL OUTCOMES 

UI Author Year Primary / Secondary Outcome** Outcome Definition 

18505967 Ahn 2008 secondary Prostate cancer nd 18505967 Ahn 2008 secondary Aggressive prostate cancer Gleason sum >=7 or clinical stage III or IV) Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must explicitly stated in the original paper. Otherwise, please enter “nd” 

UI Author 

Year Comments 

-----Confounders: Please report all confounders controlled in the analyses reported in the follow

(adjusted results) 

UI Author 

Year Confounder Groups Please List Name of Confounder (including matching factors) 

18505967 Ahn 

2008 

Other nutrients or dietary factors (e.g., certain food consumption), including supplement use and total energy intake 

Total calcium intake 

Demographics (e.g., age, gender, race, education)? Anthropometrics (e.g., BMI, body weight, % body fat)? Yes Medical conditions History of diabetes Medication Sunlight exposure and its proxy variables (e.g., physical activity level, occupation, sun exposure, location) Smoking and other life styles variables Yes Other study center 

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS A RESULT SECTION. PLEASE CHOOSE AN APPROPRIATE TYPE OF DATA CO

FOR ALL OUTCOMES OF INTEREST. -----Main Analyses (For analyses that adjusted for confounders, choose the “best” model.) 2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) UI Author Year Outcome Exposure / Intervention Mean Follow-up, 

mo 

N 

Event 

N 

Total 

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted 

Result 95% CI 

b

*Example: OR Ca/placebo 2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) UI Author Year Outcome Unit Exposure / Intervention Mean Follow-up, 

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD* Final or Delta** Final or Delta CI / SE / SD* Net difference 

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 ≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author Year Outcome 

Exposure 

Categories(e.g., 

Tirtiles) / 

Intervention 

Groups 

Mean 

Vit D 

level / 

dose 

Mean 

Ca 

level / 

dose 

No. of 

Cases*

No. of 

Noncases 

Crude or 

Adjusted 

analysis? 

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%) 

Outcome 

effect 

size 

CI 

18505967 Ahn 2008 prostate cancer 

quintiles based on season of collection (standardized) Quintile 1 (12.8-42.5 nmol/L) 

nd nd 119 157 

Adjusted for age at cohort entry; time since screening; calendar year; 

OR 1.00 (Refer

Quintile 2 (42.5-

51.3 nmol/L) nd nd 125 156 1.12 0.79-1
Quintile 3 (51.4-

60.5 nmol/L) nd nd 190 157 1.61 1.16-2

Quintile 4 (60.6-

71.7 nmol/L) nd nd 167 156 1.42 1.02-1

Quintile 5 (71.8-

129.5 nmol/L) nd nd 148 155 1.32 0.94-1

18505967 Ahn 2008 prostate cancer 

quintiles based on season of collection (standardized) Quintile 1 (12.8-42.5 nmol/L) 

nd nd 119 157 

Adjusted for age at cohort entry; time since screening; calendar year; study center; DM; BMI; physical activity; Ca intake 

OR 1.00 (Refer

Quintile 2 (42.5-

51.3 nmol/L) nd nd 125 156 1.10 0.78-1

Quintile 3 (51.4-

60.5 nmol/L) nd nd 190 157 1.53 1.10-2

Quintile 4 (60.6-

71.7 nmol/L) nd nd 167 156 1.33 0.95-1

Quintile 5 (71.8-

129.5 nmol/L) nd nd 148 155 1.18 0.83-1

18505967 Ahn 2008 

Aggressive prostate cancer (Gleason sum >=7 or clinical stage III or IV) 

Serum 25(OH)DQuintile 1 (12.8-42.5 nmol/L) 

nd nd 68 157 

Adjusted for age at cohort entry; time since screening; calendar year; study center; DM 

OR 1.00 (Refer

Quintile 2 (42.5-

51.3 nmol/L) nd nd 73 156 1.20 0.80-1

Quintile 3 (51.4-

60.5 nmol/L) nd nd 130 157 1.96 1.34-2

Quintile 4 (60.6-

71.7 nmol/L) nd nd 105 156 1.61 1.09-2

Quintile 5 (71.8-

129.5 nmol/L) nd nd 90 155 1.37 0.92-2
Aggressive 

prostate cancer (Gleason sum >=7 or clinical stage III or IV) 

Serum 25(OH)DQuintile 1 (12.8-42.5 nmol/L) 

nd nd 68 157 

Adjusted for age at cohort entry; time since screening; calendar year; study center; DM; BMI; physical activity; Ca intake 

OR 1.00 (Refer

Quintile 2 (42.5-

51.3 nmol/L) nd nd 73 156 1.18 0.78-1

Quintile 3 (51.4-

60.5 nmol/L) nd nd 130 157 1.92 1.31-2

Quintile 4 (60.6-

71.7 nmol/L) nd nd 105 156 1.56 1.05-2

Quintile 5 (71.8-

129.5 nmol/L) nd nd 90 155 1.34 0.87-1

Duplicate one row per exposure category or intervention group. *Number of subjects with outcome **Please choose one and delete the others ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 ****P value for testing the linear trend of the OR/RR across different categories or doses ≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) UI Author Year Outcome Unit 

Exposure 

Category / 

Intervention 

Group 

Crude or 

Adjusted 

analysis? 

Mean 

Follow-up 

(months) 

No. 

Analyzed Baseline 

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / SD*

Net 

difference**

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. *Please choose one and delete the others **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH 

CONTROLS (WITHOUT DISEASE) 

UI Author Year Outcome Group 

Time between 

Baseline 

Exposure and 

Outcome 

Assessments 

Crude or 

Adjusted 

analysis? 

No. 

Analyzed 

Mean 

25(OH)D 

Level 

Vit D 

level 

CI / 

SE / SD*

Mean Ca 

intake or 

Ca 

balance 

Ca 

CI / 

SE / SD*

P 

between 

groups 

18505967 Ahn 2008 Prostate cancer 

cases: 

2-8 years crude 749 59.0 19.1 nd nd 25(OH)D: 0.18 

18505967 Ahn 2008 Prostate cancer controls: 2-8 years crude 781 57.6 18.9 nd nd Duplicate one table per outcome OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE UI Author Year Outcome Results UI Author 

Year Comments for Results 

-----Subgroup Analyses Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA) 

Allocation 

Concealment 

(y/n/nd/NA) 

Appropriate 

Washout 

Period 

(y/n/nd/NA) 

Dropout 

Rate 

<20% 

Blinded 

Outcome 

Assessment 

(y/n/nd) 

Intention 

to Treat 

Analysis 

(y/n/nd) 

Appropriate 

Statistical 

Analysis**

(y/n) 

Assessment 

for 

Confounding 

(y/n/nd/NA) 

Adverse Event(s): **Explanation for Overall Quality Grade (if not Grade A):NA=not applicable *Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) **Please do not leave blank. Type nd if there was no data on adverse. QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author Year Population Exposure (All) Dietary assessment* Biomarkers* Comparator Statistical Analysis Outc

18505967 

Ahn 

2008 

a) Eligibility criteria clear? (y/n) 

y 

a) Exposure assessor blinded to outcome info? (y/n) 

y 

a) Method reported? (y/n) 

y 

a) One of the prespecified methods was used? (y/n) 

y 

a) Level of the exposure in comparative categories (eg quartiles) is given (ranges)? (y/n) applicable for categorical analyses only 

y 

a) Adjusted or matched for ANY confounders (other than age and sex)?** (y/n) 

y 

a) Cleadefinitioof outcomincludintime of ascertament? (y/n) 

b) Sampling of population random or consecutive? (y/n) 

nd 

b) Outcome assessor blinded to exposure measurement? (y/n) 

nd 

b) Food composition database or suppl composition reported? (y/n) 

y 

Time from sample collection to sample analysis reported? (y/n) 

y 

b) Loss follow-u<20%? (y/n) 

c) Internal calibration of method perform (if FFQ)? (y/n/NA) 

n 

b) Justification of final adjusted model selection? (y/n) 

y 

c) Do thauthors specify primary outcom(y/n) 

OVERALL Grade (A/B/C): B Explanation for Overall Quality Grade (if not Grade A): While all cases of aggressive cancers were selected; only a randomly pic

cancers were selected. 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers **We will judge in the end if the set of confounders is adequate 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author 

Year 

Study 

Design* Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding So

11075874 Ahonen 

2000 

Casecohort study 

Employees in two Finnish governmental agencies and five industrial companies 

Previously clinically detected prostate cancer 

1981-1982 Helsinki 

Heart Study 

Finnish Cancer FoundatioFoundation, Medical ReseTampere University HospUniversity 

*Leave appropriate choice of study design and delete all others **Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCTPOPULATION (BASELINE)**

UI Author Year Study Design*

Location 

(e.g., City 

and Country, 

latitude) 

N 

enrolled 

N 

analyzed 

Mean 

(SD) 

Age, 

yr 

Age 

Range / 

IQR 

Male, 

% 

Race / 

Ethnicity 

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc) 

HeSt

11075874 Ahonen 

2000 

Casecohort study 

Finland 62° (various cities) 

715 cases: 149 control: 566 

715 nd 40-57 100% nd nd nd 

*Please copy from above**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. Background Diet*

UI Author Year Exposure Dietary Assessment Method** Food Composition Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data 

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data 

Time 

between 

Biomarker 

Sampling 

and 

Analysis 

S

sa

11075874 Ahonen 

2000 

25(OH)D and/or 1,25(OH)2D 

Radioimmunoassay 

(Incstar Corporation) 

Intra-assay coefficient of variation = 8.5%, Interassay coefficient of variation = 16% 

Same day Ja

MS

Dietary calcium intake 

nd nd nd nd nd 

* Write “nd” if there was no data reported. Please do not leave blank **Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief ***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Count

nutrient analysis (please specify) ****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author Year Vit D and/or Ca Intervention(s) Source (e.g., brand name, foods, or formulation) Vit D and/or Ca Dose Intervention Duration Intervention Freq

taken 

Co-intervention(s) *: Duplicate one row per intervention, including control intervention. *Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitam

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. LIST OF ALL OUTCOMES 

UI Author Year Primary / Secondary Outcome** Outcome Definition 

11075874 Ahonen 2000 Nd Prostate cancer nd Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. **Must have been explicitly stated in the original paper. Otherwise, please enter “nd” UI Author 

Year Comments 

-----Confounders: Please report all confounders controlled in the analyses reported in the follow

(adjusted results) 

UI Author 

Year Confounder Groups Please List Name of Confounder (including matching factors) 

11075874 Ahonen 

2000 

Other nutrients or dietary factors (e.g., certain food consumption), including supplement use and total energy intake 

Demographics (e.g., age, gender, race, education)? Yes Anthropometrics (e.g., BMI, body weight, % body fat)? Yes Medical conditions Systolic blood pressure, HDL Medication Treatment with gemfibrozil Sunlight exposure and its proxy variables (e.g., physical activity level, occupation, sun exposure, location) 

Yes 

Smoking and other life styles variables Yes Other Time of sample retrieval (matched) 

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLEC

ALL OUTCOMES OF INTEREST -----Main Analyses (For analyses that adjusted for confounders, choose the “best” model) 2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) UI Author Year Outcome Exposure / Intervention Mean Follow-up, 

mo 

N 

Event 

N 

Total 

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted 

Result 95% CI 

b

*Example: OR Ca/placebo 2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) UI Author Year Outcome Unit Exposure / Intervention Mean Follow-up, 

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD* Final or Delta** Final or Delta CI / SE / SD* Net difference 

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 ≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author Year Outcome 

Exposure 

Categories(e.g., 

Tirtiles) / 

Intervention 

Groups 

Mean 

Vit D 

level / 

dose 

Mean 

Ca 

level / 

dose 

No. of 

Cases*

No. of 

Noncases 

Crude or 

Adjusted 

analysis? 

Outcome 

Metric (e.g. 

OR, RR, 

HR, %) 

Outcome 

effect 

size 

 

11075874 Ahonen 

2000 

Prostate cancer 

Quartile cut off based on total original cohort; Quartile 4: 25(OH)D > 55 nmol/L 

nd nd 34 144 crude OR 1 

Quartile 3: 25(OH)D = 41-54 nmol/L 

nd nd 26 148 crude OR 0.8 0

1

Quartile 2: 25(OH)D = 31-40 nmol/L 

nd nd 41 143 crude OR 1.3 0

2
Quartile 1: 25(OH)D 

= < 30 nmol/L 

nd nd 48 131 crude OR 1.7 1

3

11075874 Ahonen 

2000 

Prostate cancer 

Quartile cut off based on total original cohort; Quartile 4: 25(OH)D > 55 nmol/L 

nd nd 34 144 adjusted for 

HDL; SBP; BMI 

OR 1 

Quartile 3: 25(OH)D = 41-54 nmol/L 

nd nd 26 148 Adjusted OR 0.8 0

1

Quartile 2: 25(OH)D = 31-40 nmol/L 

nd nd 41 143 Adjusted OR 1.4 0

2

Quartile 1: 25(OH)D = < 30 nmol/L 

nd nd 48 131 Adjusted OR 1.8 1

3

Prostate cancer in those <52 years old at entry 

Group 1: 25(OH)D >40 

nd nd nd nd adjusted 

HDL; SBP; BMI 

OR 1 

Group 2: 25(OH)D ≤40 

nd nd nd nd adjusted OR 3.5 1

7

Prostate cancer in those >51 years old at entry 

Group 1: 25(OH)D >40 

nd nd nd nd Adjusted OR 1 

Group 2: 25(OH)D ≤40 

nd nd nd nd adjusted OR 1.2 0

2

Duplicate one row per exposure category or intervention group. *Number of subjects with outcome **Please choose one and delete the others ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 ****P value for testing the linear trend of the OR/RR across different categories or doses ≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) UI Author Year Outcome Unit 

Exposure 

Category / 

Intervention 

Group 

Crude or 

Adjusted 

analysis? Mean Follow-up 

(months) 

No. 

Analyzed Baseline 

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / SD*

Net 

difference**
Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH 

CONTROLS (WITHOUT DISEASE) UI Author Year Outcome Group 

Time between 

Baseline Exposure 

and Outcome 

Assessments 

Crude or 

Adjusted 

analysis? 

No. 

Analyzed 

Mean 

25(OH)D 

Level 

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance 

Ca CI 

/ SE / 

SD*

P 

between 

groups 

Cases: Control: 

Duplicate one table per outcome OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE UI Author Year Outcome Results UI Author 

Year Comments for Results 

-----Subgroup Analyses Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA) 

Allocation 

Concealment 

(y/n/nd/NA) 

Appropriate 

Washout 

Period 

(y/n/nd/NA) 

Dropout 

Rate 

<20% 

Blinded 

Outcome 

Assessment 

(y/n/nd) 

Intention 

to Treat 

Analysis 

(y/n/nd) 

Appropriate 

Statistical 

Analysis**

(y/n) 

Assessment 

for 

Confounding 

(y/n/nd/NA) 

Adverse Event(s): **Explanation for Overall Quality Grade (if not Grade A):NA=not applicable *Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) **Please do not leave blank. Type nd if there was no data on adverse. QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author Year Population Exposure (All) Dietary assessment* Biomarkers* Comparator Statistical Analysis 

11075874 Ahonen 

2000 

a) Eligibility criteria clear? (y/n) 

Y 

a) Exposure assessor blinded to outcome info? (y/n) 

Y 

a) Method reported? (y/n) 

na a) One of 

the prespecified methods was used? (y/n) 

y a) Level of 

the exposure in comparative categories (eg quartiles) is given (ranges)? (y/n) applicable for categorical analyses only 

y 

a) Adjusted or matched for ANY confounders (other than age and sex)?** (y/n) 

y 

a) Cdefoutincof asc(y/n

b) Sampling of population random or consecutive? (y/n) 

NA 

b) Outcome assessor blinded to exposure measurement? (y/n) 

nd 

b) Food composition database or suppl composition reported? (y/n) 

na Time from 

sample collection to sample analysis reported? (y/n) 

n 

b) Lfollo<20

c) Internal calibration of method perform (if FFQ)? (y/n/NA) 

na b) 

Justification of final adjusted model selection? (y/n) 

y 

c) Dauta pout

OVERALL Grade (A/B/C): C Explanation for Overall Quality Grade (if not Grade A): details of prostate cancer diagnosis not reported; 39% of the stored 

for additional factors relevant to prostate cancer 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers **We will judge in the end if the set of confounders is adequate 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author 

Year 

Study 

Design* Inclusion Exclusion Enrollment Years Trial or Cohort Name 

12663277 Al-Delaimy 

2003 

Cohort Study 

Men, 40-75 y, health professional 

Kcal intake outside 800-4200 kcal/day, ≥70 items omitted on FFQ Nonmelanoma cancer before IHD, CVD at baseline. 

1986 Health Professionals 

Follow-up Study 

*Leave appropriate choice of study design and delete all others **Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCTPOPULATION (BASELINE)**

UI Author Year Study Design*

Location 

(e.g., City 

and 

Country, 

latitude) 

N 

enrolled***

N 

analyzed 

Mean 

(SD) 

Age, 

yr 

Age 

Range 

/ IQR 

Male, 

% 

Race / 

Ethnicity 

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc) 

HS

12663277 AlDelaimy 

2003 

Cohort Study 

US, various 39,800 39,800 

(415,965 person years) 

~54 (~9) 

40-75 100% White 

close to 100% 

~25.5 ± ~3.4 H

*Please copy from above**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. ***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg

assessment), number of subjects had outcome data ...etc. Background Diet*

UI Author Year Exposure Dietary Assessment Method** Food Composition Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data 

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data 

Time 

between 

Biomarker 

Sampling 

and 

Analysis 

Se

b

sa

12663277 AlDelaimy 

2003 

25(OH)D and/or 1,25(OH)2D 

nd nd nd nd 

Dietary calcium intake 

FFQ USDA, release 

10, 1995 + other sources 

Yes Random sample of 127 men in Boston. FFQ compared to diet record. Correlation coefficient = 0.64 

* Write “nd” if there was no data reported. Please do not leave blank **Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief ***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Countnutrient analysis (please specify) ****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author Year Vit D and/or Ca Intervention(s) Source (e.g., brand name, foods, or formulation) Vit D and/or Ca Total Daily Dose Intervention Duration Intervention Fre

take

Co-intervention(s) *: Compliance/Adherence: Duplicate one row per intervention, including control intervention. *Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitam

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. LIST OF ALL OUTCOMES 

UI Author Year Primary / Secondary Outcome** Outcome Definition 

12663277 Al-Delaimy 2003 1° Fatal ischemic heart disease Including sudden death. Death various sources, confirmed by medical recor

1° Nonfatal MI Self-reporting with medical record confirmation (WH2° Total ischemic heart disease Implied combination of fatal IHD and nonfatal MI 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd” 

UI Author 

Year Comments 

-----Confounders: Please report all confounders controlled in the analyses reported in the follow

(adjusted results) 

UI Author 

Year Confounder Groups Please List Name of Confounder (including matching factors) S

c

12663277 Al-Delaimy 

2003 

Other nutrients or dietary factors (e.g., certain food consumption), including supplement use and total energy intake 

Yes E

Demographics (e.g., age, gender, race, education)? Yes AAnthropometrics (e.g., BMI, body weight, % body fat)? Yes BMedical conditions Yes DMedication Yes ASunlight exposure and its proxy variables (e.g., seasonal variation of 25(OH)D, UV exposure, location) Smoking and other life styles variables (e.g., physical activity, occupation, alcohol consumption) 

Yes S

a

Other Yes F

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLEC

ALL OUTCOMES OF INTEREST -----Main Analyses (For analyses that adjusted for confounders, choose the “best” model) 2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) UI Author Year Outcome Exposure / Intervention Mean Follow-up, 

mo 

N 

Event 

N 

Total 

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted 

Result 95% CI 

b

*Example: OR Ca/placebo 2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) UI Author Year Outcome Unit Exposure / Intervention Mean Follow-up, 

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD* Final or Delta** Final or Delta CI / SE / SD* Net difference 

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author Year Outcome 

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups 

Mean 

Vit D 

level 

/ 

dose 

Mean 

Ca 

level 

/ 

dose 

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean 

Follow-up, 

mo 

Crude or 

Adjusted 

analysis? 

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%) 

Outcome 

effect 

size 

12663277 AlDelaimy 

2003 

IHD (fatal + nonfatal) 

Total calcium Quintile 1 

523 300 7960 12 years Adjusted 

(“multivariate”) 

RR 1.0 

Quintile 2 670 296 7960 1.03 Quintile 3 803 267 7960 0.92 Quintile 4 995 299 7960 1.01 Quintile 5 1377 296 7960 0.94 

12663277 AlDelaimy 

2003 

Nonfatal MI 

Total calcium Quintile 1 

523 212 7960 12 years Adjusted 

(“multivariate”) 

RR 1.0 

Quintile 2 670 206 7960 1.01 Quintile 3 803 197 7960 0.96 Quintile 4 995 220 7960 1.04 Quintile 5 1377 195 7960 0.92 

12663277 AlDelaimy 

2003 

Fatal IHD Total calcium 

Quintile 1 

523 88 7960 12 years Adjusted 

(“multivariate”) 

RR 1.0 

Quintile 2 670 90 7960 1.17 Quintile 3 803 70 7960 0.93 Quintile 4 995 79 7960 1.06 Quintile 5 1377 101 7960 1.10 

Duplicate one row per exposure category or intervention group. *Number of subjects with outcome **Please choose one and delete the others ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 ****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author Year Outcome Unit 

Exposure 

Category / 

Intervention 

Group 

Crude or 

Adjusted 

analysis? Mean Follow-up 

(months) 

No. 

Analyzed Baseline 

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / SD*

Net 

difference**

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. *Please choose one and delete the others **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH 

CONTROLS (WITHOUT DISEASE) UI Author Year Outcome Group 

Time between 

Baseline Exposure 

and Outcome 

Assessments 

Crude or 

Adjusted 

analysis? 

No. 

Analyzed 

Mean 

25(OH)D 

Level 

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance 

Ca CI 

/ SE / 

SD*

P 

between 

groups 

Cases: Control: 

Duplicate one table per outcome OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE UI Author Year Outcome Results UI Author 

Year Comments for Results 

-----Subgroup Analyses Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA) 

Allocation 

Concealment 

(y/n/nd/NA) 

Appropriate 

Washout 

Period 

(y/n/nd/NA) 

Dropout 

Rate 

<20% 

Blinded 

Outcome 

Assessment 

(y/n/nd) 

Intention 

to Treat 

Analysis 

(y/n/nd) 

Appropriate 

Statistical 

Analysis**

(y/n) 

Assessment 

for 

Confounding 

(y/n/nd/NA) 

Adverse Event(s): **Explanation for Overall Quality Grade (if not Grade A):NA=not applicable *Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) **Please do not leave blank. Type nd if there was no data on adverse. QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author Year Population Exposure (All) Dietary assessment* Biomarkers* Comparator Statistical Analysis 

12663277 AlDelaimy 

2003 a) Eligibility 

criteria clear? (y/n) 

Y 

a) Exposure assessor blinded to outcome info? (y/n) 

nd 

a) Method reported? (y/n) 

Y a) One of 

the prespecified methods***was used? (y/n) 

NA a) Level of 

the exposure in comparative categories (eg quartiles) is given (ranges)? (y/n) applicable for categorical analyses only 

Y 

a) Adjusted or matched for ANY confounders (other than age and sex)?** (y/n) 

Y 

a) deouincof asc(y/

b) Sampling of population random or consecutive? (y/n) 

Y 

b) Outcome assessor blinded to exposure measurement? (y/n) 

nd 

b) Food composition database or suppl composition reported? (y/n) 

Y Time from 

sample collection to sample analysis reported? (y/n) 

Y 

b) fol<2

c) Internal calibration of method perform (if FFQ)? (y/n/NA) 

Y b) 

Justification of final adjusted model selection? (y/n) 

N 

c) aua pou

OVERALL Grade (A/B/C): A Explanation for Overall Quality Grade (if not Grade A): No flaws. Well analyzed. *Check “NA” and skip all questions if study did not use dietary assessment or biomarkers **We will judge in the end if the set of confounders is adequate ***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author 

Year 

Study 

Design* Inclusion Exclusion Enrollment Years Trial or Cohort Name 

7892882 Aloia 

1995 

RCT Healthy white women between 6 months and 6 years after 

a natural menopause. 

Nd nd nd 

*Leave appropriate choice of study design and delete all others **Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCTPOPULATION (BASELINE)**

UI Author Year Study Design*

Location 

(e.g., City 

and 

Country, 

latitude) 

N 

enrolled***

N 

analyzed 

Mean (SD) 

Age, yr 

Age 

Range 

/ IQR 

Male, 

% 

Race / 

Ethnicity 

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc) 

S

7892882 Aloia 

1995 

RCT Mineola, NY, 

USA, 40° 

118 64 (+30 in 

HRT arm) 

-Calcium group: 52(0.6) yrs -Placebo group: 53.4(0.6) yrs 

nd 0% White 

100% 

-Weight: calcium group 65.8 (1.5) kg; placebo group 65.6 (1.8) kg -BMI: calcium group 24.6(0.5); placebo group 24.7(0.6) 

N

*Please copy from above**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. ***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg

assessment), number of subjects had outcome data ...etc. Background Diet*

UI Author Year Exposure Dietary Assessment Method** Food Composition Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data 

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data 

Time 

between 

Biomarker 

Sampling 

and Analysis 

Se

w

b

sam

7892882 Aloia 

1995 

25(OH)D and/or 1,25(OH)2D 

nd nd nd nd 

Dietary calcium intake 

Nd nd nd nd nd nd 

* Write “nd” if there was no data reported. Please do not leave blank **Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief ***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Count

nutrient analysis (please specify) ****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author Year Vit D and/or Ca Intervention(s) Source (e.g., brand name, foods, or formulation) Vit D and/or Ca Dose Intervention Duration Intervention Fre

take

7892882 Aloia 

1995 

Calcium supplement nd about type 1700 mg Ca 2.9 +/- 1.1 yrs. nd Calcium placebo Nd 

Co-intervention(s) *: 400 IU vitamin D in all groups Compliance/Adherence: nd Duplicate one row per intervention, including control intervention. *Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitam

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. LIST OF ALL OUTCOMES 

UI Author Year Primary / Secondary Outcome** Outcome Definition 

7892882 Aloia 1995 2° Body weight Change in kg/yr Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. **Must have been explicitly stated in the original paper. Otherwise, please enter “nd” UI Author 

Year Comments 

-----Confounders: Please report all confounders controlled in the analyses reported in the follow

(adjusted results) 

UI Author 

Year Confounder Groups Please List Name of Confounder (including matching factors) 

7892882 Aloia 

1995 

Other nutrients or dietary factors (e.g., certain food consumption), including supplement use and total energy intake 

Demographics (e.g., age, gender, race, education)? No Anthropometrics (e.g., BMI, body weight, % body fat)? No Medical conditions Medication Sunlight exposure and its proxy variables (e.g., seasonal variation of 25(OH)D, UV exposure, location) Smoking and other life styles variables (e.g., physical activity, occupation, alcohol consumption) 

No 

Other 

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLEC

ALL OUTCOMES OF INTEREST -----Main Analyses (For analyses that adjusted for confounders, choose the “best” model) 2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) UI Author Year Outcome Exposure / Intervention Mean Follow-up, 

mo 

N 

Event 

N 

Total 

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted 

Result 95% CI 

b

*Example: OR Ca/placebo 2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author Year Outcome Unit Exposure / Intervention Mean Follow-up, 

mo 

No. 

Analyzed Baseline 

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final or 

Delta CI 

/ SE / 

SD*

Net 

difference 

7892882 Aloia 

1995 

Body weight 

kg Calcium 2.9 yrs 36 65.8 SD = 1.5 Delta = 

+0.1 

Nd 0.0 

placebo 2.9 yrs 28 65.6 SD = 1.8 Delta = 

+0.1 

nd 

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 ≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) UI Author Year Outcome 

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups 

Mean 

Vit D 

level / 

dose 

Mean 

Ca 

level / 

dose 

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis? 

Outcome 

Metric (e.g. 

OR, RR, HR, 

%) 

Outcome 

effect size 

C

SE 

S

*

Duplicate one row per exposure category or intervention group. *Number of subjects with outcome **Please choose one and delete the others ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) UI Author Year Outcome Unit 

Exposure 

Category / 

Intervention 

Group 

Crude or 

Adjusted 

analysis? Mean Follow-up 

(months) 

No. 

Analyzed Baseline 

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / SD*

Net 

difference**

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. *Please choose one and delete the others **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH 

CONTROLS (WITHOUT DISEASE) UI Author Year Outcome Group 

Time between 

Baseline Exposure 

and Outcome 

Assessments 

Crude or 

Adjusted 

analysis? 

No. 

Analyzed 

Mean 

25(OH)D 

Level 

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance 

Ca CI 

/ SE / 

SD*

P 

between 

groups 

Cases: Control: 

Duplicate one table per outcome OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE UI Author Year Outcome Results UI Author 

Year Comments for Results 

-----Subgroup Analyses Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA) 

Allocation 

Concealment 

(y/n/nd/NA) 

Appropriate 

Washout 

Period 

(y/n/nd/NA) 

Dropout 

Rate 

<20% 

Blinded 

Outcome 

Assessment 

(y/n/nd) 

Intention 

to Treat 

Analysis 

(y/n/nd) 

Appropriate 

Statistical 

Analysis**

(y/n) 

Assessm

for 

Confound

(y/n/nd/N

7892882 Aloia 

1995 

RCTparallel Y ND nd No nd nd y n 

Adverse Event(s): ** nd Explanation for Overall Quality Grade (if not Grade A): High dropout rate. Inadequate reporting of outcomes of interest. NA=not applicable *Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) **Please do not leave blank. Type nd if there was no data on adverse. QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES UI Author Year Population Exposure (All) Dietary assessment* Biomarkers* Comparator Statistical Analysis Outco

a) Eligibility criteria clear? (y/n) 

a) Exposure assessor blinded to outcome info? (y/n) 

a) Method reported? (y/n) 

a) One of the prespecified methods***was used? (y/n) 

a) Level of the exposure in comparative categories (eg quartiles) is given (ranges)? (y/n) applicable for categorical analyses only 

a) Adjusted or matched for ANY confounders (other than age and sex)?** (y/n) 

a) Clear definition of outcome, including timascertainme(y/n) 

b) Sampling of population random or consecutive? (y/n) 

b) Outcome assessor blinded to exposure measurement? (y/n) 

b) Food composition database or suppl composition reported? (y/n) 

Time from 

sample collection to sample analysis reported? (y/n) 

b) Loss to follow-up <2(y/n) 

c) Internal calibration of method perform (if FFQ)? (y/n/NA) 

b) Justification of final adjusted model selection? (y/n) 

c) Do the authors spea primary outcome? (

OVERALL Grade (A/B/C): Explanation for Overall Quality Grade (if not Grade A):*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers **We will judge in the end if the set of confounders is adequate ***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author 

Year 

Study 

Design* Inclusion Exclusion Enrollment Years Trial or Cohort Nam

16280427 Alonso 

2005 

Cohort Study 

University graduates or registered nurses 

History of CVD, cancer, DM, prevalent HTN, extreme total energy intakes (<400 or >3500 women; <600 or >4200 men), missing data 

12/99-1/2002 U Navarra 

Follow-up Study 

*Leave appropriate choice of study design and delete all others **Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCTPOPULATION (BASELINE)**

UI Author Year Study Design*

Location 

(e.g., City 

and 

Country, 

latitude) 

N 

enrolled***

N 

analyzed 

Mean 

(SD) 

Age, 

yr 

Age 

Range 

Male, 

% 

Race / 

Ethnicity 

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc) 

HS

16280427 Alonso 

2005 

Cohort Study 

Navarra, Spain 42° 40’ 

~7470 (incl missing data) 

6686 36 

(~11) 

20-90 39% nd 

(educated Spaniards) 

BMI 23.1 N

H

*Please copy from above**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. ***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg

assessment), number of subjects had outcome data ...etc. Background Diet*

UI Author Year Exposure Dietary Assessment Method** Food Composition Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data 

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data 

Time 

between 

Biomarker 

Sampling 

and 

Analysis 

Se

b

sa

25(OH)D and/or 1,25(OH)2D 

16280427 Alonso 

2005 

Dietary calcium intake 

FFQ Spanish food 

composition tables (referenced) 

(Previously validated in Spain) 

NA NA NA 

* Write “nd” if there was no data reported. Please do not leave blank **Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief ***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Countnutrient analysis (please specify) ****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author Year Vit D and/or Ca Intervention(s) Source (e.g., brand name, foods, or formulation) Vit D and/or Ca Total Daily Dose Intervention Duration Intervention Fre

take

Co-intervention(s) *: Compliance/Adherence: Duplicate one row per intervention, including control intervention. *Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitam

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. LIST OF ALL OUTCOMES 

UI Author Year Primary / Secondary Outcome** Outcome Definition 

16280427 Alonso 2005 1° HTN, incident Physician diagnosis (self-reported) Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. **Must have been explicitly stated in the original paper. Otherwise, please enter “nd” UI Author 

Year Comments 

16280427 Alonso 

2005 

In a validation study of 127 participants, with a HTN threshold of 160/95, negative predictive value of self-reported = 98%; wit

85% and PPV=82% 

-----Confounders: Please report all confounders controlled in the analyses reported in the follow

(adjusted results) 

UI Author 

Year Confounder Groups Please List Name of Confounder (including matching factors) Spe

con

16280427 Alonso 

2005 

Other nutrients or dietary factors (e.g., certain food consumption), including supplement use and total energy intake 

Yes Na 

con

Demographics (e.g., age, gender, race, education)? Yes AgeAnthropometrics (e.g., BMI, body weight, % body fat)? Yes BMMedical conditions Yes HypMedication Sunlight exposure and its proxy variables (e.g., seasonal variation of 25(OH)D, UV exposure, location) Smoking and other life styles variables (e.g., physical activity, occupation, alcohol consumption) 

Yes Phy

Other 

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLEC

ALL OUTCOMES OF INTEREST -----Main Analyses (For analyses that adjusted for confounders, choose the “best” model) 2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) UI Author Year Outcome Exposure / Intervention Mean Follow-up, 

mo 

N 

Event 

N 

Total 

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted 

Result 95% CI 

b

*Example: OR Ca/placebo 2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) UI Author Year Outcome Unit Exposure / Intervention Mean Follow-up, 

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD* Final or Delta** Final or Delta CI / SE / SD* Net difference 

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author Year Outcome 

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups 

Mean 

Followup 

Mean 

Ca 

level / 

dose 

No. of 

Cases 

(Event)* 

Person 

Years 

(N) 

Crude or 

Adjusted 

analysis? 

Outcome 

Metric (e.g. 

OR, RR, HR, 

%) 

Outcome 

effect size 

Duplicate one row per exposure category or intervention group. *Number of subjects with outcome **Please choose one and delete the others ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 ****P value for testing the linear trend of the OR/RR across different categories or doses ≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) UI Author Year Outcome Unit 

Exposure 

Category / 

Intervention 

Group 

Crude or 

Adjusted 

analysis? Mean Follow-up 

(months) 

No. 

Analyzed Baseline 

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / SD*

Net 

difference**

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. *Please choose one and delete the others **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH 

CONTROLS (WITHOUT DISEASE) UI Author Year Outcome Group 

Time between 

Baseline Exposure 

and Outcome 

Assessments 

Crude or 

Adjusted 

analysis? 

No. 

Analyzed 

Mean 

25(OH)D 

Level 

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance 

Ca CI 

/ SE / 

SD*

P 

between 

groups 

Cases: Control: 

Duplicate one table per outcome OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author Year Outcome Exposure Categories(e.g., Tertiles) / Mean Follow- up Mean Ca level / dose No. of Cases (Event)* Person Years (N) Crude or Adjusted analysis? Outcome Metric (e.g. OR, Outcome effect size 
Intervention 

Groups 

RR, HR, 

%) 

16280427 Alonso 

2005 

HTN Quintile 1 2 y nd 

(mean 0.9±0.2)1

39 (14.3/1000 p-yr) 

2734 pyr (~1337) 

Adjusted HR 1 -- 

Quintile 2 nd 

(mean 1.0±0.2)2

39 (14.3/1000 p-y 

2726 pyr (~1337) 

0.98 0

1

Quintile 3 nd 

(mean 1.2±0.2)3

35 (12.9/1000 p-y 

2706 pyr (~1337) 

0.82 0

1

Quintile 4 nd 

(mean 1.4±0.3)4

30 (11.2/1000 p-y 

2668 pyr (~1337) 

0.73 0

1

Quintile 5 nd 

(mean 1.7±0.4)5

37 (13.7/1000 p-y 

2692 pyr (~1337) 

0.97 0

1

UI Author 

Year Comments for Results 

Quintiles are for total dairy consumption, not calcium. 

-----Subgroup Analyses Please copy the appropriate table above for all subgroup analyses of interest. 1 Mean±SD calcium intake within quintile of total dairy consumption 2 Mean±SD calcium intake within quintile of total dairy consumption 3 Mean±SD calcium intake within quintile of total dairy consumption 4 Mean±SD calcium intake within quintile of total dairy consumption 5 Mean±SD calcium intake within quintile of total dairy consumption 
QUALITY of INTERVENTIONAL STUDIES 

UI Author Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA) 

Allocation 

Concealment 

(y/n/nd/NA) 

Appropriate 

Washout 

Period 

(y/n/nd/NA) 

Dropout 

Rate 

<20% 

Blinded 

Outcome 

Assessment 

(y/n/nd) 

Intention 

to Treat 

Analysis 

(y/n/nd) 

Appropriate 

Statistical 

Analysis**

(y/n) 

Assessment 

for 

Confounding 

(y/n/nd/NA) 

Adverse Event(s): **Explanation for Overall Quality Grade (if not Grade A):NA=not applicable *Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) **Please do not leave blank. Type nd if there was no data on adverse. QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author Year Population Exposure (All) Dietary assessment* Biomarkers* Comparator Statistical Analysis 

16280427 

Alonso 2005 

a) Eligibility criteria clear? (y/n) 

Y 

a) Exposure assessor blinded to outcome info? (y/n) 

nd 

a) Method reported? (y/n) 

Y a) One of 

the prespecified methods***was used? (y/n) 

NA a) Level of 

the exposure in comparative categories (eg quartiles) is given (ranges)? (y/n) applicable for categorical analyses only 

N 

a) Adjusted or matched for ANY confounders (other than age and sex)?** (y/n) 

Yes 

adoinoa(

b) Sampling of population random or consecutive? (y/n) 

Y 

b) Outcome assessor blinded to exposure measurement? (y/n) 

nd 

b) Food composition database or suppl composition reported? (y/n) 

Y Time from 

sample collection to sample analysis reported? (y/n) 

NA 

bfo<

c) Internal calibration of method perform (if FFQ)? (y/n/NA) 

N b) 

Justification of final adjusted model selection? (y/n) 

No 

caa o

OVERALL Grade (A/B/C): C Explanation for Overall Quality Grade (if not Grade A): No data on range of Ca intake within quintiles *Check “NA” and skip all questions if study did not use dietary assessment or biomarkers **We will judge in the end if the set of confounders is adequate ***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

18208636 Andersen, 

2008

RCT General Pakistani immigrants primarily 

living in the Copenhagen area

Denmark (latitude 55 N°), recruited 

through various information meetings, 

radio and television, and posters.

Medications known to affect bone 

metabolism or serum 25(OH)D 

concentrations, serious illness, pregnancy, 

planning pregnancy within 1 yr, 

breastfeeding, and serum ionized Ca 

concentrations >1.5 mmol/L. 

Subjects with Incomplete data in one or more 

of the explanatory variables were excluded 

from the analyses.

Jan 2002 to 

Nov 2002

nd nd Mc

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean (SD) 

Age, yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat ...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or 

Ca intake 

...etc.)

18208636 Andersen, 

2008

RCT Copenhagen 

area, 

Denmark (55 

N°)

199 147 Median 

age -

Adolescent 

girls: 12.2

Women: 

36.2

Men: 38.3

Range –

Adolescent 

girls: 10.1-

14.7

Women: 

18.1-52.7

Men: 17.9-

63.5

42 Pakistani Median BMI -

Adolescent girls: 

19.5

Women: 27

Men: 26.7

Generally 

healthy

No 

hypercalcimia

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

18208636 Andersen, 

2008

25(OH)D HPLC using 

a diode 

array 

detector

Yes

Interassay 

CV=6.3% and 

intraassy 

CV=4.3%

nd All seasons 

(blood were 

drawn three 

time, baseline, 6 

mo and 1 yr)

See baseline 

variables

Dietary 

calcium 

intake

FFQ General Intake 

Estimation 

System 

described 

elsewhere

no no Median Ca 

intake (mg/d)

-

Adolescent 

girls: 510

Women: 495

Men: 548

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

18208636 Andersen, 

2008

Vitamin D3 Scanphrm A/S (Birkerod, Denmark) 10 ug/d 1 yr Daily

Vitamin D3 20 ug/d 1 yr Daily

placebo Cellulosum microcristallium 0 1 yr Daily

Co-intervention(s) *: none

Compliance/Adherence:

Tablet counting. The median compliance was 85 (range 43-100), 92 (42-115) and 93 (33-105)% for girls, women, and men, 

respectively

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

18208636 Andersen, 2008 primary 25(OH)D

primary BMD, BMC DXA, whole body, or lumbar spine
Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

18208636 Andersen, 

2008

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes* age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes/no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes/no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up

(months)

No. 

Analyzed** ** Baseline Baseline IQR*

Final

**

Final 

IQR*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P 

between

groups***

18208636 Andersen, 

2008 25(OH)D nmol/L Girls -Placebo

crude 12 8 / 7 7.3 5.3, 23.6 5.75 4.88, 

16.0 nd nd Ref

Girls - Vit D3 

10 ug/d 9 / 7 16.9 12.1, 21.1 47.0 28.7, 61.5 0.03

Girls - Vit D3 

20 ug/d 9 / 7 8.8 5.2, 17.1 29.3 28.5, 64.0 NS

18208636 Andersen, 

2008 25(OH)D nmol/L Women -Placebo

crude 12 29 / 19 11.7 7.5, 19.4 10.1 8.38, 

16.1 nd nd Ref

Women - Vit 

D3 10 ug/d 30 / 21 9.95 6.9, 14.3 40.9 37.4, 47.7 <0.0001

Women - Vit 

D3 20 ug/d 30 / 22 14.0 8.3, 17.5 46.2 38.6, 53.2 <0.0001

18208636 Andersen, 

2008 25(OH)D nmol/L Men -Placebo

crude 12 27 / 20 20 15, 25.2 19.1 13.1, 

22.6 nd nd Ref

Men - Vit D3 

10 ug/d 26 / 19 22.9 12.6, 28.2 39.4 31, 48.2 <0.0001

Men - Vit D3 

20 ug/d 31 / 26 18.9 13.6, 29.2 54.7 45.2, 65.1 <0.0001

18208636 Andersen, 

2008

BMC –

whole 

body

G

Girls -

Placebo

crude

12 8 / 7 1666

1399, 

1767 1923

1730, 

2145 nd

nd

Ref

Girls - Vit D3 

10 ug/d 9 / 7 1308 1104, 1726 1595 1302, 1953 NS

Girls - Vit D3 

20 ug/d 9 / 7 1473 1209, 1887 1625 1380, 21440 NS

18208636 Andersen, 

2008

BMD –

lumbar 

spine

g/cm2 Women -

Placebo

crude

12 29 / 18 0.99

0.91, 

1.12 1.00

0.89, 

1.16 nd

nd

Ref

Women - Vit 

D3 10 ug/d 30 / 21 1.06 0.99, 1.06 1.06 1.01, 1.11 NS

Women - Vit 

D3 20 ug/d 30 / 21 0.98 0.93, 1.05 0.99 0.93, 1.06 NS

18208636 Andersen, 

2008

BMD –

lumbar 

spine

g/cm2 Men -

Placebo

crude

12 27 / 19 1.03

0.96, 

1.14 1.06

0.90, 

1.14 nd

nd

Ref

Men - Vit D3 

10 ug/d 25 / 19 1.03 0.94,1.07 1.05 0.97, 1.11 NS

Men - Vit D3 

20 ug/d 31 / 26 0.92 0.89, 1.08 1.00 0.88, 1.12 NS

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
****Baseline / follow-up n 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

18208636 Andersen, 

2008 RCT nd nd NA

no nd yes yes no yes B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A):

Very small size for girls (therefore downgraded to C). Dropout rates were different between treatment groups. 

Compliance was lower for girls. Blinding was not described.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

8675093 Weisgerber 

1996

RCT Newly diagnosed 

adenomatous polyps > 

4mm

Age 30-75 y

Biopsy for cell 

proliferation after the 

intervention

Conditions predisposing to colorectal 

cancer other than sporadic adenomas

Contraindication to calcium supplement

Contraindication to biopsy

Severe restriction of general health

Drug use that may interfere with the 

study

More specifically:

FAP

IBD

Chronic alcohol abuse

Intestinal malabsorption syndromes

Cancers other than non-melanoma skin 

cancer

Renal insufficiency

Gastrectomy, Ileostomy, colectomy

Vegetarian diet

Consumption of > 1 L milk/day > 600 g 

dairy products/day (milk-alkali 

syndrome)

Renal stones, hematuria

Sarcoidosism, hyperparathyroidism, 

hypercalcemia, abnormal serum 

calcium/Cr

Tx with cholestyramine, calcium and/or 

Vit D supplement, anticoagulation

nd nd Europe Against 

Cancer, Sandoz AG, 

Nurnberg 

TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

8675093 Weisgerber 

1996

RCT Heidelberg 

and 

surrounding 

areas, 

Germany

44#30 62 

(nd)

46-75 53## nd nd nd (other than 

previously 

resected 

colorectal 

adenomatous 

polyps)

Total: 2638

(kcal/d)

Fiber: 33 (g/d)

Calcium: 928 

(mg/d)

Vit D: 4 

(microg/d)

*Please copy from above
**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

# 48 patients included but 4 were excluded due to non-compliance during run-in phase before randomization. The other 14 exclusions after randomization were: 1 (death), 6 (noncompliance during the intervention phase), 3 (good compliance but poor absorption assessed by a fecal study), and 4 (did not undergo biopsy). 

## Distribution of sex (men) unbalanced (33% in placebo vs. 73% in calcium supplement) 

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

8675093 Weisgerber 

1996

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd Vit D: 4 

(microg/d)

8675093 Weisgerber 

1996

Dietary 

calcium 

intake

nd nd nd Calcium: 928 

(mg/d) by 

FFQ FFQ (baseline) Federal Food 

Code of 

Germany

N

24HR (during 

supplementation)

Federal Food 

Code of 

Germany

n

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or 

Ca Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

8675093 Weisgerber 

1996

Calcium supplement 2000 mg/d 9 mon A 1000mg tablet was take with breakfast 

and evening meal

Placebo - -

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome**

Outcome Definition

8675093 Weisgerber 

1996

Unlcear PI Change in PI% of all examined crypts before and after calcium treatment

8675093 Weisgerber 

1996

Unlcear PI Change in curve of PI% (function of percentile distance from the base of the crypt column) of all 

examined crypts before and after calcium treatment

8675093 Weisgerber 

1996

Unlcear PI Change in PI% of each of 5 compartments of equal size into which each crypt column was divided 

before and after calcium treatment

8675093 Weisgerber 

1996

Unlcear Calcium 

balance Total fecal calcium and urinary calcium

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

PI: proliferation index 

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes/no*

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes/no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 25(OH)D, UV

exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, alcohol 

consumption)

Yes/no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SE

Final

or 

Delta**

Final 

or 

Delta 

SE

Net 

difference

Net 

difference 

CI / SE / 

SD*

P 

between

8675093 Weisgerber 

1996

PI (total) % 

change

Calcium 9 15 13.5 1.5 11.4 1.2 nd nd 0.7 

(MW)##

Placebo 15 13.7 0.9 10.7 1.1

8675093 Weisgerber 

1996

PI (highest 

compartment)#

% 

change

Calcium 9 15 28.2 2.8 23.1 2.4 nd nd 0.4 

(MW)##

Placebo 15 27.3 2.6 21.5 1.8

8675093 Weisgerber 

1996

PI (lowest 

compartment)#

% 

change

Calcium 9 15 0.6 0.2 0.5 0.2 nd nd 0.8 

(MW)##

Placebo 15 0.7 0.4 0.7 0.3

8675093 Weisgerber 

1996

PI (curve) % 

change

Calcium 9 15 nd nd nd nd nd nd NS 

(unclear)

Placebo 15 nd nd nd nd

8675093 Weisgerber 

1996

Total fecal 

calcium

% 

change

Calcium 6 15 1021 170 2828 316 +1807 357 <0.001##

Placebo 15 914 141 723 78 -192 112

8675093 Weisgerber 

1996

Water soluble 

fecal calcium 

% 

change

Calcium 6 15 130 28 337 158 +206 37 <0.01##

Placebo 15 114 23 100 16 -40 18

8675093 Weisgerber 

1996

Total urine 

calcium 

% 

change

Calcium 6 15 100 24 109 12 +10 24 0.6##

Placebo 15 68 9 74 11 +5 9

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

# As many as 5 compartments were separately evaluated without any biologically plausible explanations. Thus, only compartments with highest and lowest baseline PI were selected. 

## only final values were analyzed, not net difference. 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 
UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author Comments for Results
Year

Two participants 

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

8675093 Weisgerber 

1996 RCT Y nd Y Y (38%) Y N

Y (as 

baseline 

estimate is 

similar 

between 

groups)

N Y B

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A): As high as 38% of originally randomized patients were excluded due to several reasons.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year

Population Exposure (All) Dietary 

assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

15531486 Armas

2004

RCT men in good health; <16 oz 

milk qd; <10 h sun exposure 

per wk

granulomatous conditions; liver, kidney disease; 

DM; on anticonvulsants, barbiturates or steroids

2003 - academic SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

15531486 Armas

2004

RCT Omaha, NE 

(41.2o)

30 30 33 

(11.5)

20-61 100 nd BMi 27.1 good 

health

4 subjects took 

multivitamin 

averaging 1 time per 

wk before enrollment

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? (y/n) 

If Yes, Provide 

Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

15531486 Armas

2004

25(OH)D RIA (IDS & 

DiaSorin)

n nd July nd

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca 

Total Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

15531486 Armas

2004

vit D2 Sidmark Lab., NC 50000 IU 1 time only one tablet

vit D3 Tishcon Corp., NC 50000 IU 1 time 10 tablets of 5000 IU each

no supplement, seasonal 

effect only

Co-intervention(s) *:

Compliance/Adherence: 100%

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

15531486 Armas

2004

primary change in 25(OH)D sum of 25(OH)D2 and 25(OH)D3

(AUC) for 25 (OH)D

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

15531486 Armas

2004

4 subjects took multivitamin averaging 1 time per wk, stopped 1 wk before and throughout the study; control 25 (OH)D level used to adjust for sunlight exposure 

in the active intervention subjects

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

15531486 Armas

2004

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no*

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

yes sunlight exposure

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Delta**or 

Final

Final 

or 

Delta 

CI / SE 

/ SD*

Net 

difference

Net 

difference 

CI / SE / 

SD*

P 

between

15531486 Armas

2004

change in 

25(OH)D

nmol/L vit D2 7d 10 0*** 8***

vit D3 7d 10 0*** 15***

vit D2 14d 10 0*** 2***

vit D3 14d 10 0*** 17***

vit D2 28d 10 0*** -5***

vit D3 28d 10 0*** 12***

Area under 

the curve 

(AUC) for 

25 (OH)D

nmol.d/L vit D2 28d 10 150.5 58.5 <0.002

vit D3 28d 10 511.8 80.9

***adjusted for seasonal risk in 25(OH)D; all values estimated from Figure 2 in paper 

 Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)*

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 
Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

15531486 Armas

2004 RCT nd nd nd

y n n n n y C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): unclear how the subjects were chosen; relatively small number of subjects; incomplete reporting of analysis; 

did not adjust for all potentially relevant variables

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

1330360 Ascherio 

1992

Cohort 

study

Male health 

professionals, 40-

75 y

Caloric intake <800 or >4200 kcal/d, incomplete FFQ, 

nonmelanoma cancer, CVD, diabetes, kidney failure, 

high cholesterol, digoxin, nitrates, antihypertensive 

medications

1986 Health 

Professionals 

Follow-up Study

NIH EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

1330360 Ascherio 

1992

Cohort 

study

US, various 30,681 30,681 Median 

~50

40-75 100 White 

close to 

100%

nd Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

1330360 Ascherio 

1992

Dietary 

calcium 

intake

FFQ nd Yes

Ca correlation 0.53

NA NA NA nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

1330360 Ascherio 1992 1° Incident HTN self-reported diagnosis (collected BP data, but apparently didn’t use)

Validated

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

1330360 Ascherio 

1992

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes Age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes EtOH

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year

Outcome Unit Exposure / 

Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Ca 

intake

No. of 

Cases 

(Event)* 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

1330360 Ascherio 

1992

Incident 

HTN

Ca intake 

Categories

<500 85 1677 4 y Adjusted RR 1.17 0.91, 

1.50

NS 0.53

500-

699

297 7504 0.91 0.77, 

1.07

NS

700-

899

333 8576 0.89 0.76, 

1.04

NS

900-

1099

195 5038 0.91 0.76, 

1.09

NS

≥1100 338 7890 1.00 -- --

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No.

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Ca 

intake

No. of 

Cases 

(Event)* 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

1330360 Ascherio 

1992

Incident 

HTN

Ca intake 

Categories

Age≤50 <500 nd 14354 4 y Adjusted RR 1.52 nd <.05 nd

500-

1099

nd 0.86 nd NS

≥1100 nd 1.00 -- --

Age>50 <500 nd 16314 0.98 nd NS nd

500-

1099

nd 0.91 nd NS

≥1100 nd 1.00 -- --

Duplicate one row per exposure category or intervention group. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

1330360 Ascherio 

1992

a) Eligibility 

criteria 

clear? (y/n)

Yes

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Yes a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Yes

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Yes

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Probably

a) 

Prospective 

collection of 

data? (y/n)

Yes

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Yes

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

No Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up

<20%? (y/n)

Yes

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

Yes

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Yes b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

No

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Yes

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

No

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Definition of HTN not clear (self reported, probably didn’t use BP threshold, probably should have if not)
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

8621198 Ascherio 

1996

Cohort 

study

Female nurses, 30-55 

y, completed FFQ

HTN, CVD, DM, nonmelanoma cancer, 

antihypertensive drug, on special diet, recent 

pregnancy prior to FFQ

1976 Nurses’ 

Health Study

NIH EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

8621198 Ascherio 

1996

Cohort 

study

US, various 59,670 41,541 nd 30-55 0 White 

98%

nd Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc. 

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported?

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

8621198 Ascherio 

1996

Dietary 

calcium 

intake

FFQ USDA + other 

sources

Yes

correlation Ca 0.62

NA NA NA nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

8621198 Ascherio 1996 1° Incident HTN Self-reported; apparently did not use BP threshold

Validated

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

8621198 Ascherio 

1996

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes Age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes EtOH

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Ca 

intake

No. of 

Cases 

(Event)* 

Person 

years

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

8621198 Ascherio 

1996

Hypertension Ca intake 

category 1

<400 87 5,581 14 y Adjusted RR 1.0 -- -- 0.76

category 2 400-

599

608 36,605 1.07 0.85, 

1.35

NS

category 3 600-

799

712 42,544 1.05 0.83, 

1.31

NS

category 4 800-

1000

407 24,240 1.03 0.82, 

1.31

NS

category 5 ≥1000 712 41,325 1.04 0.83, 

1.31

NS

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

8621198 Ascherio 

1996

a) Eligibility 

criteria 

clear? (y/n)

Yes

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Yes a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Yes

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Yes

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Yes

a) 

Prospective 

collection of 

data? (y/n)

Yes

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Yes

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl

composition 

reported? 

(y/n)

Yes Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Probably

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

?

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Yes b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Yes

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Yes

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

No

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Probably incomplete definition of incident HTN (BP not used) 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

9743511 Ascherio 

1998

Cohort 

study

Male health 

professionals, 40-75 y

Calorie intake <800 or >4200/day, 

incomplete FFQ, CVD, DM

1986 Health Professionals 

Follow-up Study

Gov’t EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

9743511 Ascherio 

1998

Cohort 

study

US, various 43,738 43,738 

(implied)

nd 40-75 100 mostly 

White

nd Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

9743511 Ascherio 

1998

Dietary 

calcium 

intake

FFQ nd Yes

Correlation Ca 

0.53

NA NA NA nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome**

Outcome Definition

9743511 Ascherio 

1998

1° Incident stroke Fatal or nonfatal stroke by report, confirmed by medical records with standard definitions, excluding 

infection or neoplasia caused strokes

specific stroke 

types not extracted

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

9743511 Ascherio 

1998

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes Total energy intake

Demographics (e.g., age, gender, race, education)? Yes Age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions Yes HTN, hypercholesterolemia

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes Smoking, EtOH, physical 

activity

Other Parental early MI, profession

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Median 

Ca 

intake

No. of 

Cases 

(Event)* 

Total N 

(person 

years)

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

9743511 Ascherio 

1998

Stroke Calcium intake 

Quintile 1

500 75 ~8748 

(64,728)

8 y Adjusted 

“multivariate”

RR 1.0 -- -- 0.10

Quintile 2 700 69 ~8748 

(65,534)

0.95 0.68, 

1.32

NS

Quintile 3 800 51 ~8748 

(64,596)

0.72 0.50, 

1.03

NS

Quintile 4 1000 63 ~8748 

(64,425)

0.84 0.60, 

1.19

NS

Quintile 5 1400 70 ~8748 

(64,112)

0.88 0.63, 

1.23

NS

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment* Biomarkers* Comparator Statistical Analysis Outcome D

9743511 Ascherio 

1998

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

implied

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Only 

median

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospe

collecti

data? (

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Y

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

No (in 

other 

papers 

though)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Probably

b) Anal

was pla

when c

was for

(y/n)

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justific

of sam

size (in

sample 

calcula

(y/n)

OVERALL Grade (A/B/C): A

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

15767334 Baron 

2005

RCT-post hoc 

(Ca suppl)

Cohort study (Vit 

D; Dietary Ca)

Men

Details were referred to 

original RCT (See Baron 

NEJM 1999 paper)

nd 1988 (mentioned) –

1992 (inferred)

From Baron NEJM 1999 

paper: Calcium Polyp 

Prevention Study

NCI and 

GlaxoSmithKlein

MC

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat ...etc)

Health Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or 

Ca intake 

...etc.)

15767334 Baron 

2005

RCTpost hoc 

(Ca 

suppl)

Cohort 

study 

(Vit D; 

Dietary 

Ca)

Cleveland 

Clinic

Dartmouth–

Hitchcock

University of 

Iowa

University of 

Minnesota

University of 

North 

Carolina

University of 

Southern 

California

672 672

542 w/ full 

PSA data 

(58% of 

930)

61.8 

(8.7)

nd 100 African 

American: 

5.4%

nd From Baron NEJM 

1999 paper: Had >1 

histologically 

confirmed large-bowel 

adenoma removed 

within 3 months of 

enrollment but 

sub seq uent ly 

exam ined and 

jud ged f ree of 

p olyps. In good 

heath.

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

15767334 Baron 

2005

25(OH)D, 

1,25(OH)2D

Competitive 

protein-binding 

assay (Quest 

Diagnostics).

Interbatch 

Pearson r for 

25(OH)D = 

0.95

Interbatch 

Pearson r for 

1,25(OH)2D = 

0.58

nd Nd nd

15767334 Baron 

2005

Dietary 

calcium 

intake

FFQ (Block, 

1986)

nd (need to 

refer to NEJM 

1999 paper)

no nd nd 910 mg

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) Vit D and/or Ca Dose Intervention Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

15767334 Baron 

2005 Ca nd CaCO3 3g (= elemental 

Ca 1200 mg)

Mean 44 mo 

(Compliance >/= 

50%: 38%) 

nd

placebo

Co-intervention(s) *: Nd

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

15767334 Baron 

2005 Secondary Prostate cancer risk

Incident cases were sought through the periodic follow-up questionnaires. All reports of prostate cancer (by 

questionnaire or death certificate) were verified by review of hospital records.

15767334 Baron 

2005 Secondary Total serum PSA

Prostate-specific antigen measurements were determined using a solid-phase, two-site chemoluminescent 

immunometric assay (IMMULITE PSA, Diagnostic Products Co., Los Angeles, CA)
Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

15767334 Baron 2005 PSA measurements only available among 544 men (81%)

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Log-calories

Demographics (e.g., age, gender, race, education)? Yes

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., physical activity level, occupation, 

sun exposure, location)

Season of blood draw For 25(OH)D analysis only

Smoking and other life styles variables no*

Other Treatment (calcium supplement or placebo)

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

15767334 Baron 

2005 Prostate 

cancer risk

Calcium 

carbonate 

supplement

122.3 33 327 RR Ca/Placebo 0.83 0.52-

1.32

Placebo 123.8 37 345

15767334 Baron 

2005 Prostate 

cancer risk

Calcium 

carbonate 

supplement

48 9 327 RR Ca/Placebo 0.56 0.25-

1.29

Placebo 48 15 345

15767334 Baron 

2005

PSA>4 ng Calcium 

carbonate 

supplement

48 14 279 RR Ca/Placebo 0.63 0.33-

1.21

Placebo 48 21 263

15767334 Baron 

2005

PSA>6 ng Calcium 

carbonate 

supplement

48 10 279 RR Ca/Placebo 0.73 0.32-

1.63

Placebo 48 13 263

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final or 

Delta CI 

/ SE / 

SD*

Net 

difference

Net 

difference 

CI / SE / 

SD*

P 

between

15767334 Baron 

2005

PSA 

change

ng/mL Calcium 

carbonate 

supplement

48 263 1.72 2.93 +0.28 0.19 -0.25 nd 0.34

Placebo 48 279 1.88 2.52 +0.53 0.18

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases*

No. of 

Noncases

Crude or 

Adjusted

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD **

P between 

groups***

P for 

trend****
15767334 Baron 

2005

Prostate 

cancer 

risk

Baseline dietary 

calcium intake –

tertile 1

<675.2 nd nd adjusted RR 1.0 (Ref) nd 0.51

Baseline dietary 

calcium intake –

tertile 2

675.2-

990.8

nd nd 1.48 0.81-

2.70

Baseline dietary 

calcium intake –

tertile 3

>990.8 nd nd 1.20 0.64-

2.23

15767334 Baron 

2005

Prostate 

cancer 

risk

Baseline 25(OH)D –

tertile 1

<25.2 

ng/mL

nd nd adjusted RR 1.0 (Ref) nd 0.70

Baseline 25(OH)D –

tertile 2

25.2-34 

ng/mL

nd nd 1.22 0.66-

2.26

Baseline 25(OH)D –

tertile 3

>34.0 

ng/mL

nd nd 1.32 0.72-

2.43

15767334 Baron 

2005

Prostate 

cancer 

risk

Baseline 

1,25(OH)2D – tertile 

1

<36.4 

pg/mL

nd nd adjusted RR 1.0 (Ref) nd 0.92

Baseline 

1,25(OH)2D – tertile 

2

36.4-

47.08 

pg/mL

nd nd 1.10 0.55-

1.83

Baseline 

1,25(OH)2D – tertile 

3

>47.08 

pg/mL

nd nd 1.02 0.57-

1.82

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 
UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate <20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

15767334 Baron 

2005

Male 

subgroup 

of RCT

nd nd nd Y 

(42/672=6%) nd Y N

Y (but only 

some) Y C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Inadequate adjustment for confounding; no data on number of cases per exposure category

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

15767334 Baron 

2005

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods 

was used? 

(y/n)

n a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

n

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

y

b) Loss to 

follow-up 

<20%? (y/n)

y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

n

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

n b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

n

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): This is a subgroup analysis from a RCT. Prostate cancer outcome was not planned outcome in the 

original RCT. No adjustment for other factors relevant to prostate cancer (like FH).

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

16103450 BertoneJohnson

2005

Casecohort 

study

43 to 69 years old female registered nurses in the US

who participated in the Nurses’ health cohort study and 

those who did not have cancer and had provided blood 

samples.

Those who had 

cancer before start 

of the study

Original cohort 

1976

Study cohort 

1989-1990

Nurses’ 

health 

study

Gov GR

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled N analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

16103450 BertoneJohnson

2005

Casecohort 

study

U.S. 1459

735 with 

breast 

cancer

724 

controls

1425

(701 breast 

cancer and 

724 

controls)

57 

(7.0)

nd 0% ND BMI at age 18=21.1

BMI at blood 

collection=25

Post 

menopausal 

68%

Ever 

smokers 56%

Family h/o 

breast cancer 

17%

Parity = 3

Plasma 25 (OH) D 

at 1989-1990 31.5 

ng/mL

Plasma 1,25 

OH2D = 33.5 

ng/mL

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration (or 

Validity) of Dietary 

Assessment? (y/n) If 

Yes, Provide Data

Biomarker 

Assay****

Analytical Validity 

of Biomarker Data 

Reported? (y/n) If 

Yes, Provide Data

Time between 

Biomarker 

Sampling and 

Analysis

Background 

exposure data

16103450 BertoneJohnson

2005

25(OH)D 

and/or 

1,25(OH)2D

RIA N ~3-10 y ND

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome**

Outcome Definition

16103450 BertoneJohnson

2005

Primary

Breast cancer risk Risk of developing or newly diagnosed breast cancer

Secondary Breast cancer risk by age <60y and 

≥60y

Risk of developing or newly diagnosed breast cancer stratified by age 

groups

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

16103450 Bertone-Johnson

2005 Blood were withdrawn in 3 batches and analyzed by 3 different methods; 25(OH)D has different cut-offs for these 3 batches

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

16103450 BertoneJohnson

2005

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes; plasma alpha-carotene level, intakes 

of alcohol

Demographics (e.g., age, gender, race, education)? Yes (matched by age, menopausal status)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI at age 18

Medical conditions Family of breast cancer; benign breast 

disease

Medication Use of post menopausal hormones

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

ND

Smoking and other life styles variables Yes (intakes of alcohol)

Other Parity; age at first birth

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean Vit 

D level / 

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

No. of 

Noncases

**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

16103450 BertoneJohnson

2005

Breast 

cancer 

risk

25(OH)D quintile 1 ≤20 

ng/mL(1st

batch)

≤28 (2nd

batch)

≤18 (3rd

batch)

Nd 159 138 Adjusted

(both 

analyses 

available)

RR 1.0

.04 (only 

data 

available for 

unadjusted 

analyses)

16103450 BertoneJohnsonBreast 

cancer 

25(OH)D quintile 2 21 to 28

29 to 34

149 129 Adjusted RR 0.95 0.66-

1.36

nd
2005 risk 19 to 24

16103450 BertoneJohnson

2005

Breast 

cancer 

risk

25(OH)D quintile 3 29 to 33

35 to 39

25 to 29

Nd 125 141 Adjusted RR 0.74 0.51-

1.06

nd

16103450 BertoneJohnson

2005

Breast 

cancer 

risk

25(OH)D quintile 4 34 to 39

40 to 47

30 to 36

144 152 Adjusted RR 0.80 0.58-

1.11

nd

16103450 BertoneJohnson

2005

Breast 

cancer 

risk

25(OH)D quintile 5 ≥40 

ng/mL

≥48 

ng/mL

≥37 

ng/mL

124 141 Adjusted RR 0.73 0.49-

1.07

nd

16103450 BertoneJohnson

2005

Breast 

cancer 

risk

25(OH)2 D

quintile 1

≤28.5 

ng/mL

138 127 Adjusted RR 1.0 nd

0.39

16103450 BertoneJohnson

2005

Breast 

cancer 

risk

25(OH)2D

quintile 2

28.6 to 

31.5 

ng/mL

111 121 Adjusted RR 0.68 0.46-

1.02

nd

16103450 BertoneJohnson

2005

Breast 

cancer 

risk

25(OH)2D

quintile 3

31.6 to 

34.3

117 122 Adjusted RR 0.73 0.50-

1.07

nd

16103450 BertoneJohnson

2005

Breast 

cancer 

risk

25(OH)2D 

quintile 4

34.4 to 

38.1

123 122 Adjusted RR 0.78 0.53-

1.14

nd

16103450 BertoneJohnson

2005

Breast 

cancer 

risk

25(OH)2D 

quintile 5

≥38.2 129 126 Adjusted RR 0.76 0.52-

1.11

nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI

Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean Vit 

D level /

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

16103450 BertoneJohnson

2005

Breast 

cancer 

risk

25(OH)D quintile 1

Stratified by <60y 

age at blood 

collection

≤20 

ng/mL(1st

batch)

≤28 (2nd

batch)

≤18 (3rd

batch)

Nd 97 94 Adjusted

(both 

analyses 

available)

RR 1.0

0.20

16103450 BertoneJohnson

2005

Breast 

cancer 

risk

25(OH)D quintile 2

Stratified by <60y 

age at blood 

collection

21 to 28

29 to 34

19 to 24

84 86 Adjusted RR 0.96 0.62-

1.49

nd

16103450 BertoneJohnson

2005

Breast 

cancer 

risk

25(OH)D quintile 

3

Stratified by age 

<60y at blood 

29 to 33

35 to 39

25 to 29

Nd 77 87 Adjusted RR 0.80 0.51-

1.26

nd
collection

16103450 Bertone-

Johnson

2005

Breast 

cancer 

risk

25(OH)D quintile 4

Stratified by age 

<60y at blood 

collection

34 to 39

40 to 47

30 to 36

90 102 Adjusted RR 0.85 0.55-

1.32

nd

16103450 Bertone-

Johnson

2005

Breast 

cancer 

risk

25(OH)D quintile 5

Stratified by age 

<60y at blood 

collection

≥40 

ng/mL

≥48 

ng/mL

≥37 

ng/mL

70 76 Adjusted RR 0.92 0.57-

1.48

nd

16103450 Bertone-

Johnson

2005

Breast 

cancer 

risk

25(OH)D quintile 1

Stratified by ≥60y 

age at blood 

collection

≤20 

ng/mL(1st

batch)

≤28 (2nd

batch)

≤18 (3rd

batch)

62 47 Adjusted RR1.0

0.03

16103450 Bertone-

Johnson

2005

Breast 

cancer 

risk

25(OH)D quintile 2

Stratified by ≥60y 

age at blood 

collection

21 to 28

29 to 34

19 to 24

65 49 Adjusted RR 1.07 0.60-

1.92

16103450 Bertone-

Johnson

2005

Breast 

cancer 

risk

25(OH)D quintile 3

Stratified by age 

≥60y at blood 

collection

29 to 33

35 to 39

25 to 29

48 57 Adjusted RR 0.64 0.35-

1.16

16103450 Bertone-

Johnson

2005

Breast 

cancer 

risk

25(OH)D quintile 4

Stratified by age 

≥60y at blood 

collection

34 to 39

40 to 47

30 to 36

54 55 Adjusted RR 0.68 0.38-

1.24

16103450 Bertone-

Johnson

2005

Breast 

cancer 

risk

25(OH)D quintile 5

Stratified by age 

≥60y at blood 

collection

≥40 

ng/mL

≥48 

ng/mL

≥37 

ng/mL

54 71 Adjusted RR 0.57 0.31-

1.04

16103450 Bertone-

Johnson

2005

Breast 

cancer 

risk

25(OH)2 D

quintile 1 Stratified 

by ≥60y age at 

blood collection

≤28.5 

ng/mL

60 49 Adjusted RR 1.0 nd

0.23

16103450 Bertone-

Johnson

2005

Breast 

cancer 

risk

25(OH)2D

quintile 2 Stratified 

by ≥60y age at 

blood collection

28.6 to 

31.5 

ng/mL

55 53 Adjusted RR 0.76 0.42-

1.38

nd

16103450 Bertone-

Johnson

2005

Breast 

cancer 

risk

25(OH)2D

quintile 3 Stratified 

by ≥60y age at 

31.6 to 

34.3

50 38 Adjusted RR 1.0 0.53-

1.88

nd
blood collection

16103450 Bertone-

Johnson

2005

Breast 

cancer 

risk

25(OH)2D 

quintile 4 Stratified 

by ≥60y age at 

blood collection

34.4 to 

38.1

39 47 Adjusted RR 0.61 0.32-

1.15

nd

16103450 Bertone-

Johnson

2005

Breast 

cancer 

risk

25(OH)2D 

quintile 5 Stratified 

by ≥60y age at 

blood collection

≥38.2 53 51 Adjusted RR 0.72 0.40-

1.32

nd

 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

16103450 BertoneJohnson

2005 a) Eligibility 

criteria 

clear? (y)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

na

a) Method 

reported? 

(y/n)

na a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

na

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(n)

n

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

na

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

na Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

y

b) Loss to 

follow-up 

<20%? (y/n)

y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

n

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

na b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

na

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A):

3 different cut-off thresholds for vitamin D levels. Some of those with cancers were not analyzed, no 

explanation provided

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

17965037 Bjorkman

2008

RCT Age ≥65 years, chronically impaired 

mobility, stable general condition, and no 

known present disease (except 

osteoporosis) or medication (vitamin D 

supplements, glucocorticoids, 

antiepileptics, etc.) affecting calcium or 

bone metabolism.

Markedly elevated creatinine levels 

(>125 umol/l), hypercalcemia 

(ionized calcium >1.32 mmol/l), 

hypothyroidism (thyrotopin >5.3 

mU/l) or hyperthyroidism 

(thyrotropin<0.2 mU/L)

September to 

December 

2005

nd A special 

governmental 

subsidy

MC

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

17965037 Bjorkman

2008

RCT Helsinki, 

Finland

60° 10' 

North

218 218 84.5 65-

104.3

18.4 nd nd All required 

assistance of >2 

persons in almost 

all activities of daily 

living. 

Mean GFR = 64.3, 

ranged from 17 to 

163.

67% had dementia; 

43% had 

cerebrovascular 

disease; 14% had 

hip fracture

Frail and 

chronically 

bedridden

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17965037 Bjorkman

2008

25(OH)D HPLC Within assay 

CV=5.6% at 21.6 

nmol/l (n=14); 

3.7% at 138 

nmol/l (n=15). The 

total CV=7.3% at 

16.4 nmol/l (n=12) 

5.7% at 167 

nmol/l (n=15)

nd nd 23 (ranged 9-

60) nmol/l

17965037 Bjorkman

2008

Dietary 

calcium 

intake

nd nd no nd 500 mg/day

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s) Source (e.g., brand name, foods, or formulation) Vit D and/or Ca Dose

Intervention 

Duration

Intervention Frequency (e.g. 

capsules were taken 2 times 

a day)

17965037 Bjorkman

2008

Cholecalciferol 400 

IU/day

Cholecalciferol (Vigantol, Merck KGaA, Darmstadt, 

Germany 20,000 IU in Migliol oil). 26 drops=~0.84 mL oil 

was diluted 3-fold with Migliol oil

Vitamin D 400 

IU/day (group II)

6 months Nd

17965037 Bjorkman

2008

Cholecalciferol 1200 

IU/day

Cholecalciferol (Vigantol, Merck KGaA, Darmstadt, 

Germany 20,000 IU in Migliol oil)

Vitamin D 1200 

IU/day (group 

III)

6 months nd

Placebo

Co-intervention(s) *:

Before the start of intervention, the use of dairy products was roughly evaluated to be insufficient among 40 patients (18%), who 

received a daily calcium carbonate substitution of 500 mg during the intervention.

Compliance/Adherence: The oil was swallowed entirely in the presence of the nurse and given with a small amount of food or drink.

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17965037 Bjorkman

2008

Primary 25(OH)D level Changes from baseline to 6-month after vitamin D supplementation

secondary mortality All cause

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17965037 Bjorkman

2008

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no*

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Event* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

17965037 Bjorkman

2008

All cause 

mortality

Placebo 0 9 68 Crude nd 0.262

Cholecalciferol 400 

IU/day

17 77

Cholecalciferol 1200 

IU/day

10 73

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 
***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline

CI / SE / 

SD*

Delta** Delta 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P 

between 

groups***

17965037 Bjorkman

2008 25(OH)D nmol/l Placebo Crude 6 59 +1.9 10.2 <0.0001

Cholecalciferol 

400 IU/d 60 +26.5 11.8

Cholecalciferol 

1200 IU/d 63 +49.1 19.5

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

17965037 Bjorkman

2008 Most common causes of death in each group were pneumonia, Alzheimer’s disease and vascular dementia. 

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17965037 Bjorkman

2008

RCT -

Parallel nd yes

NA

yes nd yes yes no yes A/B

Adverse Event(s): ** Nd

Explanation for Overall Quality Grade (if not Grade A): B for mortality outcome due to underpowered study and secondary outcome; A for changes in 25(OH)D 

outcome

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive?

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

18689559 Blum

2008

2o/subgroup 

analysis of an 

RCT(?)

healthy ≥65 y; subgroup from a larger 

trial: those who did not travel to a 

latitude ≤35o N 3 mo prior to initial study 

visit and 3 mo prior to visit at year one.

conditions/medications related to bone; 

BMD >2SD below the reference mean; 

dietary Ca >1500 mg/d

nd nd NIH SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

18689559 Blum

2008

2o/subgroup 

analysis of an

RCT(?)

Boston, US,

42o N

389 

(original 

trial)

257 (for 

this study)

70

(4.9)

65-86 47 97% 

white

45% BMI 25-30 healthy Mean Vit D 189 

IU/d; Ca 721 mg/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? (y/n) 

If Yes, Provide 

Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

18689559 Blum

2008

25(OH)D CPBA n n subjects 

grouped by 

season of 

enrollment

Mean Vit D 

189 IU/d 

Dietary 

calcium 

intake

Ca 721 mg/d

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

18689559 Blum

2008

vit D + Ca nd vit D3 700 IU + Ca 500 

mg/d

3 y nd

Placebo Placebo 3 y nd

Co-intervention(s) *:

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

18689559 Blum

2008

Primary 25(OH)D at 1 y

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

18689559 Blum

2008

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes* age, sex

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Yes season of visit

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Delta

**

Delta 

SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

18689559 Blum

2008

25(OH)D nmol/L vit D + Ca 1 y 132 74.7 33.8 +48.5 35.3 39.2 <0.01

placebo 1 y 125 71.2 29.8 +9.3 21.5

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

18689559 Blum

2008

subgroup 

analysis 

of an 

RCT

nd nd

NA

nd nd n y y n C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Unclear if there were subjects who met the inclusion criteria but were not selected in this study

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

17535985 Bodnar

2007

Nested casecontrol studynulliparity; no preexisting medical 

conditions; bank serum <22 wk gestation

1997-2001 Pregnancy Exposures & 

Preeclampsia Prevention Study

NIH SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

17535985 Bodnar

2007

Casecohort 

study

Pittsburgh, 

PA

1198 in the 

eligible 

cohort;

55 cases; 

220 controls 

(notmatched)

49 cases; 

216 

controls

24 

(est.)

20-29 

(est.)

0 78% white

(in cases); 

68% white 

(in control)

prepregnancy BMI 

≥25 = 58% of 

cases; 41% of 

controls

no 

preexisting 

medical 

conditions

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? (y/n) 

If Yes, Provide 

Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17535985 Bodnar

2007

25(OH)D ELISA y; interassay 

CV 10.3%

5-9 years nd nd

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17535985 Bodnar

2007

primary preeclampsia gestational HTN & proteinuria and return of all abnormalities by 12 wk postpartum

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17535985 Bodnar

2007

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes* race, education

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* prepregnancy BMI

Medical conditions sample gestational age

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Yes season

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / SE 

/ SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

17535985 Bodnar

2007 Cases: 30 wk (est.) adj 49 45.4 38.6-53.4 0.01

Control: 30 wk (est.) 216 53.1 47.4-

59.9

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

17535985 Bodnar

2007

early pregnancy 25(OH)-D <37.5 nmol/L was associated with an increased risk of preeclampsia (adj OR 5.0, 95%CI 1.7-14.1), independent of 

race, season, sample gestational age, prepregnancy BMI and education.

UI Author

Year Comments for Results

17535985 Bodnar

2007

used specialized methods to control for unmeasured confounding (like calcium intake); ELISA could only detect 5-300 nmol/L of 25 (OH)D, sample measures 

outside of this range were excluded (3 samples).

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17535985 Bodnar

2007

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

n

a) Method 

reported? 

(y/n)

n a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

n

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

n

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

n Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

y

b) Loss to 

follow-up 

<20%? (y/n)

y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

n

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

n

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): did not adjust for some potential confounders

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

18198394 Bolland 

2008

RCT Postmenopausal >5 yr, age ≥55 y, life 

expectancy >5 y, LS density within 

normal limits

Osteoporosis treatment, Ca 

supplementation, major organ 

disease, 25(OD)D<25 nmol/L

~2000 Same as 

Reid 2005

Govt (suppl 

supplied by 

industry)

EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

18198394 Bolland 

2008

RCT Auckland, 

New Zealand

36°

1471 1471 74 

(~4.2)

≥55 y 0 nd BMI 26.4 healthy 25(OD)D≥25 nmol/L

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

18198394 Bolland 

2008

Dietary 

calcium 

intake

nd nd nd nd No nd Dietary 

calcium 857 

mg/d 

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

18198394 Bolland 

2008

Ca supplement Calcium citrate (Citracal) 1 g (elemental) 5 years 2 x 200 mg before breakfast; 3 x 200 mg 

evening

Identical placebo

Co-intervention(s) *: None

Compliance/Adherence: Calcium: 396 (54%) alive, continuing followup, continuing intervention at 5 years. Overall compliance 55%

Placebo: 443 (60%) alive, continuing followup, continuing intervention at 5 years. Overall compliance 58%

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

18198394 Bolland 2008 1° (this analysis; 2° for original RCT) Death Family, hospital, and national records

1° (this analysis; 2° for original RCT) Sudden death Standard criteria adjudicated by blinded cardiologist

“Adjudicated” analysis used

1° (this analysis; 2° for original RCT) MI Standard criteria adjudicated by blinded cardiologist

“Adjudicated” analysis used

1° (this analysis; 2° for original RCT) Stroke Standard criteria adjudicated by blinded neurologist

“Adjudicated” analysis used

1° (this analysis; 2° for original RCT) CVD Composite (MI, Stroke, Sudden death) composite

“Adjudicated” analysis used

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

Did not data extract angina TIA or composite outcomes including these outcomes (reported by participants or family member; adjudicated data not reported by authors), 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

18198394 Bolland 

2008

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

No

Demographics (e.g., age, gender, race, education)? Yes But all ≥55 yo

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions Yes h/o outcomes

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other No

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

18198394 Bolland 

2008

MI Calcium 5 yr 31 732 RR Ca/placebo 1.49 0.86, 

2.57

NS

Placebo 5 yr 21 739

MI Calcium 5 yr 11.1 nd Ratio of rates per 1000 person 

years

1.67 0.98, 

2.87

.06

Placebo 5 yr 6.6 nd

Stroke Calcium 5 yr 34 732 RR Ca/placebo 1.37 0.83, 

2.28

NS

Placebo 5 yr 25 739

Stroke Calcium 5 yr 11.4 nd Ratio of rates per 1000 person 

years

1.45 0.88, 

2.49

NS

Placebo 5 yr 7.8 nd

Sudden 

death

Calcium 5 yr 3 732 RR Ca/placebo 0.51 0.13, 

2.01

NS

Placebo 5 yr 6 739

Sudden 

death

Calcium 5 yr 0.9 nd Ratio of rates per 1000 person 

years

0.51 0.10, 

2.04

NS

Placebo 5 yr 1.8 nd

Composite Calcium 5 yr 60 732 RR Ca/placebo 1.21 0.84, 

29.2

NS

Placebo 5 yr 50 739

Composite Calcium 5 yr 23.3 nd Ratio of rates per 1000 person 

years

1.43 1.01, 

2.04

.04

Placebo 5 yr 16.3 nd

*Example: OR Ca/placebo 

NOTE: RR analysis: No. of patients with events (not # of events) used. 

NOTE: Ratio of rates analysis: rates per 1000 patient years extracted. 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline CI 

/ SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome Exposure Categories(e.g., 

Mean 

Vit D 

Mean 

Ca 

No. of 

Cases 

No. of 

NonCrude or Adjusted 

Outcome 

Metric (e.g. 

Outcome 

effect size

CI / 

SE / 

P between 

groups***

P for 

trend****
Tertiles) / 

Intervention Groups

level / 

dose

level / 

dose

(Event)* cases / 

Total N**

analysis? OR, RR, HR, 

%)

SD

**

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
UI Author

Year Comments for Results

18198394 Bolland 2008 RR analysis: No. of patients with events (not # of events) used. 

Ratio of rates analysis: rates per 1000 patient years extracted.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

18198394 Bolland 

2008 RCT Yes Yes NA Yes Yes Yes Yes Partial Mostly B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A):

Since these are 2° outcomes (from original study perspective), fully adjusted analyses should have been 

performed. In addition, multiple methods for assessing outcomes (Tables 2, 3, 4) is confusing, making it 

unclear which outcome is most meaningful. Their approach or logic was not adequately described in Methods.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

17243866 BoltonSmith 

2007

RCT Healthy women ≥60 years 

of age were recruited to 

provide about equal 

numbers in the age groups 

60-64, 65-69, 70-74, and 

≥75 years

Clinical osteoporosis or chronic disease (e.g., DM, CVD, 

cancer, fat malabsorption syndromes), routine 

medication that interferes with vit K, vit D or bone 

metabolism (notably warfarin and steroids), and 

consumption of nutrient supplements that provided >30 

ug vit K, 10 ug (400 IU) vit D, or 500 mg calcium daily.

nd nd UK Food 

Standards 

Agency

MC

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17243866 BoltonSmith 

2007

RCT UK 123 106 Vit D+Ca: 

69.4 (6.4)

Placebo: 

67.8 (6.0)

≥60 0 nd Mean BMI: 26 Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17243866 BoltonSmith 

2007

25(OH)D Radioimmunoassay 

(RIA kit, DiaSorin, 

Wokingham, UK)

no nd Winter 

(baseline 

measure only); 

nd for followup measures

Vit D+Ca: 

25.0 ug/L

Placebo: 

22.8 ug/L

17243866 BoltonSmith 

2007

Dietary 

calcium 

intake

FFQ, designed 

for studies of 

osteoporosis 

in Scottish 

women

nd nd Nd Vit D+Ca: 

1078 mg/day

Placebo: 

1068 mg/day

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 
***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) Vit D and/or Ca Dose Intervention Duration

Intervention Frequency 

(e.g. capsules were taken 2 

times a day)

17243866 BoltonSmith 

2007

100 mg of elemental 

calcium + 10 ug of vitamin 

D3

A chewable tablet form contains calcium 

carbonate and vitamin vitamin D3 (provided by 

Hoffmann-La Roche, Basel, Switzerland)

100 mg of elemental 

calcium + 10 ug of 

vitamin D3

2 years 2 tablets per day with 

breakfast

placebo

Co-intervention(s) *: None

Compliance/Adherence: Good supplement adherence based on pill count (median, 99; IQE 97.3-99.8%). It should be noted that noncompliant women 

were excluded.

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

17243866 Bolton-Smith 

2007

nd Femoral neck 

BMD DEXA of the femur was carried out every 6 months using the same Lunar machine.

17243866 Bolton-Smith 

2007

nd 25(OH)D Measured at baseline and yearly intervals. Assay performance was monitored against external 

quality assurance.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

17243866 Bolton-Smith 

2007

Original RCT had 4 groups: placebo, vit K supplement, vit D+Ca supplement, and vit K+vit D+Ca supplement. For the purpose of our review, only 

placebo and vitD+Ca groups were extracted.

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including matching 

factors)

Specific comments for 

confounders

17243866 BoltonSmith 2007Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy intake

total energy intake, calcium and other nutrient intakes, 

serum markers of vitamin D and vitamin K status

Demographics (e.g., age, gender, race, education)? Yes*

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes* (physical activity)

Other bone area; markers of bone turnovers

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Delta** Delta 

CI *

Net 

difference

Net 

difference 

CI / SE / SD*

P 

between

17243866 BoltonSmith 

2007

Femoral 

neck BMD

mg/cm2 Vit D+Ca 24 50 Nd Nd +1.9 -6.5, 

10.3

+1.2 nd NS

Placebo 24 56 nd nd +0.7 -10.2, 

11.6

17243866 BoltonSmith 

2007

25(OH)D ug/L Vit D+Ca 24 50 25.0 6.2 Final: 

29.8

SD: 

6.0

nd nd <0.001

Placebo 24 56 22.8 6.1 19.5 5.3

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year

Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

17243866 Bolton-Smith 2007 Data presented in the result table were unadjusted but the author stated that the adjusted results were similar to unadjusted results.

For 25(OH)D outcome, it is unclear if seasonal variation was controlled for (by collecting blood samples during the same season at follow up)

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17243866 BoltonSmith 

2007

RCTParallel yes yes

NA

yes nd no yes yes yes B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Reasons for withdrawal included noncompliance or other violations of the inclusion criteria, low BMD 

necessitating further medical intervention, and dislike the tablets. Dropout rate=14%

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name Funding Source Extractor

18842771 Bortolotti 

2008

RCT BMI > 27, Ca intakes < 

800 mg/d

BMI < 27, high 

intake of Ca

nd nd Nestec SA, Switzerland 

(subsidiary of Nestle SA)

MB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SEM) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc) (SEM)

Health Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

18842771 Bortolotti 

2008

RCT Lausanne, 

Switzerland 

(latitude = 46 

N)

10 10 22.2 

(1.2)

nd 30% nd Weight(kg) = 78.1 

(9.1)

Height(m) = 1.65 

(0.06)

BMI(kg/m2) = 28.5 

(1.4)

Overweight/obese Ca intakes < 

800 mg/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

18842771 Bortolotti 

2008

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd nd

Dietary 

calcium 

intake

nd nd nd Ca balance n nd Ca intake 

mg/d (SEM) = 

586 (137)

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or 

Ca Total Daily 

Dose

Intervention 

Duration

Intervention Frequency 

(e.g. capsules were taken 2 

times a day)

18842771 Bortolotti 

2008

Ca Dairy Ca supplement – Arla Foods, Viby, Denmark. Natural milk 

mineral concentrate: 6% protein, 13% lactose, 74% ash, 6% 

moisture, and 24% Ca, present almost entirely as calcium 

phosphate.

800 mg/d 5 wks Sachets were taken 2 times 

a day

placebo Made of maltodextrin and filler. Made by Roquette, Lestrem, 

France

- 5 wks Sachets were taken 2 times 

a day

Co-intervention(s) *: Subjects consumed their habitual low-Ca diet

Compliance/Adherence: Authors state that compliance was assessed by counting the number of returned empty sachets. No specifics regarding compliance were 

provided.

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

18842771 Bortolotti 2008 2 weight

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

18842771 Bortolotti 

2008

Study was a RCT crossover design in which 5 subjects received placebo and 5 received Ca for 5 wks. This was followed by a 10-week washout period 

before the 2nd intervention period. Total study length was therefore 20 weeks. After 4 weeks of each intervention period, either 500 mg lactose or 300 mg 

slow-release caffeine was administered. After the 5th week, the lactose or caffeine, whichever was not administered a week prior, was administered. This 

was done to explore possible synergistic effects between Ca and caffeine as far as energy expenditure and lipid oxidation.

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

18842771 Bortolotti 

2008

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

no

Demographics (e.g., age, gender, race, education)? no*

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions no

Medication no

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

no

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other no

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SEM*

Final** Final 

SEM*

Net 

difference

Net 

difference CI 

/ SE / SD*

P 

between

18842771 Bortolotti 

2008

weight kg Ca 1.25 10 78.1 9.1 80.0 3.2 +0.4 NS

placebo 1.25 10 78.1 9.1 79.6 3.0

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

18842771 Bortolotti 

2008

RCTcrossover

nd/NA nd Y Y nd nd Y NA Y B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Weight loss was not 1 outcome and lactose/caffeine was administered during the study as an acute 

intervention. No information on allocation concealment or blinded outcome assessment.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

8333412 Bostick 

1993

Cohort 

study

Women aged 55-69

Resided in Iowa verified by 

driver’s license

Responded to the baseline 

questionnaire (n=41837)

Hx of cancer (excl. skin cancer) 

(n=3519)

>30 items on the FFQ blank (n=2299)

Implausibly high (>5000) or low 

(<600) energy intake (kcal/d) (n=291)

1986 Iowa Women’s 

Health Study

NCI TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake ...etc.)

8333412 Bostick 

1993

Cohort 

study

Iowa, US

(40°23′ -

40°30′ N)

41837 35216 61.5 

(nd)

nd 0% nd BMI=27.0 kg/m2

Height=64.1 inches

Waist/hip=0.837

nd Total energy 

intake=1801.5 kcal/d

Total Ca=1118.3 mg/d

Total Vit D=411.7 IU/d

Dietary fiber=20.4 g/d

Total fat=68.7 g/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

8333412 Bostick 

1993

Dietary 

calcium 

intake

FFQ (Harvard 

FFQ by Willet)

USDA Nutrient 

Database

Yes: reported in 

Munger et al. AJEpi 

1992

NA NA nd Total 

Ca=1118.3 

mg/d

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

8333412 Bostick 1993 Not explicitly described but the only outcome reported Colon cancer State Health registry of Iowa/SEER

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

# rectal cancer cases were excluded. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

8333412 Bostick 

1993

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes (total energy intake, total Vit E intake, 

low fat meat variable)

Demographics (e.g., age, gender, race, education)? Yes (age, parity)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (height)

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis

# Simultaneous inclusion of vit D, (calcium,) milk product in the models yielded no material difference 

# considered but omitted because of not reaching <0.1 statistically significant level: education, BMI, Waist/hip, physical activity, any type of Vit/mineral supplement, fat, fiber, 

vegetables, fruits, red meat, alcohol, and phosphorus. 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure /Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Ca 

dose

No. of 

Cases 

(Event)* 

No. of 

Total 

personyear**

Mean 

follow 

up, 

months

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

8333412 Bostick 

1993

Colon 

cancer 

(total Ca 

intake 

[mg])

Q1 <629 54 33473 nd Adj (age) RR (HR) 1.0 Ref Nd

0.01

Q2 629-

896

44 33477 nd 0.82 0.55-

1.22

Nd

Q3 897-

1188

42 33465 nd 0.78 0.52-

1.16

Nd
Q4 1189-

1547

44 33565 nd 0.82 0.55-

1.23

nd

Q5 1548- 28 33466 nd 0.52 0.33-

0.82

nd

8333412 Bostick 

1993

Colon 

cancer 

(total Ca 

intake 

[mg])

Q1 <629 54 33473 nd Adj (full 

multivariate 

model)

RR (HR) 1.0 Ref Nd

0.22

Q2 629-

896

44 33477 nd 0.89 0.59-

1.33

Nd

Q3 897-

1188

42 33465 nd 0.88 0.58-

1.33

Nd

Q4 1189-

1547

44 33565 nd 0.97 0.63-

1.50

nd

Q5 1548- 28 33466 nd 0.68 0.41-

1.11

nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

# full multivariate model listed in the confounders table. 

## data on dietary calcium, supplemental calcium, total Vit D, dietary Vit D, supplemental Vit D, total dairy intake, and fat containing dairy intake were also presented but not extracted. 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 
Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

8333412 Bostick 1993 Follow up: over 5 years

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

8333412 Bostick 

1993

a) Eligibility 

criteria 

clear? (y/n)

N/nd

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

n

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

n/nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y 

<1%

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

n

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

y b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

nd

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Study designed for cancer incidence and mortality; not specifically for colon cancer; power calculation for 

colon cancer not stated; blinding for assessors not reported; confirmation of cancer cases by histology not 

reported; post-hoc analysis using an existing database. 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

9921960 Bostick 

1999

Cohort 

study

Women 55-69 y, 

post-menstrual

Ischemic heart disease, incomplete FFQ, 

implausible energy intake (<600 or >5000 kcal/d)

1986 Iowa Women’s 

Health Study

NCI EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

9921960 Bostick 

1999

Cohort 

study

Iowa

~42°

34,486 34,486 61 55-69 0 White 

~100%

~27 Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

9921960 Bostick 

1999

Dietary 

calcium 

intake

FFQ nd Yes

Reliability 

coefficients 0.57-

0.82

Validity coefficients 

0.67 & 0.51

NA NA NA nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

9921960 Bostick 1999 1° Ischemic heart disease mortality Health registry, death certificates, ICD-9 codes.

Not validated

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

9921960 Bostick 

1999

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

Yes Total energy intake, dietary vitamin E, saturated fat 

intake (total Ca intake for supplemental Vit D analysis)

Demographics (e.g., age, gender, race, education)? Yes Age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI, waist:hip ratio

Medical conditions Yes DM

Medication Yes Estrogen

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical 

activity, occupation, alcohol consumption)

Yes Smoking, EtOH, physical activity

Other Yes Education, marital status

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Vit D 

dose

Ca 

intake

No. of 

Cases 

(Event)* 

N 

(person 

years)

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

9921960 Bostick 

1999

IHD 

death

Total Ca intake 

Quartile 1

<696 127 ~8621.5 

(74,224)

8 y Adjusted RR 1.00 -- -- .09

Quartile 2 696-

1051

84 ~8621.5 

(74,497)

0.62 0.45, 

0.85

<.05

Quartile 3 1052-

1425

94 ~8621.5 

(74,588)

0.75 0.55, 

1.03

>.05

Quartile 4 >1425 82 ~8621.5 

(74,570)

0.67 0.47, 

0.94

<.05

Duplicate one row per exposure category or intervention group.36

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

9921960 Bostick 

1999

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

FFQ a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

?

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A):

No ascertainment of outcome “other studies have indicated that the validity of the IHD on death certificates is 

relatively high.”

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

329893 Braun 

1995

Casecohort 

study

Cohort: a population-based registry of the residents in 

Washington county (Maryland) in 1974 with blood sample 

donation and filling in a short questionnaire 

Cases: histologically confirmed colon cancer diagnosed between 

1984 and 1991 identified through the cancer registry in the 

county

Controls: 2 matching participants without colon cancer (by the 

date of diagnosis of the case) per case from the same cohort

1974 Washington 

County Cohort

nd TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

329893 Braun 

1995

Casecohort 

study

Washington, 

Maryland, USA

39 N

Cohort: 

20,305

Cases: 61

Controls: 

122

Cases: 

61

Controls: 

122

55 

(median)

nd nd nd nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time between 

Biomarker 

Sampling and 

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure 

data

329893 Braun 

1995

25(OH)D 

and/or 

1,25(OH)2D

RIA (25-D)

Radioreceptor 

assay (1,25-D)

Coefficients of 

variation:

Interset, 14.1% 

(25-D) and 

8.7% (1,25-D)

Intraset, 8.9% 

(25-D) and 

12.4% (1,25-D)

Nd (~18 y 

inferred, mean 

14 y between 

sampling and 

diagnosis 

reported)

(Late) August 

though 

November

nd

Dietary 

calcium 

intake

nd nd nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

329893 Braun 1995 nd Colon cancer Washington county cancer registry with histological confirmation (unclear when)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

329893 Braun 

1995

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

No

Demographics (e.g., age, gender, race, education)? Yes matching: age, race, sex

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

Yes matching: date of blood 

sampling

Smoking and other life styles variables No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 

No adjusted analysis reported except for matching.
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

followup time

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

329893 Braun 

1995

Colon 

cancer

Q1 <17.2

10-17 y 

(cases) 61 122 crude OR

1 (ref) -

nd 0.57

Q2 17.2-

20.6

0.3 0.1-

1.0

Q3 20.7-

24.6

0.5 0.2-

1.5

Q4 24.7-

30.1

0.7 0.2-

2.0

Q5 >30.1 0.4 0.1-

1.4
329893 Braun 

1995

Colon 

cancer

[25(OH)D ( 

ng/ml)]

Q1 <26.6

10-17 y 

(cases) 61 122 crude OR

1 (ref) -

nd 0.88

Q2 26.6-

32.5

1.6 0.6-

4.4

Q3 32.6-

36.0

1.1 0.4-

3.3

Q4 36.1-

41.3

1.1 0.4-

3.3

Q5 >41.3 1.1 0.4-

3.2

329893 Braun 

1995

Colon 

cancer

[1,25(OH)D 

(pg/ml)]

Q1 <17.2 10-17 y 

(cases)

61 122 crude OR 1 (ref) - nd 0.57

Q2 17.2-

20.6

0.3 0.1-

1.0

Q3 20.7-

24.6

0.5 0.2-

1.5

Q4 24.7-

30.1

0.7 0.2-

2.0

Q5 >30.1 0.4 0.1-

1.4

329893 Braun 

1995

Colon 

cancer

[25(OH)D 

(ng/ml)]

Q1 <26.6 10-17 y 

(cases)

61 122 crude OR 1 (ref) - nd 0.88

Q2 26.6- 1.6 0.6-

4.5

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

329893 Braun 1995 Cases: ~18-20 y crude 61 23.6 9.2 nd nd nd [25(OH)D] Control: 122 34.7 7.9

329893 Braun 1995 Cases: ~18-20 y crude 61 23.2 7.8 nd nd nd [1,25(OH)D] Control: 122 34.6 10.0

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

329893 Braun 

1995

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

NA

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

NA

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

NA

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

No clear inclusion (and selection) process of participants, probably post-hoc analysis of already available 

database. No reports on verification of cancer diagnosis or adjustments of family history. How often 

participants were excluded due to unavailability of blood samples is also unclear.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name Funding Source Extractor

7612803 Braun

1995

Case-cohort 

study

Resident of Washington 

County, MD.

Serum sample stored.

None 

(implied)

1974 (Washington 

County)

nd

Corresponding/lead author is NCI 

employee

EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

7612803 Braun

1995

Casecohort 

study

Washington 

County, MD

39.7° (39° 42’)

183

(61 cases, 

122 

controls)

183 Mode 

55-64 

(51%)

<45 –

75+

100% White 

100%

nd No 

prostate 

cancer at 

baseline 

(pre-1980)

<5% with baseline 

25(OH)D <15 

ng/mL

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary

Assessment? (y/n) 

If Yes, Provide 

Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure 

data

7612803 Braun

1995

25(OH)D 

and/or 

1,25(OH)2D

25D: RIA (125I) 

(Hollis 1993)

1,25D: 

Radioreceptor 

assay (Hollis 

1986)

25D: CV 11.1% 

interset; 22.0% 

intraset

1,25D: CV 

14.3% interset; 

21.3% intraset

~18-20 yr (Late) August 

through 

November

nd

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

7612803 Braun

1995

Primary (in post hoc analysis, maybe not for primary analysis) Prostate cancer Diagnosed 1980-1992, 6-18 y after blood sample

Cancer registry

Prostate cancer severity of disease

Method of diagnosis:

Less severe: incidental finding on TURP

More severe: other cases

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

7612803 Braun

1995 Blood samples drawn only from August-November

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

7612803 Braun

1995

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

None

Demographics (e.g., age, gender, race, education)? Yes Age (matched & subgroup 

analysis)

(all male, White)

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

Month commented on Unclear if used in any 

analysis

Smoking and other life styles variables No

Other “Severity of disease”

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of Noncases 

(controls)**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, %)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

7612803 Braun 

1995

Prostate 

cancer

[25(OH)D]

Q1 <24.1

nd

7 24

crude OR

1.0 (ref) -

nd 0.60

Q2 24.1-

29.5 17 25 2.3 0.7-7.8

Q3 29.6-

35.4 16 24 2.3 0.7-7.7

Q4 35.5-

41.3 4 25 0.6 0.1-2.5

Q5 >41.3 17 24 2.4 0.8-

8.2
7612803 Braun 

1995

Prostate 

caner

[25(OH)D]

Q1 <24.1

nd

7 24

crude OR

1.0 (ref) -

nd NS

Q2 >24.1 54 98 1.9 0.7-

5.5

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

SD

Mean Ca 

intake or 

Ca 

balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

7612803 Braun

1995 Cases: 18 y Crude 61 34.3 9.9 NS

Control: 122 33.2 10.8

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

7612803 Braun

1995

Prostate cancer, adjusted for “method of diagnosis” and age above or below median “Did not differ significantly between cases and controls”

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

7612803 Braun

1995

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

NA a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y a) Level of 

the 

exposure in

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

No 

(1°)

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Y†

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

NA Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

+/-

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

?

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Small, underpowered. 1° analysis was not controlled for relevant factors. Other analysis poorly described. 

Limited applicability for prostate cancer assessment (no blacks).

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

† Cases and controls chosen prior to Vit D level assessment
6793058; 6989438 ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

6793058

6989438

Maxwell

1981; Brooke 1980

RCT pregnant Asians nd government SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

6793058 Maxwell

1981

RCT London, UK 126 126 nd nd 0 Asians weight at 3rd trimester: 

63.7 Kg

nd 25(OH)D level at 28-

32 wk: 20.1 nmol/L; 

~25% vegetarians

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

6793058 Maxwell

1981

25(OH)D nd nd nd 25(OH)D level 

at 28-32 wk: 

20.1 nmol/L

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

6793058 Maxwell

1981

calciferol 1000 IU/d 3

rd trimester only

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

6793058 Maxwell

1981

primary weight gain 3rd trimester

secondary birth weight

6989438 Brooke 1980 25(OH)D in cord blood & maternal blood at term

infant symptomatic hypocalcemia <1.8 mmol/L

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

6793058 Maxwell

1981

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no*

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, 

RR, HR, %) and direction 

of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

6793058 Maxwell

1981

infants with birth 

weight <2500 g

calciferol 7 59 NS

control 15 67

6989438 Brooke 

1980

infant with 

symptomatic 

hypocalcemia

calciferol 0 59 chi2=4.6 <0.01

control 5 67

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final Final 

SD*

Net 

difference

Net 

difference CI 

/ SE / SD*

P 

between

6793058 Maxwell

1981

maternal 

weight gain 

3

rd trimester

g/d calciferol 59 63.3 20.7 <0.001

control 67 46.4 29.5

6793058 Maxwell

1981

infant birth 

weight

g calciferol 59 3157 469 NS

control 67 3034 524

6989438 Brooke 

1980

infant birth 

length

cm calciferol 59 49.7 0.3 NS

control 67 49.5 0.4

Brooke

1980

maternal 

term 25 

(OH)D level

nmol/L calciferol 59 20.2 168 12.5 nd

control 67 20.0 16.2 2.7

Brooke

1980

cord 25 

(OH)D level

nmol/L calciferol 59 137.9 10.8 nd

control 67 10.2 2.0

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

6793058 Maxwell

1981 Unclear how weight gain differences between groups were determined not due to edema.

-----Subgroup Analyses 
Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

6793058; 

6989438

Maxwell

1981; 

Brooke 

1980

RCT

nd nd

NA

y y y n n n B

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A): study methodology not completely reported; small sample size

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name Funding Source Extractor

18755319 Brunner 

2008

RCT-post 

hoc**

Postmenopausal women (50 to 79 

yrs old)

nd 1993-1998 WHI NIH, National Heart, Lung and 

Blood Institute

JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N enrolled*** N analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

18755319 Brunner 

2008

RCTpost hocUS 40 

centers

36,282 joined at 

the initial stage 

of the Ca/vitD 

trial, 33,067 

joined at the first 

annual visit

2928 had 

objective 

physical 

function 

measures

nd 50-79 

yr

0 nd nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

18755319 Brunner 

2008

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd nd

18755319 Brunner 

2008

Dietary 

calcium 

intake

nd nd nd nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. 

capsules were taken 2 times a day)

18755319 Brunner 

2008

Ca+VitD 500mg calcium carbonate + 200IU vitD3 (by 

Glaxo SmithKline, Bensalem, PA)

1000mg calcium 

carbonate + 400IU vitD3

Average 7.1 yrs two times a day

Placebo

Co-intervention(s) *: Hormone therapy, dietary modification

Compliance/Adherence: No information on adherence rate (however, adherence was assessed at least annually from the weight of remaining pills along with a 

structured interview.)

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

18755319 Brunner 

2008

Secondary Grip 

strength

Two measurements were made in the dominant hand with staff coaching for maximal performance (Jamar hand 

dynamometer; Lafayette Instruments) 

18755319 Brunner 

2008

Secondary Chair 

stands

Conducted if the subject was able to stand at least once without using hands/arms from a straight-backed, nonpadded, 

flat-seated, armless chair. Two 15-second trials of repeated chair stands were performed with arms folded across the 

chest with a 1- to 2-minute rest in between trials. Counted as the participant arose, and counts for both trials recorded. 

18755319 Brunner 

2008

Secondary Timed 

walk

The timed walk utilized a course marked on the floor with end lines 6m apart and “X” marked just beyond each end line. 

Participants used ambulatory aids as needed, walking at usual speed to one X with a second trial performed to the other 

X. The result was recorded as number of seconds from start to when a foot completely crossed the end line. 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

18755319 Brunner 

2008

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

Yes Total Ca intake <600mg**

Demographics (e.g., age, gender, race, education)? Yes* Age (continuous), age 70 years or older**, Asian or 

white ethnicity**

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* Weight <127 lb**

Medical conditions History of two or more falls in past year; relative who 

broke bone before age 40; history of any fracture**

Medication Never used hormones**

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical 

activity, occupation, alcohol consumption)

Yes* Current smoker**

Other Treatment arm in the hormone therapy and dietary 

modification trials

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 

** Fracture risk score
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Delta** Delta

SD*

Net 

difference

Net 

difference 

SE*

P 

between

18755319 Brunner 

2008

Grip 

strength 

(year 2)

Kg CaD 24 months 1334 -1.20 5.63 0.06 0.21 0.790

Placebo 24 months 1265 -1.27 5.30

18755319 Brunner 

2008

Grip 

strength 

(year 5)

Kg CaD 60 months 1185 22.81 5.78 -2.49 5.81 0.15 0.24 0.524

Placebo 60 months 1162 22.96 5.75 -2.64 5.69

18755319 Brunner 

2008

Chair 

stands 

(year 2)

Counts CaD 24 months 1250 -0.09 1.55 0.03 0.06 0.623

Placebo 24 months 1188 -0.12 1.60

18755319 Brunner 

2008

Chair 

stands 

(year 5)

Counts CaD 60 months 1065 6.52 1.87 -0.38 1.81 0.04 0.08 0.603

Placebo 60 months 1053

6.63 1.82 -0.43

1.81

18755319 Brunner 

2008

Timed walk 

(year 2)

seconds CaD 24 months 1298 +0.11 7.08 -0.12 0.27 0.580

Placebo 24 months 1238 +0.23 6.38

18755319 Brunner 

2008

Timed walk 

(year 5)

seconds CaD 60 months 1160 6.5 5.51 +0.26 6.28 -0.54 0.26 0.030

Placebo 60 months 1141 6.19 4.64 +0.81 6.43

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
UI Author

Year Comments for Results

18755319 Brunner 

2008 Only those women who were at least 80% adherent to study pills were examined in a subgroup analysis (data not shown). No substantial differences in 

physical functioning related to treatment assignment were found. 

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

18755319 Brunner 

2008

RCTParallel nd nd n nd nd y y y y C

Adverse Event(s): ** Nd

Explanation for Overall Quality Grade (if not Grade A):

Different number of participants who had objective physical function measures. Only small fraction of women 

had such data from WHI. No information on blinded outcome assessment. Referred to original design paper for 

RCT methodology. 

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

17656420 Burleigh

2007

RCT Patients were 

aged 65 years 

or over

Subjects with hypercalcemica, urolithiasis or renal dialysis therapy, 

patients who were terminal orbed-bound with a reduced Glasgow 

Coma Scale (GCS), those already prescribed calcium and vitamin D 

supplements, and those who were deemed „nil by mouth‟ at time of 

admission.

nd nd Nd JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

17656420 Burleigh

2007

RCT Scotland 

(55° 57' N)

205 199 83.0 

(7.6)

nd 40% nd Under weight 40%

Normal weight 50%

Overweight 10%

Inpatient with 

high levels of 

comorbidity,

mortality and 

polypharmacy

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17656420 Burleigh 

2007

25(OH)D 

and/or 

1,25(OH)2D

Using the 

Nicholas 

Advantage 

Analyser 

(Nicholas 

Institute 

Diagnostics, 

San Juan 

Capitrano, 

California, USA)

n nd nd 25(OH)D

22.0 nmol/L

17656420 Burleigh

2007

Dietary 

calcium 

intake

nd nd nd nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand 

name, foods, or 

formulation) 

Vit D and/or Ca Total 

Daily Dose Intervention Duration

Intervention Frequency 

(e.g. capsules were taken 2 

times a day)

17656420 Burleigh 

2007 

VitD+Ca cholecalciferol +calcium 

carbonate

800iu cholecalciferol 

+1200mg calcium

carbonate

The intervention was continued until time of 

patient discharge or death. Median length of 

hospital inpatient stay=30days 

Once daily

17656420 Burleigh 

2007 

Ca calcium carbonate 1200mg calcium 

carbonate

Continued until time of patient discharge or 

death. Median length of hospital inpatient 

stay=30days

Once daily

Co-intervention(s) *: nd

Compliance/Adherence: Control group=87%, Intervention group=89%, compliance method – a percentage (total study drug taken/total study drug 

prescribed, as recorded in drug prescription charts)

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

17656420 Burleigh 

2007

primary Fall Defined as the patient unintentionally coming to rest on the ground, or other lower level, other than as a 

consequence of sustaining violence or an epileptic seizure, documented by ward nursing staff in an official accident

17656420 Burleigh 

2007

primary fracture Any fracture incurred during the inpatient stay was verified in medical and nursing note

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

including matching factors) Specific comments for confounders

17656420 Burleigh

2007

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy intake

No statistical analysis of baseline characteristics 

between control and intervention group.

Demographics (e.g., age, gender, race, education)? no*

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

17656420 Burleigh

2007

Fall VitD+Ca Median 30 

days (IQR

14.75–

71.00)

36 100 RR VitD+Ca / Ca 0.82 0.59-

1.16

0.263

Ca Median 30 

days (IQR

14.75–

71.00)

45 103

17656420 Burleigh

2007

Fracture VitD+Ca Median 30 

days (IQR

14.75–

71.00)

1 100 nd NS

Ca Median 30 

days (IQR

14.75–

71.00)

3 103

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI 

/ SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

17656420 Burleigh

2007

VitD 

levels 

VitD levels(nmol/l) increased in the treatment group, but not in the control group, but this did not reach statistical significance (median change in 

vitD in control group; 0.00 vs. intervention group; 2.00, Mann-Whitney U test P=0.113)

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17656420 Burleigh

2007

RCTparallel y yNA Y Y Y Y N Y C

Adverse Event(s): ** Two individuals developed hypercalcaemia. 

Explanation for Overall Quality Grade (if not Grade A): No statistical analysis of baseline characteristics between control and intervention group, Intervention duration 

varied, Serum vit D analysis was performed in only 1 in 4 patients. 

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 
QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

17502530 Caan 2007 RCT Women 50-79 y, postmenopausal none 1994-1999 WHI Govt EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

17502530 Caan 

2007

RCT US 36282 36282 nd 50-79 0 White 83%

Black 9%

Hispanic 4%

AmInd 0.4%

As/PacIs 2%

BMI <25 28%

 25 to <30 35%

 30 to <35 22%

 >35 14%

Healthy, 

postmenopausal

Total Ca intake

<600 mg/d 20%

600 to <1200 

41%

≥1200 39%

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

17502530 Caan 

2007

Dietary 

calcium 

intake

WHI 

adaptation of 

Block FFQ

(see other 

article)

Yes (not reported 

here)

See previous 

table

Total Ca 1150 

mg/d

Total 

cholecalciferol 

9 μg/day

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

17502530 Caan 

2007

Ca + Vit D Ca carbonate

Cholecalciferol

1000 mg

400 IU

7 years 500 mg/200 IU 2x/day

Placebo 7 years 2x/day

Co-intervention(s) *:

Factorial design overlaid on HT vs placebo.

Allowed to take calcium (up to 1000 mg/d) and cholecalciferol (up to 600 IU/d, then 1000 IU/d after 1999)

Compliance/Adherence: Proportion consuming ≥80% of study medications at year 1 60%; through year 7 56-63% annually. At least 66% took 50% or 

more through year 7.

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17502530 Caan 2007 2° (1° for this article) Weight Kg

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17502530 Caan 

2007

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes Total Ca intake

Total cholecalciferol intake

Energy intake

Demographics (e.g., age, gender, race, education)? Yes Age, race, education

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI, waist circumference

Medical conditions Yes DM

Medication Yes hormone replacement

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes Smoking, exercise

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final or 

Delta CI 

/ SE / 

SD*

Net 

difference

Net 

difference CI 

/ SE / SD*

P 

between

17502530 Caan 

2007

Weight Kg Ca+D 7 yr 18129 76.0 16.9 nd -0.13 (-0.21, -0.05) 0.001

Placebo 18055 75.9 17.1 nd

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final 

or 

Delta 

CI / SE 

/ SD*

Net difference

Net 

difference 

CI

P 

between

17502530 Caan 

2007

Weight Kg Ca+D 7 yr 50-54 y

2592

nd nd -0.24 -0.45, -0.03 <0.05

Placebo 2561 nd nd

55-59 y

4134

nd nd -0.08 -0.24, +0.09 NS

4135 nd nd

60-69 y

8276

nd nd -0.15 -0.27, -0.03 <0.05

8243 nd nd

70-79 y

3174

nd nd -0.10 -0.27, +0.09 NS

3167 nd nd

Overall 

(interaction), 

AGE

NS

17502530 Caan 

2007

Weight Kg Ca+D 7 yr White

15047

nd nd -0.13 -0.22, -0.04 <0.05

Placebo 15106 nd nd

Black

1682

nd nd -0.32 -0.59, -0.06 <0.05

1635 nd nd

Hispanic

789

nd nd -0.08 -0.48, +0.32 NS

718 nd nd

Asian/PacIs

369

nd nd +0.19 -0.37, +0.75 NS

353 nd nd

Overall 

(interaction), 

ETHNICITY

NS

17502530 Caan 

2007

Weight Kg Ca+D 7 yr BMI<25

4974

nd nd -0.08 -0.23, +0.06 NS

Placebo 5117 nd nd

BMI 25-30

6409

nd nd -0.09 -0.22, +0.04 NS

6327 nd nd

BMI 30-35

4037

nd nd -0.23 -0.40, -0.06 <0.05

3992 nd nd
BMI ≥35

2621

nd nd -0.17 -0.38, +0.04 NS

2539 nd nd

Overall 

(interaction), 

BMI

0.04

17502530 Caan 

2007

Weight Kg Ca+D 7 yr Base Ca 

<1200/d

10819

nd nd -0.19 -0.29, -0.09 <0.05

Placebo 10658 nd nd

Base Ca 

≥1200

7002

nd nd -0.05 -0.17, +0.08 NS

7095 nd nd

Overall 

(interaction), 

BASE CA 

INTAKE

0.09

QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17502530 Caan 

2007 RCT Yes Yes NA Yes Yes Yes Yes Yes Yes B

Adverse Event(s): ** Women with intolerable GI symptoms were treated by reducing the number of times per day or days per week 

that study medication was taken w/o unblinding participant or study staff. No other data on AEs provided.

Explanation for Overall Quality Grade (if not Grade A):

It was the consensus among the Tufts EPC that overall, the methodological quality of the trial was B, 

particularly when the trial is being used to guide decisions about DRI, as opposed to decisions about whether 

to actively recommend supplementation for an individual woman.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 
QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort Name Funding Source Extractor

11566656 Chan 

2001

Cohort Male physicians, subjects who returned the dietary 

questionnaires, did not have a diagnosis of cancer 

at baseline, and provided information on body mass 

index

nd 1995 Physician’s 

Health Study

The CaP Cure Young 

Investigator Award (JMC) 

and National Institutes of 

Health 

JHL/SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

11566656 Chan 

2001

Cohort US 22071 20885 53.3 nd 100 nd BMI=24.9 nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

11566656 Chan 

2001

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd Nd

11566656 Chan 

2001

Dietary 

calcium 

intake

Short selfadministered 

questionnaire 

Database from 

the prospective 

Health 

Professional 

Follow-up Study

nd nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

11566656 Chan 

2001

Secondary Prostate 

cancer 

Requested permission to obtain hospital records and pathology reports for review by the study investigators. 

Information on tumor grade and stage at diagnosis was extracted, and the diagnosis of prostate cancer was confirmed 

by medical chart review in 99% of cases. 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

11566656 Chan

2001

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes* - Age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* - BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes* - Smoking, exercise

Other Randomized treatment in the original trial (aspirin, βcarotene, or placebo), food score

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

11566656 Chan 

2001

Prostate 

cancer 

Dairy calcium 

intake Group 1

0-150 155 132 Adjusted RR 1.00 0.05

Group 2 151-

300

206 132 Adjusted RR 1.21 0.96-

1.53

Group 3 301-

600

377 132 Adjusted RR 1.35 1.09-

1.66

Group 4 > 600 274 132 Adjusted RR 1.29 1.04-

1.62
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical

Analysis Outcome Design

11566656 Chan 

2001

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Nd

a) Method 

reported? 

(y/n)

y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

N a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

n Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Post-hoc analysis of RCT (but, we categorized this as a cohort study because the treatment in the original 

trial was not Ca), Dietary assessment method was not validated. 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

19001601 Chebowski

2008

RCT

Casecohort 

study

Post menopausal enrolled in WHI trial of hormonal 

therapy and dietary modification. Aged 50-79 y and 

life expectancy of >3y, no prior breast cancer, and 

no other cancers within 10 y

Women with h/o 

hypercalcemia, kidney 

stones, corticosteroid or 

calcitriol use

Until March 

2005

WHI Gov GR

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

19001601 Chebowski

2008

RCT

Casecohort 

study

US

38 N

68.132 36,282 ND 50-79 0 CaD: 

White 

82.8%

Black 

9.3%

Hispanic 

4.3%

American 

Indian 

0.4%

Asian 

pacific 

Islander 

2.0%

Unknown 

1.2%

Placebo: 

White 

83.4%

Black 9%

Hispanic 

4%

American 

Indian 

0.4%

Asian 

pacific 

Islander 

2.0%

Unknown 

1.2%

CaD <25 26.2%

25-<30 35.8%

≥ 30 38%

Placebo <25 

26.8%

25-<30 36.0%

≥ 30 37.2%

CaD : 

Alcohol 

use in Non 

drinker 

10.3%

Past 

drinker 

17.7%

Current 

drinker 

72%

Smoking:

Never 

smoked 

52%

Past 

smoker 

40.3% 

Current 

smoker 

7.8%

Baseline vitD 

supplementation:

CaD arm 

Yes: 47.1%

No: 52.9%

Placebo arm

Yes 47. 6%

No 52.4%

Baseline Ca 

supplementation:

CaD arm 

<800: 34.3%

800-<1200: 26.5%

≥1200: 39.3%

Placebo arm

<800: 33.8%

800-<1200: 26.2%

≥1200: 40.0%

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 
***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure data

19001601 Chebowski

2008

25(OH)D 

and/or 

1,25(OH)2D

DiaSorin Liason 

Chemiluminescent 

immunoassay

Y

11.8%

ND ND Equal % of 

subjects in 

both arms 

were taking 

vitamin D

19001601 Chebowski

2008

Dietary 

calcium 

intake

Modified 

block FFQ

ND N NA NA ND the % of 

subjects in 

the placebo 

arm who 

were getting 

Ca were 

higher for the 

highest level 

≥1200

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

19001601 Chebowski

2008

Calcium 

carbonate 

Vit D3

GlaxoSmith Kline 400 IU vit D

1000 mg Ca

7 years 200 IU vit D x twice daily

500 mg Ca x twice daily

Co-intervention(s) *:

Hormone use was similar in both arms. CaD arm: Tamoxifen use 0.08%; raloxifene use 0.10% Placebo arm: Tamoxifen use 0.06%; 

raloxifene use 0.11%

Compliance/Adherence: 60%-63% during first 3 years of follow-up

Duplicate one row per intervention, including control intervention. 
*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

19001601 Chebowski

2008

Not clear. Most likely 

secondary outcome

Incident invasive 

breast cancer

Confirmed by both local and central medical record and pathology report review by trained 

adjudicators. Tumor characteristics were coded by SEER program guidelines.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

19001601 Chebowski

2008 The trial is unable to discern the independent effects of Ca and Vit D, since the use of supplementation is the same in both arms.

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

This sections is only applicable for the nested case-control study of Vitamin D biomarker section

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

19001601 Chebowski

2008

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Both arms liberally used Ca D supplements

Demographics (e.g., age, gender, race, education)? Yes

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes

Medical conditions

Medication Hormonal therapy, estrogen alone or 

combined with progestin

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Latitude of the clinical center

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) (This is from RCT part of the study) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, 

RR, HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

19001601 Chebowski

2008

Total breast 

cancer

Calcium 

carbonate 400 

IU

Vit D3 1000 mg

7 y 668 18176 HR 0.96 0.86 

to 

1.07

NS

Placebo 693 18106

Death from 

breast cancer

Calcium 

carbonate 400 

IU

Vit D3 1000 mg

7 y 23 18176 HR 0.99 0.55 

to 

1.76

NS

Placebo 23 18106

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI 

/ SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) (This section is from the nested case-control study that examined prerandomization levels were associated with breast cancer) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI 

P 

between 

groups***

P for 

trend****

19001601 Chebowski

2008

Invasive 

breast 

cancer

≥67.6 Q1 

Baseline 

25(OH)D

81.9 

(13.2)

CaD 86

Pl 76

195 7 y Adj OR 0.89 0.58 

to 

1.36

0.2 

(main 

effect)

55.4≤67.6 Q2 

Baseline 

25(OH)D

60.9 

(3.5)

CaD 95

Pl 86

185 7 y Adj OR 1.25 0.83 

to 

1.90

43.9≤55.4 Q3 

Baseline 

25(OH)D

49.2 

(3.3)

CaD 

102

Pl 92

171 7 y Adj OR 1.07 0.70 

to 

1.62

32.4≤43.9 Q4 

Baseline 

25(OH)D

38.5 

(3.3)

CaD 71

Pl 102

171 7 y Adj OR 0.69 0.45 

to 

1.06

<32.4 Q5 

Baseline 

25(OH)D

23.6 

(5.9)

CaD 94

Pl 91

176 7 y Adj OR 0.91 0.60 

to 

1.39

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 
UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

19001601 Chebowski

2008

RCTParallel y y n y nd y y y y B

Adverse Event(s): ** ND (patients were excluded if they had kidney stones, etc.)

Explanation for Overall Quality Grade (if not Grade A):

It was the consensus among the Tufts EPC that overall, the methodological quality of the trial was B, 

particularly when the trial is being used to guide decisions about DRI, as opposed to decisions about whether 

to actively recommend supplementation for an individual woman.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

19001601 Chebowski

2008

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

n

a) Method 

reported? 

(y/n)

y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

y

b) Outcome 

assessor 

blinded to

exposure 

measurement? 

(y/n)

n

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

n Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

n

b) Loss to 

follow-up 

<20%? (y/n)

y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

n

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

y b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

n

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

na

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Time from sample collection to analysis not reported, unclear how the effect of VitD was delineated when 

both arms had vitD intake at baseline.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

1ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

17874029 Chel

2008

RCT Nursing 

home 

residents

outside sunshine >1/wk; vit D or Ca 

supplement; >1 vit D-fortified food or drink; 

completely immobilized; poor life 

expectancy

nd nd Solvay Pharm. provided meds; 

ZonMw (the Netherlands Org for 

Health Research & Development

SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

17874029 Chel

2008

RCT The 

Netherlands, 

52o N

338 338 84 (6) nd 22 nd nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background

exposure 

data

17874029 Chel

2008

25(OH)D 

and/or 

1,25(OH)2D

RIA 

(Diasorin)

y; interassay 

CV 10% at 30 

nmol/L

nd nd

100 IU/d vit D 

from food

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

17874029 Chel

2008

vit D3 600 IU/d vs. 

placebo

Solvay 4.5 mo 1 tab

vit D3 4200 IU/wk vs. 

placebo 

Solvay 4.5 mo 7 tabs once a wk

vit D3 18,000 IU/mo vs. 

placebo

Solvay 4.5 mo one powder once a month

Co-intervention(s) *:

Compliance/Adherence: 276/338 completed the 4 mo study; compliance with meds ~80% in a random sample of 96/338 participants

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17874029 Chel

2008

primary

25(OH)D concentration

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17874029 Chel

2008

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no*

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions no

Medication no

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Final

**

Final 

SD*

Net 

difference

Net 

difference 

CI 

P 

between

17874029 Chel

2008

increase in 

25(Oh)D

nmol/L Any vit D 

supplement

4 mo 139 38.5 35.7-41.3 0.000

Placebo 4 mo

600 IU daily 4 mo 46 23.0 8.3 69.9 17.8 47.2 42.3-52.1 0.000

Placebo daily 4 mo 45 25.2 12.1 25.5 12.0

4200 IU 1x/wk 4 mo 48 40.7 35.8-45.6 0.000

Placebo weekly 4 mo 44

18,000 IU 

1x/mo

4 mo 45 27.6 22.8-32.5 0.000

Placebo

monthly

4 mo 48

600 IU daily 4 mo 46 6.6 1.7-11.4 0.009

4200 IU 1x/wk 4 mo 48

4200 IU 1x/wk 4 mo 48 11.2 6.3-16.1 0.000

18,000 IU 

1x/mo

4 mo 45

18,000 IU 

1x/mo

4 mo 45 -17.8 -22.7-

-12.8

0.000

600 IU daily 4 mo 46

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 
UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
UI Author

Year Comments for Results

17874029 Chel

2008 Figure 2 in paper does not seem to agree with results in Table 2.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17874029 Chel

2008 RCT y n

NA

y nd n y y y B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A):

Compliance assessed in a random sample of 96/338 participants; baseline medical conditions not reported; 

12% of participants died during study period (number not stratified between placebo and active intervention)

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
Reference List 

 (1) Chel V, Wijnhoven HA, Smit JH, Ooms M, Lips P. Efficacy of different doses and time intervals of oral vitamin D supplementation with or without calcium in 

elderly nursing home residents.[see comment]. Osteoporosis International. 2008;663-671. 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort Name Funding Source Extractor

16280447 Cheng

2005

RCT 10-12 y old girls; Tanner 1 to 2; 

dietary calcium <900 mg/d

serious medical conditions; 

medications that affect bone 

metabolism; 

nd nd government and 

industry

SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

16280447 Cheng

2005

RCT Jyvaskyla, 

Finland

62°24'N

195 165 11.2 10-12 0 nd BMI: 18.2 no serious 

medical 

conditions

dietary calcium: 

670 mg/d; vit D 2.5 

μg/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

16280447 Cheng

2005

25(OH)D enzyme

immunoassay 

(Immunodiagnostic 

Systems Ltd, UK)

y; intra and 

interassay 

CV: 4.2%, 

6.1%

nd baseline: Dec 

to Feb

vit D 2.5 μg/d

Dietary 

calcium 

intake

FFQ x 3 d nd n NA NA dietary 

calcium: 670 

mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca Total Daily 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

16280447 Cheng

2005

Calcium and vit D Tums or Kalcipos (calcium); 

Deetipat (vit D3)

1000 mg calcium carbonate + 

200 IU (5 μg) vit D3/d 

24 mo one tab in am; one tab in pm;

drops in am

Calcium and placebo Tums or Kalcipos (calcium) 1000 mg calcium carbonate + 

vit D placebo

one tab in am; one tab in pm;

drops in am

dairy product 1000 mg calcium equivalent

placebo calcium placebo + vit D 

placebo

one tab in am; one tab in pm;

drops in am

Co-intervention(s) *: none

Compliance/Adherence: 126 completed intervention with >50% compliance

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

16280447 Cheng

2005

primary bone indexes by dual-energy X-ray absorptiometry

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

16280447 Cheng

2005

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes* age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* BMI; Tanner stage

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes* physical activity

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Delta** Delta 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

16280447 Cheng

2005

change in 

BMC (ITT 

analysis)

g

Calcium and 

vit D3

adj

24 mo 46 1328

292

34.7%

1.3%

NS

Calcium and 

placebo 41 1431 274 35% 1.4%

dairy 

product 39 1343 235 38.1% 1.4%

placebo 39 1383 257 35% 1.4%

areal 

BMD g/cm2

Calcium and 

vit D3

adj

24 mo 46 0.934

0.1

9.8%

0.5% aBMD increased 

more in the dairy 

group with 

compliance>50% 

than in placebo 

(P=0.044)

Calcium and 

placebo 41 0.945 0.1 9.7% 0.5%

dairy 

product 39 0.935 0.1 10.4% 0.5%

placebo 39 0.939 0.1 8.9% 0.5%

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

16280447 Cheng

2005 With the use of hierarchical linear model to control for growth velocity; differences in BMD between dairy and placebo disappeared.

16280447 Cheng

2005

other bone indices see Table 3 in paper for other bone indices
UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

16280447 Cheng

2005 RCT y nd NA

y y y y y y C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): small sample size in each group. Underpowered and compliance was low.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

15213038 Cifuentes 

2004

RCT Weight-stable, 

overweight, postmenopausal women

Women with disease states, including osteoporosis, 

and those using medication known to influence 

calcium or bone metabolism.

2000-2003 Nd NIH KP

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

15213038 Cifuentes 

2004

RCT New 

Brunswick, 

NJ, USA

40.486°

73 57 61(5) 52-75 0% Nd BMI: 26.9(1.9) Nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

15213038 Cifuentes 

2004

25(OH)D 

and 

1,25(OH)2D

RIA N Nd April and 

October

25(OH)D 

Nl Ca/Wt 

maint: 84.1 

nmol/L

Nl Ca/Wt 

loss: 73.3

High Ca/Wt 

maint: 68.9

High Ca/Wt 

loss: 61.6

Sig difference 

among 

groups

Dietary 

calcium 

intake

3 day diet 

record (at 

baseline and 

after 6 weeks)

Nd N Nd Nd Nd nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Total Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

15213038 Cifuentes 

2004

Calcium Supplement of calcium citrate, 

Mission Pharmacal, San Antonio, TX

1.2 g/d in high 

calcium group

6 weeks 2 Ca tablets in the morning, 3 in the 

evening

Placebo Supplement of calcium citrate, 

Mission Pharmacal, San Antonio, TX

0.4 g/d in normal 

calcium group

6 weeks 2 tablets in the morning, 3 in the evening (4 

placebo tablets and 1 calcium tablet)

Co-intervention(s) *:

Weight loss group (targeted loss of ≥2.5% of bodyweight), weight maintenance group. Each group was split into high calcium 

and normal calcium groups.

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

15213038 Cifuentes 2004 Primary Weight change Change in weight in kg

Secondary Curve 4- Ca25(OH)D Change in 25(OH)D after 6 weeks of calcium intervention vs placebo

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

NS but substantial differences (in small number of participants) in baseline weight

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

15213038 Cifuentes 

2004

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes Baseline body weight

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Season of blood sample collection

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other Year of recruitment, estrone, sNTx

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Final Final Net 

difference

Net 

difference 

CI / SE / 

SD*

P 

between

15213038 Cifuentes 

2004

Body 

weight

Kg Calcium, both 

weight 

maintenance (WM) 

and weight loss 

(WL) groups

6 weeks 10

16

70.9

71.5

5.1

5.8

70.9

67.9

5.5

5.7

0.9 nd 0.3227

Placebo, both 

weight 

maintenance (WM) 

and weight loss 

(WL) groups

6 weeks 15

16

68.0

74.5

7.7

7.3

68.4

71.2

7.5

7.1

25(OH)D nmol/L Calcium, both 

weight 

maintenance (WM) 

and weight loss 

(WL) groups

6 weeks 10

16

81.4

74.1

14.6

22.0

80.1

76.9

16.2

18.2

1.5 Nd 0.1639

Placebo, both 

weight 

maintenance (WM) 

and weight loss 

(WL) groups

6 weeks

15

16

96.6

85.8

19.9

21.9

98.4

94.6

26.0

27.7

1,25(OH)D pmol/L Calcium, both 

weight 

maintenance (WM) 

and weight loss 

(WL) groups

6 weeks 10

16

117.0

102.3

34.0

32.4

116.9

113.8

29.8

36.2

11.4 nd 0.9663
Placebo, both 

weight 

maintenance (WM) 

and weight loss 

(WL) groups

6 weeks

15

16

92.9

135.8

42.9

41.4

99.4

145.2

35.0

41.3

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

15213038 Cifuentes 

2004

RCTparallel Y nd Y N Y nd Mostly Y Y B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): No mention of intention-to-treat or compliance rate, high dropout rate. Questionable statistics.

Comment

Really 2 separate trials. Combining wt maintenance and wt loss in statistical test is of questionable value. 

However, they did control for various factors, including the substantial differences in baseline weights. 

However, the very small number of subjects may have precluded meaningful adjustment (of 6 variables)

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence
Colditz 1992ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort Name

Funding 

Source Extractor

13151203 Colditz 

1992

Cohort 

study

-participant of Nurses’ 

Health Study

-female

- ≥10 food items blank on 1980 dietary 

questionnaire

- Implausibly high or low score for total food 

intake on 1980 dietary questionnaire

-hx of DM, CHD, or cancer before the return of 

the 1980 questionnaire

1976-1986 Nurses’ Health 

Study

NIH MB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

13151203 Colditz 

1992

Cohort 

study

various 98464 84360 nd nd (NHS 

participants 

30-55 yrs)

0% Predominantly 

white

nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

13151203 Colditz 

1992

25(OH)D 

and/or 

1,25(OH)2D

Dietary 

calcium 

intake

SFFQ nd nd nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

13151203 Colditz 

1992

nd

NIDDM

Report of one of the following: 1. at least one classical symptom (wt loss, hunger, thirst, polyuria, or pruritis) plus a 

plasma fasting glucose concentration ≥ 7.77 mmol/L or a random plasma glucose ≥ 11.10 mmol/L, or 2.at least two 

elevated plasma glucose concentrations ≥ 11.10 mmol/L in the absence of symptoms. 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

13151203 Colditz 

1992

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes Controlled for age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes Controlled for BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation 

of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes Controlled for EtOH consumption

Other Also adjusted for family hx of DM, prior wt 

change, and time period. 

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

13151203 Colditz 

1992

NIDDM in 

BMI < 29 

participants

Quintile 1 Adjusted RR 1.0

Quintile 2 Adjusted RR 1.16

Quintile 3 Adjusted RR 0.67

Quintile 4 Adjusted RR 0.69

Quintile 5 Adjusted RR 0.70 0.47-

1.04

P>0.05 

(Q1 vs. 

Q5)

0.005

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

13151203 Colditz 

1992

NIDDM in 

BMI ≥ 29 

participants

Quintile 1 Adjusted RR 1.0

Quintile 2 Adjusted RR 0.95

Quintile 3 Adjusted RR 0.92

Quintile 4 Adjusted RR 0.91

Quintile 5 Adjusted RR 0.84 0.59-

1.18

P>0.05 

(Q1 vs. 

Q5)

0.26

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

13151203 Colditz 

1992

NIDDM in 

BMI < 29 

participants

Quintile 1 Adjusted for 

same as 

above in 

addition to 

Mg and K

RR 1.0

Quintile 2 RR 1.19

Quintile 3 RR 0.71

Quintile 4 RR 0.77

Quintile 5 RR 0.85 0.53-

1.37

P>0.05 

(Q1 vs. 

Q5)

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI

Autho

r

Year

Population Exposure (All) Dietary 

assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

1315120

3

Colditz 

1992

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecif

ied 

methods*

** was 

used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparativ

e 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

N

a) Adjusted 

or matched 

for ANY 

confounder

s (other 

than age 

and sex)?** 

(y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment

? (y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive

? (y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement

? (y/n)

Y

b) Food 

compositio

n database 

or suppl 

compositio

n reported? 

(y/n)

N

Time 

from 

sample 

collection 

to 

sample 

analysis 

reported

? (y/n)

NA b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)

? (y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): No Ca ranges given for quintiles. Food composition database that was used was not reported. 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

8220092 Corder

1993

Casecohort

study

Ambulatory, generally healthy in 1964-1971. Sera stored. 

Stayed as a Kaiser member.

Cases: Diagnosed with prostate cancer before 1988. Blacks 

oversampled (for power).

Controls: Alive without prostate cancer at time of (matched) 

case diagnosis. Matched for race, age±3 yr, initial 

screening±3 day of year (to account for possible seasonal 

variation)

“Orientals” 

excluded (for 

power).

Prostate cancer 

not confirmed.

Missing sera.

Vit D screening 

1964-71

Cancer 

diagnosis 

<1988

(Kaiser 

Permanente)

NCI

National 

MS Society

EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

8220092 Corder

1993

Casecohort 

study

San 

Francisco 

Bay area, US

37° 46'

200 cases

200 

controls

181 

cases

181 

controls

57 (nd)

38-81

100

Black 91 

pairs

White 90 

pairs

nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration (or 

Validity) of Dietary 

Assessment? (y/n) If 

Yes, Provide Data

Biomarker 

Assay****

Analytical Validity 

of Biomarker Data 

Reported? (y/n) If 

Yes, Provide Data

Time between 

Biomarker 

Sampling and 

Analysis

Background 

exposure

data

8220092 Corder

1993

25(OH)D 

and/or 

1,25(OH)2D

Competitive 

protein binding 

(Haddad 1971) 

25-D

Do not 

distinguish 

between D2 and 

D3

no Mean 11.5 

years to 

diagnosis 

(range 1-23 yr)

25(OH)D: 15-

80 ng/ml

1,25(OH)2D: 

19-50 pg/ml

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 
***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

8220092 Corder

1993

Primary Prostate cancer diagnosis Invasive adenocarcinoma by histopathology

8220092 Corder

1993

Secondary Prostate cancer stage Gleason grade

8220092 Corder

1993

Secondary Prostate cancer death Death record

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

8220092 Corder

1993

“To avoid exclusion of all 19 controls [matched to 19 excluded cases] and 6 cases paired to excluded cases and controls, 6 case-control pairs were salvaged 

from their respective pair members by forming the best age and race matches.” 

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

8220092 Corder

1993

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

No

Demographics (e.g., age, gender, race, education)? Yes Race (matched), age 

(matched)

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

Yes Day of year (matched)

Smoking and other life styles variables No

Other No

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result

95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

8220092 Corder

1993

Prostate cancer “A separate model for men less than 57 years of age was not predictive of risk.”

“In a conditional logistic model, the measured values of 25-D, 1,25-D, and their interaction were jointly predictive of the risk of 

prostate cancer (P=.02)”

“Risk in relation to vitamin D metabolite levels depended on age at serum storage (P=.002) and age at case diagnosis (P=.05).”

“Pattern of risk was similar in black and white men (P=0.51).”

Palpable tumor (n=56) & 

Gleason Grade 7-10 

(n=44)

Detailed OR data for these 2 outcomes for men ≥57 years: Higher quartiles of both 25-D and 1,25-D were protective.

Prostate cancer death 

(n=51) Vitamin D metabolite levels unrelated to risk of prostate cancer death overall and in subgroups by age.

The odds [ratio] of prostate cancer for eqch quartile of 25-D and 1,25-D compared to their lowest quartiles. All men. N=181 pairs (Unadjusted for other variables, implied) 

Quartile of 1,25-D (pg/mL)

Quartile of 25-D (ng/mL) 1 (5-26) 2 (27-32) 3 (33-39) 4 (40-81)

1 (3-18) 1.00 0.53 P<.05 0.28 P<.05 0.15 P<.05

2 (19-23) 0.96 0.58 0.35 0.21

3 (24-28) 0.93 0.63 0.43 0.29

4 (29-52) 0.90 0.69 0.53 0.41
The odds [ratio] of prostate cancer for eqch quartile of 25-D and 1,25-D compared to their lowest quartiles. Men ≥57 years old at baseline. N=91 pairs (57 is median age; 30 black, 61 

white) (Unadjusted for other variables, implied) 

Quartile of 1,25-D (pg/mL)

Quartile of 25-D (ng/mL) 1 (5-26) 2 (27-32) 3 (33-39) 4 (40-81)

1 (3-18) 1.00 0.22 P<.05 0.05 P<.05 0.01 P<.05

2 (19-23) 0.79 0.23 0.07 P<.05 0.02 P<.05

3 (24-28) 0.62 0.24 0.09 0.03 P<.05

4 (29-52) 0.48 0.24 0.12 0.06

P=.0001 by (unadjusted) logistic regression (P=.98 for men<57 at serum storage). 

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI

Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

8220092 Corder

1993

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

NA a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

No a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

NA Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

Y

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Vit D measured with competitive protein binding and calf thymus receptor assays. Inadequate adjustment.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

8682453 Duris

1996

Other 

intervention 

study

Patients with adenomatous polyps after 

polypectomy receiving calcium chemoprevention 

(n=175) and patients with adenomatous polyps 

after polypectomy who did not receive calcium 

chemoprevention (n=9)

Patients with colorectal cancer after surgery 

receiving calcium chemoprevention and patients 

with colorectal cancer after surgery who did not 

receive calcium chemoprevention

nd Group with polyps: nd

Patients with colorectal cancer after 

surgery receiving calcium 

chemoprevention (Group C): 1992

Patients with colorectal cancer after 

surgery who did not receive calcium 

chemoprevention (Group A): 1984; 

Group B): 1985

nd nd AT

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI

Auth

or

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N enrolled*** N analyzed Mean (SD) Age, 

yr

Age Range / IQR Male, %

Race / 

Ethnicit

y

Anthr

opom

etry 

data 

(e.g., 

BMI, 

weigh

t, or 

%bod

y fat 

...etc)

Health 

Status

Specific 

Nutritio

n Status 

Data 

(e.g.,

malnour

ish, low 

Vit D or 

Ca 

intake 

...etc.)

86824

53

Duris

1996

Other 

intervention 

study

Bratislava, 

Slovak 

Republic

(48° 40' 0" 

N)

Patients with 

polyps and

calcium, n=175

Patients with 

polyps without 

calcium, n=9

Patients with 

CRC and 

calcium, n=50

Patients with 

CRC without

calcium (Group 

A, 1984 year), 

n=46

Patients with 

CRC without 

calcium (Group 

B, 1985 year), 

n=47

Patients with 

polyps and 

calcium, n=175

Patients with 

polyps without 

calcium, n=9

Patients with 

CRC and 

calcium, n=50

Patients with 

CRC without 

calcium (Group 

A, 1984 year), 

n=46

Patients with 

CRC without 

calcium (Group 

B, 1985 year), 

n=47

Patients with 

polyps and 

calcium: 55 yr

Patients with 

polyps without 

calcium: 48.7 yr

For CRC group: 

nd

Patients with 

polyps and 

calcium, range: 

38-75

Patients with 

polyps without 

calcium, range: 

30-69

For CRC group: 

nd

Patients 

with polyps 

and 

calcium: 

61.7%

Patients 

with polyps 

without 

calcium: 

66.7%

For CRC 

group: nd

nd nd Patien

ts with 

history 

of 

polyps

, 

n=184

Patien

ts with 

history 

of 

CRC, 

n=143

nd

*Please copy from above
**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

8682453 Duris

1996

25(OH)D 

and/or 

1,25(OH)2D

na na na na na

8682453 Duris

1996

Dietary 

calcium 

intake

nd nd nd nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca 

Total Daily Dose Intervention Duration Intervention Frequency (e.g. capsules were taken 2 times a day)

8682453 Duris

1996

Caclium (patients with 

polyps)

Calcium carbonicum 2 g Mean: 3.1 yr range 1-6 yr 

(based on follow up period)

nd

8682453 Duris

1996

Caclium (patients with 

CRC)

Calcium carbonicum (implied) nd ~50 mo (based on Kaplan Meier 

figure for survival)

nd

Co-intervention(s) *: nd

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

8682453 Duris

1996

nd Adenomas recurrence nd (only for patients with history of polyps)

8682453 Duris

1996

nd Survival nd (only for patients with CRC history)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

8682453 Duris

1996

This publication includes two separate groups of patients who were analyzed separately; therefore, it could be considered as two different studies reported in the 

same publication (first study on patients with adenomatous polyps after polypectomy; second study on patients with CRC after surgery)

Although the %patients with adenomatous recurrence is based on the initial number of patients, the article reports that 5 patients died and 6 additional patients 

did not attend examination visits

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

8682453 Duris

1996

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

no

Demographics (e.g., age, gender, race, education)? no

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions no

Medication no

Sunlight exposure and its proxy variables (e.g., seasonal variation of 25(OH)D, 

UV exposure, location)

no

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, 

RR, HR, %) and direction 

of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

8682453 Duris

1996 Adenomas 

recurrence

Calcium carbonicum, 

2g/day

37.2 12 175 nd nd nd nd nd nd nd

No chemoprevention 36 5 9

Survival

Calcium carbonicum 

(implied)

nd nd 50 nd nd nd 0.048 nd nd nd

No chemoprevention 

(Group B: patients from 

1985)

nd nd 47

Survival

Calcium carbonicum 

(implied)

nd nd 50 nd nd nd nd nd nd nd

No chemoprevention 

(Group C: patients form 

1984)

nd nd 46

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year

Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 
Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

8682453 Duris

1996

Case 

series NA NA NA y nd y n n n C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A):

Study design has no validity to test the hypothesis implied. Authors seem to have two case series (one with 

polyps and another one with CRC) and they use calcium chemoprevention to two subgroups (one subgroup 

with polyps and another with CRC). The comparison between those who received calcium with those patients 

without calcium does not turn this case series study to a case control or case cohort study. A lot of information 

on the concept, the research questions, population recruited, and the results are not reported.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

8890661 Dwyer 1996 Cohort Study NHANES I

25-74 yo

White or black.

Sufficient data

HTN at baseline 1971-75 NHANES I nd EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

8890661 Dwyer 

1996

Cohort 

Study

US, various 6634 6634 46 

(~14)

25-74 63% White 

86%

Black 

14%

BMI 25.4 No 

HTN

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

8890661 Dwyer 

1996

Dietary 

calcium 

intake

24 hour recall nd nd NA NA NA nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

8890661 Dwyer 1996 1° Incident HTN HTN medication prescribed

2° Incident HTN SBP≥160 or DBP≥95 or medication prescribed

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

8890661 Dwyer 

1996

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes Calories

Demographics (e.g., age, gender, race, education)? Yes Age, Sex, Race

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes EtOH

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI P btw

8890661 Dwyer 

1996

HTN (Rx) Calcium intake, per 

1 g/day increase

10 year 1704 6634 OR (increase in Ca intake) 0.90 0.77, 

1.04

NS

HTN (BP or 

Rx)

Calcium intake, per 

1 g/day increase

10 year 1222 5527 OR (increase in Ca intake) 0.99 0.85, 

1.172

NS

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Followup

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

Total 

N

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI P between 

groups***

P for 

trend****

8890661 Dwyer 

1996

HTN (Rx) Quartile 1 10 y nd nd ~1658 Adjusted 

(age)

% 29.8% nd

Quartile 2 nd nd ~1658 Unadjusted % ~27% 

(figure)

Quartile 3 nd nd ~1658 Unadjusted % ~25% 

(figure)

Quartile 4 nd nd ~1658 Adjusted 

(age)

% 21.3%

HTN (Rx), 

Age ≤40 y

Quartile 2 10 y nd nd nd Adjusted OR 0.89 0.81, 

0.97

<.05 <.05 

younger 

vs older

Quartile 3 nd nd nd 0.79 0.66, 

0.94

<.05

Quartile 4 nd nd nd 0.70 0.54, 

0.91

<.05

HTN (Rx), 

Age >40 y

Quartile 2 10 y nd nd nd Adjusted OR 1.01 0.94, 

1.08

NS

Quartile 3 nd nd nd 1.02 0.89, 

1.18

NS

Quartile 4 nd nd nd 1.04 0.84, 

1.28

NS

HTN (Rx), 

Male

Quartile 2 10 y nd nd nd Adjusted OR 0.98 0.89, 

1.08

NS NS male 

vs female

Quartile 3 nd nd nd 0.96 0.79, 

1.17

NS

Quartile 4 nd nd nd 0.95 0.70, 

1.28

NS

HTN (Rx), 

Female

Quartile 2 10 y nd nd nd Adjusted OR 0.96 0.89, 

1.03

NS

Quartile 3 nd nd nd 0.92 0.80, 

1.07

NS

Quartile 4 nd nd nd 0.87 0.71, 

1.11

NS

HTN (Rx), 

Black

Quartile 2 10 y nd nd nd Adjusted OR 0.94 0.82, 

1.09

NS NS black 

vs white

Quartile 3 nd nd nd 0.86 0.67, 

1.19

NS

Quartile 4 nd nd nd 0.84 0.55, 

1.29

NS

HTN (Rx), 

White

Quartile 2 10 y nd nd nd Adjusted OR 0.97 0.91, 

1.04

NS

Quartile 3 nd nd nd 0.94 0.83, 

1.08

NS
Quartile 4 nd nd nd 0.92 0.75, 

1.12

NS

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

Age 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

8890661 Dwyer 

1996

HTN (Rx) Calcium intake, per 

1 g/day increase

10 year nd nd OR (increase in Ca intake)

Age ≤40 y

0.75 nd

.004

nd nd Age >40 y 1.00 nd

HTN (BP or 

Rx)

Calcium intake, per 

1 g/day increase

10 year nd nd OR (increase in Ca intake)

Age ≤40 y

0.83 nd

.004

nd nd Age >40 y 1.14 nd

Sex 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95%

CI

P 

btw Result 95% CI

P 

btw

8890661 Dwyer 

1996

HTN (Rx) Calcium intake, per 

1 g/day increase

10 year nd nd OR (increase in Ca intake)

Male

0.94 nd

NS

nd nd Female 0.85 nd

HTN (BP or 

Rx)

Calcium intake, per 

1 g/day increase

10 year nd nd OR (increase in Ca intake)

Male

1.10 nd

NS

nd nd Female 0.82 nd

Race 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

8890661 Dwyer 

1996

HTN (Rx) Calcium intake, per 

1 g/day increase

10 year nd nd OR (increase in Ca intake)

Black

0.82 nd

NS

White 0.91 nd

HTN (BP or 

Rx)

Calcium intake, per 

1 g/day increase

10 year nd nd OR (increase in Ca intake)

Black

0.80 nd

NS

nd nd White 1.01 nd
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

8890661 Dwyer 

1996

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

nd Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

?

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

nd b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Thorough analyses. Incomplete data available from database. Methods not fully described. Numbers in 

subgroups and incident rates not fully enumerated. 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

17189552 Eagan

2006

RCT-post 

hoc**

Calcium intakes <800mg/d 

and energy intakes 

<2200kcal/d

> 20% overweight or 15% underweight 

according to the Metropolitan Life 

Insurance Tables

nd nd Dairy Management, 

Inc. (Rosemont, IL)

JHL 

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight,

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

17189552 Eagan

2006

RCTpost 

hoc**

Indiana

40°N

154 51 19.4±1.6 nd 0 nd BMI: 22.31

Weight: 62.4kg

nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17189552 Eagan

2006

25(OH)D 

and/or 

1,25(OH)2D

Immunosorbent 

assay (Dia-Sorin, 

Inc., Stillwater, 

MN)

n nd nd 25(OH)D

24.5 ng/mL

17189552 Eagan

2006

Dietary 

calcium 

intake

3-day food 

records

Food and 

Nutrient 

Database 28 

(Minneapolis, 

MN)

n nd nd nd Total Ca

723.5 mg/d

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

17189552 Eagan

2006

High dairy Foods from dairy 1300-1400mg Ca/day from 

dairy

1y

17189552 Eagan

2006

Medium dairy Foods from dairy 1000-1100mg Ca/day from 

dairy

1y

17189552 Eagan

2006

Control Maintain current dietary 

consumption

1y

Co-intervention(s) *: None

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17189552 Eagan

2006

nd Weight To the nearest 0.5 pound (1.1 kg), was measured using a standard physician’s balance beam scale

17189552 Eagan

2006

nd BMI

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17189552 Eagan

2006

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes – energy intake

Demographics (e.g., age, gender, race, education)? No

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* - BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other 25(OH)D

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)** **

No. 

Analyzed Baseline Baseline SD*

Final 

**

Final 

SD*

Net 

difference***

Net 

difference 

SD*

P 

between 

groups***

17189552 Eagan

2006

Weight Kg High dairy Adjusted 18 months 19 61.2 7.6 61.5 7.4 0.3 3.0 NS

17189552 Eagan

2006 Weight Kg Medium dairy Adjusted 18 months 14 66.1 13.7 66.3 14.8 0.1 6.7 NS

17189552 Eagan

2006 Weight Kg Control Adjusted 18 months 18 60.8 11.6 61.2 10.9 0.4 1.7 NS

17189552 Eagan

2006 BMI Kg/m2 High dairy Adjusted 18 months 19 21.9 2.6 22.1 2.5 0.2 1.3 NS

17189552 Eagan

2006 BMI Kg/m2 Medium dairy Adjusted 18 months 14 23.4 4.7 23.6 5.1 0.1 1.3 NS

17189552 Eagan

2006 BMI Kg/m2

Control Adjusted 18 months 18 21.9 3.4 22.0 3.0 0.1 0.6 NS

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****Assessed the impact of the 1-year dairy intervention 6 months after completion of the intervention. 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 
Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17189552 Eagan

2006

RCTparallel nd nNA

y nd y y y Y C

Adverse Event(s): ** Nd

Explanation for Overall Quality Grade (if not Grade A): Small number of subjects for the follow-up study (original study N=154, 135 completed one-year intervention, 

51 subjects included in this study) 

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

16278262 El-Hajj 

2006

RCT 10-17yr girls in four schools from the greater Beirut area to 

ensure balanced representation geographically and 

socioeconomically

nd 2001-2002 nd nd JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

16278262 El-Hajj 

2006

RCT Greater 

Beirut area, 

Lebanon 

(33°53'N)

179 168 13.2 

(no sd)

10-17y 0% nd Height 152.7cm

Weight 47.3 kg

% fat mass 28.3%

Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

16278262 El-Hajj 

2006

25(OH)D 

and/or 

1,25(OH)2D

25(OH)D

-

Competitive 

protein 

biding assay

Y, intra- and 

interassay CVs 

less than 13% 

nd nd 25(OH)D

- 14.0 ng/ml

1,25(OH)D

- RIA

Y, intra- and 

interassay CVs 

less than 10%

1,25(OH)D

- 82.3 ng/ml

16278262 El-Hajj 

2006

Dietary 

calcium 

intake

Food 

Frequency 

Questionnaire 

nd nd nd nd nd 677.3mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 
***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

16278262 El-Hajj 

2006

Low vitD Diluted Vigantol oil, Merck KGaA, 

Darmstadt, Germany 

200IU/d 1y Weekly, usually taken on the weekends

16278262 El-Hajj 

2006

High vitD Vigantol oil, Merck KGaA, 

Darmstadt, Germany

2000IU/d 1y Weekly, usually taken on the weekends

16278262 El-Hajj 

2006

Placebo Oily solution nd 1y Weekly, usually taken on the weekends

Co-intervention(s) *: None

Compliance/Adherence: Placebo - 98%, Low dose group - 98%, High dose group - 97%

Method - the % of the dose taken was calculated as (total volume-returned volume)/total volume*100. 

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

16278262 El-Hajj 2006 Primary % change in BMC at the lumber spine 

16278262 El-Hajj 2006 Primary % change in total hip BMC

16278262 El-Hajj 2006 25(OH)D

16278262 El-Hajj 2006 Height 

16278262 El-Hajj 2006 Weight

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

16278262 El-Hajj 

2006

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

Dietary calcium intake was comparable across 

treatment groups and was not controlled for.

Demographics (e.g., age, gender, race, education)? no*

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)

No. 

Analyzed Baseline Baseline SD*

Final 

or 

Delta**

Final 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

16278262 El-Hajj 

2006

25(OH)D ng/ml Placebo Adjusted 1y 55 14 7 16 8• Placebo vs. 

Low vitD=NS

• Placebo vs. 

High=p<0.001

• Low vitD vs. 

High 

vitD=p<0.001

Low vitD Adjusted 1y 58 14 9 17 6

High vitD Adjusted

1y 55 14 8 38 31

16278262 El-Hajj 

2006

1,25(OH)D ng/ml Placebo Adjusted 1y 55 86 30 76 30 • Placebo vs. 

Low vitD=NS

• Placebo vs. 

High=p<0.001

• Low vitD vs.

High 

vitD=p<0.001

Low vitD Adjusted 1y 58 78 29 78 30

High vitD Adjusted

1y 55 83 27 105 33

16278262 El-Hajj 

2006

Total body 

BMC

Kg Placebo Adjusted 1y 55 1.2 0.3 Delta =

5.0 % 4.7 • Placebo vs. Low vitD=NS

• Placebo vs. 

High=NS

• Low vitD vs.

High vitD=NS

Low vitD Adjusted 1y 58 1.1 0.3 6.1 % 5.7

High vitD Adjusted

1y 55 1.1 0.3 6.2 % 5.8

16278262 El-Hajj 

2006

Height cm Placebo Adjusted 1y 55 154 10 Delta 

=2.0% 1.8 • Placebo vs. Low vitD=NS

• Placebo vs. 

High=NS

• Low vitD vs.

High vitD=NS

Low vitD Adjusted 1y 58 152 9

2.7% 2.3

High vitD Adjusted 1y 55 152 10 2.8% 2.4

16278262 El-Hajj 

2006

Weight kg Placebo Adjusted 1y 55 48 11 Delta

=8.6% 7.8 • Placebo vs. Low vitD=NS

• Placebo vs. 

High=NS

• Low vitD vs.

High vitD=NS

Low vitD Adjusted 1y 58 47 11 8.8% 8.3

High vitD Adjusted

1y 55 47 13 9.7% 8.5
Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

Premenarcheal girls (mean age = 10)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)

No. 

Analyzed Baseline Baseline SD*

Final ** Final 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

16278262 El-Hajj 

2006

25(OH)D ng/ml Placebo Adjusted 1y 8 13 7 11 6Overall: 

<0.001

Placebo vs. 

Low=NS, 

Placebo vs. 

High=<0.001, 

Low vs. 

High=<0.001

Low vitD Adjusted 1y 12 15 6 16 5

High vitD Adjusted

1y 14 14 5 28 9
16278262 El

-Hajj 

2006

Total 

body 

BMC

kg Placebo Adjusted

1y8 0.8

0.2 Delta=

7.4 % 3.9 Overall: 0.06

Each pair 

comparison= 

NS Low vitD Adjusted 1y 12 0.7 0.2 11.4 % 4.0 

High vitD Adjusted 1y 14 0.8 0.2 11.6 % 4.2 

16278262 El-Hajj 

2006

Height cm Placebo Adjusted 1y

8 1428 Delta=3.8% 1.5 Overall: 0.07

Each pair 

comparison= 

NS

Low vitD Adjusted 1y 12 1419 5.0% 1.4

High vitD Adjusted 1y 14 1407 5.6% 1.3

16278262 El-Hajj 

2006

Weight kg Placebo Adjusted 1y

8 37 11 Delta=14.9% 5.2 Overall: 0.25

Each pair 

comparison= 

NS

Low vitD Adjusted 1y 12 358 15.3% 4.7

High vitD Adjusted 1y 14 368 18.4% 6.2
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

16278262 El-Hajj 

2006

RCTparallel y y n y nd y y y y C

Adverse Event(s): ** None

Explanation for Overall Quality Grade (if not Grade A): BMC - No adjustment for height, bone area, lean mass, pubertal stage, and bone age; rated C for ht and wt 

outcome because of small sample size (≤34)

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment Years Trial or Cohort 

Name

Funding 

Source Extractor

8078115 Feliciano

1994

RCT ≥37 wk 

gestation

gastrointestinal disease; congenital 

anomalies

Fall 1986; Spring 

1987

- non-profit SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

8078115 Feliciano

1994

RCT Beijing (40 oN); 

Jiamusi (47 

oN); Nanin 

(22oN); Wuhan 

(30oN) China

255 255 newborn nd Asians 6 mo weight: 7.8 Kg; 

length; 67 cm

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

8078115 Feliciano

1994

25(OH)D 

and/or 

1,25(OH)2D

nd nd 86% infant 

breastfed until 5-

6 mo; other 

foods: powdered 

cow milk; rice 

porridge

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

8078115 Feliciano

1994

Kremers-Urban Co., Milwaukee, 

WI

100 IU 6 mo nd

200 IU

400 IU

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

8078115 Feliciano

1994

primary weight

primary length

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

8078115 Feliciano

1994

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no*

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model) 

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE /

SD*

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P 

between

groups***

8078115 Feliciano

1994

weight 

gain in 

North, 

born in 

spring

g 100 IU 6 mo 17 4208

1695

NS

weight 

gain in 

North, 

born in 

spring

200 IU 13 5296

1064

weight 

gain in 

North, 

born in 

spring

400 IU 12 3745

2000

weight 

gain in 

North, 

born in 

fall

g 100 IU 6 mo 15 5190

927

NS

weight 

gain in 

North, 

born in 

fall

200 IU 13 5046

862

weight 

gain in 

North, 

born in 

fall

400 IU 13 4846

763

weight 

gain in 

South, 

born in 

spring

g 100 IU 6 mo 15 4810

873

NS

weight 

gain in 

south, 

born in 

spring

200 IU 20 4536

706
weight 

gain in 

south, 

born in 

spring

400 IU 20 4609

1005

weight 

gain in 

South, 

born in 

fall

g 100 IU 21 4563

958

NS

weight 

gain in 

south, 

born in 

fall

200 IU 19 4342

585

weight 

gain in 

south, 

born in 

fall

400 IU 23 4572

671

Length 

gain in 

North, 

born in 

spring

cm 100 IU 15 19.3

3.6

NS

Length 

gain in 

North, 

born in 

spring

200 IU 13 19

1.7

Length 

gain in 

North, 

born in 

spring

400 IU 12 18.8

2.4

Length 

gain in 

North, 

born in 

fall

cm 100 IU 18 17.9

3.0

NS

Length 

gain in 

North, 

born in 

fall

200 IU 15 17.5

1.9

Length 

gain in 

North, 

born in 

fall

400 IU 16 18.7

3.5
Length 

gain in 

South, 

born in 

spring

cm 100 IU 15 16.6

1.7

NS

Length 

gain in 

South, 

born in 

spring

200 IU 20 16.6

2.1

Length 

gain in 

South, 

born in 

spring

400 IU 20 16.7

1.8

Length 

gain in 

South, 

born in 

fall

cm 100 IU 22 15.6

1.8

NS

Length 

gain in 

South, 

born in 

fall

200 IU 10 16.5

3.4

Length 

gain in 

South, 

born in 

fall

400 IU 23 17.1

3.7

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
UI Author

Year Comments for Results

8078115 Feliciano

1994 unclear if it is randomized within each city or randomized in the overall study

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

8078115 Feliciano

1994 RCT nd n

NA

y n n y n n C

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A): incomplete reporting of study methodology; small number of subjects in each group

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

15342452 Feskanich

2004

Casecohort 

study

Ongoing cohort study with participants 

who were ages 30-55y at study initiation 

(N=121,700)

Subjects provided blood samples aged 

43-70 y between 06/89-(12/)90 

(N=32,826)

Cases: confirmed invasive 

adenocarcinoma (inferred) diagnosed 

between 1989-06/2000

Controls: 1:2 matching cases (year of 

birth [=age], month of blood draw) 

Previous non-cutaneous 

cancer (in cases and controls)

Non-adenocarcinoma (SCC, 

CIS, metastatic) (in cases) 

(n=32)

Non-confirmed cases (in 

cases) (n=26)

1976 Nurses’ 

Health 

Study

nd JHL/TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N enrolled*** N 

analyzed

Mean 

(SD) 

Age, 

yr

Age

Range

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

15342452 Feskanich

2004

Casecohort 

study

US

(various 

latitudes)

Original cohort 

(N=121,700), 

Subjects provided 

blood samples 

(N=32,826), cases 

(N=193) and 

controls (N=383)

576 60 (no 

SD)

43-70 

(inclusion)

0% nd BMI 25.1 Aspirin 

user 

(>10y): 

10%

HRT 

user: 

34% 

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical Validity of 

Biomarker Data 

Reported? (y/n) If 

Yes, Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure 

data

15342452 Feskanich

2004

25(OH)D 

and/or 

1,25(OH)2D

RIA Intraset coefficient of 

variation (CV) based 

on 21 masked 

samples from cases 

and controls: 

25(OH)D=11.8%

1,25(OH)2D=10.1%

~10 y or 

13 y

nd Total Vit D 

intake: 9.3 

g/d,

25(OH)D

24.1ng/mL

15342452 Feskanich

2004

Dietary 

calcium 

intake

FFQ nd nd nd nd Total Ca 

intake:

1049.2 

mg/day

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

15342452 Feskanich

2004

nd

Colorectal cancer

Reported by a participant on a NHS questionnaire

Invasive adenocarcinoma (inferred) confirmed by medical records (96%) or by the participants by 

letter or telephone incase medical records were unavailable

Identified cases from death record information

15342452 Feskanich

2004

nd Colon cancer nd

15342452 Feskanich

2004

nd Rectal cancer nd

15342452 Feskanich

2004

nd Proximal and distal 

colon cancer nd

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups

Please List Name of 

Confounder (including 

matching factors)

Specific comments for confounders

15342452 Feskanich

2004

Other nutrients or dietary factors (e.g., certain 

food consumption), including supplement use 

and total energy intake

Intakes of calcium, folate, 

methionine, retinol, red meat

Matching factors: year of birth, month of blood draw

# sensitivity analysis: cases diagnosed within the first year after blood 

draw excluded and average UV light at zip code of residence added to 

Demographics (e.g., age, gender, race, the full model (results not materially changed [data not shown]). 

education)?

Yes – matched on age

Anthropometrics (e.g., BMI, body weight, % 

body fat)?

Yes - BMI

Medical conditions

Medication Use of HRT, duration of 

aspirin use 

Sunlight exposure and its proxy variables (e.g., 

physical activity level, occupation, sun 

exposure, location)

Physical activity

Smoking and other life styles variables Yes - pack years of smoking, 

alcohol

Other Family history of colorectal 

cancer, menopausal status

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean Vit D level 

/ 

dose*****(ng/mL)

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases

**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

15342452 Feskanich

2004

Colorectal 

cancer 

25(OH)D –

quintile 1

Lab1

14.9

Lab2

17.4

53 77 Adjusted OR 1.0 (ref) 0.02

25(OH)D –

quintile 2

19.6 24.8 47 79 Adjusted 0.93 0.53-

1.63

25(OH)D –

quintile 3

24.1 29.6 35 75 Adjusted 0.79 0.44-

1.40

25(OH)D –

quintile 4

27.9 34.5 29 77 Adjusted 0.58 0.31-

1.07
25(OH)D –

quintile 5

35.3 44.5 29 75 Adjusted 0.53 0.27-

1.04

15342452 Feskanich

2004

Colorectal 

cancer 

1,25(OH)2D –

quintile 1

24.6 18.7 34 77 Adjusted OR 1.0 (ref) 0.51

1,25(OH)2D –

quintile 2

29.4 24.2 42 78 Adjusted 1.45 0.78-

2.69

1,25(OH)2D –

quintile 3

33.2 29.8 33 76 Adjusted 0.93 0.48-

1.78

1,25(OH)2D –

quintile 4

36.8 33.8 38 76 Adjusted 1.21 0.64-

2.26

1,25(OH)2D –

quintile 5

43.7 42.3 46 75 Adjusted 1.77 0.93-

3.36

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 

** ***median from lab 1 and lab 2, lab 1 values are from blood samples assayed in 2000. lab2 values are from blood samples assayed 2003. 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

15342452 Feskanich

2004 Cases: 11y Adjusted** 193 1004mg

Control: 11y Adjusted** 383 1072mg

Duplicate one table per outcome 

**Adjusted by age 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

15342452 Feskanich

2004

Colon cancer 25(OH)D (values for each quartile not provided) exhibited an inverse linear association, but was not significant (p=0.17). 

15342452 Feskanich

2004

Rectal cancer 25(OH)D (values for each tertile not provided) exhibited a strong inverse linear association (p=0.03). 

15342452 Feskanich

2004

Cancer at the distal colon 

and rectum A significant inverse dose-response association with 25(OH)D (p=0.02).

15342452 Feskanich

2004

Colorectal cancer Sensitivity analysis: cases diagnosed within the first year after blood draw excluded and average UV light at zip code of 

residence added to the full model (results not materially changed [data not shown]). 

15342452 Feskanich

2004

Colorectal cancer Some post-hoc subgroup analyses: 

Vit D intake high (≥7.5 g/d) and low (<7.5 g/d) “association remained inverse”

UV light high lesion OR between Q1 & Q5: 0.25 [0.10-0.69] vs. low lesion OR: 1.24 [0.42-3.64] (Interaction 

between group P=0.16)

Ca intake high (≥900 mg/d) [Trend P=0.08] vs. low (<900 mg/d) [Trend P=0.14] “no evidence of attribution” 

15342452 Feskanich

2004

Colorectal cancer Subgroup Women Age ≥ 60: OR between Q1 & Q5 = 0.35 (0.14-0.87); Trend P=0.006 

15342452 Feskanich

2004

Colorectal cancer Subgroup Women Age < 60: OR between Q1 & Q5 = 1.36 (0.48-3.92); Trend P=0.70 

15342452 Feskanich

2004

Colorectal cancer Postmenoposal HRT user: OR between Q1 & Q5 = 0.61 (0.16-2.41); Trend P not reported

15342452 Feskanich

2004

Colorectal cancer Postmenoposal non HRT user: OR between Q1 & Q5 = 0.41 (0.15-1.12); Trend P not reported

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

15342452 Feskanich

2004

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

NA

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B**** 

Explanation for Overall Quality Grade (if not Grade A): Some unclear/no reporting, no internal calibration of FFQ

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

**** C (Grade for subgroup analysis - No information on range of plasma 25(OH)D for quartiles or tertiles)
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

15668485 Flood 

2005

Cohort 

study

Women found to or not to have 

breast disease participated in 

the BCDDP from 1973-1980 

(n=64182)

Completed baseline 

questionnaire from 1979-1981 

(n=61431)

Failed to complete dietary 

assessment questionnaire from 

1987-1989 (n=9738)

Already with colorectal cancer 

at the dietary assessment or 

earlier (n=479)

Reported an incorrect order of 

entry date and exit date (n=6)

Skipped >30 items of the 

dietary assessment or reported 

>3800 or <400 kcal/d total 

energy intake (n=5647)

Reported implausibly high Ca 

intake >3000 mg/d (n=207)#

1973-1980 The Breast Cancer 

Detection Demonstration 

Project (BCDDP)

NCI and 

American 

Cancer 

Society

TTE

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

# Although not provided, this exclusion seems to have been used in sensitivity analysis, which did not materially alter the results. 

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled*** N analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

15668485 Flood 

2005

Cohort 27 cities 

across the 

US (25°

46'-54° 40')

61431 45354 (details 

on the 

reasons for 

exclusions 

spelled out 

above)

61.9 

(nd)

nd 0% nd BMI=24.7 kg/m2

Ht=64.0 (inches)

Some with 

previous 

breast 

cancer 

(details not 

reported) 

Total energy 

intake ~1273 

kcal/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

15668485 Flood 

2005

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd Nd

15668485 Flood 

2005

Dietary 

calcium 

intake

62-item 

National 

Cancer 

Institute/

Block FFQ

USDA Y (cited two 

original Block 

papers and a NCI 

paper) 

nd nd nd Nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

15668485 Flood 

2005

Nd

Colorectal 

cancer

Self reports, statewide cancer registry, national death index. Only self reports were validated by obtaining the 

pathology reports (94% confirmed). Cases without the pathology confirm were excluded in sensitivity analysis, which 

did not materially alter the results. Non-confirmed cases by the pathology reports not appearing in the registry were 

considered non-cases

nd Colon cancer 

vs. rectal cancer Same as above

Proximal vs. 

distal colon 

cancer

Same as above (not data extracted)
Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

15668485 Flood 

2005

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

folate, vitamin D, fiber, meat, fat, fruits, vegetables, 

grains, energy

Demographics (e.g., age, gender, race, education)? Age, ed ucat ion (t hrough high 

school/m ore t han high school)

Anthropometrics (e.g., BMI, body weight, % body fat)? b od y m ass index (kg/m2), height

Medical conditions history of menopausal or hormone replacement 

therapy (yes/no) 

Medication Non-steroidal anti-inflammatory (NSAID) drug use 

(yes/no)

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

smoking (ever/never), alcohol,

weekday physical activity index expressed in units 

of Metabolic Equivalent Time

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis

1. Af t er p erf orm ing all of t hese t est s, none of t he f act ors list ed ab ove generat ed any m at erial changes in eit her t he d iet ary ca lcium 

m od el, t he t ot al calcium m od el, or t he sup p lem ent al calcium m od el (d at a not show n), and t he aut hor s d id not includ e t hem in 

any of t he f inal calcium m od els. 

2. Ad just ing f or rep ort ed colorect al cancer -screening or rest rict ing t he cohort t o only t hose sub ject s w ho had no p rior hist ory of 

b reast d isease result ed in no q ualit at ive d if f erences in risk est im at es 

3. Sim ult aneous inclusion of all t hese p ot ent ial conf ound ers in t he p rop ort ional hazard s regression m od els also d id not p rod uce any 

m at erial changes in t he result s f rom t hose ob t ained in t he age- and energy-ad just ed m od els. 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

follow-up 

time, mo

Mean Ca 

level / 

dose

No. of 

Cases

(Event)*

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect size CI** P between groups***

P for 

trend****

15668485 Flood 

2005

Colorectal 

cancer (Total 

calcium [mg])

Q1 17 <472 102 nd Age and 

energy 

only

RR (HR) 1.00 Ref Nd 0.02

Q2 17 472-635 110 nd Age and 

energy 

only

RR (HR) 1.03 0.79-

1.35

Nd

Q3 17 636-844 86 nd Age and 

energy 

only

RR (HR) 0.80 0.60-

1.06

Nd
Q4 17 845

-1270 106 nd Age and 

energy 

only

RR (HR) 0.960.73-

1.26

Nd

Q5 17 >1270 80 nd Age and 

energy 

only

RR (HR) 0.74 0.55-

0.99

Nd

15668485 Flood 

2005

Rectal cancer 

(Total calcium 

[mg])

Q1 17 <472 nd nd Age and 

energy 

only

RR (HR) 1.00 Ref Nd 0.30

Q2 17 472-635 nd nd Age and 

energy 

only

RR (HR)

1.19 0.57

-

2.48

Nd

Q3 17 636-844 nd nd Age and 

energy 

only

RR (HR)

1.10 0.52

-

2.32

Nd

Q4 17 845-1270 nd nd Age and 

energy 

only

RR (HR) 1.23 0.60-

2.53

Nd

Q5 17 >1270 nd nd Age and 

energy 

only

RR (HR) 0.93 0.43-

2.01

Nd

15668485 Flood 

2005

Colon cancer 

(Total calcium 

[mg])

Q1

17

<472 nd nd

Age and 

energy 

only

RR (HR)

0.68 0.42

-

1.08

Nd

0.10

Q2

17

472-635 nd nd

Age and 

energy 

only

RR (HR)

0.83 0.53

-

1.29

Nd

Q3

17

636-844 nd nd

Age and 

energy 

only

RR (HR)

0.54 0.33

-

0.90

Nd

Q4

17

845-1270nd nd

Age and 

energy 

only

RR (HR)

0.89 0.57

-

1.38

Nd

Q5

17

>1270 nd nd

Age and 

energy 

only

RR (HR)

1.0 Ref

Nd

15668485 Flood 

2005

Proximal 

colon cancer 

(Total calcium 

[mg])

Q1

17

<472 nd nd

Age and 

energy 

only

RR (HR)

0.71 0.40

-

1.26

Nd

0.24

Q2

17

472-635 nd nd

Age and 

energy 

only

RR (HR)

0.71 0.40

-

1.26

Nd

Q3

17

636-844 nd nd

Age and 

energy 

only

RR (HR)

0.86 0.49

-

1.49

Nd
Q4

17

845-1270 nd nd

Age and 

energy 

only

RR (HR)

0.76 0.43-

1.34

Nd

Q5

17

>1270 nd nd

Age and 

energy 

only

RR (HR)

1.0 Ref

Nd

15668485 Flood 

2005

Distal colon 

cancer (Total 

calcium [mg])

Q1 17 <472 nd nd Age and 

energy 

only

RR (HR) 1.00 Ref Nd 0.26

Q2 17 472-635 nd nd Age and 

energy 

only

RR (HR) 0.84 0.59-

1.18

Nd

Q3 17 636-844 nd nd Age and 

energy 

only

RR (HR) 0.66 0.46-

0.96

Nd

Q4 17 845-1270 nd nd Age and 

energy 

only

RR (HR) 0.78 0.55-

1.11

Nd

Q5 17 >1270 nd nd Age and 

energy 

only

RR (HR) 0.69 0.48-

0.99

Nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 
UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

15668485 Flood 

2005

Some data on Vit D reported

Correlation between dietary Ca and supplemental Ca was low (r=0.01)

Correlation between dietary Ca and dietary Vit D was high (r=0.87) 

Correlation between dietary Ca and total Vit D was low (r=0.33)

Correlation between supplemental Ca and total Vit D was low (r=0.10)

Explanation of the use of only age and energy adjusted model

Simultaneous inclusion of all the potential confounders in the proportional hazards regression models did not produce any material changes in the results 

from those obtained in the age- and energy-adjusted models.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

15668485 Flood 

2005

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Nd

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y 

but

not 

use

d 

eve

ntu

ally

a) Clear 

definition of 

outcome, 

including 

time of 

ascertainm

ent? (y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y 

“all”

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? 

(y/n)

Y 

(90.3

%)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

y b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y 

“not 

mat

eria

lly 

alte

red”

c) Do the 

authors 

specify a 

primary 

outcome? 

(y/n)

n

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Post-hoc analysis of an already available database. Otherwise, the reporting is good except for the blinding 

of the assessors of exposure and outcomes; not all cases confirmed by histology; participants per calcium 

quintile not reported; power calculation not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

1937662 Ford 1991 Cohort study 25-74 yo

Traced between 1982-84

Detailed exam/interview

Serum Ca available

HTN at baseline 1971-75 NHANES I nd EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

1937662 Ford 

1991

Cohort 

study

US, various 6913 5411 nd 25-44: 

~59%

45-64: 

~28%

≥65: 

~13%

35% White: 

88%

Black: 

12%

“Normal”: BMI<27.8 

men / <27.3 women: 

~78%

“Obese”: BMI 27.8-

<31.1 men / 27.3-

<32.3 women: ~16%

“Severe obesity”: 

BMI ≥31.1 men / 

≥32.3 women ~7%

normotensive nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

1937662 Ford 

1991

Dietary 

calcium 

intake

nd, not 

referenced

nd, not 

referenced

nd, not referenced NA NA NA nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 
****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation)

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary Outcome** Outcome Definition

1937662 Ford 1991 1° Hypertension SBP≥160 mm Hg or DBP≥95 mm Hg or taking antihypertensive

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

1937662 Ford 

1991

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes Caloric intake

Demographics (e.g., age, gender, race, education)? Yes Age (subanalyses by race, 

sex)

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean

Follow-up

Mean 

Ca level 

/ dose

No. of 

Cases 

(Event)* 

Total 

N

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

1937662 Ford 

1991

Incident 

HTN, 

white men

Quartile 1 10 y <343.75 

mg/day

47 (22%) ~215 Adjusted OR 1.0 --

Quartile 2 343.76-

591.11

78 (20%) ~382 0.91 0.60, 

1.38

NS

Quartile 3 591.12-

953.77

104 

(23%)

~448 1.09 0.73, 

1.63

NS

Quartile 4 >953.77 131 

(20%)

~662 0.96 0.64, 

1.45

NS

Incident 

HTN, 

white 

women

Quartile 1 10 y <343.75 

mg/day

186 

(22%)

~865 Adjusted OR 1.0 --

Quartile 2 343.76-

591.11

183 

(23%)

~806 1.11 0.87, 

1.43

NS

Quartile 3 591.12-

953.77

172 

(22%)

~775 1.17 0.90, 

1.51

NS

Quartile 4 >953.77 104 

(17%)

~619 1.01 0.74, 

1.38

NS

Incident 

HTN, 

black men

Quartile 1 10 y <343.75 

mg/day

20 (42%) ~48 Adjusted OR 1.0 --

Quartile 2 343.76-

591.11

17 (38%) ~45 0.68 0.28, 

1.65

NS

Quartile 3 591.12-

953.77

18 (32%) ~56 0.54 0.22, 

1.33

NS

Quartile 4 >953.77 9 (27%) ~34 0.35 0.11, 

1.13

.08

Incident 

HTN, 

black 

women

Quartile 1 10 y <343.75 

mg/day

94 (42%) ~225 Adjusted OR 1.0 --

Quartile 2 343.76-

591.11

35 (29%) ~120 0.61 0.37, 

1.01

.053

Quartile 3 591.12-

953.77

31 (42%) ~74 1.11 0.62, 

2.01

NS

Quartile 4 >953.77 11 (30%) ~37 0.77 0.33, 

1.81

NS

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

1937662 Ford 

1991

a) Eligibility 

criteria 

clear? (y/n)

No

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

No a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Yes

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Yes

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Yes

a) 

Prospective 

collection of 

data? (y/n)

Yes

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Yes

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

No Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

No

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

Unclear

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

No b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

No

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Yes

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

No

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Very unclear reporting, particularly of numbers of subjects analyzed. Different methods used in different analyses without 

justification. Inadequate adjustment in primary model. >20% without sufficient data to include in analyses. Outdated 

definition of HTN.
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

17372031 Forman 

2007

Cohort 

study

-participant of HPFS or 

NHS who submitted blood 

samples and had 

25(OH)D measured

-Cases from case-control studies derived from 

HPFS and NHS except from the nested casecontrol study of colon polyps in the NHS, from 

which both cases and controls were included. 

-prevalent HTN at the time of blood collection

NHS: 1990 –

1998

HPFS: 1994

- 2002

Health Professionals’ 

Follow-up Study

(HPFS) and

Nurses’ Health Study

(NHS)

AHA MB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17372031 Forman 

2007

Cohort 

study

various 1811 (613 

men, 1198 

women)

1811 Men: 65

± 8 years

Women: 

57 ± 7 

years

nd 34% - 95% of 

men and 

85% of 

women 

were white

BMI ~ 25 ± 4 nd Low vit D intake in 

part of cohort

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17372031 Forman 

2007

25(OH)D 

and/or 

1,25(OH)2D

25(OH)D 

measured in 

several 

batches 

using RIA

Yes – coeff of 

variation 

ranged from 

5.4% to 8.7%

nd nd nd

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome**

Outcome Definition

17372031 Forman 

2007

1o (for this post hoc 

analysis)

Incident 

HTN

Subject reporting that their physician made a dx of HTN since preceding questionnaire (biennial 

questionnaires administered in both NHS and HPFS)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups

Please List Name of 

Confounder (including 

matching factors)

Specific comments for confounders

17372031 Forman 

2007

Other nutrients or dietary factors 

(e.g., certain food consumption), 

including supplement use and total 

energy intake

Demographics (e.g., age, gender, 

race, education)?

Yes Age and race were included in all models

Anthropometrics (e.g., BMI, body 

weight, % body fat)?

Yes BMI was included in all models

Medical conditions

Medication

Sunlight exposure and its proxy 

variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles 

variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes Physical activity was included in all models

Other Family hx of HTN, smoking status, menopausal status, season of blood draw, and intakes 

of vit D, EtOH, folate, Na, K, Ca, and Mg were tested individually and kept in model only if 

their inclusion changed the RR for 25(OH)D level by > 10%. Only menopausal status 

altered the effect estimate for < 15 ng/mL by > 10% and was maintained in final 

multivariable models.

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome Exposure Categories

Mean 

Vit D 

level

No. of 

Cases

(Event)*

 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric Outcome 

effect size CI** P between groups***

P for 

trend****

17372031 Forman 

2007

Incident 

HTN

25(OH)D ≥ 30 

ng/mL (♂)

≥ 30 

ng/mL

22 233 Adjusted 4-year RR 1.0 

(reference)

25(OH)D 

between 15 and 

29 ng/mL (♂)

15 and 

29

33 347 Adjusted 4-year RR 1.12 0.51-

2.48

NS

25(OH)D < 15 

ng/mL (♂)

< 15 6 33 Adjusted 4-year RR 6.13 1.00-

37.8

.05

25(OH)D ≥ 15 

ng/mL (♂)*

≥ 15 

ng/mL

55 580 Adjusted 4-year RR 1.0 

(reference)

25(OH)D < 15 

ng/mL (♂)*

< 15 6 33 Adjusted 4-year RR 5.68 1.01–

32.3

<.05

25(OH)D ≥ 30 

ng/mL (♂)

≥ 30 

ng/mL

nd 233 Adjusted 8-year RR 1.0 

(reference)

25(OH)D < 15 

ng/mL (♂)

< 15 9 33 Adjusted 8-year RR 3.53 1.02-

12.3

< .05

25(OH)D ≥ 15 

ng/mL (♂)*

≥ 15 

ng/mL

124 580 Adjusted 8-year RR 1.0 

(reference)

25(OH)D < 15 

ng/mL (♂)*

< 15 9 33 Adjusted 8-year RR 3.03 0.94-

9.76

NS

25(OH)D ≥ 30 

ng/mL (♀)

≥ 30 

ng/mL

58 nd Adjusted 4-year RR 1.0 

(reference)

25(OH)D 

between 15 and 

29 ng/mL (♀)

15 and 

29

60 nd Adjusted 4-year RR 0.85 0.53-

1.34

NS

25(OH)D < 15 

ng/mL (♀)

< 15 11 nd Adjusted 4-year RR 2.67 1.05-

6.79

< .05

25(OH)D ≥ 15 

ng/mL (♀)*

≥ 15 

ng/mL

118 nd Adjusted 4-year RR 1.0 

(reference)

25(OH)D < 15 

ng/mL (♀)*

< 15 11 nd Adjusted 4-year RR 2.98 1.24-

7.20

<.05

25(OH)D ≥ 30 

ng/mL (♀)

≥ 30 

ng/mL

nd nd Adjusted 8-year RR 1.0 

(reference)

25(OH)D < 15 

ng/mL (♀)

< 15 20 nd Adjusted 8-year RR 1.70 0.92-

3.16

NS

25(OH)D ≥ 15 

ng/mL (♀)*

≥ 15 

ng/mL

254 nd Adjusted 8-year RR 1.0 

(reference)

25(OH)D < 15 

ng/mL (♀)*

< 15 20 nd Adjusted 8-year RR 1.42 0.79-

2.56

NS
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

* Versus ≥15 ng/mL. Separate analysis from tertiles analysis

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

17372031 Forman 

2007

Incident 

HTN

HPFS and NHS data were combined to compute a pooled result using random-effects model. Those with vit D levels < 15 ng/mL compared 

to those with levels ≥ 30 ng/mL had a 4-year RR of 3.18 (95% CI: 1.39 – 7.29), p<.05

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 
QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

173720

31

Forman 

2007

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecifie

d 

methods***

was used? 

(y/n)

Y a) Level of 

the 

exposure in 

comparativ

e 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounder

s (other 

than age 

and sex)?** 

(y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment

? (y/n)

N

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of 

population 

random or 

consecutive

? (y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement

? (y/n)

Y

b) Food 

compositio

n database 

or suppl 

compositio

n 

reported? 

(y/n)

N Time from 

sample 

collection 

to sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors 

specify a 

primary 

outcome? 

(y/n)

Y

c) 

Justification 

of sample 

size 

(includes 

sample size 

calculations)

? (y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Time from 

sample collection to analysis not reported, no clear definition of 

outcome, food composition database not reported, no sample size 

calculations.

Data incomplete (formatting error in the table); potentially incomplete definition of outcome (no BP 

measurement). Small subset of all potentially available participants. Outcome did not include BP 

measurements.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

18838623 Forman 

2008

Casecohort 

study

Fasting for ≥ 8 hours; no diagnosis of hypertension; no use of 

antihypertensive medications; no diagnosis of cancer (except 

nonmelanoma skin cancer); no diagnosis of either coronary 

heart disease or diabetes; and BMI < 30 kg/m2

nd 1989 Nurses’ 

Health 

Study 2

American Heart 

Association & 

National Institutes of 

Health

JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country,

latitude)

N enrolled*** N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

18838623 Forman 

2008

Casecohort 

study

US 116,671 Female 

registered nurses 

joined the prospective 

cohort study in 1989, 

29616 subjects 

contributed blood 

samples 1997-1999, 

750 cases and 750 

controls selected. 

742 cases 

and 742 

controls 

43 

(nd)

40-46 0 nd BMI 24.1 nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

18838623 Forman 

2008

25(OH)D 

and/or 

1,25(OH)2D

Enzyme 

immunoassay

Y, coefficient 

variation=3.2%

nd nd 26.6 ng/mL

18838623 Forman 

2008

Dietary 

calcium 

intake

nd nd nd nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 
***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

18838623 Forman 

2008

Primary Hypertension Self-reported by the health professionals on biennial questionnaires (obtained medical records from a subset of 

randomly selected NHS 2 participants to validate hypertension, sensitivity 94%, specificity 85%)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

18838623 Forman 

2008

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

Yes Ca, phosphorus, uric acid

Demographics (e.g., age, gender, race, education)? Yes* Age**, race**

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* BMI

Medical conditions Yes Family history of hypertension

Medication Yes Oral contraceptive use, creatinine

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes* Physical activity

Other Yes Date of blood sample collection**, day of menstrual 

cycle**, time of day of the blood collection**, PTH

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis

**Matching factors
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

18838623 Forman 

2008

Hypertension < 30.0 520 975 OR 1.64 1.29, 

2.10

nd 1.47 1.10, 

1.97

nd

≥ 30.0 222 509

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend 

18838623 Forman 

2008

Hypertension Quartile 1 ng/mL

37.9** ***

151 369 Adjusted OR 1.0 0.01

Quartile 2 29.2 195 374 Adjusted 1.52 1.06, 

2.18

Quartile 3 23.8 188 370 Adjusted 1.55 1.07, 

2.23

Quartile 4 16.7 208 371 Adjusted 1.66 1.11, 
2.48

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 

** ***median vitD level 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical

Analysis Outcome Design

18838623 Forman 

2008

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

n

a) Method 

reported? 

(y/n)

n

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

n

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

n

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

n

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

n

b) Loss to 

follow-up 

<20%? (y/n)

n

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

n

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Relied on self-reported hypertension, insufficient power to examine the association between plasma 

25(OH)D levels and incident hypertension

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

17971526 Freedman 

2007

Cohort 

study

Noninstitutionalized US population, age 17 y 

or older who completed physical examination

(n=17,705)

No 25(OH)D 

measurement

(n=875)

Unknown mortality 

status (n=11)

Missing birthdate

(n=1)

1988-1994 NHANES III NIH/NCI, 

USPHS/DHHS

TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17971526 Freedman 

2007

Cohort 

study

US

Mean 

latitude=38.3N

16818 16818 44.0 

(nd)

nd 45.4 NonHispanic 

white: 

71.2

NonHispanic 

black: 

14.1

Mexican 

American: 

5.8

Other: 8.9

BMI=26.7 kg/m2

%body fat=23.4

nd Vit D: 4.7 mcg/d

Ca: 811.8 mg/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of Dietary 

Assessment? (y/n) If 

Yes, Provide Data

Biomarker 

Assay****

Analytical Validity 

of Biomarker Data 

Reported? (y/n) If 

Yes, Provide Data

Time between 

Biomarker 

Sampling and 

Analysis

Background 

exposure

data

17971526 Freedman 

2007

25(OH)D 

and/or 

1,25(OH)2D

RIA kit The mean 

coefficient of 

variation:

17.6% (range 10–

25%) for lower 

25(OH)D values 

(20–62.5 nmol/L)

15% (range12–

18%) for higher 

values (85–147.5 

nmol/L)

Nd (~7 to ~13 y)

(follow-up of the 

entire cohort 

146578 personyears)

Vit D intake: 

4.7 mcg/d

17971526 Freedman 

2007

Dietary 

calcium 

intake

24HR USDA food 

composition 

database

nd nd nd Ca intake: 

811.8 mg/d

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17971526 Freedman 2007 Primary Cancer mortality Based on ICD-10 codes#

17971526 Freedman 2007 Secondary Lung cancer mortality Based on ICD-10 codes#

17971526 Freedman 2007 Secondary Digestive cancer mortality Based on ICD-10 codes#

17971526 Freedman 2007 Secondary Breast cancer mortality Based on ICD-10 codes#

17971526 Freedman 2007 Secondary Prostate cancer mortality Based on ICD-10 codes#

17971526 Freedman 2007 Secondary Non-Hodgkin’s lymphoma/leukemia mortality Based on ICD-10 codes#

17971526 Freedman 2007 Secondary Colorectal cancer mortality Based on ICD-10 codes#

17971526 Freedman 2007 Secondary Other cancers mortality Based on ICD-10 codes#

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

# Reported ICD-10 codes include: C33 – C34 (lung, trachea, and bronchus); C18 – C21 (colon, rectum, and anus); C15, C16, C22, C25 (other digestive system, i.e., esophagus, stomach, liver, pancreatic 

cancer); C50 (breast); C61 (prostate); C82 – C85, C91 – C95 (non-Hodgkin lymphoma/leukemia); and C00 – C14, C17, C23 – C24, C26 – C32, C37 – C41, C43 – C49, C51 – C52, C54 – C60, C62 – C65, C67 

– C80, C88, C90, C97 (other cancers, including buccal, larynx, melanoma, gynecological sites, kidney, bladder, brain, multiple myeloma). 

Note: these are based on a death registry or a cancer database. Cases were not verified with medical records or pathology reports.

**Must explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

17971526 Freedman 

2007

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

Yes (calcium intake and serum retinol 

level)

Final model includes: sex, race/ethnicity, and 

smoking pattern

Demographics (e.g., age, gender, race, education)? Yes (sex, race/ethnicity, and 

education)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (BMI and total body fat)

Medical conditions Yes (disease history)

Medication No

Sunlight exposure and its proxy variables (e.g., physical 

activity level, occupation, sun exposure, location)

Yes (season and location/latitude)

Smoking and other life styles variables Yes (smoking pattern) Never, former, current (<20pack-y), current (20 

or more pack-y), current (unknown pack-y) 

Other Levels of physical activity

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

 Final model includes: sex, race/ethnicity, and smoking pattern 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

(nmol/L)

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

Total N**

Mean 

follow-

up 

period, 

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

**

P 

between 

groups***

P for 

trend****

17971526 Freedman 

2007

Cancer 

Mortality

6-Q1 <50

nd

175 5744

105

Adjusted

HR

reference-

nd 0.65

6-Q2 50 to 

<62.5

103 3143 1.22 0.91-

1.64

6-Q3 62.5 to 

<80

117 3713 1.02 0.69-

1.50

6-Q4 80 to 

<100

80

4218

1.00 0.71-

1.40

6-Q5 100 to 

<120

41 0.92 0.58-

1.46

6-Q6 120 or 

over

20 1.49 0.85-

2.64

17971526 Freedman 

2007

Lung 

Cancer 

Mortality

4-Q1 <50 nd 57 5744 105 Adjusted

HR

reference-

nd 0.41

4-Q2 50 to 

<80

51 6856 0.78 0.50-

1.22

4-Q3 80 to 

<100

23

4218

0.65 0.36-

1.18

4-Q4 100 or 

over

22 1.14 0.60-

2.18

17971526 Freedman 

2007

Digestive 

Cancer 

Mortality

2-Q1 <62.5

nd

34

Nd

105 Adjusted

HR

reference-

nd 0.18

2-Q2 62.5 or 

over

37 1.42 0.73

-

1.76

17971526 Freedman 

2007

Breast 

Cancer 

Mortality

2-Q1 <62.5

nd

20

Nd

105 Adjusted

HR

reference-

nd 0.76

2-Q2 62.5 or 

over

8 0.28 0.08

-

0.93

17971526 Freedman 

2007

Prostate 

Cancer 

Mortality

2-Q1<62.5

nd

22

nd

105 Adjusted

RR

reference-

nd 0.95

2-Q2 ≥62.5 25 0.91 0.39

-

2.14

17971526 Freedman 

2007

Non-

Hodgkin’s 

lymphoma 

or 

leukemia 

Mortality

2-Q1 <62.5

nd

16

nd

105 Adjusted

HR

reference-

nd 0.96

2-Q2 62.5 or 

over

24 1.34

0.62-

2.91

17971526 Freedman 

2007

Colorectal 

Cancer 

Mortality

3-Q1 <50

nd

28

nd

105 Adjusted

HR

reference-

nd 0.02

3-Q2 50 to 

<80 24 0.44 0.20

-

0.95

3-Q3 80 or 

over

14 0.28 0.11

-

0.68

17971526 Freedman 

2007

Other 

Cancers 

3-Q1 <50 nd 38 nd 105 Adjusted HR reference-

nd 0.84

3-Q2 50 to 60 1.83 0.93-
Mortality <80 3.61

3-Q3 80 or 

over

32 1.86 0.75-

4.63

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

(nmol/L)

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

**

P between 

groups***

P for 

trend****

17971526 Freedman 

2007

Cancer 

Mortality

(Winter/lower 

latitude)

5-Q1 <50

nd

74

nd Adjusted HR

reference -

Interaction 

(between 

winter/lower 

vs. 

summer/higher 

subgroups) 

P=0.36

0.65

5-Q2 50 to 

<62.5 37 1.02 0.59-1.76

5-Q3 62.5 to 

<80 42 1.16 0.52-2.56

5-Q4 80 to 

<100 30 0.95 0.51-1.79

5-Q5

100 or 

over

23 1.08 0.54-

2.16

17971526 Freedman 

2007

Cancer 

Mortality

(Summer/higher 

latitude)

5-Q1 <50

nd

101

Nd Adjusted HR

reference -

0.95

5-Q2 50 to 

<62.5 66 1.29 0.90-1.85

5-Q3 62.5 to 

<80 75 0.96 0.65-1.41

5-Q4 80 to 

<100 50 1.00 0.65-1.54

5-Q5

100 or 

over

38 1.09 0.66-

1.81

17971526 Freedman 

2007

Cancer

Mortality

(Males)

5-Q1 <50

nd

88 1993

Adjusted HR

reference -

Interaction 

(between 

winter/lower 

vs. 

summer/higher 

subgroups) 

P=0.70

0.08

5-Q2 50 to 

<62.5 57 1461 1.03 0.73-1.44

5-Q3 62.5 to 

<80 71 1845 0.99 0.57-1.74

5-Q4 80 to 

<100 58

2333

1.21 0.83-

1.78

5-Q5

100 or 

over

44 1.35 0.78-

2.31

17971526 Freedman 

2007

Cancer 

Mortality

(Females)

5-Q1 <50

nd

87 3751

Adjusted HR

reference -

Interaction 

(between 

winter/lower 

vs. 

summer/higher 

subgroups) 

P=0.26

0.12

5-Q2 50 to 

<62.5

46 1682 1.40 0.94-

2.08

5-Q3 62.5 to 

<80

46 1868 1.02 0.62-

1.67

5-Q4 80 to 

<100

22 1885 0.72 0.40-

1.26

5-Q5

100 or 

over

17 0.78 0.40-

1.53

17971526 Freedman 

2007

Cancer 

Mortality (NonHispanic white)

4-Q1 <50 nd 61 2964 Adjusted HR reference - Interaction 

(between 

winter/lower 

vs. 

summer/higher 

0.80

4-Q2 50 to 

<80

135 5206 1.12 0.78-

1.60

4-Q3 80 to 

<100

57 3813 1.02 0.66-

1.56
4

-Q4 100 or 

over

45 1.10 0.70

-

1.74

subgroups) 

P=NS

17971526 Freedman 

2007

Cancer 

Mortality (Non-

Hispanic black)

3-Q1 <50

nd

80 1666

Adjusted HR

reference-

Interaction 

(between 

winter/lower 

vs. 

summer/higher 

subgroups) 

P=NS

0.14

3-Q2 50 to 

<80 42 609 0.84 0.53

-

1.33

3-Q3 80 or 

over

22 101 1.41 0.80

-

2.48

17971526 Freedman 

2007

Cancer 

Mortality

(Mexican 

American)

3-Q1 <50

Nd

33 414

Adjusted HR

reference-

Interaction 

(between 

winter/lower 

vs. 

summer/higher 

subgroups) 

P=NS

0.37

3-Q2 50 to 

<80 39 433 0.89 0.42

-

1.87

3-Q3 80 or 

over

15 122

0.66 0.28-

1.55
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17971526 Freedman 

2007

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Nd

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

y

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

Nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

n b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

Nd

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A):

No details on enrollment and blinding assessment, some may have been excluded due to unavailability of 

data (e.g., blood sample), leading to the possibility of selection bias. NO adjustments on family history.

How the diagnosis of cancer was verified was unclear.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

18381472 Freedman

2008

Casecohort 

study

Cases: All p art icip ant s of 

Prost at e, Lung, Colorect al, and 

Ovarian (PLCO) Cancer Screening 

Trial w ho p rovid ed b aseline 

b lood sam p les and b ackground 

q uest ionnaires, no hist ory of 

b reast cancer at b aseline, b ut

w ere d iagnosed w it h an 

incid ent b reast cancer b et w een 

t he d at e of t he b aseline b lood

collect ion (1993-2001) and June 

30, 2005.

Noncases: All p art icip ant s of 

Prost at e, Lung, Colorect al, and 

Ovarian (PLCO) Cancer Screening 

Trial w ho p rovid ed b aseline 

b lood sam p les and b ackground 

q uest ionnaires b ut had not 

rep ort ed a b reast cancer as of 

June 30, 2005.

Hist ory of one of t he 

f our PLCO cancers, a 

recent hist ory of 

screening p roced ures 

f or one of t he cancers, 

or w ere und ergoing 

t reat m ent f or any

cancer (ot her t han 

nonm elanom a skin 

cancer).

Novem b er 

1993 and 

July 2001

Prost at e, 

Lung, 

Colorect al, 

and Ovarian 

(PLCO) Cancer 

Screening 

Trial

NIH GR

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N enrolled N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

18381472 Freedman

2008

Casecohort 

study

10 US 

centers

38 00 N

1,005 

cases and 

1,005 

noncases

2010 66.5 nd 0 ~90% 

Caucasian

~21 Ever sm oker 

~ 37-47%

Hist ory of 

b enign 

b reast 

d isease 16% 

- 31%

HRT use 63% 

– 78%

Nullip arous 

7% t o 11%

Total calcium 

intake 1.1 to 1.7 

g/d

Supplement 

with vitD use 

25% to 60%

*Please copy from above
**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of Dietary 

Assessment? (y/n) If 

Yes, Provide Data

Biomarker 

Assay****

Analytical Validity 

of Biomarker Data 

Reported? (y/n) If 

Yes, Provide Data

Time between 

Biomarker 

Sampling and 

Analysis

Background 

exposure

data

18381472 Freedman

2008

25(OH)D 

and/or 

1,25(OH)2D

RIA Coeff variation 8.2% 

for 25(OH)D

12.8% for 

1,25(OH)2D

~5y FFQ for Ca 

and vit D

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

18381472 Freedman

2008

Primary outcome Breast cancer risk Incident breast cancer classified according to their behavior and histological patterns

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

18381472 Freedman

2008

Used quintiles to assess sensitivity of their findings to different analytical approaches. Data available for incident breast cancer risk after excluding first 2y 

of followup

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

18381472 Freedman

2008

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes, age at first birth, race

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes - BMI

Medical conditions Menopausal status, age at menarche, benign 

fibrocystic disease, family h/o breast cancer

Medication Hormonal replacement

Sunlight exposure and its proxy variables (e.g., physical activity 

level, occupation, sun exposure, location)

Smoking and other life styles variables Yes smoking status, alcohol intake

Other Months of the blood draw, mammography, parity

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean Vit 

D level Followup

No. of 

Cases

(Event)*

No. of 

Noncases

/ Total 

N**

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

18381472 Freedman

2008

Incident 

breast 

cancer

Quintiles 1

<18.3 ng/mL

25(OH)D 12 y 172 2010 Y RR 1.0

0.81

18381472 Freedman

2008

Incident 

breast 

cancer

Quintiles 2

18.3-<23.5 ng/mL

25(OH)D 12 y 188 2010 Y RR 1.02 0.75-

1.41

18381472 Freedman

2008

Incident 

breast 

cancer

Quintiles 3

23.5-<28.3 ng/mL

25(OH)D 12 y 244 2010 Y RR 1.36 0.99-

1.87
18381472 Freedman

2008

Incident 

breast 

cancer

Quintiles 4

28.3-<33.7 ng/mL

25(OH)D 12 y 205 2010 Y RR 1.13 0.82-

1.55

18381472 Freedman

2008

Incident 

breast 

cancer

Quintiles 5

≥33.7 ng/mL

25(OH)D 12 y 196 2010 Y RR 1.04 0.75-

1.45

18381472 Freedman

2008

Incident 

breast 

cancer

Quintiles 1

<28.2 pg/mL

25(OH)2D 12 y 166 2010 Y RR 1.0 1.0

0.14

18381472 Freedman

2008

Incident 

breast 

cancer

Quintiles 2

28.2-<33.5 pg/mL

25(OH)2D 12 y 186 2010 Y RR 1.22 1.22

18381472 Freedman

2008

Incident 

breast 

cancer

Quintiles 3

33.5-<39 pg/mL

25(OH)2D 12 y 206 2010 Y RR 1.28 1.28

18381472 Freedman

2008

Incident 

breast 

cancer

Quintiles 4

39-<46.3 pg/mL

25(OH)2D 12 y 234 2010 Y RR 1.47 1.47

18381472 Freedman

2008

Incident 

breast 

cancer

Quintiles 5

≥46.3 pg/mL

25(OH)2D 12 y 212 2010 Y RR 1.23 1.23

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups
Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

18381472 Freedman

2008

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

na

a) Method 

reported? 

(y/n)

y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

n Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

y

b) Loss to 

follow-up 

<20%? (y/n)

N

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

y

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

n b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A lacks data on exposure and dietary assessment

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort Name

Funding 

Source Extractor

9061275 Gaard 

1996

Cohort 

study

Attended NHSS health screening (n=62998)

Returned dietary assessment questionnaire 

(n=51982)

Answered 20 or more questions and had total 

energy intake of >501.9 kcal/d (n=51152) 

Previous cancer 

(n=617)

1977-1983 NHSS nd TTE

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range Male, % Race / Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

9061275 Gaard 

1996

Cohort 

study

Norway 

(Finnmark [69° 

44’N], Sogn 

og Fjordane

[61° 04'N], 

Oppland [60° 

47'N])

50535 50535 43 

(nd)

20-

53(invited)

49% (male 

and female 

were 

separately 

analyzed)

nd nd nd Male

Total energy: 

2033.7 kcal/d

Ca intake: 907 

mg/d

Total fat: 87.2 

g/d

Female

Total energy: 

1343.5 kcal/d

Ca intake: 637 

mg/d

Total fat: 55.4 

g/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

9061275 Gaard 

1996

Dietary 

calcium 

intake

FFQ The Norwegian 

Food 

Composition 

table (Blaker et 

al. 1991)

Yes “acceptable” 

(reported 

separately in 

Loken et al 1987 in 

Finish)

na na nd 907 mg/d (M); 

637 mg/d (F)

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

9061275 Gaard 1996 Primary (only reported outcome) Colon cancer Norwegian cancer registry (compulsory reporting of cancer cases by histopathology departments)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

9061275 Gaard 1996 Rectal cancer not reported in this article

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

9061275 Gaard 

1996

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Energy

Demographics (e.g., age, gender, race, education)? Yes (age [20-44/45-49/55-], attained age [-

50/51-54/55-]) 

Men and women were 

separately analyzed

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (BMI, height)

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes (smoking [current/ex-/never])

Other Nd

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

followup time, 

mo

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

Personyears**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI ** P between 

groups***

P for 

trend****

Men

9061275 Gaard 

1996

Colon 

cancer

(total Ca 

[mg])

Q1

134.4

-758 22 73785 adjusted RR (OR?) 1.00 Ref Nd

0.15
Q2

134.4

759-

912

24 72101

adjusted

RR (OR?) 1.02 0.57-

1.83

Nd

Q3

134.4

913-

1066

24 71950

adjusted

RR (OR?) 1.04 0.58-

1.86

Nd

Q4

134.4

1067- 13 70992

adjusted

RR (OR?) 0.57 0.29-

1.13

nd

Women 134.4

9061275 Gaard 

1996

Colon 

cancer 

(total Ca 

[mg])

Q1

134.4

-527 15 71563 adjusted RR (OR?) 1.00 Ref Nd 0.94

Q2

134.4

528-

628

20 70540 Adjusted RR (OR?) 1.25 0.63-

2.46

Nd

Q3 134.4

629-

743

7 69896 Adjusted RR (OR?) 0.46 0.19-

1.12

Nd

Q4 134.4

744- 18 69926 adjusted RR (OR?) 1.20 0.60-

2.39

nd
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

9061275 Gaard 

1996

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Nd

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

n

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

y b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

n

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Post-hoc analysis of an existing cohort. Some limited reporting. Cases not confirmed by histology; a series 

of potential correlations are reported as outcomes; power calculation not reported; analyses of the whole 

sample is not provided (only per gender); consecutive sampling only for part of the population while random 

sampling for another part; blinding not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

17311057 Gale

2008

Cohort study Caucasian women ≥16 y; singleton pregnancy <17 

wk gestation

1991-92 - non-profit SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17311057 Gale

2008

Cohort 

study

Southampton, 

UK

466 440 26.3 

(est.)

0 Caucasians prepregnancy wt: 59 

Kg (est.)

vit D intake (food & 

supplements): 2.9 

μg in late pregnancy

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

17311057 Gale

2008

25(OH)D 

and/or 

1,25(OH)2D

RIA y; intra and 

interassay CV 

<10%)

5 y not explicitly 

reported

UV-B exposure 

from 2974 

(bottom quartile 

of 25 (OH)D) to 

32017 (top 

quartile of 25 

(OH)D) Wh/m2

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17311057 Gale

2008

primary birth length

birth weight

9 mo length

9 mo weight

atopic eczema at 9 mo modified UK Working Party Diagnostic Criteria, 1994

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year

Comments

17311057 Gale

2008 Data from a longitudinal cohort of UK children whose mothers had taken part in a nutritional survey during pregnancy

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17311057 Gale

2008

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes* age

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions no

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Yes UVB exposure

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed

Baseline Baseline CI 

/ SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level 

Mean 

Ca 

level / 

dose

No. of 

Cases

*

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD **

P between 

groups***

P for 

trend****

17311057 Gale

2008

atopic 

eczema at 

9 mo

Quartile 1:<30 nmol/L 9 440 crude OR 1.0

Quartile 2: 30-50 10 440 1.11 0.43-

2.84

Quartile 3: >50-75 15 440 1.75 0.73-

4.17

Quartile 4: >75 14 440 1.62 0.67-

3.89

Duplicate one row per exposure category or intervention group. 
*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year

Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final Final 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

17311057 Gale

2008

birth 

weight Kg Quartile 1:<30 nmol/L

crude 3.38 0.46 0.247

Quartile 2: 

30-50 3.40 0.56

Quartile 3: 

>50-75 3.49 1.57

Quartile 4: 

>75 3.43 0.51

birth 

length cm

Quartile 

1:<30 nmol/L

crude 50 1.83 0.150

Quartile 2: 

30-50 50 2.29

Quartile 3: 

>50-75 50.5 2.25

Quartile 4: 

>75 50.1 2.09

17311057 Gale 

2008

9 mo

weight Kg Quartile 1:<30 nmol/L

crude 9.10 1.07 0.873

Quartile 2: 

30-50 9.03 1.14

Quartile 3: 

>50-75 9.24 1.34

Quartile 4: 

>75 9.07 1.06

9 mo 

length cm

Quartile 

1:<30 nmol/L

crude 71.2 2.85 0.861

Quartile 2: 

30-50 71.4 2.60

Quartile 3: 

>50-75 71.7 2.89

Quartile 4: 

>75 71.1 2.67

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

17311057 Gale

2008 no adjustment for potential confounders like FH of atopy

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17311057 Gale

2008

a) Eligibility 

criteria 

clear? (y/n)

n

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

n

a) Method 

reported? 

(y/n)

y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)?

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

n

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

n

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

n Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

y

b) Loss to 

follow-up 

<20%? (y/n)

y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

n b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

n

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): no adjustment for potential confounders

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

8850273 Gann 

1996

Casecohort 

study

US male 

physicians

Prior history of MI, stroke, TIA, unstable angina, cancer except for 

nonmelanoma skin cancer, current renal or liver disease, peptic 

ulcer or gout, contraindication to aspirin use, current use of aspirin, 

other platelet-active agents, or vitamin A supplements.

nd Physicians’ 

Health Study 

(PHS)

NIH KP/SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N enrolled*** N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

8850273 Gann 

1996

Casecohort 

study

United 

States 

(multiple 

locations)

22,071 in original 

cohort, 520 cases 

matched 1:2 with 

controls, 646 total 

with adequate 

exposure data

232 cases 

and 414 

controls

62 yrs 40-84 yrs 

at 

baseline

100% Nd Nd Nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

8850273 Gann 

1996

25(OH)D 

and/or 

1,25(OH)2D

RIA for 25-D, 

radioreceptor 

assay using calf 

thymus receptor 

for 1,25-D

Y; CV = 8.1% 

for 25-D, 7.9% 

for 1,25-D

nd 66.4% collected 

in fall

nd

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 
****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

8850273 Gann 1996 Nd Prostate cancer Medical records and pathology reports

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

8850273 Gann 

1996

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes Age (match)

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Season of blood collection (for 25-D)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes Smoking (match)

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI P between 

groups***

P for 

trend****

8850273 Gann 

1996

Total 

prostate 

cancer

Quartile 1: 25-D 

6.3-21.3 ng/mL

Nd nd Nd Nd adjusted OR 1.00 nd Nd

0.82

Quartile 2: 25-D 

21.4-28.4

Nd Nd Nd Nd 1.10 Nd Nd

Quartile 3: 25-D 

28.5-37.4

Nd Nd Nd Nd 1.16 Nd Nd

Quartile 4: 25-D 

37.5-77.8

nd Nd Nd Nd 0.92 0.56-

1.50

nd
Total 

prostate 

cancer

Quartile 1: 1,25-D 

13.8-28.5 pg/mL

Nd nd Nd Nd adjusted OR 1.00 nd Nd

0.50

Quartile 2: 1,25-D 

28.6-33.8

Nd Nd Nd Nd 1.13 Nd Nd

Quartile 3: 1,25-D 

33.9-40.1

Nd Nd Nd Nd 0.85 Nd Nd

Quartile 4: 1,25-D 

40.2-129.1

nd Nd Nd Nd 0.88 0.53-

1.45

nd

Note: ORs are controlled for age and smoking by matching, 25-D is additionally adjusted for season of blood collection 

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Median 

25(OH)D 

Level

Vit D 

level 

CI / SE 

/ SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

8850273 Gann 

1996 Cases: nd crude 232 29.3 0.80

Control: 414 28.5

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
8850273 Gann 

1996

Total prostate 

cancer

Models adjusting for BMI, exercise, smoking, and alcohol produced nearly identical results, although they were not specifically listed.

Prostate cancer by 

age

Quartiles of 25-D and 1,25-D did not list ranges, CI for comparison of Quartile 4 to quartile one was given and was not significant for 

either ages >61 yrs or ≤61 yrs.

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI P between 

groups***

P for 

trend****

8850273 Gann 

1996

Total 

prostate 

cancer; 

age 61 y

Quartile 1: 25-D 

6.3-21.3 ng/mL

Nd nd Nd Nd adjusted OR 1.00 nd Nd

nd

Quartile 2: 25-D 

21.4-28.4

Nd Nd Nd Nd 1.19 Nd Nd

Quartile 3: 25-D 

28.5-37.4

Nd Nd Nd Nd 1.75 Nd Nd

Quartile 4: 25-D 

37.5-77.8

nd Nd Nd Nd 1.48 0.73-

2.98

nd

Total 

prostate 

cancer; 

age >61 y

Quartile 1: 25-D 

6.3-21.3 ng/mL

Nd nd Nd Nd adjusted OR 1.00 nd Nd

nd

Quartile 2: 25-D 

21.4-28.4

Nd Nd Nd Nd 1.00 Nd Nd

Quartile 3: 25-D 

28.5-37.4

Nd Nd Nd Nd 0.82 Nd Nd

Quartile 4: 25-D 

37.5-77.8

nd Nd Nd Nd 0.76 0.39-

1.47

nd

Total 

prostate 

cancer; 

age 61 y

Quartile 1: 1,25-D 

13.8-28.5 pg/mL

Nd nd Nd Nd adjusted OR 1.00 nd nd

nd

Quartile 2: 1,25-D 

28.6-33.8

Nd Nd Nd Nd 1.61 nd nd
Quartile 3: 1,25

-D 

33.9-40.1

Nd Nd Nd Nd 1.10 nd nd

Quartile 4: 1,25-D 

40.2-129.1

nd Nd Nd Nd 0.93 0.44-

1.95

nd

Total 

prostate 

cancer; 

age >61 y

Quartile 1: 1,25-D 

13.8-28.5 pg/mL

Nd nd Nd Nd adjusted OR 1.00 nd Nd nd

Quartile 2: 1,25-D 

28.6-33.8

Nd Nd Nd Nd 0.81 Nd Nd

Quartile 3: 1,25-D 

33.9-40.1

Nd Nd Nd Nd 0.65 Nd Nd

Quartile 4: 1,25-D 

40.2-129.1

nd Nd Nd Nd 0.82 0.39-

1.47

nd
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

8850273 Gann 

1996

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

y

a) Method 

reported? 

(y/n)

na a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

na

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

y

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

na Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

n

b) Loss to 

follow-up 

<20%? (y/n)

NA

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

n

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

na b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

n

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Less than half of physicians who were cases provided samples adequate for analysis. Results were not 

provided for fully adjusted model.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

2857364 Garland 

1985

Cohort 

study

Randomly selected from the 

population of men aged 40-55 

years who had been employed 

for at least 2 years at the 

Western Electric Company’s

Hawthorne Works in 

Chicago 

Age at first examination less than 40 y, vital status 

unknown at the twentieth anniversary, malignancy 

diagnosed before second examination, death before 

second examination, termination of employment with 

the company or transfer to another plant, withdrawal 

from the study, lack of information from the second 

examination with respect to diet or cigarette smoking 

1957-1958 Western 

Electric 

Health 

Study

American 

heart 

association

JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

2857364 Garland 

1985

Cohort 

study

Chicago, 

US

41° N

2107 1954 48.7 

(4.4)

100 65% Americans 

of Germen, 

Polish, or 

Bohemian 

ancestry, most of 

others from the 

British Isles

BMI 25.5 nd Nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

2857364 Garland 

1985

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd nd

2857364 Garland 

1985

Dietary 

calcium 

intake

28-day diet 

histories

Food 

composition 

table (Ref 2)

nd nd nd nd mg/1000kcal

Cancer: 316.7 

No cancer: 

326.7

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

2857364 Garland 1985 nd Colorectal cancer Medical and hospital records

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

2857364 Garland 

1985

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes (Dietary intake)

Demographics (e.g., age, gender, race, education)? Yes* - age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* - BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes (Cigarette consumption, ethanol 

consumption)

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI

Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

2857364 Garland 

1985

Colorectal 

cancer 

Ca (mg/1000kcal) –

quartile 1

102-

241

19 488 Adjusted for 

age

HR nd nd nd

Ca (mg/1000kcal) -

quartile 2

242-

306

12 489

HR

nd nd

Ca (mg/1000kcal) - 307-

12 489

HR

nd nd
quartile e 3 383

Ca (mg/1000kcal) -

quartile 4

384-

906

6 458

HR

nd nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or Ca 

balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 19 yr 49 289.9 

/1000kcal

nd ≤ 0.05

Control: 19 yr 1905 nd nd

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
2857364 Garland 

1985

Results on the model with multiple factor adjustment are not shown; it is reported that these results were similar to the models (univariate and age adjustred) 

shown in the article

Based on coefficient and SE, HR (95% CI) can be calculated: 1 (1-0.99) both for univariate and for age adjusted models (for calcium); however, p-values given 

are one-tailed, which may no longer be statistically significant if converted to two-tailed p-values (same applies for one way analysis)

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

2857364 Garland 

1985

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

n

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

N

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

N

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Y

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

N

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Validity of 28-day dietary histories was not examined; exposure assessor blinding not reported; power 

calculation not reported; use of one-tailed test for significance in Cox regression and in one way analysis 

(exact p-value not given); results poorly reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

2572900 Garland

1989

Casecohort 

study

Community volunteer cohort 

participants

Cases: colon caner cases (ICD-8 

153.0-153.8) diagnosed between 

1/1/75 & 12/31/83 

Controls: 1:2 matching controls (by 

race, sex, age, month of blood draw, 

census registry status) 

Cases:

Non-white cases

Previous cancer 

(excl. non-melanoma 

skin cancer)

1974 (SepNov)nd NCI, The Dairy Bureau of 

Canada, National Heart 

Lung and Blood Institute 

JHL/TTE

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

2572900 Garland

1989

Casecohort 

study

Washington 

county, 

Maryland (38° 

42')

Original 

Cohort 

(n=25620)

Cases 

(N=34)

Controls 

(N=67)

101 62.8 

(no 

SD)

nd 49.5% White: 

100%

nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of 

Dietary 

Assessment? (y/n) 

If Yes, Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure 

data

2572900 Garland

1989

25(OH)D HPLC and 

UV 

absorbance 

detection

Inter-assay 

coefficient of 

variation (CV) 

=7.6%

At least ~9 

y 

(assuming 

last dx) 

max ~15 y

Aug-Nov nd

2572900 Garland

1989

Dietary 

calcium 

intake

nd nd nd nd nd nd
* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

2572900 Garland

1989

nd Colon 

cancer 

ICD-8 153.0-153.8 (probably registry data, unclear about confirmation by medical records/pathological reports 

or by other means)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

2572900 Garland

1989

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Matching factors: race, sex, age, 

month blood was taken
Demographics (e.g., age, gender, race, education)? Yes

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

Month blood was taken

Smoking and other life styles variables No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P between 

groups***

P for 

trend 

2572900 Garland

1989

Colon 

cancer

25(OH)D – quintile 1 4-19 9 8 Adjusted 

(matching)

OR 1.0 (ref)
25(OH)D – quintile 2 20-26 7 13 0.48 Nd

25(OH)D – quintile 3 27-32 5 18 0.25 Nd ≤0.05 (vs. 

Q1)

25(OH)D – quintile 4 33-41 4 17 0.21 Nd ≤0.05 (vs. 

Q1)

25(OH)D – quintile 5 42-91 9 11 0.73 Nd

Garland

1989

Colon 

cancer

25(OH)D – group 1 0-29 42** *** Adjusted 

(matching)

OR 1.0 (ref)

25(OH)D – group 2 ≥ 30 57***** 0.5 Nd 0.13

Garland

1989

Colon 

cancer

25(OH)D – group 1 0-19 17***** Adjusted 

(matching)

OR 1.0 (ref)

25(OH)D – group 2 ≥20 82***** 0.3 Nd 0.05 (1-

sided)

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 

** ***Total N 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / SE 

/ SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

2572900 Garland

1989 Cases: 

11 mo to ~9 y

Adjusted 

(matching)

34 30.5 

ng/ml

Nd P=0.05

Control: 67 33.3 

ng/ml

Nd
Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

2572900 Garland

1989

a) Eligibility 

criteria 

clear? (y/n)

N

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

ND

a) Method 

reported? 

(y/n)

NA a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

N

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

ND

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

NA Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

NA

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Poor reporting, post-hoc analysis of a prospective cohort study, no controlling for family history of colon 

cancer

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

7493659 Ghadirian 

1995

RCT Postmenopausal 

nuns

≥50 y

Acute illness, medical treatments that may affect blood 

pressure, lipids and other parameters, memory lapses, 

therapeutic diets, high anxiety

≤1994 none Dairy 

Bureau

EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

7493659 Ghadirian 

1995

RCT Montreal, 

Canada

45.7°

265 158 Maybe 

~80

50-69: 

25%

≥70: 

75%

0% Probably 

almost all 

white

59.7 Kg Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

7493659 Ghadirian 

1995

Dietary 

calcium 

intake

FFQ & 24 hr 

recall

Canadian 

Nutrient File

no NA NA nd 776 mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

7493659 Ghadirian 

1995

Dairy diet Regular food Achieved 1242 mg/d

(30 g dairy protein)

4 wk 3 meals

Dairy free diet Achieved 377 mg/day

Co-intervention(s) *:

Compliance/Adherence: Non-compliant and those who provided incomplete data were excluded.

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

7493659 Ghadirian 1995 2° Weight Kg

2° SBP/DBP

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

7493659 Ghadirian 

1995

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? No

Anthropometrics (e.g., BMI, body weight, % body fat)? No (NA for weight analysis)

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

SD*

Final Final 

SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

7493659 Ghadirian 

1995

Weight Kg Dairy diet 1 81 59.84 11.33 59.94 11.37 +0.5 NS 

(implied)

Dairy free diet 77 59.65 15.34 59.25 14.80

SBP mm 

Hg

Dairy diet 1 81 140.34 20.55 137.65 22.14 -5.44 NS 

(implied)

Dairy free diet 77 131.71 23.91 134.46 21.31

DBP mm 

Hg

Dairy diet 1 81 81.17 9.87 73.39 10.67 -2.19 NS 

(implied)

Dairy free diet 77 79.09 9.89 73.50 10.42

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

7493659 Ghadirian 

1995 RCT nd nd NA No No No No No No C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Poorly reported, poorly analyzed. Very high dropout rate.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

16492906 

and 

17450530

Giovannucci 

2006 and 

Giovannucci 

2007***

Cohort 

study

Male health 

professionals

-Cancer (except nonmelanoma 

skin cancer)

-men who did not adequately 

complete SFFQ

1986 - 2002 Health Professionals 

Follow-up Study

NCI, NIH, 

NHLBI

 KP/SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT 

***note: data in this document is derived from Giovannucci 2006. Giovannucci 2007 contained no extra information, but slightly different numbers because of different included 

confounders. 

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

16492906 Giovannucci 

2006

Cohort 

study

United 

States

(various)

51,529 in 

original 

cohort

47,750 nd 40-75 yrs 

at 

baseline

100% >91% 

Caucasian

nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of 

Dietary 

Assessment? (y/n) 

If Yes, Provide Data

Biomarker 

Assay****

Analytical

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

16492906 Giovannucci 

2006

25(OH)D 

and/or 

1,25(OH)2D

25(OH)D 

and 

1,25(OH)D 

by RIA

Intrapair CV 

ranged from 

5%-7%

nd All samples 

drawn in 1993 

to 1994

NA

Dietary 

calcium 

intake

 SFFQ USDA

Yes: used a sample 

of 127 cohort 

members from 

Boston area. Total 

energy-adjusted Ca 

was 815 280 mg/d 

based on diet 

records and 839 346 

mg/d based on 

SFFQ. Their 

correlation was 0.61

 None

NA NA Nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

16492906 Giovannucci 2006 nd Prostate cancer Cases derived from self report, pathology reports, hospital records. T1a cancers excluded.
Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

16492906 Giovannucci 

2006

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Total calories, red meat, fish, α-linolenic acid, 

zinc supplements, tomato sauce

Demographics (e.g., age, gender, race, education)? Yes Age, race

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI at age 21, height

Medical conditions Family history of prostate cancer, history of 

diabetes

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation 

of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes Cigarette pack years, vigorous 

physical activity level

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

16492906 Giovannucci 

2006

Total 

prostate 

cancer

Total calcium 

<500 mg/d

nd nd 183 Nd adjusted RR 0.98 0.84-1.15

0.10

Total calcium = 

500-749 mg/d

nd nd 1072 Nd 1 Reference

Total calcium = 

750-999 mg/d

nd nd 1099 Nd 1.07 0.98-1.16

Total calcium = 

1,000-1,499 mg/d

nd nd 898 Nd 1.03 0.94-1.14
Total calcium = 

1,500-1,999 mg/d

nd nd 207 Nd 1.06 0.91-1.23

Total calcium = 

≥2,000 mg/d

nd nd 85 nd 1.28 1.02-1.60

Fatal 

prostate 

cancer

Total calcium 

<500 mg/d

nd nd 21 Nd adjusted RR 1.05 0.65-1.69

0.01

Total calcium = 

500-749 mg/d

nd nd 94 Nd 1 Reference

Total calcium = 

750-999 mg/d

nd nd 81 Nd 0.95 0.70-1.28

Total calcium = 

1,000-1,499 mg/d

nd nd 76 Nd 1.04 0.77-1.42

Total calcium = 

1,500-1,999 mg/d

nd nd 26 Nd 1.56 1.00-2.43

Total calcium = 

≥2,000 mg/d

nd nd 14 Nd 2.02 1.14-3.58

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 
Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

16492906 Giovannucci 

2006

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

y

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

NA

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported?

(y/n)

Y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

NA

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

n

c) Do the 

authors specify 

a primary 

outcome? (y/n)

n

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): A

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding 

Source Extractor

18541825 Giovannucci

2008

Case-cohort 

study

US male health care 

professionals

Provided blood 

sample

Age 40-75 in 1986

History of CVD pre-1994.

Participant reported MI not 

confirmed by medical 

records.

Non-CVD death

Blood sample drawn 

1/1993-12/1995

CVD assessed 

through 1/31/2004

Health Professionals 

Follow-up Study (HPFS)

Gov’t (NIH) EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled

N

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

18541825 Giovannucci

2008

Casecohort 

study

US-wide

(~25-45)

18225 1354:

454 

cases

900 

controls

63.8 (8.6)

(implied 

at time of 

blood 

draw)

40-75 100% White 

94%

AA 0%

Asian 

0.7%

Other 5%

BMI

Cases: 26.1 (3.3)

Controls 25.6 (3.4)

P=.01 difference

No CVD 

(baseline)

Current 

smoker 

9.3%

FHx 

MI<60 

16%

DM 9.3%

HTN 37%

Total fat intake 

31% of Kcal

Saturated fat 10%

Marine O3 0.12%

Multivitamin use 

47% (of cases)

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of Dietary 

Assessment? (y/n) If 

Yes, Provide Data

Biomarker 

Assay****

Analytical Validity 

of Biomarker Data 

Reported? (y/n) If 

Yes, Provide Data

Time between 

Biomarker 

Sampling and 

Analysis

Background 

exposure data

18541825 Giovannucci

2008

25(OH)D RIA (Hollis 

1993)

Yes

CV=11.5%

Unclear (but 

frozen)

Mean (SD)

Cases 23.0 

(7.6)

Controls 24.5 

(8.3)

% in 4 

categories, 

controls only:

≤15 ng/mL 

9.7%

15.1-22.5 34%

22.6-29.9 33%

≥30 23%

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome**

Outcome Definition

18541825 Giovannucci

2008

Primary (for post hoc 

analysis)

Nonfatal MI or fatal 

CHD

By questionnaire: “professionally diagnosed”

Medical record review (confirmed) by study MDs: MI – WHO criteria

Deaths identified from state and national records, next of kin, or postal system.

Fatal CHD: confirmed by hospital records, autopsy, or cause of death on death certificate if 

evidence of previous CHD was available.

Nonfatal MI 352 participants; Fatal CHD 102 participants.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

18541825 Giovannucci

2008

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes Marine O3 intake (adjusted)

Demographics (e.g., age, gender, race, education)? Yes Age (matched)

Gender (all male)

Ethnicity, white vs other (adjusted)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI (adjusted)

Medical conditions Yes DM (adjusted)

HTN (adjusted)

Medication

Sunlight exposure and its proxy variables (e.g., physical activity 

level, occupation, sun exposure, location)

Yes Physical activity (adjusted)

US region (northeast, mid-Atlantic, 

Midwest, south) (adjusted)

Month and year of blood draw 

(matched)

Smoking and other life styles variables Yes Smoking status (matched)

Alcohol intake (adjusted)

Other Yes Family history of MI<60 y (adjusted)

Baseline LDL-c (adjusted)

Baseline HDL-c (adjusted)

Triglycerides (adjusted)

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

F/up N 

Event

N 

Total

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome

effect 

size

CI P between 

groups***

P for 

trend****

18541825 Giovannucci

2008

Nonfatal 

MI or fatal 

CHD

25(OH)D

Level 1

≤15.0 

ng/mL

10 y 63 150 Adjusted RR 2.09 1.24, 3.54 <.05

Level 2 15.1-

22.5

156 463 1.43 0.96, 2.13 NS

Level 3 22.6-

29.9

165 464 1.60 1.10, 2.32 <.05

Level 4 ≥30.0 70 277 1.00 -- -- .02

18541825 Giovannucci

2008

Nonfatal 

MI or fatal 

CHD

All All 10 y 454 1354 Adjusted OR (per 1 

ng/mL)

0.98 0.96, 

0.998

.05

18541825 Giovannucci

2008

Nonfatal 

MI or fatal 

CHD

All All 10 y 454 1354 Adjusted Risk 

reduction 

per 1 ng/mL

-2.1% -0.2%, -4.0% <.05

18541825 Giovannucci

2008 Nonfatal 

MI or fatal 

CHD

25(OH)D

Level 1

≤15.0 

ng/mL

10 y nd nd Adjusted RR

No 

cholesterol 

lowering 

drugs at 

baseline

2.30 1.33, 3.97 <.05

Level 4 ≥30.0 

ng/mL

1.0 -- --

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final 

or 

Delta 

CI / SE 

/ SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 
**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between Baseline 

Exposure and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

SD

P between 

groups

18541825 Giovannucci

2008 Cases: 10 y Crude 454 23.0 7.6 .002

Control: 900 24.5 8.3

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

18541825 Giovannucci

2008

The most adjusted model was chosen. Similar results (somewhat “stronger”) if only accounted for matching variables. Very similar results if omitted lipidadjustment.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

No statistical evidence of interaction by age (range approximately 48-83). 

Interaction data also reported for HTN, BMI, aspirin use, physical activity, alcohol use, LDL-c, Tg, HDL-c.
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

18541825 Giovannucci

2008

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

NA a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y a) Level of 

the 

exposure in

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Y

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

NA Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

Y

b) Loss to 

follow-up 

<20%? (y/n)

NA

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

+/-

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): A

Explanation for Overall Quality Grade (if not Grade A): Appropriate matching, adjustment, and statistical analysis. No clear flaws.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

14652238 Grau 

2003

Post hoc 

analysis of an 

existing RCT

Subjects had at least one histologically confirmed large-bowel 

adenoma removed within 3 months before recruitment, with the 

entire large-bowel mucosa visualized endoscopically and judged 

to be free of remaining polyps. 

nd 1988 Calcium Polyp 

Prevention 

Study

nd JHL/TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., City and 

Country, latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat ...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

14652238 Grau 

2003

Post hoc 

analysis 

of an 

existing 

RCT

Six clinical centers: the 

Cleveland Clinic 

Foundation, DartmouthHitchcock Medical 

Center, the University of 

Southern California—

Southern California 

Permanente Medical 

group, the University of 

Iowa, the University of 

Minnesota, and the 

University of North 

Carolina 

930 803 60.9 

(nd)

nd 72.5% White -

84.4%

Black -

8.3% 

Hispanic 

- 7.2% 

nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical Validity 

of Biomarker Data 

Reported? (y/n) If 

Yes, Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date

when the 

biomarker 

samples 

were drawn

Background 

exposure 

data

14652238 Grau 

2003

25(OH)D 

and/or 

1,25(OH)2D

Radioimmunoassay 

kit from Nicholas 

Institute Diagnostics 

(Capistrano, CA)

Y, inter-batch 

Pearson correlation 

coefficient 

25(OH)VitD=.95

1,25(OH)2VitD=.58

11-15y 

(1988-

1992 to 

~2003)

nd nd

14652238 Grau 

2003

Dietary 

calcium 

intake

SFFQ nd nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) Vit D and/or Ca Dose Intervention Duration

Intervention Frequency (e.g. 

capsules were taken 2 times a day)

14652238 Grau 

2003

Ca Ca supplementation (no brand 

name)

3g of calcium carbonate or 

1200mg of elemental calcium

4 y nd

placebo nd N/A 4 y nd

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

14652238 Grau 

2003

1° Recurrence of colorectal 

adenomas nd

14652238 Grau 

2003

2° Occurrence of “advanced” 

colorectal adenomas (i.e., 

advanced lesions only)

Defined by the study pathologists as advanced lesions: tubulovillous adenomas (25-74% villous 

component), villous adenomas (75% or more villous), this containing advanced dysplasia or invasive 

cancer, or those larger than 1cm in diameter (as assessed by the endoscopist)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

14652238 Grau 

2003

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes - age, gender

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

Yes - month of blood draw

Smoking and other life styles variables Yes - alcohol intake, smoking status

Other Center, VDR genotypes

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Followup, mo

N 

Event

N 

Total

Outcome Metric (e.g. 

OR, RR, HR, %) and 

direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI P btw

14652238 Grau 

2003

Recurrent adenoma

[25(OH)D≤29.1ng/mL]

Placebo 4 y 95 203 RR 1.05 0.85-

1.29

Interaction 

Calcium 99 200 P=0.012

14652238 Grau 

2003

Recurrent adenoma

[25(OH)D>29.1ng/mL]

Placebo 4 y 107 200 RR 0.71 0.57-

Calcium 75 195 0.89

14652238 Grau 

2003

Recurrent “advanced” 

adenoma

[25(OH)D≤29.1ng/mL]

Placebo 4 y 30 203 RR 1.02 0.63-

1.64

Interaction 

Calcium 28 200 P=0.106

14652238 Grau 

2003

Recurrent “advanced” 

adenoma

[25(OH)D>29.1ng/mL]

Placebo 4 y 39 200 RR 0.58 0.36-

0.93 Calcium 23 195

*Example: OR Ca/placebo 

Similar findings were observed when V-D levels were considered in tertiles or quartiles. 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD **

P between 

groups***

P for 

trend****

14652238 Grau 

2003

Recurrent 

adenoma vs. a 

unit (12 ng/mL) 

change in 

25(OH)D

Overall adj RR 0.99 0.91-

1.07

Interaction 

(calcium vs. 

placebo) 

P=0.006

Calcium adj RR 0.88 0.77-

0.99

placebo adj RR 1.09 0.97-

1.22

14652238 Grau 

2003

Recurrent 

“advanced” 

adenoma vs. a 

unit (12 ng/mL) 

change in 

25(OH)D

Overall adj RR 0.95 0.79-

1.15

Interaction 

(calcium vs. 

placebo) 

P=0.48

Calcium adj RR 0.78 0.58-

1.05

placebo adj RR 1.10 0.86-

1.40

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 
UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

14652238 Grau 

2003

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

NA a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Y

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

NA Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Post-hoc “subgroup” analyses of a RCT. Consecutiveness not fully preserved. No controlling for family 

history of colorectal cancer

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort Name

Funding 

Source Extractor

17227996 Grau 

2007

RCT Subjects had at least one histologically 

confirmed adenoma within 3 months before 

enrollment, with the large bowel mucosa 

entirely examined and judged free of 

remaining polyps. 

Subjects diet during Calcium trial, 

died after Calcium Trial and before 

Calcium follow-up, refused to 

participate, or unable to be 

contacted 

1988-1992 Calcium Polyp 

Prevention 

Study 

National 

Institute of 

Health

JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., City and 

Country, latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat ...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

17227996 Grau 

2007

RCT US

The Cleveland Clinic 

Foundation (41.51° N), 

Dartmouth Hitchcock 

Medical Center (43.71° 

N), The University of 

South CaliforniaSouthern California 

Kaiser Permanente 

Medical Group (34.02° 

N), the University of Iowa

(41.39° N), the University 

of Minnesota (44.98° N), 

and the University of 

North Carolina (35.94° N)

930 822 60.6 

(no 

sd)

nd Male 

71.7%

Female 

28.3%

nd nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc. 
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17227996 Grau 

2007

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd nd

17227996 Grau 

2007

Dietary 

calcium 

intake

Semiquantitative 

food frequency 

questionnaire 

nd nd nd nd nd 876mg

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca Total Daily 

Dose

Intervention 

Duration

Intervention Frequency (e.g. 

capsules were taken 2 times a day)

17227996 Grau 

2007

Ca Ca supplementation 1200mg of elemental calcium 

(3g of calcium carbonate)

4y 1 time/day

17227996 Grau 

2007

placebo nd

Co-intervention(s) *: None

Compliance/Adherence: 50% (no information on measurement)

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

17227996 Grau 

2007

Primary

All 

adenomas

For each colonoscopy a participant reported, copies of the endoscopy report and relevant pathology reports were 

obtained. Slides of each lesion removed from the bowel were sent to a study pathologist for uniform review regarding 

diagnosis and, for neo-plastic lesions, the degree of dysplasia. If the local and study pathologists disagreed, we accepted 

the study pathologist’s diagnosis. 

17227996 Grau 

2007

nd Advance 

adenomas

Advanced lesions were defined as adenomas with at least 25% villous component, those containing advanced dysplasia 

or invasive cancer, or those with an estimated diameter of at least 1 cm (as assessed by the endoscopist)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors) Specific comments for confounders

17227996 Grau 

2007

Other nutrients or dietary factors 

(e.g., certain food consumption), 

including supplement use and 

total energy intake

For analysis of subjects who did not take calcium supplements 

before the first colonoscopy in the follow-up period, RR were 

adjusted fir age, sex, center, follow-up time and number of 

colonoscopies from the end of the active trial up to the last 

Demographics (e.g., age, gender, colonoscopy in the follow-up period under consideration. 

race, education)?

Yes* - Age, gender

Anthropometrics (e.g., BMI, body 

weight, % body fat)?

no*

Medical conditions

Medication

Sunlight exposure and its proxy 

variables (e.g., seasonal variation 

of 25(OH)D, UV exposure, 

location)

Smoking and other life styles 

variables (e.g., physical activity, 

occupation, alcohol consumption)

no*

Other Center, follow-up time, number of colonoscopies from 

the end of the active trial up to the last colonoscopy in 

the follow-up period under consideration, and calcium 

supplement use before the first colonoscopy in the 

follow-up period under consideration. 

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

17227996 Grau 

2007

All 

adenomas

Calcium group 5 years 51 162 RR 0.63 0.46-

0.87

nd

Placebo group 5 years 80 185

17227996 Grau 

2007

All 

adenomas

Calcium group 5-10 years 82 208 RR 1.09 0.85-

1.39

nd

Placebo group 5-10 years 82 216

17227996 Grau 

2007

Advanced

adenomas

Calcium group 5 years 21 162 RR 0.85 0.43-

1.69

nd

Placebo group 5 years 23 185

17227996 Grau 

2007

Advanced

adenomas

Calcium group 5-10 years 26 208 RR 1.10 0.65-

1.88

nd

Placebo group 5-10 years 26 216

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

Subjects who did not take calcium supplements before the first colonoscopy in the follow-up period 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

17227996 Grau 

2007

All 

adenomas

Calcium group 5 years 28 102 RR 0.59 0.40-

0.90

nd

Placebo group 5 years 48 114

17227996 Grau 

2007

All 

adenomas

Calcium group 5-10 years 53 121 RR 1.05 0.77-

1.43

nd

Placebo group 5-10 years 50 123

17227996 Grau 

2007

Advanced

Adenomas

Calcium group 5 years 10 102 RR 0.62 0.29-

1.33

nd

Placebo group 5 years 14 114

17227996 Grau 

2007

Advanced

Adenomas

Calcium group 5-10 years 18 121 RR 1.18 0.57-

2.43

nd

Placebo group 5-10 years 15 123

*Example: OR Ca/placebo 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17227996 Grau

2007

RCTParallel nd nd NA n y y y y y B

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

Only 597 subjects in the Calcium Follow-up Study (74%) underwent at least one colonoscopy, no uniform 

interval between the end of the active trial and the first post-treatment colonoscopy. No details about the 

frequency of use and dose of elemental calcium in the supplements taken during the observational postintervention phase

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

10511329 Harris

1999

RCT men 20-35 y 

or 60-75 y

travel to southern areas in last month; vit D supplement in last 6 mo; 

outdoor occupation; calcium >600 mg/d; calcium supplement in last 6 

mo; meds that affect vit D metabolism; >3 alcohol drinks/d; kidney stone 

last 5 y; liver, kidney, gastrointestinal diseases

nd - USDA SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

10511329 Harris

1999

RCT Boston, MA 20 18 Young: 

26

Old:

69

nd 100 nd BMI

Young: 26.6

Old: 31

nd vit D intake

Young: 51 IU/d

Old: 90 IU/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? (y/n) 

If Yes, Provide 

Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

10511329 Harris

1999

25(OH)D HPLC inter- and 

intraassay CV: 

10%, 8% 

(external 

validity)

3 wks February vit D intake

Young: 51 

IU/d

Old: 90 IU/d

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

10511329 Harris

1999

vit D2 Drisdol (Sanofi Winthrop, NY) 1800 IU/d 3 wk qAM

placebo

Co-intervention(s) *:

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

10511329 Harris

1999

secondary 25(OH)D total sum of D2 and D3

primary 25(OH)D2

primary 25(OH)D3

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

10511329 Harris

1999

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes* age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Yes blood drawn in February in 

Boston

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes/no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model) 

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Delta** Delta 

SD*

Net 

difference

Net 

difference 

CI / SE / SD*

P 

between

10511329 Harris

1999

change in 

25(OH)D2 in 

young

nmol/L vit D2 

supplment

3 wk 6 0 0 37 9.4 nd

placebo 3 7.5 13 -7.5 13

change in 

25(OH)D2 in 

old

nmol/L vit D2 

supplment

3 wk 5 0 0 19.5 12.8 nd

placebo 4 5.0 10.0 0.0 0.0

change in 

25(OH)D3 in 

young

nmol/L vit D2 

supplment

3 wk 6 32.4 10.7 -6.7 6.8 nd

placebo 3 34.9 0.0 -1.7 6.3

change in 

25(OH)D3 in 

old

nmol/L vit D2 

supplment

3 wk 5 39.9 9.3 -12.0 5.7 nd

placebo 4 34.9 6.1 -3.7 6.3

change in 

total 

25(OH)D in 

young

nmol/L vit D2 

supplment

3 wk 6 32.4 10.7 30.4 9.5 nd

placebo 3 42.4 13 -9.2 15

change in 

total 

25(OH)D in 

old

nmol/L vit D2 

supplment

3 wk 5 39.9 9.3 7.5 13 nd

placebo 4 39.9 6.1 -3.7 6.3

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)
UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

10511329 Harris

1999 ANOVA of the 3-wk change in 25(OH)D2 showed a significant interaction between age and supplementation group (P=0.02) 
UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

10511329 Harris

1999 RCT nd nd NA

y n n n y y C

Adverse Event(s): ** None

Explanation for Overall Quality Grade (if not Grade A): small sample size; compliance not reported; did not report all relevant statistical analyses

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

15671222 Hartman 

2005

Cohort study

Participants 

are included in 

an RCT

Subjects ≥ 35 yr with 1 or 

more histologically 

confirmed colorectal 

adenomas identified by 

complete colonoscopy 

Subjects must not have had resected 

adenomatous polyps previously, nor could have 

been diagnosed with cololectal cancer, 

inflammatory bowel disease, or polyposis 

syndrome, ≤ 150% of their recommended weight 

and could not be currently using lipid-lowering 

medications. 

1991-1994 The Polyp 

Prevention 

Trial 

nd JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

15671222 Hartman 

2005

Cohort study

Participants 

are included 

in an RCT

US 38° N,

8 clinical 

centers

2079 1905 61.1(9.9) nd 64 Caucasian 

90%

nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

15671222 Hartman 

2005

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd VitD

4.4±2.4 μg/d

15671222 Hartman 

2005

Dietary 

calcium 

intake

FFQ USDA Y (4 day food 

records from a 

subset)

nd nd nd 981± 435

mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 
***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

15671222 Hartman 

2005

nd Recurrent 

adenomas Ascertained by complete colonoscopy at baseline and after 1 and 4y 

15671222 Hartman 

2005

nd Advanced 

adenomas

Subjects had maximal diameter ≥ 1 cm or had at least 25% villous elements or displayed evidence 

of high-grade dysplasia. 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

15671222 Hartman 

2005

This original study (The Polyp Prevention Trial) was a multicenter randomized clinical trial designed to determine the effects of a high-fiber, high-fruit and 

vegetable, low fat diet on the recurrent of adenomatous polyps in the large bowel. For this study, the association of calcium with risk of colorectal adenomas 

was examined. 

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

15671222 Hartman 

2005

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Energy intake 

Demographics (e.g., age, gender, race, education)? Yes/no* - age, gender

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes/no*

Medical conditions

Medication Use of nonsteroidal anti-inflammatory drugs

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes/no*

Other Intervention assignment, gender*intervention 

group 

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

15671222 Hartman 

2005

Recurrent 

adenomas Ca quintile 1 < 666 mg/d

156 nd Adjusted OR 1.0 0.20

Ca quintile 2 666-

814

163 nd Adjusted OR 1.12 0.83-

1.51

Ca quintile 3 815-

969 

154 nd Adjusted OR 1.02 0.76-

1.38

Ca quintile 4 970-

1226 

150 nd Adjusted OR 1.00 0.74-

1.36

Ca quintile 5 >1226 131 nd Adjusted OR 0.86 0.62-
1.18

15671222 Hartman 

2005

Advanced 

adenomas Ca quintile 1 < 666 mg/d

23 nd Adjusted OR 1.0 0.98

Ca quintile 2 666-

814

26 nd Adjusted OR 1.19 0.66-

2.16

Ca quintile 3 815-

969 

22 nd Adjusted OR 1.00 0.54-

1.85

Ca quintile 4 970-

1226 

23 nd Adjusted OR 1.56 0.88-

2.77

Ca quintile 5 >1226 21 nd Adjusted OR 0.93 0.49-

1.79

15671222 Hartman 

2005

Multiple 

recurrent 

adenomas

Ca quintile 1

< 666 

mg/d

58 nd Adjusted OR 1.0

0.36

Ca quintile 2 666-

814

73 nd Adjusted OR 1.33 0.90-

1.96

Ca quintile 3 815-

969 

71 nd Adjusted OR 1.29 0.87-

1.92

Ca quintile 4 970-

1226 

69 nd Adjusted OR 1.30 0.87-

1.93

Ca quintile 5 >1226 47 nd Adjusted OR 0.88 0.56-

1.36

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 
UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

15671222 Hartman 

2005

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

N a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

n

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Power calculation not performed; study not initially designed for assessing the relation between calcium 

intake and adenomas; blinding not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

16286519 HarveyBerino 

2005

RCT Age 18 to 60 years, BMI between 

25 and 34.9, current calcium 

consumption ≤500 mg/d, current 

dairy product consumption < 1 

serving/d, no medical problems that 

would contraindicate calorie 

restriction, non-smokers, 

agreement to follow study diet as 

prescribed

History of major medical or psychiatric 

problems including metabolic disease (i.e. 

hepatic, endocrine, or renal disease), 

diabetes requiring oral agents or insulin, 

lactose intolerance, planned a pregnancy 

within next 12 months, unable to participate 

in exercise program, unwilling to stop taking 

dietary supplements, taking medications that 

would influence metabolism or weight 

change.

Nd Nd National Dairy 

Council, 

Northeast Dairy 

Foods Research 

Center, University 

of Vermont, 

Cabot Cheese

KP

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

16286519 HarveyBerino 

2005

RCT Vermont, 

USA

44°N

54 44 45.2(6.7) 18-60 7% Nd BMI = 30(2.5), 

weight = 81(9), Body 

fat % = 44(4.8)%

Nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment?

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

16286519 HarveyBerino 

2005

25(OH)D 

and/or 

1,25(OH)2D

NA NA NA NA NA

Dietary 

calcium 

intake

7-day food 

record

Other (Food 

Processor, 

version 7.9, 

ESHA, Salem, 

OR)

N NA NA NA NA

* Write “nd” if there was no data reported. Please do not leave blank
**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca 

Total Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

16286519 HarveyBerino 2005Dairy (high Ca) 3-4 dairy servings/d (milk, yogurt, 

cheese)

Goal of 1200 to 1400 

mg/d Ca

12 months Nd

Control (low Ca) One dairy serving/d Goal of 400-500 

mg/d Ca

12 months nd

Co-intervention(s) *: Calorie restriction in both groups with behavioral weight loss program, aiming for 500 kcal/d restriction from baseline levels

Compliance/Adherence: 7 dropped out from not being able to follow menus

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

16286519 Harvey-Berino 2005 Primary Body weight Change in bodyweight in kg

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

16286519 Harvey-Berino 

2005

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? No

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final or 

Delta CI 

/ SE / 

SD*

Net 

difference

Net 

difference 

CI / SE / SD*

P 

between

16286519 HarveyBerino 

2005

Body 

weight

Kg High dairy 12 mo. 23 82.7 SD = 10.0 Delta = 

-10.8

SD = 

5.9

-1.2 Nd 0.56

Low dairy 12 mo. 21 80.9 SD = 8.7 Delta = 

-9.6 

SD = 

6.5

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

16286519 HarveyBerino 

2005

RCTparallel nd Nd

Nd

Y Nd N Y N Y B

Adverse Event(s): ** Nd

Explanation for Overall Quality Grade (if not Grade A): Not much explanation of methodology with respect to randomization, blinding

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

14553957 Hatton 

2003

RCT Completed CPEP trial 

protocol; in Oregon

Delivered an infant without 

serious health problems

Previously nulliparous

Read English

CKD, calciuria, hematuria, 

urolithiasis, frequent Ca supplements 

or antacids

≤1996 Calcium for Prevention of 

Preeclampsia Trial

(CPEP) [Oregon center 

only]

GSK

NIH

EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

14553957 Hatton 

2003

RCT Portland, OR

45.5°

497 62 nd nd 0 nd nd Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

14553957 Hatton 

2003

Dietary 

calcium 

intake

none NA NA none NA nd nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca 

Total Daily Dose Intervention Duration Intervention Frequency (e.g. capsules were taken 2 times a day)

14553957 Hatton 

2003

Ca supplement Ca carbonate 2 g ~20-30 weeks (during 

pregnancy until delivery)

2x500 mg capsules 2x/day with meals

Placebo

Co-intervention(s) *: All received prenatal vitamin (Ca 50 mg, Fe 30 mg, vit D2 400 IU, other vitamins)

Compliance/Adherence: nd (but all had to meet a compliance test prior to randomization)

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

14553957 Hatton 2003 2° BP (post-partum)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

14553957 Hatton 

2003

RCT was conducted during pregnancy. The calcium was discontinued upon delivery. The researchers then contacted women again and measured BP in 

children (primary focus) and mothers.

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

14553957 Hatton 

2003

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? No

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final Final 

SD

Net 

difference

Net difference 

CI / SE / SD*

P 

between

14553957 Hatton 

2003

SBP mm 

Hg

Ca supplement 

(prenatal)

2 y 37 nd nd 101.9 12.9 NS

Placebo 25 nd nd 104.1 9.6

DBP mm 

Hg

Ca supplement 

(prenatal)

2 y 37 nd nd 67.1 7.7 NS

Placebo 25 nd nd 67.8 8.2

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

14553957 Hatton 

2003 RCT nd nd NA No nd No Unclear No No C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Outcome of convenience in post hoc analysis of small subgroup. Incomplete data presented. No adjustment

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI

Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort Name Funding Source Extractor

12499343 Heaney

2003

RCT men in good general health, ≤1 serving milk qD; 

planning winter vacation to areas with significant solar 

radiation

vitamin 

supplement

nd - Health Future 

Foundation

SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

12499343 Heaney

2003

RCT Omaha, NE 

41.2oN

67 67 38.7 

(11.2)

nd 100 nd BMI 26.2 (2.4) good 

general 

health

est. <5 μg/d intake of 

vit D

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

12499343 Heaney

2003

25(OH)D3 Nichols method 

(Nichols 

Institute 

Diagnostics); 

similar to IDS

nd nd October to 

March, 2 

successive 

years

est. <5 μg/d 

intake of vit D

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Vit D Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

12499343 Heaney

2003

zero 

dose

zero dose ~20 wk

1000 IU Douglas Laboratory, Pittsburgh 25 μg (1000 IU) ~20 wk 1 tab

5000 IU Tishcon, NY 125 μg (5000 IU) ~20 wk 1 tab

10000 

IU

Tishcon, NY 250 μg (10,000 IU) ~20 wk 2 tabs

Co-intervention(s) *:

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

12499343 Heaney

2003

primary slope Δ25(OH)D/ Δ vitD dose

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

12499343 Heaney

2003

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes* age, sex

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* body weight, % body fat

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Yes UV exposure, location

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI

Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

12499343 Heaney

2003

Regression on actual dose Δ25(OH)D3 (nmol/L)= -0.038 + 0.700 vitD dose (μg/d)

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

12499343 Heaney

2003 RCT nd nd NA nd nd nd y y n C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): unclear how many subjects in each group; not all relevant data reported

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

9405029 Heikkinen 

1997

RCT 47-56 yo women, Last 

menstrual period within 6.24 

months prior to study

Contraindications 

for HRT

>=1989 Kuopio Osteoporosis Risk 

Factor and Prevention 

Study

Schering, 

Professional 

Organization

KP

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SEM) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

9405029 Heikkinen 

1997

RCT Kuopio 

Province, 

Eastern 

Finland

(63°N)

464 320 52.9(0.29) 47-56 0% Nd 26.4(0.47) Nd Nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

9405029 Heikkinen 

1997

25(OH)D 

and/or 

1,25(OH)2D

NA NA NA NA NA

Dietary 

calcium 

intake

NA NA NA NA NA NA NA

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

9405029 Heikkinen 

1997

Vit D3 plus Ca D-Calsor, Orion Corporation, 

Espoo, Finland

300 IU Vit D3/day, 500 

mg/day calcium lactate

30 mo Nd

Ca D-Calsor, Orion Corporation, 

Espoo, Finland

500 mg/day calcium 

lactate

30 mo nd

Co-intervention(s) *: Hormone replacement therapy (a third group was HRT+ Vit D, and a fourth was HRT alone)

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design.

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

9405029 Heikkinen 1997 secondary Body weight Change in kg over 30 months

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

9405029 Heikkinen 

1997

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? No

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final or 

Delta CI 

/ SE / 

SD*

Net 

difference

Net 

difference 

CI / SE / 

SD*

P 

between

9405029 Heikkinen 

1997

Body 

weight

kg Vit D3 plus Ca 30 83 71.5 SD = 1.24 Final = 

72.8

Final 

SD = 

1.3

0.9 Nd Not 

significant

Ca 30 95 67.6 SD = 1.07 Final = 

69.8

Final 

SD = 

1.26

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 
*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

9405029 Heikkinen 

1997

RCTparallel Yes ND NA No Nd Nd Yes No No C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Baseline weights are not evenly distributed between intervention groups. High dropout rate. Unclear if 3 year or 

30 month data. No discussion of washout, blinding, intention to treat

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

15585800; 

17661558

Hollis 

2004; 

Basile 

2006

RCT Lactating mothers, within 1 month after 

birth, were recruited for inclusion in the 

study if they planned to fully breastfeed 

for the next 3 months

Preexisting type 1 or 2 

diabetes, HTN, parathyroid 

disease, and uncontrolled 

thyroid disease.

nd nd NIH, Medical 

University of 

South Carolina

MC

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

15585800 Hollis 

2006

RCT Nd 64 18 2000 

IU grp: 

29 (6)

4000 

IU grp: 

30.8 

(5.2) 

nd 0 White: 72%; 

African 

American: 

28%

Mothers: nd

Mean birth 

weight=3448 g

Mothers: 

healthy

Infants: 

GA 36-41 

weeks

Nd

17661558 Basile 

2006

RCT nd 64 25 2000 

IU grp: 

30.6 

(4.6)

4000 

IU grp: 

29.6 

(4.9) 

nd 0 White: 64%; 

African 

American: 

36%

Mothers: nd

Mean birth 

weight=3460 g 

(ranged 2315-4165)

Mothers: 

healthy

Infants: 

mean GA 

38 weeks

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

15585800; 

17661558

Hollis 

2004; 

Basile 

2006

25(OH)D HPLC and 

radioimmunoassay

nd nd nd Subjects were 

instructed to 

limit sun 

exposure (for 

mother and 

infant). See 

results for 

baseline 

25(OH)D levels

Dietary 

calcium 

intake

nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. 

capsules were taken 2 times a day)

15585800; 

17661558

Hollis 2004; 

Basile 2006

Group 1: vitamin D2 + 

multivitamin

Nd 1600 IU vitamin D2 + 

400 IU vitamin D3

3 months Nd

15585800; 

17661558

Hollis 2004; 

Basile 2006

Group 2: vitamin D2 + 

multivitamin

nd 3600 IU vitamin D2 + 

400 IU vitamin D3

3 months nd

Co-intervention(s) *: nd

Compliance/Adherence:

Compliance with vitamin d supplement (%):

Group 1: returned month 1 = 10.3%, month 2 =12.1%; month 3=10.2%

Group 2: returned month 1 = 8.4%, month 2 =10.4%; month 3=7.6%

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

15585800; 

17661558

Hollis 2004; Basile 

2006

Primary Maternal circulating total 

25(OH)D

Maternal serum total vitamin D2, total vitamin D3, 25(OH)D2, and 

25(OH)D3 

primary Infant circulating total 25(OH)D Infant serum total vitamin D2, total vitamin D3, 25(OH)D2, and 

25(OH)D3

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

15585800; 

17661558

Hollis 2004; Basile 2006 Also have separate results for changes in 25(OH)D2 and 25(OH)D3

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

15585800; 

17661558

Hollis 2004; 

Basile 2006

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no*

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Final 

**

Final 

SD*

Net 

difference

Net 

difference CI 

/ SE / SD*

P 

between

17661558 Basile 

2006

Maternal 

circulating 

total 25(OH)D

mg/dL 2000 IU/d 3 12 22.4 8.8 33.9 6.5 nd nd 0.03

4000 IU/d 3 13 28.5 8.6 43.0 11.6

17661558 Basile 

2006

infant 

circulating 

total 25(OH)D

mg/dL 2000 IU/d 3 12 7.8 1.1 27.8 3.9 nd nd 0.01

4000 IU/d 3 13 13.4 3.3 30.8 5.0

15585800 Hollis 

2006

Maternal 

circulating 

total 25(OH)D

Ng/mL 2000 IU/d 3 9 27.6 3.3 36.1 2.3 nd Nd nd

4000 IU/d 3 9 32.9 2.4 44.5 3.9

15585800 Hollis 

2006

infant 

circulating 

total 25(OH)D

Ng/mL 2000 IU/d 3 9 7.9 1.1 27.8 3.9 nd nd nd

4000 IU/d 3 9 13.4 3.3 30.8 5.0

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 
Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

15585800; 

17661558

Hollis 

2004; 

Basile 

2006

RCT -

parallel nd nd

NA

no nd no no no no C

Adverse Event(s): ** No episodes of hypercalciuria or hypercalcemia

Explanation for Overall Quality Grade (if not Grade A):

It is very likely Basile and Hollis are the same study but the number of mother-infant pairs were different. Basile 

2004 claimed that Hollis is the pilot study but the number of enrolled mothers (N=64) were the same and only a 

small fraction of mothers were included in the analyses. Although reported as a RCT, the analyses were done 

to compare within group changes only. Poor reporting of interventions and compliance.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

17309935 Hsia 

2007

RCT-post 

hoc

-Participant of WHI hormone therapy and/or dietary 

modification trial

-Women, 50-79 yrs of age

-Menopausal 1995-2005 Women’s Health 

Initiative fracture trial

NHLBI MB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

17309935 Hsia 

2007

RCTpost hocVarious (40 

clinical 

sites)

36,282 36,282 62 (7) 50-79 0% 83% 

white

9% black

4% 

Hispanic

BMI = 29 ± 6

Waist 

circumference = 89 

± 14 cm

“generally 

healthy” 

postmenopausal 

women

See background 

exposure data

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

17309935 Hsia 

2007

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd

Dietary 

calcium 

intake

At baseline, mean 

Ca intake (diet + 

supplements) was 

1148 ± 654 mg/d in 

the active tx group 

and 1154 ± 658 

mg/d in the 

placebo group.

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 
***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

17309935 Hsia 

2007

Vit D/Ca 25-hydroxy vit D3 / calcium 

carbonate

400 IU / 1000 

mg

Mean = 7.0 ± 1.4 

yrs

200 IU / 500 mg 2x daily

Placebo nd - Mean = 7.0 ± 1.4 

yrs

Twice daily

Co-intervention(s) *: Concurrent Ca supplementation was permitted, as was vit D, up to 400 IU daily.

Compliance/Adherence: 60% of study participants took at least 80% of their study medication through year 6.

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

17309935 Hsia 

2007

2o Weight nd

2o SBP nd

2o DBP nd

2o MI Algorithm that included symptoms, ECG findings, and cardiac enzymes

2o CHD death Centrally adjudicated

2o CABG or PCI Hospital record review

2o Angina Required hospitalization w/ confirmatory stress test or obstructive coronary disease by 

angiography

2o Hospitalized heart 

failure Hospital record review

2o Stroke Rapid onset of a persistent neurological deficit not due to trauma, tumor, infection, or other cause

2o TIA nd

For all outcomes, centrally trained physician-adjudicators classified outcomes on the basis of 

medical record review.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

17309935 Hsia 

2007

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

Ca and vit D intake Groups matched on total Ca intake and total 

vit D intake (supplements + diet)

Demographics (e.g., age, gender, race, education)? Yes Groups matched on age and race

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes Groups matched on BMI

Medical conditions DM, high cholesterol requiring pills, CVD, 

CHD

Groups matched on these medical conditions

Medication statin use, aspirin use, NSAID use, use of 

postmenopausal hormone therapy

Groups matched on use of these medications

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes Groups matched on smoking

Other Baseline characteristics were balanced 

between groups except for HTN (P = 0.03)

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, 

RR, HR, %) and direction 

of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

17309935 Hsia 

2007

MI Ca/D 7 yr 411 18176 Hazard Ratio 1.05 0.91, 

1.20

0.52

Placebo 390 18106

CHD death Ca/D 7 yr 130 18176 Hazard Ratio 1.01 0.79, 

1.29

0.92

Placebo 128 18106

MI or CHD death Ca/D 7 yr 499 18176 Hazard Ratio 1.04 0.92, 

1.18

0.50

Placebo 475 18106

CABG or PCI Ca/D 7 yr 674 18176 Hazard Ratio 1.09 0.98, 

1.22

0.12

Placebo 607 18106

MI/CHD 

death/CABG/PCI

Ca/D 7 yr 920 18176 Hazard Ratio 1.08 0.99, 

1.19

0.10

Placebo 841 18106

Angina Ca/D 7 yr 404 18176 Hazard Ratio 1.08 0.94, 

1.24

0.30

Placebo 377 18106

Hospitalized heart 

failure

Ca/D 7 yr 394 18176 Hazard Ratio 0.95 0.83, 

1.10

0.50

Placebo 407 18106

Stroke Ca/D 7 yr 362 18176 Hazard Ratio 0.95 0.82, 

1.10

0.51

Placebo 377 18106

TIA Ca/D 7 yr 213 18176 Hazard Ratio 1.16 0.95, 

1.42

0.13

Placebo 182 18106

Stroke/TIA Ca/D 7 yr 563 18176 Hazard Ratio 1.02 0.91, 

1.15

0.75

Placebo 547 18106

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD* Delta**

Delta 

SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

17309935 Hsia 

2007

Weight Ca/D 2 yr 18176 BMI=29.1 5.9 +1.4% 10.5 -0.3% 0.03

placebo 18106 BMI=29.0 5.9 +1.7% 12.0

SBP Ca/D 2 yr 18176 127 17 +1.1% 12.4 +0.4% 0.01

placebo 18106 128 17 +0.7% 12.4

DBP Ca/D 2 yr 18176 76 9 -0.2% 12.4 +0.4% 0.007

placebo 18106 76 9 -0.6% 12.4

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 
UI Author

Year Outcome Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Age Exposure / Intervention

Mean Followup, moN 

Event

N 

Total

Outcome Metric (e.g. 

OR, RR, HR, %) and 

direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

17309935 Hsia 

2007

CHD (MI or 

CHD death)

50-

59

Ca/D 7 yr 84 Hazard Ratio 0.94 0.70-

1.27

> 

placebo 87 .05

60-

69

Ca/D 7 yr 239 Hazard Ratio 1.08 0.90-

1.30

> 

placebo 220 .05

70-

79

Ca/D 7 yr 176 Hazard Ratio 1.05 0.85-

1.30

> 

placebo 168 .05

*Example: OR Ca/placebo 

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Age Exposure / Intervention

Mean Followup, moN 

Event

N 

Total

Outcome Metric (e.g. 

OR, RR, HR, %) and 

direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

17309935 Hsia 

2007

Stroke 50-

59

Ca/D 7 yr 51 Hazard Ratio 0.90 0.62-

1.32

> 

placebo 56 .05

60-

69

Ca/D 7 yr 164 Hazard Ratio 0.97 0.78-

1.20

> 

placebo 170 .05

70-

79

Ca/D 7 yr 147 Hazard Ratio 0.96 0.76-

1.20

> 

placebo 151 .05

*Example: OR Ca/placebo 
2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome

Total 

Ca 

intake, 

mg

Exposure / 

Intervention

Mean Followup, moN 

Event

N 

Total

Outcome Metric (e.g. 

OR, RR, HR, %) and 

direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

17309935 Hsia 

2007

CHD (MI or 

CHD death)

<800 Ca/D 7 yr 210 Hazard Ratio 1.12 > 

placebo 181 .05

800 -

<1200

Ca/D 7 yr 128 Hazard Ratio 1.01 > 

placebo 125 .05

1200 Ca/D 7 yr 143 Hazard Ratio 0.93 > 

placebo 158 .05

*Example: OR Ca/placebo 

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome

Total 

Ca 

intake, 

mg

Exposure / 

Intervention

Mean Followup, moN 

Event

N 

Total

Outcome Metric (e.g. 

OR, RR, HR, %) and 

direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

17309935 Hsia 

2007

Stroke <800 Ca/D 7 yr 139 Hazard Ratio 1.07 > 

placebo 127 .05

800 -

<1200

Ca/D 7 yr 92 Hazard Ratio 1.04 > 

placebo 87 .05

1200 Ca/D 7 yr 121 Hazard Ratio 0.80 > 

placebo 152 .05

*Example: OR Ca/placebo 

UI Author

Year Comments for Results

17309935 Hsia 

2007

Other subgroups evaluated: BMI, waist circumference, diabetes, smoking, HTN, high cholesterol requiring medication, CHD risk factors, CHD at baseline, 

CVD at baseline, statin use at baseline, aspirin use at baseline, dietary Ca intake, total vit D intake, EtOH use, HRT arm, dietary modification arm. CHD risk 

with active vit D/Ca was inversely related to BMI. Stroke risk with active vit D/Ca was lower among women with high cholesterol and those taking statins at 

baseline. Stroke risk was with active vit D/Ca was also inversely related to the number of CHD risk factors. All other demographic/clinical characteristics were 

not statistically significant.
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17309935 Hsia 

2007

RCTpost 

hoc

Nd# Nd# NA Y Y nd Y Y Y B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): 

It was the consensus among the Tufts EPC that overall, the methodological quality of the trial was B, 

particularly when the trial is being used to guide decisions about DRI, as opposed to decisions about whether 

to actively recommend supplementation for an individual woman.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

# These items were explicitly described in Wactawski-Wenda et al. N Engl J Med 2006, which met the “y” criteria.

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

10471422 Iso 

1999

Cohort study Female 

nurses

Inadequate FFQ, implausible food intake, 

nonmelanoma cancer, CVD

1980 Nurses’ Health 

Study

NIH EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

10471422 Iso 

1999

Cohort 

study

US, various 86,368 85,764 ~46 (Probably 

32-57)

0 White 

98%

~14% BMI ≥29 Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

10471422 Iso 

1999

Dietary 

calcium 

intake

FFQ nd here done elsewhere NA NA NA nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

10471422 Iso 1999 1° All stroke Self-report, medical record review, death index etc, death certificates (standard definitions)

also data for stroke types not extracted

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

10471422 Iso 

1999

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes Age

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes Smoking

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Median 

Ca 

intake

No. of 

Cases 

(Event)* 

Total 

N

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI 

P 

between 

groups***

P for 

trend****

10471422 Iso 

1999

Stroke Calcium intake 

quintile 1

395 165 ~17153 14 y Adjusted RR 1.0 -- -- NS

quintile 2 645 132 ~17153 0.79 0.63, 

1.00

.05

quintile 3 675 117 ~17153 0.71 0.56, 

0.90

<.05

quintile 4 837 142 ~17153 0.87 0.70, 

1.09

NS

quintile 5 1145 134 ~17153 0.83 0.66, 

1.04

NS

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

10471422 Iso 

1999 a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor blinded 

to outcome info? 

(y/n)

implied

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Median 

only

a) Adjusted 

or matched 

for ANY 

confounder

s (other 

than age 

and sex)?** 

(y/n)

Y

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

Y

a) Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor blinded 

to exposure 

measurement? 

(y/n)

Y

b) Food 

compositio

n 

database 

or suppl 

compositio

n 

reported? 

(y/n)

N Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up <20%? 

(y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

?

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

elsewhereb) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): A

Explanation for Overall Quality Grade (if not Grade A):
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

10471422 Iso 

1999

Cohort study Female 

nurses

Inadequate FFQ, implausible food intake, 

nonmelanoma cancer, CVD

1980 Nurses’ Health 

Study

NIH EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

10471422 Iso 

1999

Cohort 

study

US, various 86,368 85,764 ~46 (Probably 

32-57)

0 White 

98%

~14% BMI ≥29 Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

10471422 Iso 

1999

Dietary 

calcium 

intake

FFQ nd here done elsewhere NA NA NA nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

10471422 Iso 1999 1° All stroke Self-report, medical record review, death index etc, death certificates (standard definitions)

also data for stroke types not extracted

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

10471422 Iso 

1999

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes Age

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes Smoking

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Median 

Ca 

intake

No. of 

Cases 

(Event)* 

Total 

N

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI 

P 

between 

groups***

P for 

trend****

10471422 Iso 

1999

Stroke Calcium intake 

quintile 1

395 165 ~17153 14 y Adjusted RR 1.0 -- -- NS

quintile 2 645 132 ~17153 0.79 0.63, 

1.00

0.05

quintile 3 675 117 ~17153 0.71 0.56, 

0.90

<0.05

quintile 4 837 142 ~17153 0.87 0.70, 

1.09

NS

quintile 5 1145 134 ~17153 0.83 0.66, 

1.04

NS

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

10471422 Iso 

1999 a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor blinded 

to outcome info? 

(y/n)

implied

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Median 

only

a) Adjusted 

or matched 

for ANY 

confounder

s (other 

than age 

and sex)?** 

(y/n)

Y

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

Y

a) Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor blinded 

to exposure 

measurement? 

(y/n)

Y

b) Food 

compositio

n 

database 

or suppl 

compositio

n 

reported? 

(y/n)

N Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up <20%? 

(y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

?

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

elsewhereb) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): A

Explanation for Overall Quality Grade (if not Grade A):
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

15225833 Jacobs 

2004

Case-cohort 

study

Caucasian, 

male

nd 1983, 1989 Nutritional Prevention of Cancer 

(NPC)

National Cancer 

Institute

KP/SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N enrolled*** N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

15225833 Jacobs 

2004

Casecohort 

study

Eastern 

United 

States

(25o46’N to 

41o41’N)

1312 in 

original cohort, 

249 with 

exposure and 

outcome data;

83 cases; 166 

controls

249 68 nd 100 white 26 some subjects 

were on Se to 

prevent 

recurrence of 

non-melanoma 

skin cancer

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

15225833 Jacobs 

2004

25(OH)D 

and/or 

1,25(OH)2D

RIA Y, coefficient of 

variation for 

1,25(OH) D = 

11.5% and 

25(OH)D = 

12.9%

nd nd nd

Dietary 

calcium 

intake

nd nd nd nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 
****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

15225833 Jacobs 2004 secondary Prostate cancer nd

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

15225833 Jacobs 

2004

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions

Medication Original treatment group (selenium or 

placebo)

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

Clinic site

Smoking and other life styles variables Yes Cigarette smoking- pack 

years

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / SE / 

SD **

P 

between 

groups***

P for 

trend****

15225833 Jacobs 

2004

Prostate 

cancer

Tertile 1: 25(OH)D 

= 8.1-25.3 ng/ml

Nd Nd 26 58 adjusted OR 1.00 reference 0.51

Tertile 2: 25(OH)D 

= 25.4-32.7 ng/ml

Nd Nd 33 49 1.71 0.68-4.34

Tertile 3: 25(OH)D 

= 32.8-59.7 ng/ml

Nd Nd 24 59 0.75 0.29-1.91

Prostate 

cancer

Tertile 1: 

1,25(OH)D = 13.7-

27.5 ng/ml

Nd Nd 27 56 adjusted OR 1.00 reference

0.90
Tertile 2: 

1,25(OH)D = 27.6-

32.9 ng/ml

Nd Nd 29 54 1.44 0.59-3.52

Tertile 3: 

1,25(OH)D = 33.0-

64.4 ng/ml

Nd Nd 27 56 1.06 0.42-2.66

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

15225833 Jacobs 

2004

a) Eligibility 

criteria 

clear? (y/n)

n

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

NA a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

n

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N/A

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

NA Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

n

b) Loss to 

follow-up 

<20%? (y/n)

y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

n

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Quite a few specifics left out, such as explanation of how cases were ascertained.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

11641750 Jarvinen 

2001

Cohort study Participant of a large-scale health examination survey

Being interviewed to assess dietary intake (about 

20%, unclear if consecutive)

Dietary data available and no previous cancer at 

baseline

nd 1966-1972 nd nd TTE

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit D 

or Ca intake ...etc.)

11641750 Jarvinen 

2001

Cohort 

study

Finland (64 

00 N)

9959 9959 39.1 

(nd)

15- nd nd BMI=24.8 kg/m2 nd Total energy=2602.6Kcal

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

11641750 Jarvinen 

2001

Dietary 

calcium 

intake

Diet history

Dietary survey 

(interview 

guided by 

questionnaire

Finnish food 

composition 

table (Rastas et 

al. 1989)

Y (interclass 

correlation 

coefficients 4-7 y 

apart)

Dietary Ca: 0.53-

0.55

Dietary Vit D: 0.42

NA NA nd 1414 mg/d

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome**

Outcome Definition

11641750 Jarvinen 

2001

Not explicitly described Colorectal 

cancer

Finish cancer registry (ICD153-154 [WHO 1955]); unclear about confirmation by other 

sources 

Not explicitly described Colon cancer Finish cancer registry (no clear definition)

Not explicitly described Rectal cancer Finish cancer registry (no clear definition)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

11641750 Jarvinen 

2001

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

Yes (Dietary energy intake) Folic acid, fiber taken into account in sensitivity 

analysis but the results not reported.

Demographics (e.g., age, gender, race, education)? Yes (Age, sex)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (BMI)

Medical conditions no

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Yes (geographical region)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes (smoking, occupation)

Other Cancer during the first-year f/u excluded in 

sensitivity analysis but the results not reported.

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

followup time

Mean 

Ca dose

(mg)

No. of 

Cases

(Event)*

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

11641750 Jarvinen 

2001

Colorectal 

cancer

(total Ca 

[mg])

Q1 19.6 y M:

<1178.2

F:

<862.5

20 Nd Adjusted RR (HR) 1.00 Ref Nd

0.97

Q2 M:

1178.2-

1557.1

F:

862.5-

19 nd 1.17 0.60-

2.27

nd
1110.7

Q3 M:

1557.2-

1953.2

F:

1110.8-

1416.6

18 Nd 1.37 0.67-

2.81

nd

Q4 M:

1953.3-

F:

1416.7-

15 nd 1.43 0.61-

3.39

nd

11641750 Jarvinen 

2001

Colon 

cancer

(total Ca 

[mg])

Q1 19.6 y M:

<1178.2

F:

<862.5

10 Nd Adjusted RR (HR) 1.00 Ref Nd 0.17

Q2 M:

1178.2-

1557.1

F:

862.5-

1110.7

14 nd 1.44 0.61-

3.39

nd

Q3 M:

1557.2-

1953.2

F:

1110.8-

1416.6

9 Nd 1.04 0.38-

2.83

nd

Q4 M:

1953.3-

F:

1416.7-

5 nd 0.63 0.17-

2.35

nd

11641750 Jarvinen 

2001

Rectal 

cancer

(total Ca 

[mg])

Q1 19.6 y M:

<1178.2

F:

<862.5

10 Nd Adjusted RR (HR) 1.00 ref Nd 0.19

Q2 M:

1178.2-

1557.1

F:

862.5-

1110.7

5 nd 0.77 0.25-

2.37

nd

Q3 M:

1557.2-

1953.2

F:

1110.8-

1416.6

9 Nd 1.88 0.67-

5.30

nd

Q4 M:

1953.3-

F:

10 nd 3.01 0.93-

9.73

nd
1416.7-

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

11641750 Jarvinen 

2001

Cases: 

colorectal 

cancer

19.6 y 

Adjusted 

(age and 

sex)

72 Nd

Nd 1335 Nd

0.24

Control: 9887 nd nd 1415 Nd

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

11641750 Jarvinen 

2001

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

n

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

y NA b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

n

c) Do the 

authors specify 

a primary 

outcome? (y/n)

n

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Unclear consecutiveness, some poor reporting, post-hoc analysis of an existing database; power 

calculation not reported; diet history instead of FFQ used for calcium assessment; case confirmation by 

histology not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

17442130 Jia 2007 Cohort study 75 y or older Terminal illness

Severe dementia

1999-2000 nd nd TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17442130 Jia 

2007

Cohort 

study

Aberdeen, 

UK

405 398 80# Range 

75-96

52 nd BMI: median 25.4 

kg/m2, range (23.4-

27.7)

 58% heart 

disease 

(self report)

 6% DM (self 

report)

 85% fair to 

very good

health 

status (selfperception)

 44% no 

physical 

activity

27% took Vit D 

supplement

74% had 2 or more 

portions of fruits or 

vegetables

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

# median 

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of 

Dietary 

Assessment? (y/n) 

If Yes, Provide 

Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data

Time between

Biomarker 

Sampling and

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure 

data

17442130 Jia 

2007

25(OH)D “RIA” n Nd (~6 to ~7 y)

(Median f/u of 

the entire 

cohort: 69.2 

mon [range, 

1.0-79.9])

April 1999 

and March 

2000#

nd

17442130 Jia 

2007

Dietary 

calcium 

intake

nd nd nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 
***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

# Excerpts from the paper on original cohort study (McNeill Br J Nutr 2002) “For the subjects seen in summer (June–September), repeat samples were taken 

in winter (February–March) to estimate seasonal change in vitamin D status.” In this report, it is unclear if such data are available or not. 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17442130 Jia 2007 primary mortality Mortality from any causes

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17442130 Jia 

2007

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

No See the hierarchy of the planned 

model below

Demographics (e.g., age, gender, race, education)? Yes See the hierarchy of the planned 

model below

Anthropometrics (e.g., BMI, body weight, % body fat)? No See the hierarchy of the planned 

model below

Medical conditions Yes See the hierarchy of the planned 

model below

Medication Yes See the hierarchy of the planned 

model below

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

Yes See the hierarchy of the planned 

model below

Smoking and other life styles variables Yes See the hierarchy of the planned 

model below

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis

Model 1: age, sex 

Model 2: age, sex, (self-perceived) health status, taking 5 or more kinds of medication 

Model 3: age, sex, (self-perceived) health status, taking 5 or more kinds of medication, (self-reported) heart disease, (self-reported) diabetes 

Model 4: age, sex, (self-perceived) health status, taking 5 or more kinds of medication, (self-reported) heart disease, (self-reported) diabetes, sunlight exposure 

Model 5: age, sex, (self-perceived) health status, taking 5 or more kinds of medication, (self-reported) heart disease, (self-reported) diabetes, Vit D supplement 

Model 6: age, sex, (self-perceived) health status, taking 5 or more kinds of medication, (self-reported) heart disease, (self-reported) diabetes, sunlight exposure, Vit D supplement 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome

Exposure / 

Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean Vit 

D level 

(nmol/L)

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

**

P between 

groups***

P for 

trend****

17442130 Jia 

2007 Mortality

Q1 6.0-23.0 

(M)/7.0-

19.0 (F)

nd

41 75

Adjusted 

(Model 1) HR

2.89 1.61-

5.18

nd <0.001

Q2 23.1-30.0 

(M)/29.1-

24.0 (F)

34 86 2.07 1.14-

3.76

Q3 30.1-37.0 

(M)/24.1-

30.2 (F)

21 80 1.16 0.60-

2.24
Q4 37.1

-47.0 

(M)/30.3-

39.0 (F)

17 78 1.0 0.50-

1.97

Q5 47.1-82.0 

(M)/39.1-

82.0 (F)

16 79 reference-

17442130 Jia 

2007 Mortality

Q1 6.0-23.0 

(M)/7.0-

19.0 (F)

nd

41 75

Adjusted 

(Model 2) HR

2.22 1.21-

4.07

nd 0.003

Q2 23.1-30.0 

(M)/29.1-

24.0 (F)

34 86 1.71 0.93-

3.14

Q3 30.1-37.0 

(M)/24.1-

30.2 (F)

21 80 1.03 0.53-

2.02

Q4 37.1-47.0 

(M)/30.3-

39.0 (F)

17 78 0.96 0.48-

1.92

Q5 47.1-82.0 

(M)/39.1-

82.0 (F)

16 79 reference-

17442130 Jia 

2007 Mortality

Q1 6.0-23.0 

(M)/7.0-

19.0 (F)

nd

41 75

Adjusted 

(Model 3) HR

2.22 1.22-

4.06

nd 0.001

Q2 23.1-30.0 

(M)/29.1-

24.0 (F)

34 86 1.75 0.95-

3.22

Q3 30.1-37.0 

(M)/24.1-

30.2 (F)

21 80 1.030.53-

2.00

Q4 37.1-47.0 

(M)/30.3-

39.0 (F)

17 78 0.92 0.46-

1.84

Q5 47.1-82.0 

(M)/39.1-

82.0 (F)

16 79 reference-

17442130 Jia 

2007 Mortality

Q1 6.0-23.0 

(M)/7.0-

19.0 (F)

nd

41 75

Adjusted 

(Model 4) HR

2.02 1.10-

3.72

nd 0.008

Q2 23.1-30.0 

(M)/29.1-

24.0 (F)

34 86 1.64 0.89-

3.02

Q3 30.1-37.0 

(M)/24.1-

30.2 (F)

21 80 1.01 0.52-

1.96

Q4 37.1-47.0 

(M)/30.3-

39.0 (F)

17 78 0.87 0.43-

1.75

Q5 47.1-82.0 16 79 reference-
(M)/39.1-

82.0 (F)

17442130 Jia 

2007 Mortality

Q1 6.0-23.0 

(M)/7.0-

19.0 (F)

nd

41 75

Adjusted 

(Model 5) HR

1.97 1.03-

3.75

nd 0.01

Q2 23.1-30.0 

(M)/29.1-

24.0 (F)

34 86 1.54 0.80-

2.97

Q3 30.1-37.0 

(M)/24.1-

30.2 (F)

21 80 0.95 0.48-

1.88

Q4 37.1-47.0 

(M)/30.3-

39.0 (F)

17 78 0.86 0.43-

1.74

Q5 47.1-82.0 

(M)/39.1-

82.0 (F)

16 79 reference -

17442130 Jia 

2007 Mortality

Q1 6.0-23.0 

(M)/7.0-

19.0 (F)

nd

41 75

Adjusted 

(Model 6) HR

1.74 0.91-

3.34

nd 0.03

Q2 23.1-30.0 

(M)/29.1-

24.0 (F)

34 86 1.40 0.73-

2.70

Q3 30.1-37.0 

(M)/24.1-

30.2 (F)

21 80 0.90 0.45-

1.79

Q4 37.1-47.0 

(M)/30.3-

39.0 (F)

17 78 0.80 0.39-

1.62

Q5 47.1-82.0 

(M)/39.1-

82.0 (F)

16 79 reference -

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

Model 1: age, sex 

Model 2: age, sex, (self-perceived) health status, taking 5 or more kinds of medication 

Model 3: age, sex, (self-perceived) health status, taking 5 or more kinds of medication, (self-reported) heart disease, (self-reported) diabetes 

Model 4: age, sex, (self-perceived) health status, taking 5 or more kinds of medication, (self-reported) heart disease, (self-reported) diabetes, sunlight exposure 

Model 5: age, sex, (self-perceived) health status, taking 5 or more kinds of medication, (self-reported) heart disease, (self-reported) diabetes, Vit D supplement 

Model 6: age, sex, (self-perceived) health status, taking 5 or more kinds of medication, (self-reported) heart disease, (self-reported) diabetes, sunlight exposure, Vit D supplement

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)
UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / SE 

/ SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

17442130 Jia 

2007

Cases: Nd (~6 to ~7 y)

(Median f/u: 69.2

mon [range, 1.0-

79.9])

Crude

129 26.0# 6.0-

63.0# Nd nd <0.001 

(MannControl: 269 33.0 Whitney) # 9.0-

82.0

# nd Nd

Duplicate one table per outcome 

# Median with range. Convert this into mean by using the method by Hozo (Hozo et al. 2008)

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year

Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean Vit 

D level 

(nmol/L)

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

**

P between 

groups***

P for 

trend****

17442130 Jia 

2007

Mortality 

(Men 

only)

Q1 6.0-23.0

nd

21 38

Adjusted 

(Model 3) HR

2.02 0.88-

4.65

nd 0.02

Q2 23.1-30.0 21 49 1.89 0.84-

4.27

Q3 30.1-37.0 11 39 0.99 0.40-

2.50

Q4 37.1-47.0 9 39 0.91 0.35-

2.36

Q5 47.1-82.0 9 42 reference -

17442130 Jia 

2007

Mortality

(Women 

only)

Q1 7.0-19.0

nd

20 37

Adjusted 

(Model 3) HR

2.71 1.12-

6.58

nd 0.02

Q2 29.1-24.0 13 37 1.60 0.63-

4.06

Q3 24.1-30.2 10 41 1.08 0.41-

2.89

Q4 30.3-39.0 8 39 0.97 0.35-

2.69

Q5 39.1-82.0 7 37 reference -
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17442130 Jia 

2007

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Nd

a) Method 

reported? 

(y/n)

n/NA a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

n/NA Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

y

b) Loss to 

follow-up 

<20%? (y/n)

y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

n

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

y

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A):

No details on enrollment and blinding assessment, some may have been excluded due to unavailability of 

data (e.g., blood sample), leading to the possibility of selection bias 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

8201444 Johnson 

1994

Cohort study African American women; 16-35 y; 

pregnant; nulliparity

DM, sickle cell, 

thalassemia, Hb C

nd NICHD SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

8201444 Johnson 

1994

Cohort 

study

Washington 

DC

322 322 21.6 16->31 

(est.)

0 African 

American

42% 90-110% of ideal 

prepregnancy body 

weight; 28% >120% of 

ideal prepregnancy 

body weight

nd Calcium 933.4 ± 

51.8 (SE) mg/d 

intake

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

8201444 Johnson 

1994

Dietary 

calcium 

intake

FFQ USDA n Calcium 933.4 

± 51.8 (SE) 

mg/d intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

8201444 Johnson 1994 primary birth weight

birth length

gestational age

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

8201444 Johnson 

1994

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no*

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

8201444 Johnson 

1994

birth weight; birth 

length

“None of the food energy and nutrient intakes was significantly correlated with any of the pregnancy outcome measures”. No specific 

quantitative relationship was provided for calcium.

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

8201444 Johnson 

1994

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

n

a) Method 

reported? 

(y/n)

y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

n

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

nd

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

n

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

n Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

y

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

n b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

nd

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): incomplete presentation of analysis

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name Funding Source Extractor

17552880 Kabrnova-Hlavata 

2008

Other intervention 

study

-overweight or 

obese

-female

-diabetes

-uncompensated 

thyroid 

dysfunction

-drugs affecting 

water balance

nd none Supported by grants IGA NR/7800-

4 and S-QF 3166

MB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

17552880 KabrnovaHlavata 

2008

Other 

intervention 

study

Prague, 

Czech 

Republic. 

50 N

67 67 49.1±12.1 nd 0% nd BMI=32.2±4.1

Weight=84.5±13

%body 

fat=41.5±5.5

nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17552880 KabrnovaHlavata 

2008

25(OH)D 

and/or 

1,25(OH)2D

Dietary 

calcium 

intake

nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca 

Total Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. 

capsules were taken 2 times a day)

17552880 KabrnovaHlavata 2008placebo Food/tablets 350 mg/d from food 3 wks Placebo tablets were taken 3x/day

Ca Calcium carbonate + food 500 mg/d tablet / 

350 mg/d from food

3 wks Tablets were taken 3x/day

Ca Lactoval (70% Ca phosphate, 20% 

Ca citrate, 10% Ca lactate)

500 mg/d tablet / 

350 mg/d from food

3 wks Tablets were taken 3x/day

Co-intervention(s) *:

Only those subjects who exhibited a stable weight during 1 week on 7 MJ/d diet entered the trial and received a 4.5 MJ/day 

diet for the next 3 weeks (diet supplied 350 mg/d Ca) plus tablets.

Compliance/Adherence: All subjects were advised to eat all the meals served in four daily portions in the spa dining room. A dietician checked that 

subjects took tablets.

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17552880 Kabrnova-Hlavata 2008 nd weight Analyzed by a bipedal-bimanual Body Composition Analyzer Tanita BC-418MA

nd BMI

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including matching 

factors)

Specific comments for 

confounders

17552880 KabrnovaHlavata 2008Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

Yes All three groups on 7 

MJ/day diet

Demographics (e.g., age, gender, race, education)? Yes All three groups 

matched on age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes Groups matched on BMI 

and % body fat

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical 

activity, occupation, alcohol consumption)

No

Other “The studied women were predominantly perimenopausal. The 

number of women in menopause was comparable in the 

groups.”

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year

Outcom

e

Uni

t

Exposure 

Category / 

Interventio

n Group

Crude or 

Adjusted 

analysis

?

Mean

Follow-u

p 

(months)

No. 

Analyze

d

Baselin

e

Baselin

e SD*

Delta*

*

Delt

a SD

Net 

difference***

Net 

differen

ce CI / 

SE / 

SD*

P 

between 

groups**

*

1755288

0

Kabrnova

-Hlavata 

2008

Weight kg placebo

Adjusted

3 wks 21 85.37

14.83

-4.34

1.37

NS

Ca 

carbonate

Adjusted 3 wks 25 84.95 11.75

-3.34 1.79 NS

Lactoval Adjusted 3 wks 21 83.43 11.65 -3.87 1.62 NS

BMI Kg/

m

2 placebo Adjusted

 3 wks 21 32.36 4.86-1.64 0.49 NS

Ca 

carbonate

Adjusted 3 wks 25 32.39 4.35

-1.29 0.69 NS

Lactoval Adjusted 3 wks 21 32.42 4.22 -1.51 0.65 NS

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17552880

KabrnovaHlavata 

2008

Nonrandomized 

controlled 

trial

NA NA NA N nd nd Y Y Y B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Nd on how subjects were divided into groups

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name Funding Source Extractor

8205538 Kampman 

1994

Cohort 

study

Age 55 to 69 participant of 

Netherlands Cohort Study 

on diet and cancer 

(n=120852)

Subpopulation randomly 

selected from the main 

cohort (n=3500) 

History of cancer (excluding 

skin cancer) (n=154)

Incomplete/inconsistent 

dietary data (n=235)

Events (cancer only?) within 

the first year of follow-up 

(n=28)

1986 Netherlands 

Cohort Study on 

diet and cancer

Netherlands Digestive 

Diseases Foundation, 

Dutch Cancer Society

TTE

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

8205538 Kampman 

1994

Cohort 

study

Netherlands 

(nd) (52 30 N)

3500 (see 

above)

3111 ~61 

(nd)#

55-69 

(per 

inclusion 

criteria)

~49%# nd nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

# approximated based on the data on the highest and lowest quintile of Ca intake. 

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

8205538 Kampman 

1994

Dietary 

calcium 

intake

150 item-FFQ nd N Ca=1286 

mg/d (energyadjusted 

median)

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

8205538 Kampman 1994 nd Colorectal cancer Record linkage to cancer registries and a nationwide pathology registry

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

8205538 Kampman 

1994

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes (any vitamin suppl. use, energy, energyadjusted intake of fat and dietary fiber)

Demographics (e.g., age, gender, race, education)? Yes (age, gender, level of education)

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions Yes (Hx of gallbladder surgery)

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes (smoking)

Other Family history of colorectal cancer

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

After excluding first year of follow up 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

followup 

time, 

mo

Median 

Ca 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

8205538 Kampman 

1994

Colorectal 

cancer 

(Total Ca 

[mg])

Q1 39.6 596 98 623 Adjusted 

(age, gender, 

energy)

RR

1.00 Ref 0.87

Q2 39.6 768 89 619 RR 0.83 nd

Q3 39.6 893 87 622 RR 0.96 nd

Q4 39.6 1032 81 627 RR 0.92 nd

Q5 39.6 1288 88 620 RR 0.92 nd

8205538 Kampman 

1994

Colorectal 

cancer 

(Total Ca 

[mg])

Q1

39.6

596 98 623 Adjusted 

(full 

multivariate 

model)

RR 

1.00 Ref 0.89

Q2

39.6

768 89 619 RR 0.83 0.58, 

1.22

Q3

39.6

893 87 622 RR 0.96 0.67, 

1.39

Q4

39.6

1032 81 627 RR 0.93 0.64, 

1.36

Q5 39.6 1288 88 620 RR 0.92 0.64, 

1.34

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

8205538 Kampman 

1994

Ca intake from non-dairy products, fermented dairy products, unfermented dairy products were presented as subgroup analysis but only brief results 

(energy adjusted analyses)

Ca from non-dairy products only: age-gender adjusted RR trend (Q1 vs. Q5) P=0.18; full multivariate adjusted RR (Q1 vs. Q5) trend P=0.01

Ca from fermented dairy products only: age-gender adjusted RR trend (Q1 vs. Q5) P=0.52; full multivariate adjusted RR trend (Q1 vs. Q5) P=0.32

Ca from non-fermented dairy products only: age-gender adjusted RR trend (Q1 vs. Q5) P=0.10; full multivariate adjusted RR trend (Q1 vs. Q5) P=0.11

Data on other exposures (fermented milk, hard cheese, unfermented milk) presented but not extracted. 

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

8205538 Kampman 

1994

a) Eligibility 

criteria 

clear? (y/n)

N

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported?

(y/n)

NA b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A):

Dietary calcium intake only was evaluated. Possibility of post-hoc analysis. Power calculation not reported; 

assessor blinding not reported; results without excluding 1st year of follow up are not given; power calculation 

not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

9343837 Kato 

1997

Cohort 

study

Women breast exam participants aged 

34-65

No hormonal medications or pregnancy 

for 6 mo prior to the enrollment

30 ml blood donation and answering a 

baseline questionnaire

Prior colorectal cancer 

(n=58)

8 or more blanks in the 

questionnaire (n=1000)

1985-1991 New York Univ. 

Women’s Health 

Study

NCI TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

9343837 Kato 

1997

Cohort 

study

New York 

City, NY (40°

47’) or 

Lauderhill, 

FL (26° 8')

14727 14727 nd nd 0% [Based on 

only 11573 

participants]

Caucasian: 

82%

Black: 10%

Hispanic: 5%

Others: 3%

nd [based on only 

14724 

participants] 

Aspirin use 

(last 4 wks): 

25%

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of 

Dietary 

Assessment? (y/n) 

If Yes, Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

9343837 Kato 

1997

Dietary 

calcium 

intake

70-item FFQ 

slightly 

modified from 

Block’s

nd Only n=267 

assessed; Short term 

(2-3 mo): correlation 

coefficient=0.56, 

Long-term (2-5 y): 

“somewhat lower” 

nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

9343837 Kato 

1997

Not explicitly stated but the only 

outcome reported

Colorectal 

Cancer

Self reports (in the questionnaires sent until the end of 1994) confirmed by medical records pathology 

reports, supplemented by the state cancer registries and the National Death Index 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

9343837 Kato 

1997

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes (total energy intake)

Demographics (e.g., age, gender, race, education)? Yes (age, education)

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Yes (place of enrollment [i.e., NY vs. FL])

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

9343837 Kato 

1997

Colorectal 

cancer 

(total Ca 

[mg])

Q1 nd nd nd nd 85.2 adjusted HR 1.0 Ref nd

0.178

Q2 nd nd nd nd 85.2 1.15 0.67-

1.95

nd

Q3 nd nd nd nd 85.2 0.90 0.52-

1.57

nd

Q4 nd nd nd nd 85.2 0.71 0.39-

1.28

nd
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

9343837 Kato 

1997

a) Eligibility 

criteria 

clear? (y/n)

nd

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

N

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA b) Loss to 

follow-up 

<20%? (y/n)

nd

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Study not designed initially for assessing calcium intake and CRC; power calculation not reported. Poor 

reporting throughout the paper precluded detailed assessments. Post-hoc analysis. Calcium intake per 

category not reported; blinding not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name Funding Source Extractor

8610704 Kearney 

1996

Cohort 

study

Male health 

professionals

Age 40-75 in 1986 

Responded baseline 

questionnaire 

(n=51529)

Implausibly high (4200-)/low (-800) total 

energy intake (kcal/d) or failed to fill in 

the dietary assessment (n=49999)

Precious cancer (excl. nonmelanoma 

skin cancer), ulcerative colitis, familial 

polyposis syndrome (n=47935) 

1986 The Health 

Professionals 

Follow-up Study

American Cancer 

Society, NIH, 

National Dairy 

Council 

TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

8610704 Kearney 

1996

Cohort 

study

US (25 46”-

54 40”N)

47935 47239 nd 40-75 100% nd BMI=25kg/m2 Family 

history=8.4%

Previous 

polyps=3.6%

Current 

activity=19.6 

MET

Current 

smoker=10.0%

Total energy 

intake=1958.7 

kcal/d

Fiber=23.0 g/d

Saturated fat=25.2 

g/d

Ca=947.0 mg/d

Vit D=400.9IU/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

8610704 Kearney 

1996

Dietary 

calcium 

intake

FFQ (Rim et 

al. 1992)

USDA and 

others (Rim et 

al. 1992) 

Correlation of 

coefficient (energy 

adjusted):

0.53 (before weekto-week variability 

adjusted)

0.60 (with supple) 

and 0.61 (without 

supple) (after 

week-to-week 

variability adjusted)

Ca=947.0 

mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

8610704 Kearney 

1996

nd Colon 

caner

Response to the biennial questionnaires confirmed by the hospital/pathology reports or the National Death 

Index. During the 6-year follow-up.
Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

8610704 Kearney 

1996

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes (red meat, saturated fat, fiber, vitamin E)

Demographics (e.g., age, gender, race, education)? Yes (age)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (BMI)

Medical conditions Yes (family history of colon cancer, previous 

polyps, prior screening)

Medication Yes (aspirin)

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes (smoking, alcohol, physical activity)

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Ca 

dose

No. of 

Cases 

(Event)* 

No. of 

Personyears**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

8610704 Kearney 

1996

Colon 

cancer 

(total Ca 

intake 

[mg])

Q1 “6 y” <631 59 51343 Adjusted 

(age, energy 

intake)

 OR 1.0 Ref nd

0.01

Q2 631-

765

32 51501 0.57 0.36-

0.85

nd

Q3 766-

921

36 51127 0.60 0.39-

0.90

nd
Q4 922-

1212

37 52047 0.61 0.40-

0.89

nd

Q5 1213- 39 51620 0.58 0.39-

0.87

nd

8610704 Kearney 

1996

Colon 

cancer 

(total Ca 

intake 

[mg])

Q1 “6 y” <631 59 51343 Adjusted 

(full 

multivariate 

model)

RR (OR) 1.0 Ref nd

0.22

Q2 631-

765

32 51501 0.64 0.42-

1.01

nd

Q3 766-

921

36 51127 0.73 0.47-

1.12

nd

Q4 922-

1212

37 52047 0.74 0.48-

1.15

nd

Q5 1213- 39 51620 0.75 0.48-

1.15

nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

8610704 Kearney 1996 1. Ca intake from food (dietary Ca), dairy products, and non-dairy products were presented as subgroup analysis but only brief results:

Dietary Ca: age-gender adjusted RR trend P=0.02; full multivariate adjusted RR trend P=0.62

Ca from dairy products only: age-energy adjusted RR trend P=0.001; full multivariate adjusted RR trend P=0.28

Ca from non-dairy products only: age-energy adjusted RR trend P=0.06; full multivariate adjusted RR trend P=0.30

2. Data on Vit D intake without blood Vit D level presented but not extracted (ineligible).

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

8610704 Kearney 

1996

a) Eligibility 

criteria 

clear? (y/n)

N

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Some unclear reporting (eligibility, blinding), post-hoc analysis, some important confounders (e.g., Vit D) not 

fully taken into account.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

15880532 Kesse 

2005

Cohort 

study

Women living 

in France, 

aged 40 to 65 

years

at baseline 

and insured 

with the 

Mutuelle 

Générale de 

l'Education

Nationale, a 

national 

health 

insurance 

scheme for 

teachers. 

Subjects who had reported a 

cancer diagnosis before the 

start of follow-up, nonhistologically confirmed 

colorectal cancer, a familial 

polyposis syndrome, an 

inflammatory bowl disease, 

lost to follow-up after dietary 

assessment

1990 Etude 

Epidémiologique 

auprès de femmes 

de l'Education 

Nationale.

French League against 

Cancer, European Community, 3M 

Company, Mutuelle Générale de 

l'Education Nationale, Institut Gustave 

Roussy, Institut National de la Santé 

et de la Recherche Médicale, 

Association pour la Recherche sur le 

Cancer, Fondation pour la Recherche 

Médicale

JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

15880532 Kesse 

2005

Cohort 

study

France

46° N

100,000 Adenoma 

study: 

5320 

CRC: 

67484

52.7 

(nd)

nd 0% nd BMI 23.0kg/m2nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay 

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

15880532 Kesse 

2005

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd Vit D 

(μg) 2.61±1.28** ***

15880532 Kesse 

2005

Dietary 

calcium 

intake

FFQ Conversion of 

foods into 

nutrients was

carried out 

using a French 

food 

composition 

table

compiled ad 

hoc and 

derived from

a major French 

table the 

McCance and 

Widdowson’s

food 

composition 

table (Ref)

Y, correlation 

coefficient for 

dairy products 

0.67, for calcium 

intake 0.38

Calcium (mg)

1014.15±359.55*****

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

 ONLY biomarker of interest for calcium is calcium balance 

** ***Cancer-free subjects only 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

15880532 Kesse 

2005

nd adenoma Complete colonoscopy was performed mostly for investigating anemia or bowel symptoms, as well as some 

times for screening first-degree relatives of subjects with colorectal neoplasia.

15880532 Kesse 

2005

nd Colorectal 

cancer

Mostly diagnosed when symptomatic

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

15880532 Kesse 2005 High risk of adenomas was also included as outcome. 

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

15880532 Kesse 

2005

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Energy and alcohol intake

Demographics (e.g., age, gender, race, education)? Yes - education

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes - BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes - smoking, physical activity level

Other Family hx of colon cancer 

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean Ca 

level / 

dose*****

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ 

Total 

N**

Follow 

up, mo Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

15880532 Kesse 

2005

Colorectal 

cancer

Ca quartile 1 <766.22 49 nd Median, 

82.8

Adjusted RR 1.00 0.08

Ca quartile 2 766.22-

962.63

47 nd Median, 

82.8

Adjusted RR 0.94 0.63-

1.41

Ca quartile 3 962.63-

1201.81

39 nd Median, 

82.8

Adjusted RR 0.78 0.51-

1.19

Ca quartile 4 > 

1201.81

37 nd Median, 

82.8

Adjusted RR 0.72 0.47-

1.10
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 

** ***Quartiles was calculated on the distribution of cancer-free subjects (n=67312) 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 
Please copy the appropriate table above for all subgroup analyses of interest. 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean Ca 

level / 

dose*****

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ 

Total 

N**

Follow 

up, 

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

15880532 Kesse 

2005

All 

adenomas

Ca quartile 1 <785.62 140 nd 44.4 Adjusted RR 1.00 0.04

Ca quartile 2 785.62-

1226.16

141 nd 44.4 Adjusted RR 0.97 0.76-

1.22

Ca quartile 3 981.67-

1226.16

121 nd 44.4 Adjusted RR 0.83 0.65-

1.07

Ca quartile 4 >1226.16 114 nd 44.4 Adjusted RR 0.80 0.62-

1.03

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 

** ***Quartiles was calculated on the distribution of polyp-free subjects (n=4804) 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

15880532 Kesse 

2005

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment?

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): No information on exposure assessor blinded to outcome info and outcome assessor blinded to exposure 

measurement; power calculation not reported; multiple risk factors examined

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

17536191 KesseGuyot 

2007

RCT-post 

hoc

(cohort 

follow-up 

of RCT)

12741 subjects enrolled in the 

SU.VI.MAX trial from 1994-1995 and 

had a follow-up of 8 years. Of these 

3836 women had at least 5 24-

hourdietary records over the first 18 

months 

Subjects with a recent cancer event, 

except for basal cell skin cancers and 

in situ tumors, during the 5 years 

preceding the follow-up, subjects with 

cancers other than breast cancer

1994-1995 SU.VI.MAX 

trial

Gov GR

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

17536191 KesseGuyot 

2007

RCT-post 

hoc

(cohort 

follow-up 

of RCT)

France

46o N

3836 3627 51 

(6.3)

nd 0% nd BMI: <18.5 = 4.4%

18.5-25 = 75.8%

25.1 – 30.0 = 

11.0%

>30.0 = 7.7%

Postmenopausal 

status 52% 

cases; 41% 

non-cases 41%

Family h/o 

breast cancer 

18.5% cases 

and controls 

9%

Energy adjusted 

calcium intake 

935 mg/d in 

cases; 994 mg/d 

in controls

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

25(OH)D 

and/or 

1,25(OH)2D

17536191 KesseGuyot 

2007

Dietary 

calcium 

intake

Computerized 

questionnaires

nd nd Evaluated were 

calcium, dairy 

calcium, and 

non dairy 

calcium

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17536191 Kesse-Guyot 2007 nd Incident breast cancer Self reported and identified through medical record data

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must be explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

17536191 Kesse-Guyot 

2007

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Supplement use, saturated fatty acid consumption, 

vegetable consumption, meat consumption

Demographics (e.g., age, gender, race, education)? Yes (education level, marital status and parity)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (BMI)

Medical conditions

Medication HRT use

Sunlight exposure and its proxy variables (e.g., physical activity 

level, occupation, sun exposure, location)

Physical activity

Smoking and other life styles variables Yes (total alcohol intake, smoking) 

Other Family hx of breast cancer

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

followup

Mean 

Ca 

level 

No. of 

Cases 

(Event)* 

Total 

N**

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

17536191 KesseGuyot 

2007

Breast cancer Q1 7.7 y <807 

mg

32 3627 yes RR 1

0.04

Q2 7.7 y 807-

960 

mg

24 3627 yes RR 0.73 (0.42-

1.25)

Q3 7.7 y 961-

1144 

mg

20 3627 yes RR 0.65 (0.37-

1.14)
Q4 7.7 y >1144 

mg

16 3627 yes RR 0.50 (0.27-

0.91)

Breast cancer 

in post 

menopausal 

women

Q1 7.7 y <807 

mg

14 nd yes RR 1

0.64

Q2 7.7 y 807-

960 

mg

13 nd yes RR 0.71 (0.33-

1.54)

Q3 7.7 y 961-

1144 

mg

10 nd yes RR 0.67 (0.30-

1.53)

Q4 7.7 y >1144 

mg

11 nd yes RR 0.76 (0.34-

1.70)

Breast cancer 

in premenopausal 

women

Q1 7.7 y <807 

mg

18 nd yes RR 1

0.01

Q2 7.7 y 807-

960 

mg

11 nd yes RR 0.77 (0.36-

1.66)

Q3 7.7 y 961-

1144 

mg

10 nd yes RR 0.63 (0.29-

1.38)

Q4 7.7 y >1144 

mg

5 nd yes RR 0.26 (0.10-

0.71)

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17536191 KesseGuyot

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

N

a) Level of 

the 

exposure in 

comparative 

categories 

(e.g. 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

N

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Poor reporting of critical elements

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

17106437 Koh

2006

Cohort 

study

Harvard male undergraduates (1916-1950) 

who filled out diet questionnaires

baseline cancer or no 

data on dairy intake

1960’s Harvard Alumni 

Health Study

government SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

17106437 Koh

2006

Cohort 

study

nd 11014 10011 67 nd 100 nd 43% with BMI>25 nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

17106437 Koh

2006

Dietary 

calcium 

intake

23 items FFQ 

(Willett 1985, 

1987)

USDA n nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17106437 Koh

2006

primary prostate cancer self-reported of physician-diagnosed cancer or death certificates (through 1998)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17106437 Koh

2006

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes red meat intake, vegetable 

intake

Demographics (e.g., age, gender, race, education)? Yes age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes smoking, alcohol, physical 

activity

Other paternal hx of prostate 

cancer

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Event* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect size

CI / 

SE / 

SD **

P between 

groups***

P for 

trend****

17106437 Koh

2006

prostate 

cancer

dairy calcium 0-199 

mg/d

209 10011 adj RR 1.00 (ref) 0.64

200-

449

167 10011 0.81 0.64-

1.02

450-

599

238 10011 0.91 0.73-

1.14

≥600 201 10011 0.91 0.70-

1.18

17106437 Koh

2006

fatal 

prostate 

cancer

dairy calcium 0-199 

mg/d

30 10011 adj RR 1.00 (ref)

0.52

200-

449

21 10011 0.57 0.27-

1.19

450-

599

23 10011 0.60 0.29-

1.22

≥600 25 10011 0.81 0.38-

1.71

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 
UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

17106437 Koh

2006

prostate cancer 

risk

Calcium supplement was not related to risk of prostate cancer (multivariate RR = 1.05 (0.84-1.31). Only 8% of men used supplement 

(classified as users vs. non-users). Dose not specified.

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17106437 Koh

2006

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

N

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): no internal validation of FFQ; retrospective

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding 

Source Extractor

18398033 Kurahashi 

2008

Cohort 

study

Male Japanese 

residents age 40-69 

at baseline

History of prostate cancer, 

extreme total energy intake 

reported

Cohort I launched in 

1990, Cohort II launched 

in 1993

Japan Public Health 

Center-Based 

Prospective Study

Japanese 

Ministry of 

Health

KP/SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male,

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

18398033 Kurahashi 

2008

Cohort 

study

Japan 36°N 65,801 men 

in initial 

cohort

46,036 nd 45-74 100% nd nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? (y/n) 

If Yes, Provide 

Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

18398033 Kurahashi 

2008

25(OH)D 

and/or 

1,25(OH)2D

NA NA NA NA NA

Dietary 

calcium 

intake

FFQ Standard 

Tables of Food 

Composition in 

Japan, 5th

edition

Yes, correlation 

coefficient for 

calcium, comparing 

FFQ to 14 or 28 

day diet records, 

was 0.43 for cohort 

I and 0.65 for 

cohort II

nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

18398033 Kurahashi 

2008

nd Prostate 

cancer

Active patient notification from major local hospitals in the study area, linkage with cancer registries, 

death certificates

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

18398033 Kurahashi 

2008

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Intake of green tea and genistein

Demographics (e.g., age, gender, race, education)? Yes age

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes Smoking status, drinking 

frequency

Other Area, marital status

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / SE / 

SD **

P 

between 

groups***

P for 

trend****

18398033 Kurahashi 

2008

Prostate 

cancer

Quartile 1: calcium 

median = 282.8 

mg/d

nd nd 56 nd Adjusted RR 1.00 Reference

0.16

Quartile 2: calcium 

median = 403.6 

mg/d

nd nd 68 nd 1.03 0.70-1.51

Quartile 3: calcium 

median = 521.9 

mg/d

nd nd 98 nd 1.32 0.92-1.90

Quartile 4: calcium 

median = 725.1 

mg/d

nd nd 107 nd 1.24 0.85-1.81
UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

18398033 Kurahashi 

2008

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

NA

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Quartiles give medians, not means or ranges; no adjustment for FH of prostate cancer

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

19221190 LaCroix,

2009

RCT-post 

hoc**

Casecohort 

study

Postmenopausal 

women aged 50-79 

years old. 

A predicted survival of less than 3 years; a history of 

renal calculi or hypercalcemia; or current use of oral 

corticosteroids or calcitriol, or daily use of 600 IU or 

more of supplemental vitamin D

1993-1998 WHI National Heart, 

Lung and Blood 

Institute 

JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N enrolled*** N analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

19221190 LaCroix,

2009

RCTpost 

hoc**

Casecohort 

study

40 US 

clinical 

centers

For RCT,

36,282 women;

18,176 

(intervention), 

18,106 

(control) 

For casecohort 

study, 323 

(cases) and 

1962 

(controls) 

62.4 

(nd)

50-79 

years

0% White 83.1%

Black 9.1%

Hispanic 

4.2%

American 

Indian/Native 

American 

0.4% 

Asian/Pacific 

Islander 2.0%

Unknown 

1.2% 

BMI 29.1 (5.9) nd Low Ca intakes 

(<800mg/d) 34%

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

19221190 LaCroix,

2009

25(OH)D 

and/or 

1,25(OH)2D

DiaSorin Liaison 

chemiluminescent 

immunoassay

nd nd nd nd

19221190 LaCroix,

2009

Dietary 

calcium 

intake

nd nd nd nd nd nd Daily total 

calcium, mg

CaD arm 

1148.4 

(654.2)

Placebo arm

1154.3 

(658.0)

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

19221190 LaCroix,

2009

Ca+VitD 500mg calcium carbonate + 200IU vitD3 (by 

Glaxo SmithKline, Pittsburgh, PA)

1000mg calcium 

carbonate + 400IU vitD3

Average 7 years 2 times a day

19221190 LaCroix,

2009

Placebo

Co-intervention(s) *: Hormone therapy and dietary modification was similar in both arms

Compliance/Adherence: At trial closure, 76% of women enrolled were still taking study medications and 59% were taking at least 80% of study pills. Adherence was 

assessed by weighing returned pill bottles. 

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

19221190 LaCroix,

2009

nd Mortality Causes of death were determined based on available medical records, autopsy reports, and the death certificate in 

a blinded fashion by local and central physician adjudicators.
Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

19221190 LaCroix,

2009

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes* Age, race

Anthropometrics (e.g., BMI, body weight, % body fat)? No*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Yes Latitude of clinical center, season 

of blood draw 

Smoking and other life styles variables (e.g., physical activity, occupation,

alcohol consumption)

No*

Other CaD treatment assignment

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Followup, mo

N 

Event

N 

Total

Outcome Metric (e.g. 

OR, RR, HR, %) and 

direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

19221190 LaCroix,

2009

Total mortality (same as 

Wactawski-Wende 2006 

[16481636])

CaD 84 mo 744 HR 0.91 0.83-

Placebo 84 mo 807 1.01

19221190 LaCroix,

2009

CVD death CaD 84 mo 226 HR 0.92 0.77-

Placebo 84 mo 244 1.10

19221190 LaCroix,

2009

CHD death (same as 

Hsia 2007 [17309935]

CaD 84 mo 130 HR 1.01 0.79-

Placebo 84 mo 128 1.29

19221190 LaCroix,

2009

Cerebrovascular

death 

CaD 84 mo 54 HR 0.89 0.62-

Placebo 84 mo 60 1.29

19221190 LaCroix,

2009

Cancer death (same as 

Wactawski-Wende 2006 

[16481636])

CaD 84 mo 344 HR 0.89 0.77-

Placebo 84 mo 382 1.03

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI 

/ SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

19221190 LaCroix,

2009

Total 

mortality

Tertiles of serum 

25(OH)D, nmol/L 

≥52.5 84 mo Adjusted OR 1.00

35.4-

52.4

84 mo 1.42 1.06-

1.91

<35.4 84 mo 1.46 1.07-

1.99

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 
UI Author

Year Outcome Results

19221190 LaCroix,

2009

Mortality (Nested case-control study)

Compared with women in the highest tertile of serum 25(OH)vitD, there was a significantly increased risk for death for women in the middle and 

low tertiles. The odds ratio for serum 25(OH)D level was analyzed as a continuous variable was 0.80 (95% CI, 0.67-0.95) for a difference of 29.9 

nmol/L (the interquartile range).

UI Author

Year Comments for Results

-----Subgroup Analyses 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, 

RR, HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

Participants younger than 70 years

19221190 LaCroix,

2009

Total mortality CaD 85.2 mo 466 HR 0.89 0.79-

Placebo 85.2 mo 517 1.01

19221190 LaCroix,

2009

CVD death CaD 85.2 mo 115 HR 0.85 0.66-

Placebo 85.2 mo 135 1.08

19221190 LaCroix,

2009

CHD death CaD 85.2 mo 70 HR 0.99 0.71-

Placebo 85.2 mo 70 1.38

19221190 LaCroix,

2009

Cerebrovascular

death 

CaD 85.2 mo 21 HR 0.62 0.36-

Placebo 85.2 mo 33 1.08

19221190 LaCroix,

2009

Cancer death CaD 85.2 mo 245 HR 0.91 0.76-

Placebo 85.2 mo 268 1.08

Participants 70 or older 

19221190 LaCroix,

2009

Total mortality CaD 80.4 mo 278 HR 0.95 0.80-

Placebo 80.4 mo 290 1.12

19221190 LaCroix,

2009

CVD death CaD 80.4 mo 111 HR 1.01 0.78-

Placebo 80.4 mo 109 1.32

19221190 LaCroix,

2009

CHD death CaD 80.4 mo 60 HR 1.02 0.71-

Placebo 80.4 mo 58 1.47

19221190 LaCroix,

2009

Cerebrovascular

death 

CaD 80.4 mo 33 HR 1.20 0.72-

Placebo 80.4 mo 27 2.01

19221190 LaCroix,

2009

Cancer death CaD 80.4 mo 99 HR 0.86 0.65-

Placebo 80.4 mo 114 1.12

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

19221190 LaCroix,

2009

RCTParallel y y n y nd y y y y B

Adverse Event(s): ** Nd (Study pills were discontinued if women reported kidney stones, hypercalcemia, dialysis, or the use of 

calcitriol or daily supplements of more than 1,000 IU of vitamin D during semiannual contacts.)

Explanation for Overall Quality Grade (if not Grade A):

It was the consensus among the Tufts EPC that overall, the methodological quality of the trial was B, 

particularly when the trial is being used to guide decisions about DRI, as opposed to decisions about whether 

to actively recommend supplementation for an individual woman.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 
QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

19221190 LaCroix,

2009

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

n a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

n

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

n

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

y

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

nd Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

n

b) Loss to 

follow-up 

<20%? (y/n)

y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

n

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

nd b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

n

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Reporting quality was poor overall. Comparative categories were not clear in the results section. 

Matching factors were not reported in case and control groups. 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

15354150 Lappe

2004

RCT-post 

hoc

girl 

scouts

significant health problems (see list in paper); usual dietary calcium 

intake >1100 mg; BMI ≥85%tile for age and sex; participants in 

organized team sports ≥3x/wk

nd - Natl Institute 

of Nursing

SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

15354150 Lappe

2004

RCTpost hocOmaha, NE 

41 N

63 59 9.5 nd 0 95% white

5% black

BMI 17 nd dietary intake 

calcium: 819 mg/d; 

vit D 4.5 μg/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

15354150 Lappe

2004

25(OH)D 

and/or 

1,25(OH)2D

dietary vit D 

4.5 μg/d

Dietary 

calcium 

intake

3-d food 

records

nd n dietary intake 

calcium: 819 

mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Total Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

15354150 Lappe calcium enriched diet foods, calcium-fortified foods (but no 

calcium supplement)

≥1500 mg/d 24 mo nd

usual diet

Co-intervention(s) *:

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

15354150 Lappe secondary change in BMI

change in wt

change in ht

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

15354150 Lappe study funded the calcium enriched foods

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

15354150 Lappe Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes baseline wt, energy and 

protein intake

Demographics (e.g., age, gender, race, education)? No

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes wt; ht

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes physical activity

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI

Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final or 

Delta CI 

/ SE / 

SD*

Net 

difference

Net 

difference 

CI / SE / SD*

P 

between

15354150 Lappe BMI kg/m2 calcium 

enriched

24 mo 27 17 2.0 19 2.8 NS

usual 32 17 3.0 19 3.3

wt kg calcium 

enriched

24 mo 27 32.2 4.6 42.9 7.5 NS

usual 32 33.2 6.7 44.1 9.9

ht cm calcium 

enriched

24 mo 27 137 6.3 151 7.0 NS

usual 32 138 4.6 151 6.0

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 
***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

15354150 Lappe ANCOVA with tertile of calcium intake (lowest (731±105 mg/d) vs. highest (1366±193 mg/d); baseline wt; mean energy and 

protein intake in 24 mo) on change in body wt

calcium was not a significant 

predictor

ANCOVA with tertile of calcium intake (lowest (731±105 mg/d) vs. highest (1366±193 mg/d); baseline wt; mean energy and 

protein intake in 24 mo) on change in ht

calcium was not a significant 

predictor

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

15354150 Lappe RCT 

posthocnd nd NA Y N N N Y Y B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): did not account for all relevant variables like Tanner stage, menstrual history

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

17556697 Lappe

2007

RCT >55 y women; no cancer; mentally and 

physically fit to permit 4 y participation.

More detailed inclusion criteria were 

published in a previous publication 

(Lappe 2006): women needed to be at 

least four years past last menses, in 

generally good health, living 

independently in the community, and 

weighing less than 300 pounds

More detailed inclusion criteria were published in 

a previous publication (Lappe 2006): 1) a medical 

diagnosis of any CKD, 2) Paget’s or other 

metabolic bone disease, and 3) history of cancer 

except for a) superficial basal or squamous cell 

carcinoma of the skin and b) other malignancies 

treated curatively more than 10 years prior to

entry into study.

nd none nd SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17556697 Lappe

2007

RCT Nebraska, 

41.4o N

1180 1179 67 

(7.3)

nd 0 white BMI 29 mentally and 

physically fit to 

permit 4 y 

participation

baseline 25(OH)-

D 71.8 ± 20.3

nmol/L

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17556697 Lappe

2007

25(OH)D RIA n nd nd baseline 

25(OH)D 71.8 

± 20.3 nmol/L

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 
***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand 

name, foods, or 

formulation) 

Vit D and/or Ca Dose Intervention 

Duration

Intervention Frequency (e.g. 

capsules were taken 2 times a 

day)

17556697 Lappe

2007

placebo placebo 4 y(?) nd

calcium only calcium citrate (1400 mg Ca/d) or calcium 

carbonate (1500 mg Ca/d) plus a vit D placebo

4 y(?) nd

calcium plus vit D calcium citrate (1400 mg Ca/d) or calcium 

carbonate (1500 mg Ca/d) plus 1000 IU (25μg) 

cholecalciferol (vit D3)

4 y(?) nd

Co-intervention(s) *: nd

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17556697 Lappe

2007

secondary incident cancer from medical record (including breast, colon, lung, lymph, uterus and others)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17556697 Lappe

2007

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no*

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Event* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD **

P between 

groups***

P for 

trend****

17556697 Lappe

2007

incident 

cancer 

(years 1-4)

placebo 20 288 % 6.9% chi2=7.3 with 

df 2; P<0.03 

comparing 

placebo with 

the other 2 

groups

calcium only 17 445 3.8%

calcium plus vit D 13 446 2.9%

incident placebo 16 266 6.8%
cancer 

(years 2-4)

calcium only 15 416 3.6%

calcium plus vit D 6 403 2.0%

incident 

cancer 

(years 1-4)

placebo 20 288 RR 1.0

calcium only 17 445 0.532 0.27-

1.03

0.063

calcium plus vit D 13 446 0.402 0.20-

0.82

0.013

incident 

cancer 

(years 2-4)

placebo 18 266 1.0

calcium only 15 416 0.587 0.29-

1.21

0.147

calcium plus vit D 8 403 0.232 0.09-

0.60

<0.005

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)

No. 

Analyzed Baseline Baseline SD*

Final 

or 

Delta**

Final 

SD*

Net 

difference***

Net 

difference 

SD*

P 

between 

groups***

17556697 Lappe

2007

change in 

25 OH(D) 

level at 

12 mo

placebo

12 mo nd 72.1 20.7 71.1 19.8 -0.23 14.7 nd

calcium only 71.6 20.5 71 20.3 -0.74 13.0

calcium plus 

vit D 71.8 20.0 96.0 21.4 23.9 17.8

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups
Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI

Author

Year Outcome Results

17556697 Lappe

2007

cancer risk Logistic regression showed treatment assignment and either baseline or 12 mo 25()H)-D levels were significant independent 

predictors (P<0.002, P<0.03) respectively.

RR of cancer per unit concentration of 25(OH)D was 0.983 (CI 0.968 to 0.997); P<0.01

renal calculi in placebo 1/288

renal calculi in calcium 

only 3/445

renal calculi in calcium 

plus vit D 1/446

UI Author

Year Comments for Results

17556697 Lappe

2007 unclear reporting, discrepancy between Table 1 and text

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17556697 Lappe

2007

RCT -

parallel Y N

NA Y N Y N NA N B

Adverse Event(s): ** renal calculi (see above), no significant difference between groups

Explanation for Overall Quality Grade (if not Grade A): unclear reporting, discrepancy between Table 1 and text

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment Years Trial or 

Cohort Name Funding Source Extractor

18433305 Lappe 

2008

RCT Women entered basic 

training at the US Navy

nd May 2001 to 

march 2006

nd Department of Defense Bone Health and 

Military Readiness Grant

MC

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

18433305 Lappe 

2008

RCT Great 

Lakes, IL, 

USA

41° North

5201 3700 Median: 

19

17-35 0 American 

Indian: 3%, 

Asian: 4%, nonHispanic black: 

18%, Hispanic: 

13%, nonHispanic white: 

54%, other: 4%

Mean BMI = 24 

(ranged 15-43)

Assumed 

healthy 

(Navy 

recruits)

Mean dairy 

servings/wk = 6 

(ranged 1-26)

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

18433305 Lappe 

2008

25(OH)D 

and/or 

1,25(OH)2D

nd Very little 

cutaneous 

conversion of 

vitamin D takes 

place between the 

months of 

September and 

March due to the 

latitude.

18433305 Lappe 

2008

Dietary 

calcium 

intake

Risk factor 

questionnaire 

(no further 

information)

nd n Mean dairy 

servings/wk = 6 

(ranged 1-26)

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation)

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

18433305 Lappe 

2008

Calcium + vitamin D nd 200 mg calcium and 800 

IU vitamin D/day

8 weeks 4 supplement pills per day made available in 

galley line at breakfast and dinner

placebo

Co-intervention(s) *: none

Compliance/Adherence: To monitor pill taking, project staff observed the galley food lines, visited recruits in their quarters, and conducted an exit interview.

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

18433305 Lappe 

2008

primary stress 

fractures

Stress fractures were ascertained when recruits reported to the Great lakes clinic with symptoms. All stress 

fractures were confirmed with radiography or technetium scan according to the usual Navy protocol.
Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

18433305 Lappe 

2008

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

Demographics (e.g., age, gender, race, education)? Yes Age group (<25 vs. >=25 yr)

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication Use of depomedroxyprogesterone

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical 

activity, occupation, alcohol consumption)

Yes exercise sessions/wk (high vs. low), smoking, 

run time per 1.5 mi at entry of basic training

Other Menses during training

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, 

RR, HR, %) and direction 

of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI P btw

18433305 Lappe 

2008

Stress fracture 

(ITT analysis)

Calcium + 

vitamin D

2 5.3% 2626 RR ca+vitD / placebo 0.8 0.64-

0.99

0.026

Placebo 2 6.6% 2575

18433305 Lappe 

2008

Stress fracture 

(per protocol 

analysis)

Calcium + 

vitamin D

2 6.8% 1852 OR ca+vitD / placebo nd 0.02 0.789 0.616-

1.01

0.0589

Placebo 2 8.6% 1848

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

18433305 Lappe 

2008

RCT -

parallel Y nd NA N nd Y Y Y Y B

Adverse Event(s): ** GI disruption such as constipation, diarrhea, upset stomach (4%), and musculoskeletal soreness (0.9%)

Explanation for Overall Quality Grade (if not Grade A):

Dropout rate = 29% (majority withdrew because the participants changed their mind, forgot, it was too difficult, 

or for no reported reason). Participants who developed adverse events also withdrew from the study. A little bit 

more people allocated to treatment group withdrew than the placebo group (n=774 vs. 727 respectively).

There was ITT analysis but multivariate model only for per protocol analysis.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

16522915 Larsson 

2006 

Cohort 

study

Men aged 45-79

Resides in 

Vastmanland & Orebro 

counties (n=100303)

Completed the 

questionnaire 

(n=48850)

Missing/erroneous registration 

#

Implausibly high energy intake

Previous cancer (excl. 

nonmelanoma skin cancer) at 

baseline

1997 

(Autumn)

The Cohort of 

Swedish Men

the Swedish Cancer Foundation, 

the Swedish Research

Council-Longitudinal Studies, 

the Swedish Foundation for 

International Cooperation

in Research and Higher 

Education (STINT), 

Vastmanland County

Research Fund against Cancer, 

Orebro County Council 

Research Committee,

And Orebro Medical Center 

Research Foundation

TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

16522915 Larsson 

2006 

Cohort 

study

Sweden 

(Vastmanland

[59° 37'N] & 

Orebro counties

[59.23 N])

48850 45306 60.3 

(nd)

100% nd BMI=25.8kg/m2 Hx of 

DM=6.1%

Aspirin 

use=36.4%

Vit D=6.4 g/d

Saturated fat 33.5 

g/d

Ca=809-1665 

mg/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

16522915 Larsson 

2006 

Dietary 

calcium 

intake

FFQ Swedish Food 

Administration 

Database 

(Bergstrom 

1991)

Yes: by 24HR and 

correlation 

coefficient=0.77 

(total and dietary 

calcium intake)

NA NA nd Ca=809-1665 

mg/d

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

16522915 Larsson 

2006 

Not explicitly 

described

Colorectal 

caner 

National Swedish Cancer Register (-12/31/2003) and Regional Cancer Register covering the study area (from 

1/1/2004-12/31/2004), only adenocarcinoma.

16522915 Larsson 

2006 

Not explicitly

described Colon caner National Swedish Cancer Register (-12/31/2003) and Regional Cancer Register covering the study area (from 1/1/2004-12/31/2004), only adenocarcinoma.

16522915 Larsson 

2006 

Not explicitly 

described Rectal caner 

National Swedish Cancer Register (-12/31/2003) and Regional Cancer Register covering the study area (from 

1/1/2004-12/31/2004), only adenocarcinoma. (Rectal cancers included tumors in the rectosigmoid junction and 

rectum.)

16522915 Larsson 

2006 

Not explicitly 

described Proximal 

colon caner 

National Swedish Cancer Register (-12/31/2003) and Regional Cancer Register covering the study area (from 

1/1/2004-12/31/2004), only adenocarcinoma. (proximal colon cancers defined as tumors occurring from the cecum 

to the splenic flexure)

16522915 Larsson 

2006 

Not explicitly 

described Distal colon 

caner 

National Swedish Cancer Register (-12/31/2003) and Regional Cancer Register covering the study area (from 

1/1/2004-12/31/2004), only adenocarcinoma. (distal colon cancers defined as tumors occurring in the splenic 

flexure, descending colon, and sigmoid colon)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

16522915 Larsson 

2006 

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes (multivitamin, total energy, saturated fat, 

read meat, fruit, vegetables)

Demographics (e.g., age, gender, race, education)? Yes (age, education)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (BMI)

Medical conditions Yes (family Hx, Hx of DM)

Medication Yes (Aspirin)

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes (exercise, smoking, alcohol

Other nd

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

followup, mo

Mean 

Ca 

dose

No. of 

Cases

(Event)*

No. of 

total 

subjects**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

16522915 Larsson 

2006 

Colorectal 

cancer 

(total Ca 

intake 

[mg])

Q1

80.4 <956 127 11348 Adj (age) RR (HR) 1.0 Ref Nd

0.03

Q2 80.4 956-

1179

111 11341 0.81 0.63-

1.04

Nd

Q3 80.4 1180-

1444

107 11295 0.77 0.59-

0.99

Nd
Q4 80.4 1445

- 104 11322 0.73 0.51-

0.91

Nd

16522915 Larsson 

2006 

Colorectal 

cancer 

(total Ca 

intake 

[mg])

Q1 80.4 <956 127 11348 Adj (full 

multivariate 

model)

RR (HR) 1.0 Ref Nd 0.01

Q2 80.4 956-

1179

111 11341 0.80 0.61-

1.04

Nd

Q3 80.4 1180-

1444

107 11295 0.73 0.56-

0.96

Nd

Q4 80.4 1445- 104 11322 0.68 0.51-

0.91

Nd

16522915 Larsson 

2006 

Colon 

cancer 

(total Ca 

intake 

[mg])

Q1 80.4 <956 77 11348 Adj (age) RR (HR) 1.0 Ref Nd 0.24

Q2 80.4 956-

1179

62 11341 0.74 0.53-

1.04

Nd

Q3 80.4 1180-

1444

70 11295 0.84 0.60-

1.16

Nd

Q4 80.4 1445- 67 11322 0.78 0.56-

1.08

Nd

16522915 Larsson 

2006 

Colon 

cancer 

(total Ca 

intake 

[mg])

Q1 80.4 <956 77 11348 Adj (full 

multivariate 

model)

RR (HR) 1.0 Ref Nd 0.15

Q2 80.4 956-

1179

62 11341 0.72 0.51-

1.01

Nd

Q3 80.4 1180-

1444

70 11295 0.80 0.57-

1.12

Nd

Q4 80.4 1445- 67 11322 0.72 0.50-

1.04

Nd

16522915 Larsson 

2006 

Rectal 

cancer 

(total Ca 

intake 

[mg])

Q1 80.4 <956 50 11348 Adj (age) RR (HR) 1.0 Ref Nd 0.05

Q2 80.4 956-

1179

49 11341 0.91 0.61-

1.36

Nd

Q3 80.4 1180-

1444

37 11295 0.67 0.44-

1.02

Nd

Q4 80.4 1445- 37 11322 0.69 0.45-

1.06

Nd

16522915 Larsson 

2006 

Rectal 

cancer 

Q1 80.4 <956 50 11348 Adj (full 

multivariate 

RR (HR) 1.0 Ref Nd 0.02
(total Ca 

intake 

[mg])

model)

Q2 80.4 956-

1179

49 11341 0.91 0.61-

1.37

Nd

Q3 80.4 1180-

1444

37 11295 0.63 0.40-

0.98

Nd

Q4 80.4 1445- 37 11322 0.61 0.38-

0.98

Nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 
UI Author

Year Outcome Results

UI Author

Year Comments for Results

16522915 Larsson 

2006 

Results also on proximal and distal colon cancer subsites

# Multivariate RRs were adjusted for age (in mo), education (less than high school, high school graduate, or more than high school), family history of 

colorectal cancer (yes or no), BMI (in kg/m2; <23.0, 23.0– 24.9, 25.0 –29.9, or >30.0), exercise (h/wk; 3 categories), history of diabetes (yes or no), cigarette 

smoking (never, past, or current), aspirin use (no, <10 y, or >10 y), multivitamin supplement use (no, occasional use, or regular use), total energy intake 

(continuous), and quartiles of saturated fat, total vitamin D, alcohol, fruit, vegetable, and red meat intakes.

## Sensitivity analysis of colorectal cancer #1 (excluding the participants with Ca intake >2500 mg/d): multivariate Trend P=0.006

### Sensitivity analysis of colorectal cancer #2 (excluding the cases developed cancer within the first two years of follow-up): multivariate Trend P=0.005

#### Data on similar outcomes on dietary calcium only not analyzed because only 2.1% of participants were supplemental user, precluding meaningful 

analyses.

##### Data on similar outcomes on dairy foods presented but not extracted.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

16522915 Larsson 

2006 

a) Eligibility 

criteria 

clear? (y/n)

n/nd

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Nd

a) Method 

reported? 

(y/n)

y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N 

(~50%)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

y Time from 

sample

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

y/nd

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

n

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

y b) 

Justification 

of final 

adjusted

model 

selection? 

(y/n)

n

c) Do the 

authors specify 

a primary 

outcome? (y/n)

n

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Some limited reporting (inclusion and blinding), post-hoc analysis of a database; cases not confirmed by 

pathology results

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

16522915 Larsson 

2006 

Cohort 

study

Men aged 45-79

Resides in 

Vastmanland & Orebro 

counties (n=100303)

Completed the 

questionnaire 

(n=48850)

Missing/erroneous registration 

#

Implausibly high energy intake

Previous cancer (excl. 

nonmelanoma skin cancer) at 

baseline

1997 

(Autumn)

The Cohort of 

Swedish Men

the Swedish Cancer Foundation, 

the Swedish Research

Council-Longitudinal Studies, 

the Swedish Foundation for 

International Cooperation

in Research and Higher 

Education (STINT), 

Vastmanland County

Research Fund against Cancer, 

Orebro County Council 

Research Committee,

And Orebro Medical Center 

Research Foundation

TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

16522915 Larsson 

2006 

Cohort 

study

Sweden 

(Vastmanland 

[59° 37'N] & 

Orebro counties 

[59.23 N])

48850 45306 60.3 

(nd)

nd 100% nd BMI=25.8kg/m2 Hx of 

DM=6.1%

Aspirin 

use=36.4%

Vit D=6.4 g/d

Saturated fat 33.5 

g/d

Ca=809-1665 

mg/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd nd

16522915 Larsson 

2006 

Dietary 

calcium 

intake

FFQ Swedish Food 

Administration 

Database 

(Bergstrom 

1991)

Yes: by 24HR and 

correlation 

coefficient=0.77 

(total and dietary 

calcium intake)

Ca=809-1665 

mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

16522915 Larsson 

2006 

nd Colorectal 

caner 

National Swedish Cancer Register (-12/31/2003) and Regional Cancer Register covering the study area (from 

1/1/2004-12/31/2004), only adenocarcinoma.

nd Colon caner National Swedish Cancer Register (-12/31/2003) and Regional Cancer Register covering the study area (from 

1/1/2004-12/31/2004), only adenocarcinoma.

nd

Rectal caner 

National Swedish Cancer Register (-12/31/2003) and Regional Cancer Register covering the study area (from 

1/1/2004-12/31/2004), only adenocarcinoma. (Rectal cancers included tumors in the rectosigmoid junction and 

rectum.)

nd Proximal 

colon caner 

National Swedish Cancer Register (-12/31/2003) and Regional Cancer Register covering the study area (from 

1/1/2004-12/31/2004), only adenocarcinoma. (proximal colon cancers defined as tumors occurring from the cecum 

to the splenic flexure)

nd Distal colon 

caner 

National Swedish Cancer Register (-12/31/2003) and Regional Cancer Register covering the study area (from 

1/1/2004-12/31/2004), only adenocarcinoma. (distal colon cancers defined as tumors occurring in the splenic 

flexure, descending colon, and sigmoid colon)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

16522915 Larsson 

2006 

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes (multivitamin, total energy, saturated fat, 

read meat, fruit, vegetables)

Demographics (e.g., age, gender, race, education)? Yes (age, education)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (BMI)

Medical conditions Yes (family Hx, Hx of DM)

Medication Yes (Aspirin)

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes (exercise, smoking, alcohol

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

followup, mo

Mean 

Ca 

dose

No. of 

Cases 

(Event)* 

No. of 

total 

subjects**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

16522915 Larsson 

2006 

Colorectal 

cancer 

(total Ca 

intake 

[mg])

Q1

80.4 <956 127 11348 Adj (age) RR (HR) 1.0 Ref Nd

0.03

Q2 80.4 956-

1179

111 11341 0.81 0.63-

1.04

Nd

Q3 80.4 1180-

1444

107 11295 0.77 0.59-

0.99

Nd

Q4 80.4 1445- 104 11322 0.73 0.51-

0.91

Nd

16522915 Larsson 

2006 

Colorectal 

cancer 

(total Ca 

intake 

[mg])

Q1 80.4 <956 127 11348 Adj (full 

multivariate 

model)

RR (HR) 1.0 Ref Nd 0.01

Q2 80.4 956-

1179

111 11341 0.80 0.61-

1.04

Nd

Q3 80.4 1180-

1444

107 11295 0.73 0.56-

0.96

Nd

Q4 80.4 1445- 104 11322 0.68 0.51-

0.91

Nd

16522915 Larsson 

2006 

Colon 

cancer 

(total Ca 

intake 

[mg])

Q1 80.4 <956 77 11348 Adj (age) RR (HR) 1.0 Ref Nd 0.24

Q2 80.4 956-

1179

62 11341 0.74 0.53-

1.04

Nd

Q3 80.4 1180-

1444

70 11295 0.84 0.60-

1.16

Nd

Q4 80.4 1445- 67 11322 0.78 0.56-

1.08

Nd

16522915 Larsson 

2006 

Colon 

cancer 

(total Ca 

intake 

[mg])

Q1 80.4 <956 77 11348 Adj (full 

multivariate 

model)

RR (HR) 1.0 Ref Nd 0.15

Q2 80.4 956-

1179

62 11341 0.72 0.51-

1.01

Nd

Q3 80.4 1180- 70 11295 0.80 0.57- Nd
1444 1.12

Q4 80.4 1445- 67 11322 0.72 0.50-

1.04

Nd

16522915 Larsson 

2006 

Rectal 

cancer 

(total Ca 

intake 

[mg])

Q1 80.4 <956 50 11348 Adj (age) RR (HR) 1.0 Ref Nd 0.05

Q2 80.4 956-

1179

49 11341 0.91 0.61-

1.36

Nd

Q3 80.4 1180-

1444

37 11295 0.67 0.44-

1.02

Nd

Q4 80.4 1445- 37 11322 0.69 0.45-

1.06

Nd

16522915 Larsson 

2006 

Rectal 

cancer 

(total Ca 

intake 

[mg])

Q1 80.4 <956 50 11348 Adj (full 

multivariate 

model)

RR (HR) 1.0 Ref Nd 0.02

Q2 80.4 956-

1179

49 11341 0.91 0.61-

1.37

Nd

Q3 80.4 1180-

1444

37 11295 0.63 0.40-

0.98

Nd

Q4 80.4 1445- 37 11322 0.61 0.38-

0.98

Nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 
**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

16522915 Larsson 

2006 

Results also on proximal and distal colon cancer subsites

- Multivariate RRs were adjusted for age (in mo), education (less than high school, high school graduate, or more than high school), family history of 

colorectal cancer (yes or no), BMI (in kg/m2; <23.0, 23.0– 24.9, 25.0 –29.9, or >30.0), exercise (h/wk; 3 categories), history of diabetes (yes or no), cigarette 

smoking (never, past, or current), aspirin use (no, <10 y, or >10 y), multivitamin supplement use (no, occasional use, or regular use), total energy intake 

(continuous), and quartiles of saturated fat, total vitamin D, alcohol, fruit, vegetable, and red meat intakes.

- Sensitivity analysis of colorectal cancer #1 (excluding the participants with Ca intake >2500 mg/d): multivariate Trend P=0.006

- Sensitivity analysis of colorectal cancer #2 (excluding the cases developed cancer within the first two years of follow-up): multivariate Trend P=0.005

- Data on similar outcomes on dietary calcium only not analyzed because only 2.1% of participants were supplemental user, precluding meaningful analyses.

- Data on similar outcomes on dairy foods presented but not extracted.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

16522915 Larsson 

2006 

a) Eligibility 

criteria 

clear? (y/n)

nd

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Some limited reporting (inclusion and blinding), post-hoc analysis of a database; cases not confirmed by 

pathology results

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

18332289 Larsson 

2008

Cohort 

Study

Male 

smokers, 50-

69 y

Nonmelanoma cancer, other serious disease, anticoagulant 

therapy, excessive doses of vitamin E, vitamin A, beta carotene, 

incomplete dietary data, self-reported history of stroke

1985-1988 ATBC study Gov’t EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

18332289 Larsson 

2008

Cohort 

Study

Southwestern 

Finland

~60°

26556 26556 ~57 

(nd)

50-69 100 Mostly 

white 

(implied)

~26.5 Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

18332289 Larsson 

2008

Dietary 

calcium 

intake

FFQ nd “evaluated 

previously”

nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

18332289 Larsson 

2008

1°

First stroke (and subtypes)

Hospital discharge and death registries, by ICD codes. 

Subtypes confirmed in a sample, correct between 79 & 

95% of time.

Cerebral infarction included here

Also separate analysis for much smaller numbers of cases of 

intracerebral hemorrhage and subarachnoid hemorrhage. Not 

extracted here. 

No analysis of total stroke.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

18332289 Larsson 

2008

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes Total energy intake

Demographics (e.g., age, gender, race, education)? Yes Age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions Yes DM, CHD

Medication Yes Alpha tocopherol and beta 

carotene

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes # cigarettes, physical 

activity, EtOH

Other Yes BP, total cholesterol, HDL

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Median 

Ca 

intake

No. of 

Cases 

(Event)* 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

18332289 Larsson 

2008

Cerebral 

infarction

Total Ca intake 

Quintile 1

876 518 ~5311 13.6 years Adjusted 

(“multivariate”)

RR 1.00 -- -- 0.09

Quintile 2 1178 541 ~5311 1.08 0.95, 

1.22

NS

Quintile 3 1379 542 ~5311 1.09 0.96, 

1.23

NS

Quintile 4 1581 546 ~5311 1.11 0.98, 

1.26

NS

Quintile 5 1916 555 ~5311 1.10 0.98, 

1.26

NS

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 
Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

18332289 Larsson 

2008

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Outcome ascertainment questionable; did not confirm diagnosis in most. In sample, large percentage with 

misclassification of stroke (correct in 79-90%) and stroke death (correct in 91-95%).

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name Funding Source Extractor

19056569 Larsson 

2009

Cohort 

study

-Women born between 

1917 and 1948 in 

Vastmanland County, 

Sweden

-Women born between 

1914 and 1948 in Uppsala 

County, Sweden

-erroneous or missing national 

registration number

-questionnaires that lacked a 

date, the date the subject moved 

out of study area, or date of 

death

-implausible values for energy 

intake

-cancer diagnosis except nonmelanoma skin cancer

1987-1990 Swedish 

Mammography 

Cohort

Swedish Cancer 

Foundation, Swedish 

Research Council for 

Infrastructure

KP

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) Age,

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

19056569 Larsson 

2009

Cohort 

study

Sweden 

62oN

61,433 36,664 53.7(9.7) Nd 0 Swedish BMI 24.8(3.9) nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of Dietary 

Assessment? (y/n) If 

Yes, Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

19056569 Larsson 

2009

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd nd

Dietary 

calcium 

intake

FFQ Swedish 

National Food 

Administration 

Database

Y- Pearson correlation 

coefficient between 

FFQ and dietary 

records was 0.5 for 

dietary calcium, 

Spearman correlation 

coefficient between 

FFQ and fourteen 24-h 

recalls over 1 y was 

0.77 for dietary and 

total calcium intake

nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

19056569 Larsson 2009 Primary Invasive breast cancer Linkage with national and regional Swedish Cancer registers

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

19056569 Larsson 

2009

Other nutrients or dietary factors (e.g., certain food consumption),

including supplement use and total energy intake

Total energy intake, fiber

Demographics (e.g., age, gender, race, education)? Yes Age, education

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI, height

Medical conditions History of benign breast disease

Medication Use of oral contraceptives, use of postmenopausal 

hormones

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes alcohol

Other Age at first birth, age at menarche, age at 

menopause, family history of breast cancer

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

19056569 Larsson 

2009

Invasive 

breast 

cancer

Quintile 1: <727 

mg/d calcium

nd nd 595 nd 9.4 yrs Adjusted RR 1.00 Reference nd

0.49

Quintile 2: 727-

862 mg/d 

calcium

nd nd 595 nd 9.4 yrs 0.97 0.87-1.09 nd

Quintile 3: 863- nd nd 592 nd 9.4 yrs 0.95 0.84-1.06 nd
980 mg/d 

calcium

Quintile 4: 980-

1124 mg/d 

calcium

nd nd 571 nd 9.4 yrs 0.93 0.83-1.04 nd

Quintile 5: 

≥1125 mg/d 

calcium

nd nd 599 nd 9.4 yrs 0.97 0.87-1.09 nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

19056569 Larsson 

2009

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

n

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

y b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): No data on blinding, almost half of original cohort didn’t answer second questionnaire for various reasons

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort Name

Funding 

Source Extractor

17388667 Li 2007 Casecohort 

study

Male 

physicians

Hx of MI, stroke, hx of TIA, unstable angina, cancer (except 

nonmelanoma skin cancer), current renal or liver disease, peptic 

ulcer, gout, current use of platelet-active agents, vit A or betacarotene supplements

1982 - 2000 Physicians’ 

Health Study

NIH, US Army 

Medical 

Research

 KP/SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled

N 

analyzed

Mean (SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17388667 Li 2007 Casecohort 

study

United 

Statesmultiple 

locations

 2684 1156

492 

cases

664

control

58.9 8.3 at 

study onset. 

69.3 7.3 at 

diagnosis

nd 100% 6% not of 

European 

descent

Age at study onset: 

cases = 58.9(8.3), 

controls = 59.0(8.0)

nd -Vit D deficiency 

(<20 ng/ml) in 

summer/fall: 10.8% 

in cases and 12.7% 

in controls

-Vit D deficiency in 

spring/winter: 

27.9% in cases and 

36.4% in controls

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17388667 Li 2007 25(OH)D 

and/or 

1,25(OH)2D

 

 

 

RIA Yes: mean intrapair coefficients of 

variation for 

blinded duplicate 

quality control 

samples were 

7.9% to 8.1% for 

25(OH)D and 

1,25(OH)D 

Nd Spring or 

winter: 24.1% 

of cases and 

26.0% of 

controls

nd

Dietary 

calcium 

intake

Nd Nd Nd nd

* Write “nd” if there was no data reported. Please do not leave blank 
**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17388667 Li 2007 secondary Prostate cancer Tumor Gleason score, grade, stage determined by reviewing medical and pathological reports

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must be explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes Age (matched), race

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., physical activity level, occupation, 

sun exposure, location)

Smoking and other life styles variables Yes Smoking status (matched), 

exercise

Other Follow-up period (matched)

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases*

No. of 

Noncases

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI 

/ 

P between 

groups***

P for 

trend****
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases*

No. of 

Noncases

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect size CI 

P 

between 

groups***

P for 

trend****

17388667 Li 2007 Total 

prostate 

cancer

Quartile 1: lowest 

25(OH)D

Nd Nd Nd nd adjusted OR 1.01 0.71-1.44 nd

0.91

Quartile 2 Nd Nd Nd Nd 1.26 0.89-1.80

Quartile 3 Nd Nd Nd Nd 1.00 0.71-1.41

Quartile 4: highest 

25(OH)D

nd Nd nd Nd Reference Reference

Aggressive 

prostate 

cancer

Quartile 1: lowest 

25(OH)D

Nd Nd Nd nd adjusted OR 1.27 0.76-2.13 nd

0.74

Quartile 2 Nd Nd Nd Nd 1.33 0.80-2.20

Quartile 3 Nd Nd Nd Nd 0.97 0.58-1.60

Quartile 4: highest 

25(OH)D

nd Nd nd Nd Reference Reference

Total 

prostate 

cancer age 

>= 65 y

Quartile 1: lowest 

25(OH)D

Nd Nd Nd nd adjusted OR 1.03 0.67-1.60 nd

0.95

Quartile 2 Nd Nd Nd Nd 1.32 0.86-2.03

Quartile 3 Nd Nd Nd Nd 1.02 0.68-1.54

Quartile 4: highest 

25(OH)D

nd Nd nd Nd Reference Reference

Aggressive 

prostate 

cancer age 

>= 65 y

Quartile 1: lowest 

25(OH)D

Nd Nd Nd nd adjusted OR 1.34 0.71-2.53 nd

0.68

Quartile 2 Nd Nd Nd Nd 1.41 0.75-2.62

Quartile 3 Nd Nd Nd Nd 0.91 0.49-1.70

Quartile 4: highest 

25(OH)D

nd Nd nd Nd Reference Reference

Total 

prostate 

cancer

Quartile 1: lowest 

1,25(OH)D

Nd Nd Nd nd adjusted OR 0.91 0.63-1.33 nd

0.74

Quartile 2 Nd Nd Nd Nd 1.35 0.95-1.92

Quartile 3 Nd Nd Nd Nd 0.94 0.66-1.36

Quartile 4: highest 

1,25(OH)D

nd Nd nd Nd Reference Reference
Aggressive 

prostate 

cancer

Quartile 1: lowest 

1,25(OH)D

Nd Nd Nd nd adjusted OR 1.37 0.81-2.33 nd

0.07

Quartile 2 Nd Nd Nd Nd 1.90 1.14-3.16

Quartile 3 Nd Nd Nd Nd 1.19 0.69-2.05

Quartile 4: highest 

1,25(OH)D

nd Nd nd Nd Reference Reference

Total 

prostate 

cancer age 

>= 65 y

Quartile 1: lowest 

1,25(OH)D

Nd Nd Nd nd adjusted OR 1.19 0.75-1.89 nd

0.26

Quartile 2 Nd Nd Nd Nd 1.53 0.98-2.39

Quartile 3 Nd Nd Nd Nd 1.17 0.73-1.89

Quartile 4: highest 

1,25(OH)D

nd Nd nd Nd Reference Reference

Aggressive 

prostate 

cancer age 

>= 65 y

Quartile 1: lowest 

1,25(OH)D

Nd Nd Nd nd adjustedOR 1.93 0.99-3.75 nd

0.03

Quartile 2 Nd Nd Nd Nd 2.17 1.15-4.10

Quartile 3 Nd Nd Nd Nd 1.55 0.76-3.16

Quartile 4: highest 

1,25(OH)D

nd Nd nd Nd Reference Reference

Total 

prostate 

cancer

Low 25(OH)D, 

Low 1,25(OH)D

Nd Nd Nd nd adjusted OR 1.33 0.94-1.88 nd 0.85 (p-

value for 

interaction)

Low 25(OH)D, 

High 1,25(OH)D

Nd Nd Nd nd 1.16 0.82-1.64

High 25(OH)D, 

Low 1,25(OH)D

0.85-1.70

High 25(OH)D, 

High 1,25(OH)D

Reference Reference

Aggressive 

prostate 

cancer

Low 25(OH)D, 

Low 1,25(OH)D

Nd Nd Nd nd adjusted OR 2.06 1.24-3.43 nd 0.23 (p-

value for 

interaction)

Low 25(OH)D, 

High 1,25(OH)D

Nd Nd Nd nd 1.08 0.66-1.77

High 25(OH)D, 

Low 1,25(OH)D

1.24 0.75-2.04

High 25(OH)D, 

High 1,25(OH)D

Reference Reference
UI Author

Year Comments for Results

17388667 Li 2007 Cutoff points for quartiles were only listed for controls (presumably for total prostate cancer in all age groups); not for cases or for age or aggressive disease 

subgroups. Cutoffs for controls were 18.3, 24.4, and 31.1 ng/ml for winter/spring-collected samples and 24.4, 32.0, and 39.5 ng/ml for summer/fall-collected 

samples. 

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17388667 Li 2007

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

NA

a) One of 

the 

prespecified 

methods 

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Y

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

NA

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Thorough explanations of methodology, however group comparison data was not clearly documented with 

regards to group cutoffs. Only 492/1066 (46%) cases had vit D analysis because of limited funding.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name Funding Source Extractor

8557965 Lijnen 

1995

RCT Male, “Normal”

Normotensive (not 

defined)

none <1994 None nd

Supplements provided by 

industry

EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

8557965 Lijnen 

1995

RCT Leuven, 

Belgium

51°

32 32 24±1 20-44 y 100 nd Weight 75.9±1.3 Kg Healthy 1 month low Ca diet 

run-in

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd nd

8557965 Lijnen 

1995

Dietary 

calcium 

intake

None NA NA “Low Ca diet” 

run-in

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

8557965 Lijnen 

1995

Ca supplement Ca gluconate 2 g 16 wk 1 g 2x/day

Placebo

Co-intervention(s) *: Low dairy diet

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

8557965 Lijnen 1995 2° SBP/DBP Standing and supine

2° 25(OH)D Competitive protein binding assay (Medgenix and/or Inestar Corp)

1,25(OH)D Radioreceptor assay (Medgenix and/or Inestar Corp)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

8557965 Lijnen 

1995

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? No

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SEM

Delta / 

~Final

Delta 

Range / 

~SEM

Net 

difference

Net 

difference 

CI / SE / SD*

P 

between

8557965 Lijnen 

1995

SBP 

(standing)

mm 

Hg

Ca suppl 4 16 ~124 

(figure)

~2 

(figure)

-7.8 -16, +4 -5.7 0.01

Placebo 16 ~122 ~2 -2.1 -15, +7

DBP 

(standing)

mm 

Hg

Ca suppl 4 16 ~78 ~2 -2.6 -14, +6 -3.5 0.06

Placebo 16 ~76 ~2 +0.9 -4, +16

SBP 

(supine)

mm 

Hg

Ca suppl 4 16 114 2 ~110 ~2 ~-2 NS

Placebo 16 114 2 ~112 ~2

DBP 

(supine)

mm 

Hg

Ca suppl 4 16 74 2 ~73 ~1 ~-1 NS

Placebo 16 72 2 ~72 ~1

25(OH)D ng/mL Ca suppl 4 16 ~24 ~4 ~20 ~2 ~+5 NS

Placebo 16 ~29 ~3 ~21 ~2

1,25(OH)D pg/mL Ca suppl 4 16 ~30 ~3 ~21 ~3 ~-9 <0.05

Placebo 16 ~31 ~2 ~31 ~2

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

8557965 Lijnen 

1995 RCT nd nd Y Y nd Y Y N N C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Incomplete data reporting. No data on background diet, even though diet was manipulated

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

15800268 Lin 

2005

Cohort study

Participants are 

included in an 

RCT

US female 

professionals aged

45 or older

Free of cancer and 

CVD

Excluded (n=2900)

did not provide 

sufficient dietary 

information at 

baseline

had an implausible 

total energy intake 

(<600 or >3,500 

kcal/day)

failed to provide 

information on 

potential risk factors 

at baseline

1993 (RCT) The Women’s Health Study (a 2x2 

factorial RCT evaluating low-dose 

ASA and Vit E for the primary 

prevention of cancer and CVD.

NCI and National 

Heart, Lung, and 

Blood Institute

TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat 

...etc)

Health Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or 

Ca intake 

...etc.)

15800268 Lin 

2005

Cohort 

study

Participants 

are 

included in 

an RCT

US (25

46’-54

40’)

36976 36976 Nd 

(~54 

y)

45 or over 

(enrollment 

of the RCT)

0% nd BMI=~26 FH of colorectal 

cancer=~10%

Previous colorectal 

polyps=~3%

Current use of 

hormone 

replacement=~40%

Physical activity=~ 

1300kcal/d

Total energy 

intake=~1700 

kcal/d

Total fat 

intake=~55 g/d

Total fiber 

intake=~20 g/d

Total Ca=882 

mg/d (median)

Total Vit 

D=205 IU/d 

(median)

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd nd

15800268 Lin 

2005

Dietary 

calcium 

intake

FFQ USDA + data 

from 

manufacturers

Correlation 

coefficients (FFQ 

and 4 1-week 

records): 0.56 (total 

Ca) and 0.51 

(dietary Ca)

882 mg/d 

(median)

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

15800268 Lin 

2005

nd Colorectal cancer Follow-up questionnaire (q6mo for the 1st y and annually thereafter) confirmed by medical records and 

pathology reports during a follow-up of 9 y.

nd Proximal colon 

cancer

Not fully defined (data not extracted)

nd Distal colon 

cancer

Not fully defined (data not extracted)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

15800268 Lin 

2005

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes (multivitamin, saturated fat, red meat, 

total energy intake)

Demographics (e.g., age, gender, race, education)? Yes (age)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (BMI)

Medical conditions Yes (family history, polyps)

Medication Yes (hormone replacement therapy)

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes (physical activity, smoking, alcohol)

Other Yes (RCT arms [aspirin/no, Vit E/not])

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis

# first model used only age and RCT assignments (aspirin & Vit E) 

# second model used the full multivariate model 

# performed a sensitivity analysis by excluding cases developed colorectal cancer during the first year of follow-up and added symptomatic examination, and regular screening test of 

colorectal cancer [colono- or sigmoidoscopy] to the second model.
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

15800268 Lin 

2005

Colorectal 

cancer 

(total Ca 

[mg])

Q1 Nd <614 41 7691 10 y (120 

mo)

Adj (first 

model)

RR (HR) 1.0 Ref nd

0.17

Q2 Nd 614-

<785

31 Nd 0.74 0.46-

1.18

Nd

Q3 Nd 785-

<1016

52 7690 1.22 0.81-

1.84

Nd

Q4 Nd 1016- 41 Nd 0.93 0.60- nd
<1357 1.43

Q5 Nd 1357- 58 7690 1.22 0.81-

1.82

Nd

15800268 Lin 

2005

Colorectal 

cancer 

(total Ca 

[mg])

Q1 Nd <614 41 7691 10 y (120 

mo)

Adj 

(second 

model)

RR (HR) 1.0 Ref nd

0.21

Q2 Nd 614-

<785

31 Nd 0.74 0.46-

1.18

Nd

Q3 Nd 785-

<1016

52 7690 1.19 0.78-

1.81

Nd

Q4 Nd 1016-

<1357

41 Nd 0.92 0.58-

1.44

nd

Q5 Nd 1357- 58 7690 1.20 0.79-

1.85

Nd

15800268 Lin 

2005

Colorectal 

cancer 

(total Ca 

[mg])

Q1 Nd <614 41 Nd 10 y (120 

mo)

Adj 

(sensitivity 

analysis#)

RR (HR) 1.0 Ref nd 0.11

Q2 Nd 614-

<785

31 Nd 0.74 0.45-

1.21

Nd

Q3 Nd 785-

<1016

52 Nd 1.21 0.78-

1.88

Nd

Q4 Nd 1016-

<1357

41 Nd 0.96 0.60-

1.54

nd

Q5 Nd 1357- 58 nd 1.29 0.83-

2.02

Nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

15800268 Lin 

2005

- first model used only age and RCT assignments (aspirin & Vit E)

- second model used the full multivariate model

- performed a sensitivity analysis by excluding cases developed colorectal cancer during the first year of follow-up and added symptomatic examination, and 

regular screening test of colorectal cancer [colono- or sigmoidoscopy] to the second model.

- subgroup analyses (total fat intake [high vs. low], phosphorus intake [high vs. low], total fiber intake [high vs. low], total vitamin intake [high vs. low]) 

performed: all but high fat intake group (RR between Q1 and Q5 = 1.61 [0.87-2.98]; P for trend = 0.04) and low fiber intake (RR between Q1 and Q5 = 1.80 

[1.50-3.23]; P=0.02) were NS (P for trend).

- “proximal” colon cancer and “distal” colon cancer were reported as clinical outcome (P for trend=NS); not fully extracted.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year

Population Exposure (All) Dietary 

assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

15800268 Lin 

2005

a) Eligibility 

criteria 

clear? (y/n)

N

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

nd

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A):

Poor reporting on inclusion/exclusion and actual selections, post-hoc analysis of an RCT of “cancer 

prevention” interventions: although adjusted; may have still been affected by these interventions; blinding not 

reported; power calculation not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

17533208 Lin J

2007

Cohort study of 

subjects 

enrolled in 

randomized trial

39 876 women 45 years or older who were free of cancer 

and cardiovascular disease were enrolled in the WHS trial 

and completed a self-administered questionnaire at 

baseline about their medical history and lifestyle factors. 

During an average 10 years of follow-up, 276 

premenopausal and 743 postmenopausal women had a 

confirmed diagnosis of incident invasive breast cancer and 

were included in the cohort.

8389 who provided 

insufficient dietary 

information or had 

biologically uncertain 

or unknown 

menopause status.

During 1993 

and 1995

Women’s 

Health 

Study

Gov’t GR

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

17533208 Lin J

2007

Cohort study 

of subjects 

enrolled in 

randomized 

trial

US

26 - 61

31487 31487 55 y 55-56 0% nd BMI = 26 Current smokers = 

8% to 20%

Current users of 

postmenopausal 

hormone 56% to 

72%

Current users of

multivitamins, 

15% to 76%

Calcium 

supplement 

users, 6% to 

90%

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

17533208 Lin J

2007

25(OH)D 

and/or 

1,25(OH)2D

nd No, Only 

correlation 

between vit D 

intake and 

plasma 25 

OHD are 

available

nd nd Calculated from diet 

and multivitamin 

supplement

17533208 Lin J

2007

Dietary 

calcium 

intake

Willet method USDA 

Nutrient 

Database

Yes, as 

references to 

Nurses’ Health 

Study

Calcium dietary 

intake: Dairy 

products 53% pizza 

(4%), English muffin 

(3%), orange juice 

(2%), and bread 

(2%); other sources 

of vitamin D included 

dark fish (9%), tuna 

mix (5%), cereal 

(4%), and margarine 

(4%)

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17533208 Lin J

2007

Primary Breast cancer Incident cases of invasive breast cancer

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must be explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

17533208 Lin J

2007

Vit D sources estimated from dietary questionnaire, no biomarker available. Thus excluded from the outcomes.

Also available are subgroup analyses of relationships of calcium from dietary sources, supplements and breast cancer

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups

Please List Name of 

Confounder (including 

matching factors)

Specific comments for confounders

17533208 Lin J

2007

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total 

energy intake

Yes multivitamin use and total energy intake in premenopausal 

and postmenopausal

Demographics (e.g., age, gender, race, education)? Yes age at menopause and postmenopausal

hormone therapy in postmenopausal women

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions No

Medication Yes hormone therapy in postmenopausal women

Sunlight exposure and its proxy variables (e.g., physical 

activity level, occupation, sun exposure, location)

Yes physical activity

Smoking and other life styles variables Yes smoking status, alcohol consumption

Other Yes family history of breast cancer in a first-degree relative, history 

of benign breast disease, age at menarche, parity, age at first 

birth 

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

intake 

level 

No. of 

Cases 

(Event)* 

Total N** Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

17533208 Lin J

2007

Invasive breast 

cancerPremenopausal

Total calcium 

intake Q1

nd <617 70 ? unclear 

what was 

used in 

analyses

Total 

followed 

up for 10 

y = 

10578

Age, 

randomized 

treatment, 

BMI, family 

h/o breast 

cancer, h/o 

benign breast 

disease, etc

HR 1 (Ref)

0.14
Total calcium 

intake Q2

617 to 

<789

65 ? 10578 HR 0.78 0.52 

–

1.17

Total calcium 

intake Q3

789 to 

<1026

44 ? 10578 HR 0.60 0.38 

–

0.94

Total calcium 

intake Q4

1026 

to 

<1366

59 ? 10578 HR 0.78 0.51 

–

1.19

Total calcium 

intake Q5

≥1366 38 ? 10578 HR 0.64 0.40 

–

1.03

Invasive breast 

cancerPostmenopausal

Total calcium 

intake Q1

<617 104 ?20909 HR 1.0 (Ref)

0.17

Total calcium 

intake Q2

617 to 

<789

116 ?20909 HR 1.12 0.85 

–

1.47

Total calcium 

intake Q3

789 to 

<1026

112 ?20909 HR 1.10 0.83 

–

1.44

Total calcium 

intake Q4

1026 

to 

<1366

119 ?20909 HR 1.10 0.84 

–

1.45

Total calcium 

intake Q5

≥1366 151 ?20909 HR 1.23 0.94 

–

1.61

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17533208 Lin J

2007

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative

categories 

(e.g. 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

N

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection?

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

NA

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Lack of biomarker, reliance on dietary assessment alone, unclear about total N

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

16400044 Lorenzen

2006

RCT 12y ±6 mo old girls with Danish names; calcium intake 

either 1000-1304 mg/d or <713 mg/d

nd nd - academic and 

industry

SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

16400044 Lorenzen

2006

RCT Frederiksberg, 

Copenhagen, 

Denmark 56

113 110 13.2 nd 0 white wt 51 Kg nd dietary calcium: 

957 mg/d 

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

16400044 Lorenzen

2006

25(OH)D RIA n nd nd 25(OH)D: 

34.5 mmol/L

Dietary 

calcium 

intake

FFQ (88 

questions)

nd n dietary 

calcium: 957 

mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

16400044 Lorenzen

2006

calcium calcium carbonate 500 mg 1 y two 250 mg chewables with evening meal q 

day

placebo

Co-intervention(s) *:

Compliance/Adherence: 80% in calcium; 82% in placebo

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

16400044 Lorenzen

2006

primary body weight

height

secondary 25(OH)D

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

16400044 Lorenzen

2006 enrolled subject stratified by two groups depending on calcium intake: 1000-1304 mg/d or <713 mg/d 

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

16400044 Lorenzen

2006

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes calcium intake

Demographics (e.g., age, gender, race, education)? Yes age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes weight, height, body fat

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

no

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis

FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 
2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline / SE*

Final 

**

Final 

SE*

Net

difference

Net 

difference 

CI / SE / 

SD*

P 

between

16400044 Lorenzen

2006

weight Δ in 

medium (1000-

1304 mg/d)

calcium intake 

group

Kg calcium 1 y 30 51.8 1.7 56.9 1.8 NS

placebo 1 y 30 50.7 1.6 55.6 1.6

weight Δ in low 

(<713 mg/d)

calcium intake 

group

Kg calcium 1 y 24 52.2 1.7 56.3 1.8 NS

placebo 1 y 26 49.5 1.7 52.5 1.6

height Δ in 

medium (1000-

1304 mg/d)

calcium intake 

group

cm calcium 1 y 30 162.5 1.1 166.2 1.0 NS

placebo 1 y 30 161.9 1.2 165.9 1.1

height Δ in low

(<713 mg/d)

calcium intake 

group

cm calcium 1 y 24 159.6 1.3 163.2 1.3 NS

placebo 1 y 26 160.1 1.5 163.2 1.4

25(OH)D Δ in 

medium (1000-

1304 mg/d)

calcium intake 

group

mmol/L calcium 1 y 29 37.5 2 35.1 3 NS

placebo 1 y 29 39.2 3 32.2 2

25(OH)D Δ in 

low (<713 

mg/d) calcium 

intake group

mmol/L calcium 1 y 24 30.8 2 25.7 3 NS

placebo 1 y 24 29.2 2 28.5 3

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

16400044 Lorenzen

2006 RCT nd nd NA Y Y N Y Y Y B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): relatively small sample size in each group; details of methods not completely reported; did not adjust for all 

potentially relevant confounders

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

17473911 Lyons

2007

RCT All residents living in care homes 

across South Wales, including those 

with mobility, cognitive, visual, 

hearing or communication 

impairments 

People already receiving ≥ 400 IU 

of vit D/d and those already have 

contradictions to vit D 

supplementation (not specified)

December 

2000 and 

January 2003

nd The Wales Office of 

Research and 

Development for Health 

and Social Care

JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

17473911 Lyons

2007

RCT South Wales 

(51.96° N)

3440 3343 84 

(7.5)

62-107 23.7% nd nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17473911 Lyons

2007

25(OH)D 

and/or 

1,25(OH)2D

25(OH)D –

DiaSorin 

radioimmunoassay

n nd nd nd

17473911 Lyons

2007

Dietary 

calcium 

intake

nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

17473911 Lyons

2007

Vit D Supplementation – ergo-calciferol 822IU/d 3 years Every 4 months (Two 1.25 mg vit D tablets -

100,000 IU)

17473911 Lyons

2007

placebo nd nd 3 years Every 4 months

Co-intervention(s) *: None 

Compliance/Adherence: 80% (percentage of occasions observed to take tablets)

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

17473911 Lyons

2007

Primary First fracture Confirmed by matching every participant with computerized health records and searching 

through emergency department and in-patient records 

17473911 Lyons

2007

Secondary Fractures 

(hip/wrist/forearm/vertebrae)

Confirmed by matching every participant with computerized health records and searching 

through emergency department and in-patient records

17473911 Lyons

2007

Secondary Mortality nd

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

17473911 Lyons

2007

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes -age, gender

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other Residential home, nursing or dual-registered home, 

sheltered accommodation

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, 

RR, HR, %) and direction 

of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

17473911 Lyons

2007

First fracture 

(all sites)

Vit D2 median time to first 

fracture = 387 days 

(IQR: 220–582)

205 1670 HR vit d2/placebo 0.95 0.79-

1.15

NS

Placebo 367 days (IQR:

139–618) in the 

control group

218 1673

17473911 Lyons

2007

mortality Vit D2 3 yr 947 1670 HR vit d2/placebo 1.0 0.9-

1.0

NS

Placebo 3 yr 953 1673

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 
**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

17473911 Lyons

2007

Fracture at the hip, wrist, forearm, and spine HR, intervention to control – 1.00 (95% CI; 0.8-1.3)

17473911 Lyons

2007

Fracture at the hip HR, intervention to control – 1.1 (95% CI; 0.8-1.1)

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17473911 Lyons

2007

RCTparallel Y Y NA Y nd Y Y Y Y B/C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Poor reporting on the result section, no information on background diet.

Quality rating C for mortality data due to inconsistent reporting between figure and table.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

17209177 Major 

2007

RCT Women with low Ca intake (800 mg Ca/d), 

premenopausal, stable weight, overweight or obese 

(BMI 27-40), limited exercise (<3 periods of 20 min per 

week), general good health, BP<160/95

Ca supplementation

Menopause

Smoking

Cholesterol level 

requiring treatment

Abnormal thyroid 

function

Medication that 

could affect weight

Consumption of >5 

cups coffee/day

Pregnant or 

breastfeeding

nd none Wyeth, professional 

organization (CVD, 

DM), Gov’t

EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

17209177 Major 

2007

RCT Quebec 

City, QC, 

Canada

47°

84 63 43 

(~5.5)

nd 

(premenopausal)

0 nd BMI – 31.9 (~3) Healthy, 

overweight/ 

obese

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

None

17209177 Major 

2007

Dietary 

calcium 

intake

3 d dietary 

record 

(Tremblay 

1983)

Canadian 

Nutrient File

No Ca+D: 708.0 

(119) mg/d

Placebo: 

700.5 (99) 

mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca Total Daily 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

17209177 Major 

2007

Vit D + Ca Supplements (Caltrate 600+D) Ca: 1200 mg (Ca carbonate 

per website)

Vit D 400 IU (cholecalciferol 

per website)

15 wk 1 capsule 2x/d

Placebo nd

Co-intervention(s) *: Energy restriction diet: -700 Kcal/d, maintaining “diet quality”

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17209177 Major 2007 2° Weight Kg

2° BMI

2° SBP

2° DBP

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17209177 Major 

2007

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

No

Demographics (e.g., age, gender, race, education)? No

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Final or 

Change

Final or 

Change 

SD*

Net 

difference

Net 

difference 

CI / SE / 

SD*

P 

between

17209177 Major 

2007

Weight Kg Ca + D 15 wk 30 81.5 8.3 77.5 9.0 -1.0 0.19 

Placebo 33 83.6 11.1 80.6 11.7

BMI Kg/m2 Ca + D 15 wk 30 31.4 2.5 29.8 2.8 -0.4 0.23

Placebo 33 32.3 3.54 31.1 3.7

SBP mmHg Ca + D 15 wk 30 112.4 10.8 -4.1 6.8 -2.5 0.18

Placebo 33 109.5 8.5 -1.6 7.6

DBP mmHg Ca + D 15 wk 30 74.9 8.9 -3.0 4.9 0 1.0

Placebo 33 75.2 7.0 -3.0 5.9

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17209177 Major 

2007 RCT nd nd NA N Y N

Technically

OK, but 

poor choice 

(ANOVA)

N Y C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Design methods poorly described. High dropout due to problems with diet/exercise compliance etc. These 

people were fully dropped. Questionable choice of statistical analysis.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

3755517 Mallet

1986

RCT term pregnancy, white, lived in same town nd nd nd nd SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

3755517 Mallet

1986

RCT NW France, 

48o N

77 77 25 18-36 0 white nd nd Ca intake 550 to 1000 

mg/d in 55% of the 

subjects

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker

samples were 

drawn

Background 

exposure 

data

3755517 Mallet

1986

25(OH)D Competitive 

protein 

binding 

assay

y; reproducibility 

at 20 nmol/L 6%

nd winter, Feb/Mar 45% were 

outside <1 

h/d

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

3755517 Mallet

1986

unsupplemented

vit D 1000 IU/d 1000 IU daily for last 3 mo 

pregnancy

nd

vit D 200,000 IU 

1x

!x at 7 mo pregnancy

Co-intervention(s) *:

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

3755517 Mallet

1986

primary maternal 25(OH)D at term

cord blood 25(OH)D at term

primary maternal 1,25 (OH)2D at term

cord blood 1,25 (OH02D at term

secondary birth weight

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

3755517 Mallet

1986 unsupplemented group was not randomized

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

3755517 Mallet

1986

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes* age, race

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 25(OH)D, 

UV exposure, location)

yes spent time outside

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

**

Final 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P 

between

groups***

3755517 Mallet

1986

maternal 

25(OH)D at 

term

nmol/L unsupplemented

crude

3 mo 29 nd

nd

9.4

4.9

1000 IU/d 21 nd nd 25.3 7.7

200,000 IU 27 nd nd 26 6.4

cord 

25(OH)D nmol/L unsupplemented crude 3 mo 29 nd nd 5.3 2.5

1000 IU/d 21 nd nd 15.7 5.1

200,000 IU 27 nd nd 18.2 5.2

birth weight g unsupplemented crude nd nd nd 3460 70 NS

1000 IU/d nd nd nd 3370 80

200,000 IU nd nd nd 3210 90

maternal 

1,25(OH)2D 

at term

pmol/L unsupplemented

crude

3 mo 29 nd nd 66.1

14

1000 IU/d 21 nd nd 49.9 16

200,000 IU 27 nd nd 69 22

cord 

1,25(OH)2D 

at term

pmol/L unsupplemented

crude

3 mo 29 nd nd 47

16

1000 IU/d 21 nd nd 42.6 12

200,000 IU 27 nd nd 46.1 15

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
UI Author

Year Comments for Results

3755517 Mallet

1986 curve4 data rejected due to nonRCT design when comparing to the unsupplemented group

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

3755517 Mallet

1986 RCT n n

NA nd nd nd y n n C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): small sample size; incomplete data on infants

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

18824662 Margolis

2008

RCT Women aged 50 

to 79 years

Women with < 3years of predicted survival, a history of kidney 

stone or hypercalcemia, current oral corticosteroid use or 

current calcitriol use 

1993-1998 WHI NIH JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

18824662 Margolis

2008

RCT US 36282 36282 62 (7) 50-79 0% 83% White,

9% Black,

4% Hispanic,

<1% 

American 

Indian,

2% 

Asian/Pacific 

Islander

BMI <25 28.0%

BMI 25 to <30 

35.4%

BMI ≥30 36.6%

healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

18824662 Margolis

2008

25(OH)D 

and/or 

1,25(OH)2D

Diasorin Liaison 

chemiluminescent 

immunoassay

nd nd nd 25(OH)D 

nmol/L

<34.4 25.0%,

34.4-47.6 

25.2%, 

47.7-64.6 

24.9%,

≥ 64.7 24.8%

18824662 Margolis

2008

Dietary 

calcium 

intake

Food 

frequency 

questionnaire

nd nd nd nd nd Total Ca 

intake mg/d

<600 19.7%,

600-799 

14.4%,

800-1199 

26.3%,

≥1200 39.6%

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

18824662 Margolis

2008

Ca+VitD Ca-Tablet as calcium carbonate

VitD-provided by GlaxoSmithKline

Ca 1000mg

VitD3 400IU

7y 2 times/d

18824662 Margolis

2008

Placebo nd

Co-intervention(s) *: None

Compliance/Adherence: 60% (proportion taking ≥ study medication, adherence assessed by weighing returned bottles)

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

18824662 Margolis

2008

primary Hypertension Self-report of medication prescribed for hypertension or any BP ≥ 140/90 mm Hg 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

18824662 Margolis

2008

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Ca intake, VitD intake, sodium 

intake, 

Demographics (e.g., age, gender, race, education)? Yes* Age, race, education, 

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* BMI

Medical conditions Blood pressure, hypertensive 

status

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes* Physical activity, smoking, 

alcohol intake, 

Other 25(OH)vitD

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

18824662 Margolis

2008

Hypertension CaD 74 mo 3377 8597 HR 1.01 0.96, 

to 1.06

0.69

Placebo 74 mo 3315 8525

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final or 

Delta 

CI / SE 

/ SD*

Net 

difference

Net 

difference 

CI / SE / 

SD*

P 

between

18824662 Margolis

2008

Systolic 

BP mmHg CaD 74 mo +0.22 -0.05 to 0.49 0.11

Placebo 74 mo

18824662 Margolis

2008

Diastolic 

BP mmHg CaD 74 mo +0.11 -0.04 to 0.27 0.14

Placebo 74 mo

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 
***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final 

or 

Delta 

CI / SE 

/ SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

18824662 Margolis

2008

In the subsample of subjects with measured 25(OH)vitD, those with lower levels had a higher risk of incident hypertension. Test if interaction between Ca/vitD 

treatment assignment and 25(OH)vitD on hypertension risk (p-value <.01)

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

18824662 Margolis

2008

RCTparallel nd nd n y n y y y y C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A):

Open-label use of Ca and vitD supplements as long as non-study use of vitD did not exceed 600IU daily. UL 

was raised to 1000IU after IOM report release, outcome measure - Self-report of medication prescribed for 

hypertension

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

15955467 Marniemi

2005

Cohort study 65-99 in 1986-87.

Around Turku, 

Finland.

Men<75 in NH

Women<70 in NH

Missing lab data

Obvious inaccuracies in dietary 

data

1986-87 (Turku, Finland) nd EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

15955467 Marniemi

2005

Cohort 

study

Turku, 

Finland

60°

769 755 79 (nd) 65-99 48% White 

100% 

(probably)

nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

15955467 Marniemi

2005

25(OH)D 

and/or 

1,25(OH)2D

RIA 

(Incstar)

No Frozen. 

Unclear. ≤10 

y

nd nd

15955467 Marniemi

2005

Dietary 

calcium 

intake

Interview (nd) Nutrica database 

at the Social 

Insurance 

Institution (Knuts 

1987; Hakala 

1996)

No nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

15955467 Marniemi

2005

1° AMI ICD 9 codes from national death registry and national hospital discharge registry

Stroke Same

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

15955467 Marniemi

2005

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes (Ca analyses) Weight adjusted intake of total 

energy (Ca analyses)

Demographics (e.g., age, gender, race, education)? Yes Age, sex

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

No

Smoking and other life styles variables Yes Smoking

Other Yes “Functional capacity” (Vit D 

analyses)

TC, HDL, SBP

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Followup, 

mean

Mean 

Ca 

intake

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

15955467 Marniemi

2005

AMI Calcium intake, 

Tertile 1

10 y nd nd ~252 Adjusted RR 1 Ref nd

Tertile 2 nd nd ~252 0.866 0.57, 

1.37

Tertile 3 nd nd ~252 1.14 0.70, 

1.84

AMI 25(OH)D level, 

Tertile 1

10 y nd nd ~252 Adjusted RR 1 Ref nd

Tertile 2 nd nd ~252 0.987 0.64, 

1.53

Tertile 3 nd nd ~252 0.769 0.47, 

1.27

AMI 1.25(OH)2D level, 

Tertile 1

10 y nd nd ~252 Adjusted RR 1 Ref nd

Tertile 2 nd nd ~252 1.05 0.68, 

1.62

Tertile 3 nd nd ~252 0.821 0.52, 

1.30

Stroke Calcium intake, 

Tertile 1

10 y nd nd ~252 Adjusted RR 1 Ref nd

Tertile 2 nd nd ~252 0.981 0.53, 

1.81

Tertile 3 nd nd ~252 1.34 0.70, 

2.55

Stroke 25(OH)D level, 

Tertile 1

10 y nd nd ~252 Adjusted RR 1 Ref nd

Tertile 2 nd nd ~252 1.13 0.62, 

2.05

Tertile 3 nd nd ~252 0.999 0.51, 

1.94

Stroke 1.25(OH)2D level, 

Tertile 1

10 y nd nd ~252 Adjusted RR 1 Ref nd

Tertile 2 nd nd ~252 0.631 0.37, 

1.09

Tertile 3 nd nd ~252 0.406 0.22, 

0.77

0.005

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 
**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Measure Results

UI Author

Year Comments for Results

15955467 Marniemi

2005 No data on ranges, medians, etc. of intake or level tertiles.
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

15955467 Marniemi

2005

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

N

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

Y

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C (or NA)

Explanation for Overall Quality Grade (if not Grade A): No intake values or level values provided for tertiles. Data not reported.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

12020102 Martinez

2002

Cohort study

Participants are 

included in an 

RCT

Men and women 40-80 years of age who had 

undergone removal of one or more colorectal 

adenoma(s) 3 mm or larger at colonoscopy within 

three months prior to study entry were recruited 

from the Phoenix, Arizona, metropolitan area

Individuals with a personal 

history of inflammatory 

bowel disease or hereditary 

colon cancer syndromes.

nd Wheat 

Bran Fiber 

(WBF) trial

NCI AT

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT
POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean (SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat 

...etc)

Health 

Status

Specific

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or 

Ca intake 

...etc.)

12020102 Martinez

2002

Cohort 

study

Phoenix, 

Arizona, 

metropolitan 

area

(33°29′ N)

1429 1304 According to 

calcium intake, 

1

st

quartile:64.3 

(9.3); 2nd

quartile: 66.4 

(8.5); 3rd

quartile: 66.5 

(8.9); 4th

quartile:66.2 

(8.4)

nd 57.1 nd nd Regular 

aspirin use in 

the past 10 

years: 28.2%

Previous 

polyps: 

39.2%

Family CRC 

history: 

16.9%

Current 

smoking: 

13.7%

According to 

calcium 

intake, 

Alcohol (g), 

1

st quartile: 

10.9 (22.4); 

2

nd quartile: 

7.5 (13.2); 

3

rd quartile: 

6.5 (11); 4th

quartile: 3.9 

(8.2)

According to 

calcium intake 

Energy (kcal), 

1

st

quartile:1809 

(655); 2nd

quartile: 2038 

(683); 3rd

quartile: 1986 

(689); 4th

quartile:1866 

(742)

Total fat (g), 1st

quartile: 70.9 

(13.7); 2nd

quartile: 69.9 

(12); 3rd

quartile: 68.4 

(13.1); 4th

quartile: 66.7 

(13.5)

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean (SD) 

Age, yr

Age 

Range 

/ IQR

Male, %Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat ...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or 

Ca intake 

...etc.)

12020102 Martinez

2002

Cohort 

study

Phoenix, 

Arizona, 

metropolitan 

area

1429 1304 According to 

calcium intake, 1

st quartile:64.3 

(9.3); 2nd

quartile: 66.4 

(8.5); 3rd

quartile: 66.5 

(8.9); 4th

quartile:66.2 

(8.4)

nd 57.1 nd nd Regular 

aspirin use in 

the past 10 

years: 28.2%

Previous 

polyps: 39.2

Family CRC 

history: 16.9

Current 

smoking: 

13.7

According to 

calcium 

intake, 

Alcohol (g), 1

st quartile: 

10.9 (22.4); 2

nd quartile: 

7.5 (13.2); 3rd

quartile: 6.5 

(11); 4th

quartile: 3.9 

(8.2)

According to 

calcium intake 

Dietary fiber 

(g), 1st

quartile: 20 

(5.9); 2nd

quartile: 22.2 

(6.8); 3rd

quartile: 22.8 

(7.5); 4th

quartile: 23.4 

(7.1)

Red meat (g), 1

st quartile: 

72.5 

(56.9); 2nd

quartile: 65.8 

(47.7); 3rd

quartile: 61.1 

(46.9); 4th

quartile: 50.6 

(40.2)
UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean (SD) 

Age, yr

Age 

Range 

/ IQR

Male, %Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat 

...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca

intake ...etc.)

12020102 Martinez

2002

Cohort 

study

Phoenix, 

Arizona, 

metropolitan 

area

(33°29′ N)

1429 1304 According to 

calcium intake, 1

st quartile: 

64.3 (9.3); 2nd

quartile: 66.4 

(8.5); 3rd

quartile: 66.5 

(8.9); 4th

quartile:66.2 

(8.4)

nd 57.1 nd nd Regular 

aspirin use 

in the past 

10 years: 

28.2%

Previous 

polyps: 39.2

Family CRC 

history: 16.9

Current 

smoking: 

13.7

According to 

calcium 

intake, 

Alcohol (g), 1

st quartile: 

10.9 (22.4); 2

nd quartile: 

7.5 (13.2); 3

rd quartile: 

6.5 (11); 4th

quartile: 3.9 

(8.2)

According to 

calcium intake 

Supplemental 

calcium (mg), 1st

quartile: 11.6 

(35.6); 2nd

quartile: 34.6 

(72.1); 3rd

quartile: 92.2 

(170.7); 4th

quartile: 582.8 

(516)

Supplemental 

vitamin D (IU), 1

st quartile: 65.4 

(151.8); 2nd

quartile: 115.7 

(189.3); 3rd

quartile: 163.7 

(256.2); 4th

quartile: 227.5 

(248.2)

Median total 

calcium intake 

(mg/day), 1

st quartile: 629; 

2

nd quartile: 874; 

3

rd quartile: 

1107; 4th

quartile: 1638
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

12020102 Martinez

2002

25(OH)D 

and/or 

1,25(OH)2D

na na na na na

12020102 Martinez

2002

Dietary 

calcium 

intake

113-item 

Arizona Food 

Frequency 

Questionnaire 

(AFFQ)

United States 

Department of 

Agriculture's 

Continuing Survey 

of Food Intake of 

Individuals, 1996 

and the United 

States Department 

of Agriculture's 

Nutrient Database 

for Standard 

Reference, Version 

13

y

assessment of its 

validity and 

reliability 

[recurrence. 

Cancer Epidemiol 

Biomarkers Prev 

8: 941-946] have 

been previously 

reported

nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

12020102 Martinez

2002

primary Adenoma 

recurrence

One or more adenomas or colorectal cancer detected by colonoscopy any time after 

randomization 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including matching factors) Specific comments for 

confounders

12020102 Martinez

2002

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

Dietary fiber; total vitamin D; energy intake

Demographics (e.g., age, gender, race, education)? Yes (age; gender)

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions Self reported history of polyps prior to baseline; adenoma number

(≥ 3 vs. < 3); adenoma location (any proximal vs. non-proximal)

Medication Regular use of aspirin in the previous 10 years

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical 

activity, occupation, alcohol consumption)

No

Other Number of colonoscopies after baseline

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year

Outcome Exposure / 

Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

Covariates: age, gender 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

12020102 Martinez

2002

Adenoma 

recurrence

1

st total calcium 

intake quartile 

(mg/day)

< 778 178 148 36.8 adjusted OR 1.00

0.002

Adenoma 

recurrence

2

nd total calcium 

intake quartile 

(mg/day)

778-

996

175 151 36.8 adjusted OR 0.90 0.66-

1.23

nd

Adenoma 

recurrence

3

rd total calcium 

intake quartile 

(mg/day)

997-

1279

148 178 36.8 adjusted OR 0.64 0.47-

0.88

nd

Adenoma 

recurrence

4

th total calcium 

intake quartile 

(mg/day)

>1279 138 188 36.8 adjusted OR 0.65 0.47-

0.90

nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

Covariates: age, gender, number of colonoscopies, history of polyps prior to baseline, aspirin use, dietary fiber, and total 

vitamin D intake 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

12020102 Martinez

2002

Adenoma 

recurrence

1

st total calcium 

intake quartile 

(mg/day)

< 778 178 148 36.8 adjusted OR 1.00

0.004

Adenoma 

recurrence

2

nd total calcium 

intake quartile 

(mg/day)

778-

996

175 151 36.8 adjusted OR 0.92 0.65, 

1.29

nd

Adenoma 

recurrence

3

rd total calcium 

intake quartile 

(mg/day)

997-

1279

148 178 36.8 adjusted OR 0.66 0.47, 

0.94

nd

Adenoma 

recurrence

4

th total calcium 

intake quartile 

(mg/day)

>1279 138 188 36.8 adjusted OR 0.62 0.42, 

0.90

nd
Covariates: age, gender, number of colonoscopies, history of polyps prior to baseline, aspirin use, dietary fiber, and total 

vitamin D intake, location and number of polyps at baseline 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

12020102 Martinez

2002

Adenoma 

recurrence

1

st total calcium 

intake quartile 

(mg/day)

< 778 178 148 36.8 adjusted OR 1.00

0.005

Adenoma 

recurrence

2

nd total calcium 

intake quartile 

(mg/day)

778-

996

175 151 36.8 adjusted OR 0.94 0.66, 

1.32

nd

Adenoma 

recurrence

3

rd total calcium 

intake quartile 

(mg/day)

997-

1279

148 178 36.8 adjusted OR 0.68 0.48, 

0.97

nd

Adenoma 

recurrence

4

th total calcium 

intake quartile 

(mg/day)

>1279 138 188 36.8 adjusted OR 0.62 0.42, 

0.90

nd

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

Covariates: age, gender, number of colonoscopies, history of polyps prior to baseline, aspirin use, dietary fiber, and total 

vitamin D intake, location and number of polyps at baseline / stratified by gender 

Male patients 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

12020102 Martinez

2002

Adenoma 

recurrence

1

st total calcium 

intake quartile 

(mg/day)

< 778 nd nd 36.8 adjusted OR 1.00

nd

Adenoma 

recurrence

2

nd total calcium 

intake quartile 

(mg/day)

778-

996

nd nd 36.8 adjusted OR 1.01 0.68-

1.51

nd

Adenoma 

recurrence

3

rd total calcium 

intake quartile 

(mg/day)

997-

1279

nd nd 36.8 adjusted OR 0.83 0.54-

1.26

nd

Adenoma 

recurrence

4

th total calcium 

intake quartile 

(mg/day)

>1279 nd nd 36.8 adjusted OR 0.67 0.40-

1.10

nd

 
Female patients 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Non-

cases 

/ 

Total N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

12020102 Martinez

2002

Adenoma 

recurrence

1

st total calcium 

intake quartile 

(mg/day)

< 778 nd nd 36.8 adjusted OR 1.00

nd

Adenoma 

recurrence

2

nd total calcium 

intake quartile 

(mg/day)

778-

996

nd nd 36.8 adjusted OR 0.81 0.40-

1.64

nd

Adenoma 

recurrence

3

rd total calcium 

intake quartile 

(mg/day)

997-

1279

nd nd 36.8 adjusted OR 0.42 0.21-

1.87

nd

Adenoma 

recurrence

4

th total calcium 

intake quartile 

(mg/day)

>1279 nd nd 36.8 adjusted OR 0.52 0.28-

0.98

nd
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

12020102 Martinez

2002

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Study was not design to evaluate calcium intake and adenoma recurrence; assessor blinding not reported; 

power calculation not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

7239350 Marya

1981

Other intervention 

study

pregnancy preeclampsia, antepartum hemorrhage, 

twins

nd - nd SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

7239350 Marya

1981

Other 

intervention 

study

Rohtak, India 

28 54’ N

70 70 nd nd 0 Indian nd nd daily milk <500 mL; 

vit D (diet) <30 IU/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

7239350 Marya

1981

25(OH)D 

and/or 

1,25(OH)2D

vit D (diet) 

<30 IU/d

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specified) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., bran name, 

foods, or formulation) 

Vit D and/or Ca Total Daily 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

7239350 Marya

1981

1200 IU vit D + 375 mg Calcium qd through 3rd

trimester

600,000 U vit D2 once in 7th and 

8

th month pregnancy

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

7239350 Marya

1981

secondary birth weight -

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

7239350 Marya

1981 two supplement groups were randomly selected; control group was not

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

7239350 Marya

1981

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 25(OH)D, 

UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIEATE TYPE OF DATA COLLECTION TABLE 

FOR ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHONOMIC OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final or 

Delta CI 

/ SE / 

SD*

Net 

difference

Net 

difference 

CI / SE / SD*

P 

between

7239350 Marya

1981

birth 

weight

1200 IU/d vit D 

+ calcium (3rd

trimester)

25 2.89 0.32 0.05

control 75 2.73 0.36

1.2 mil IU vit D 

total

20 3.14 0.45 0.001

control 75 2.73 0.36

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHONOMIC OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 
***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARING BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

7239350 Marya

1981

quasiRCT nd N NA Y N N N N N C

Adverse Event(s): ** no information provided

Explanation for Overall Quality Grade (if not Grade A): small sample size, no comparative data between the two supplemented groups; study methodology not 

completely reported

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

3623260 Marya

1987

RCT pregnancy nd nd - nd SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

3623260 Marya

1987

RCT Rohtak, India 

28 54’ N

400 400 nd 20-35 0 Indian nd nd diet: calcium 500 

mg/d and vit D 40 

IU/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

nd diet: vit D 40 

IU/d

3623260 Marya

1987

Dietary 

calcium 

intake

nd nd n diet: calcium 

500 mg/d 

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca Total Daily 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

3623260 Marya

1987

vit D and Ca nd calcium 375 mg and Vit D 1200 

IU from 20-24 wk onwards

≤16-20 wk nd

placebo

Co-intervention(s) *:

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

3623260 Marya

1987

primary toxemia nd

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

3623260 Marya

1987

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 25(OH)D, 

UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI P btw Result 95% CI

P 

btw

3623260 Marya

1987

toxemia ca+ vit D suppl pregnancy 12 200 6% vs. 

9%

>0.05 

no suppl pregnancy 18 200 per chi2

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

3623260 Marya

1987 RCT nd N NA Y N N N N N C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): study methodology not completely reported

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome,

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

3243609 Marya

1988

RCT pregnancy preeclampsia, antepartum hemorrhage, preterm delivery, 

twin pregnancies

nd - nd SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

3243609 Marya

1988

RCT Rohtak, India 

28 54’ N

200 200 24 22-35 0 Indian weight 54 Kg nd Vit D 35 IU/d; calcium 

429 mg/d (diet?)

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

3243609 Marya

1988

25(OH)D 

and/or 

1,25(OH)2D

nd vit D 35 IU/d 

(diet?)

Dietary 

calcium 

intake

nd nd calcium 429 

mg/d (diet?)

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca Total Daily 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

3243609 Marya

1988

vit D unclear if this is oral or parenteral 

supplementation

600,000 IU once each in 7th

and 8th month pregnancy

placebo

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

3243609 Marya

1988

primary newborn birth weight

secondary crown-heel length

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

3243609 Marya

1988

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no

Anthropometrics (e.g., BMI, body weight, % body fat)? yes weight gain in 3rd trimester

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 25(OH)D, 

UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

3243609 Marya

1988

birth weight 

<2.5 Kg

1.2 million IU vit 

D

4% vs. 

19%

no supplement

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final or 

Delta CI 

/ SE / 

SD*

Net 

difference

Net 

difference 

CI / SE / SD*

P 

between

3243609 Marya

1988

newborn 

birth weight

Kg 1.2 million IU 

vit D

100 2.99 0.36 <0.05

no 

supplement

100 2.80 0.37

gestational 

age

wk 1.2 million IU 

vit D

100 38.65 1.77 >0.05

no 

supplement

100 38.86 1.69

crown-heel 

length

cm 1.2 million IU 

vit D

100 50.06 1.79 <0.001

no 

supplement

100 48.45 2.04

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year

Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year

Comments for Results

-----Subgroup Analyses 
Please copy the appropriate table above for all subgroup analyses of interest. 

Subgroup in women with similar weight gain 3rd trimester 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final 

or 

Delta 

CI / SE 

/ SD*

Net 

difference

Net 

difference 

CI / SE / 

SD*

P 

between

3243609 Marya

1988

newborn birth 

weight in women 

with similar 

weight gain (50-

55 g/d) in 3rd

trimester

1.2 million IU 

vit D

33 

women

2.95 0.17 <0.01

no 

supplement

25 

women

2.76 0.25

 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

3243609 Marya

1988 RCT nd N NA Y N N Y Y N C

Adverse Event(s): ** no information provided

Explanation for Overall Quality Grade (if not Grade A): study methodology not completely reported

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

16391587 Mastaglia

2006

RCT 50-70 y women; 

menopause ≥1 y; BMD Tscore < -1

vit D or meds that affect mineral metabolism within 

past 12 mo; kidney stone, tumors, liver or kidney 

disease; hypercalciuria

winter, spring 

2002

- non-profit 

and industry

SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

16391587 Mastaglia

2006

RCT Buenos 

Aires, 

Argentina 

(34oS)

45 45 65 

(median, 

est.)

54.5-77 

(IQR, 

est.)

0 nd BMI 27.4 (median, 

est.)

BMD Tscore < 

-1

25(OH)D level 42 

nmol/L (median, 

est.)

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

16391587 Mastaglia

2006

25(OH)D RIA 

(DIASORIN)

y; interassay 

and intraassay 

CV 19%, 

17.6%

nd winter, spring 25(OH)D level 

42 nmol/L 

(median, est.)

Dietary 

calcium 

intake

nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

16391587 Mastaglia

2006

calcium 500 mg/d + No 

vit D

calcium carbonate calcium 500 mg/d + No 

vit D

3 mo 1 tablet qd

calcium 500 mg/d + vit D 

125 μg/d

calcium carbonate + vit D2 

(Spedrog-Caillon, Argentina)

calcium 500 mg/d + 

5000 IU/d vit D2

3 mo 2 drop qd of vit D2 + 1 tablet of calcium 

qd

calcium 500 mg/d + vit D 

250 μg/d

calcium carbonate + vit D2 

(Spedrog-Caillon, Argentina)

calcium 500 mg/d + 

10000 IU/d vit D2

3 mo 4 drop qd of vit D2 + 1 tablet of calcium 

qd

Co-intervention(s) *:

Compliance/Adherence: 89%

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary Outcome** Outcome Definition

16391587 Mastaglia

2006

primary 25(OH)D

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

16391587 Mastaglia

2006

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes age

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Yes season

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)

No. 

Analyzed

Baseline 

(median)

Baseline 

IQR

Final 

(median)

Final 

(IQR)

Net 

difference** *

Net 

difference 

CI / SE / 

SD*

P 

between 

groups***

16391587 Mastaglia

2006

25(OH)D 

at 2 mo

nmol/L calcium only crude 2 mo 13 45 31.2-

61.2 47.5 38.7-66.2

calcium + 

5000 D2 13 42

23.7-45

67.5

57.5-

91.2

NS (btw 

5000 & 

10000)

calcium + 

10000 D2 12 32.5 27.5-37.5 97.7 79.1-111.8

16391587 Mastaglia

2006

25(OH)D 

at 3 mo nmol/L calcium only crude 3 mo 13 45 31.2-61.2 55 72.5-68

calcium + 

5000 D2 13 42

23.7-45

77.5

66.2-

156.2

NS (btw 

5000 & 

10000)

calcium + 

10000 D2 12 32.5 27.5-37.5 97.7 79.3-123.1

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

16391587 Mastaglia

2006 RCT nd nd NA Y Y N N Y Y C

Adverse Event(s): ** Hypercalciuria (n=1) in control group

Explanation for Overall Quality Grade (if not Grade A): small number of subjects in each group; methodology not fully explained

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
6793058ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

6793058 Maxwell

1981

RCT pregnant Asians nd nd - government SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

6793058 Maxwell

1981

RCT London, UK 

51 N

126 126 nd nd 0 Asians weight at 3rd trimester: 

63.7 Kg

nd 25(OH)D level at 28-

32 wk: 20.1 nmol/L

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

6793058 Maxwell

1981

25(OH)D nd 25(OH)D level 

at 28-32 wk: 

20.1 nmol/L

Dietary 

calcium 

intake

nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

6793058 Maxwell

1981

calciferol nd 1000 IU/d 3

rd trimester only

placebo

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

6793058 Maxwell

1981

primary weight gain 3rd trimester

secondary birth weight

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

6793058 Maxwell

1981

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

6793058 Maxwell

1981

infants with birth 

weight <2500 g

calciferol 7 59 NS

control 15 67

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final Final 

SD*

Net 

difference

Net 

difference CI 

/ SE / SD*

P 

between

6793058 Maxwell

1981

maternal 

weight gain 3rd

trimester

g/d calciferol 59 63.3 20.7 <0.001

control 67 46.4 29.5

6793058 Maxwell

1981

infant birth 

weight

g calciferol 59 3157 469 NS

control 67 3034 524

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

6793058 Maxwell

1981 Unclear how weight gain differences between groups were determined not due to edema.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

6793058 Maxwell

1981

RCT nd nd NA Y Y Y N N N C

Adverse Event(s): ** no information provided

Explanation for Overall Quality Grade (if not Grade A): study methodology not completely reported; small sample size

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

12708719 McCullough

2003

Cohort 

study

Members of CPS II who resided in 21 

states with population based cancer 

registries and were 50-74 years old at 

enrollment (when they completed a 10-

page confidential, self-administered 

mailed questionnaire including questions 

on demographic, medical, behavioral, 

environmental, occupational, and dietary 

factors). A follow up questionnaire 

(beginning in 1997) was sent to cohort 

members to update exposure information 

and to ascertain newly diagnosed 

cancers.

Men and women lost to follow (until 

August 31, 1997); participants who 

reported any prevalent cancer (except 

non-melanoma skin cancer) at baseline; 

with extreme daily energy intake, for 

women <550 or >3500 kcal; for men 

<650 or >4000 kcal; those who left ≥ 10 

of the 68 questionnaire items (15%) 

blank; respondents who left ≥ 4 of the 

seven dairy food questions blank; and 

those with uninterpretable responses to 

calcium or multivitamin questions; also, 

patients whose self-report of CRC could 

not be verified

1992-1993 Cancer 

Prevention 

Study (CPS) 

II Nutrition 

Cohort

nd AT

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT
POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean (SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat 

...etc)

Health Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

12708719 McCullough

2003

Cohort 

study

US (21 

states)

127749 127749 According 

to calcium 

intake per 

quintile

For men, 

Q1: 62.9 

(nd); Q3: 

63.9 (nd); 

Q5: 65.1 

(nd)

For women, 

Q1: 61.3 

(nd); Q3: 

61.9 (nd); 

Q5: 62.6 

(nd)

nd 48 nd According to 

calcium intake 

per quintile

%BMI>30

For men, Q1: 

16.1; Q3: 13.6; 

Q5: 11.4

For women, Q1: 

18.6; Q3: 16.5; 

Q5: 10.7

According to 

calcium intake 

per quintile

Median 

exercise MET 

score

For men, Q1: 

11.2; Q3: 

13.4; Q5: 14.4

For women, 

Q1: 10.1; Q3: 

12; Q5: 13.5

%long-term 

multivitamin 

use

For men, Q1: 

4.1; Q3: 12.1; 

Q5: 23.2

For women, 

Q1: 4.4; Q3: 

15; Q5: 31

%family CRC 

history

For men, Q1: 

12.6; Q3: 

12.3; Q5: 12.4

For women, 

Q1: 14.1; Q3: 

14.4; Q5: 14.5

Median 

alcohol intake 

(g/day)

For men, Q1: 

17.3; Q3: 9.3; 

Q5: 6.4

For women, 

Q1: 6.1; Q3: 

4.1; Q5: 3.7

According to 

calcium intake 

per quintile

Median total 

vitamin D 

(IU/day)

For men, Q1: 

94; Q3: 208; 

Q5: 488

For women, 

Q1: 92; Q3: 

215; Q5: 485

According to 

vitamin D intake 

per quintile

Median total 

calcium 

(mg/day)

For men, Q1: 

509; Q3: 872; 

Q5: 1122

For women, 

Q1: 496; Q3: 

876; Q5: 1334
*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

12708719 McCullough

2003

25(OH)D 

and/or 

1,25(OH)2D

na na na na na

12708719 McCullough

2003

Dietary 

calcium 

intake

68-item semiquantitative FFQ 

(modification of 

the brief Health 

Habits and 

History 

Questionnaire 

(HHHQ) by Block 

et al.

USDA y

Validated using 4 

random 24h recalls 

collected over a 1-

year period. Energy 

adjusted correlation 

that controlled for 

day-to-day variation 

in 24h recalls was 

r=0.68 for dietary 

calcium

nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

12708719 McCullough

2003

primary

Colorectal 

cancer

Confirmed incident cases of fatal or non-fatal colon cancer or rectal cancer that occurred between enrollment (1992-

93) and August 31, 1997. Most cases were initially identified by self-report on the follow up questionnaires and verified 

by medical records, or from linkage with state cancer registries. Also, a few cases were initially identified through 

linkage with state cancer registries to confirm other reported cancers. CRC deaths were identified if recorded as the 

underlying or the contributory cause of death on a death certificate through August 31, 1997 among cohort members. 

Ascertainment of all deaths is accomplished through linkage with the National Death Index.

Proximal 

colon cancer Cancer at cecum to splenic flexure

Distal colon 

cancer

Cancer at descending to sigmoid colon

Rectal 

cancer

Cancer at rectum and rectosigmoid junction

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

12708719 McCullough

2003 Data on total energy intake are not given

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

12708719 McCullough

2003

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes (total energy, %saturated fat intake, fruit intake, 

vegetable intake, long-term multivitamin use)

Demographics (e.g., age, gender, race, education)? Yes (age; gender; education)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (BMI)

Medical conditions Yes (family CRC history)

Medication Yes (for women only: HRT use )

Sunlight exposure and its proxy variables (e.g., seasonal variation 

of 25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes (smoking; exercise METs)

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

Age adjusted in five-year categories 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI 

**

P 

between 

groups***

P for 

trend****

12708719 McCullough

2003

CRC 1

st quintile of 

total calcium 

intake (mg/day)

<561 156 nd nd adjusted RR 1.00 nd

<0.06

2

nd quintile of 

total calcium 

intake (mg/day)

561-

731

165 nd nd adjusted RR 1.18 nd nd

3

rd quintile of 

total calcium 

intake (mg/day)

732-

925

137 nd nd adjusted RR 0.96 nd nd

4

th quintile of 

total calcium 

intake (mg/day)

926-

1255

108 nd nd adjusted RR 0.75 nd nd

5

th quintile of 

total calcium 

intake (mg/day)

>1255 117 nd nd adjusted RR 0.87 nd nd

Adjusted for age, smoking, BMI, education, exercise METs, family CRC history, total energy, %saturated fat intake, fruit intake, vegetable intake, 

long-term multivitamin use, and gender 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

12708719 McCullough

2003

CRC 1

st quintile of 

total calcium 

intake (mg/day)

<561 156 nd nd adjusted RR 1.00 nd

0.02

2

nd quintile of 

total calcium 

intake (mg/day)

561-

731

165 nd nd adjusted RR 1.05 0.84-

1.31

nd

3

rd quintile of 

total calcium 

intake (mg/day)

732-

925

137 nd nd adjusted RR 0.88 0.70-

1.12

nd

4

th quintile of 

total calcium 

intake (mg/day)

926-

1255

108 nd nd adjusted RR 0.72 0.56-

0.93

nd

5

th quintile of 

total calcium 

intake (mg/day)

>1255 117 nd nd adjusted RR 0.87 0.67-

1.12

nd
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

12708719 McCullough

2003

For women, results on subsite analyses for CRC were imprecise due to small number of cases; therefore, only results on subsite analyses for men are 

presented.

Results for total calcium intake and CRC were unchanged when the first year of follow up was excluded from the analysis.
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

For men: age adjusted in five-year categories 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI 

**

P 

between 

groups***

P for 

trend****

12708719 McCullough

2003

CRC 1

st quintile of 

total calcium 

intake (mg/day)

<561 89 nd nd adjusted RR 1.00 nd

0.002

2

nd quintile of 

total calcium 

intake (mg/day)

561-

731

106 nd nd adjusted RR 0.95 nd nd

3

rd quintile of 

total calcium 

intake (mg/day)

732-

925

98 nd nd adjusted RR 0.85 nd nd

4

th quintile of 

total calcium 

intake (mg/day)

926-

1255

70 nd nd adjusted RR 0.63 nd nd

5

th quintile of 

total calcium 

intake (mg/day)

>1255 58 nd nd adjusted RR 0.71 nd nd

For women: age adjusted in five-year categories 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI 

**

P 

between 

groups***

P for 

trend****

12708719 McCullough

2003

CRC 1

st quintile of 

total calcium 

intake (mg/day)

<561 67 nd nd adjusted RR 1.00 nd

0.007

2

nd quintile of 

total calcium 

intake (mg/day)

561-

731

59 nd nd adjusted RR 1.07 nd nd

3

rd quintile of 

total calcium 

intake (mg/day)

732-

925

39 nd nd adjusted RR 0.71 nd nd

4

th quintile of 

total calcium 

intake (mg/day)

926-

1255

38 nd nd adjusted RR 0.64 nd nd
5

th quintile of 

total calcium 

intake (mg/day)

>1255 59 nd nd adjusted RR 0.72 nd nd

For men: adjusted for age, smoking, BMI, education, exercise METs, family CRC history, total energy, %saturated fat intake, fruit intake, vegetable 

intake, long-term multivitamin use 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca

level / 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

12708719 McCullough

2003

CRC 1

st quintile of

total calcium 

intake (mg/day)

<561 89 nd nd adjusted RR 1.00 nd

0.04

2

nd quintile of 

total calcium 

intake (mg/day)

561-

731

106 nd nd adjusted RR 1.01 0.76-

1.34

nd

3

rd quintile of 

total calcium 

intake (mg/day)

732-

925

98 nd nd adjusted RR 0.93 0.70-

1.25

nd

4

th quintile of 

total calcium 

intake (mg/day)

926-

1255

70 nd nd adjusted RR 0.71 0.52-

0.98

nd

5

th quintile of 

total calcium 

intake (mg/day)

>1255 58 nd nd adjusted RR 0.82 0.58-

1.16

nd

Proximal 

colon 

cancer

1

st quintile of 

total calcium 

intake (mg/day)

<561 26 nd nd adjusted RR 1.00 nd 0.04

2

nd quintile of 

total calcium 

intake (mg/day)

561-

731

36 nd nd adjusted RR 1.13 0.68-

1.88

nd

3

rd quintile of 

total calcium 

intake (mg/day)

732-

925

26 nd nd adjusted RR 0.81 0.47-

1.42

nd

4

th quintile of 

total calcium 

intake (mg/day)

926-

1255

23 nd nd adjusted RR 0.77 0.43-

1.47

nd

5

th quintile of 

total calcium 

intake (mg/day)

>1255 13 nd nd adjusted RR 0.57 0.28-

1.13

nd

Distal 

colon 

cancer

1

st quintile of 

total calcium 

intake (mg/day)

<561 17 nd nd adjusted RR 1.00 0.55
2

nd quintile of 

total calcium 

intake (mg/day)

561-

731

26 nd nd adjusted RR 1.25 0.67-

2.31

nd

3

rd quintile of 

total calcium 

intake (mg/day)

732-

925

31 nd nd adjusted RR 1.51 0.83-

2.77

nd

4

th quintile of 

total calcium 

intake (mg/day)

926-

1255

15 nd nd adjusted RR 0.77 0.38-

1.57

nd

5

th quintile of 

total calcium 

intake (mg/day)

>1255 13 nd nd adjusted RR 1.00 0.47-

2.13

nd

Total 

colon 

cancer

1

st quintile of 

total calcium 

intake (mg/day)

<561 64 nd nd adjusted RR 1.00 0.02

2

nd quintile of 

total calcium 

intake (mg/day)

561-

731

82 nd nd adjusted RR 1.08 0.77-

1.50

nd

3

rd quintile of 

total calcium 

intake (mg/day)

732-

925

67 nd nd adjusted RR 0.89 0.63-

1.27

nd

4

th quintile of 

total calcium 

intake (mg/day)

926-

1255

51 nd nd adjusted RR 0.72 0.49-

1.05

nd

5

th quintile of 

total calcium 

intake (mg/day)

>1255 38 nd nd adjusted RR 0.74 0.49-

1.12

nd

Rectal 

cancer

1

st quintile of 

total calcium 

intake (mg/day)

<561 23 nd nd adjusted RR 1.00 nd 0.71

2

nd quintile of 

total calcium 

intake (mg/day)

561-

731

22 nd nd adjusted RR 0.78 0.43-

1.41

nd

3

rd quintile of 

total calcium 

intake (mg/day)

732-

925

29 nd nd adjusted RR 1.02 0.58-

1.79

nd

4

th quintile of 

total calcium 

intake (mg/day)

926-

1255

16 nd nd adjusted RR 0.60 0.31-

1.16

nd

5

th quintile of 

total calcium 

intake (mg/day)

>1255 19 nd nd adjusted RR 1.01 0.53-

1.93

nd

For women: adjusted for age, smoking, BMI, education, exercise METs, family CRC history, total energy, %saturated fat intake, fruit intake, 

vegetable intake, long-term multivitamin use, and HRT use 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Mean 

Vit D 

level 

Mean 

Ca 

level / 

No. of 

Cases 

(Event)* 

No. 

of 

NonMean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend 
Intervention 

Groups

/ 

dose

dose cases 

/ 

Total N** 

RR, HR, 

%)

12708719 McCullough

2003

CRC1

st quintile of 

total calcium 

intake (mg/day)

<561 67 nd nd adjusted RR 1.00 nd

0.31

2

nd quintile of 

total calcium 

intake (mg/day)

561-

731

59 nd nd adjusted RR 1.16 0.82-

1.66

nd

3

rd quintile of 

total calcium 

intake (mg/day)

732-

925

39 nd nd adjusted RR 0.80 0.54-

1.21

nd

4

th quintile of 

total calcium 

intake (mg/day)

926-

1255

38 nd nd adjusted RR 0.78 0.51-

1.18

nd

5

th quintile of 

total calcium 

intake (mg/day)

>1255 59 nd nd adjusted RR 0.94 0.63-

1.39

nd
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

12708719 McCullough

2003

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

n

a) Method 

reported? 

(y/n)

y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

na

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

n

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

n

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

na

b) Loss to 

follow-up 

<20%? (y/n)

y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

y

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Initial cohort was assembled to evaluate cancer mortality; assessor blinding not reported; power 

calculation not reported; results are not given sufficiently (age adjusted model without CI; number of 

non-cases per calcium quintile not provided); confirmation of cases by histology not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

16365007 McCullough 

2005

Cohort 

study

Women from the 

CPS II Nutrition 

Cohort, a prospective 

study of cancer 

mortality established 

in 1982. 

Women who were lost to follow-up between enrollment in 

1992/1993 and August 31, 2001 (n = 3,514), or, who, at 

baseline, reported a history of breast cancer (n = 6,220) or 

other cancer (except nonmelanoma skin cancer; n = 5,805).

Women who were premenopausal or perimenopausal at 

baseline (n = 4,448) or with unknown menopausal status(n = 

233); women who reported extreme values of daily energy 

intake (<500 or >3,500 kcal/d), or FFQs with z15% of the 68 

questions blank (n = 7,345). Women with missing or 

uninterpretable responses for more than four dairy products (n 

= 85), calcium supplements (n = 952), or multivitamin use (n = 

543), or women who reported both greater than six servings of 

milk per day and identical responses for two types of milk (n = 

42) were also excluded. Finally, women were excluded if 

diagnosis date was unknown (n = 32).

1992- 1993 CPS II 

Nutrition 

Cohort

nd GR

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

16365007 McCullough

2005

Cohort 

study

US

30 N

97,786 68,567 63 

(nd)

nd 0 nd Mean body mass

index in 1992 = 26

Mean weight gain

since age 18 y = 26 

to 31 (units nd)

Current 

smoker 5 to 

13%

Nulliparous 

7.5 %

First birth 

after

age 30 y 7 

to 8%

Current HRT 

use 26 to 

48%

Total calcium 

(mg/d) = 706-1544

Total vitamin D 

(IU/d) 220-500

Calories (kcal/d) 

1218-1693

Total fat (g/d) 39-

57

Alcohol (g/d) 3.3-

7.0

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure data

16365007 McCullough

2005

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd Total vitamin D 

(IU/d) included 

intake from diet 

and multivitamins 

(estimated to be 

400 IU per pill). 

Nutrient estimates 

were adjusted for 

total energy using 

the residuals 

method

Dietary 

calcium 

intake

FFQ modified 

from 

Questionnaire 

developed by 

Block et al.

Diet Analysis 

System 

version 3.8a

Yes.

validated using 

four random 24-

hour recalls 

collected over a 

1-year period as 

the comparison 

measure among 

441 Nutrition 

Cohort 

participants

68-item food 

frequency 

questionnaire 

(FFQ), which is a 

modification of the 

brief Health 

Habits and History 

Questionnaire 

developed by 

Block et al.

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

16365007 McCullough

2005

nd

Incident 

breast 

cancer

New diagnosis of eit her nonf at al or f at al b reast cancer t hat occurred af t er enrollm ent in 1992 or 

1993 and b ef ore August 31, 2001. Breast cancer as a cont rib ut ing cause of d eat h am ong cohort 

m em b ers w as ascert ained t hrough linkage w it h t he Nat ional Deat h Ind ex. ER and p rogest erone 

recep t or (PR) st at us of t he t um ors w as ob t ained t hrough m ed ical record rep ort s and t hrough st at e 

cancer regist ries w hen availab le.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must be explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

16365007 McCullough

2005

“Potential effect modification of findings by potential for skin synthesis of vitamin D was examined by stratifying on UV

index by state of residence for the subgroup of women (95.5%) who reported the same state of residence in 1982 and 2001. UV

index levels were estimated using the 1997 monthly mean UV indices for major forecast cities in 50 states”

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including matching 

factors)

Specific comments for 

confounders

16365007 McCullough

2005

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

stratified by ER status of the tumor, multivitamin use (current

versus not current use), dietary fat intake (tertiles)

Demographics (e.g., age, gender, race, education)? Yes (age at menarche, age at menopause, age at child birth, 

race)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes [height (<63, 63 to <65, 65 to <67, 67 in, missing height), 

weight gain since age 18]

Medical conditions history of breast cyst

Medication

Sunlight exposure and its proxy variables (e.g., physical 

activity level, occupation, sun exposure, location)

Skin synthesis of vitamin D was examined by stratifying on UV 

index by state of residence for the subgroup of women

Smoking and other life styles variables Yes (alcohol consumption, hormone replacement therapy, current 

combined replacement therapy, past combined replacement 

therapy)

Other family hx of breast cancer in a mother or sister

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Followup

Mean 

Ca 

level / 

No. of 

Cases 

(Event)* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI 

P 

between 

groups***

P for 

trend****

16365007 McCullough

2005

Breast 

cancer

≤500 8y ≤500 457 10,620 Adjusted 

analysis

RR 1.00 NS 0.07

>500-≤750 8y >500-

≤750

729 17,880 Adjusted 

analysis

RR 0.91 (0.81-

1.02)

NS

>750-≤1000 8y >750-

≤1000

581 14,023 Adjusted 

analysis

RR 0.92 (0.81-

1.04)

NS

>1,000-≤1,250 8y >1,000-

≤1,250

407 9,120 Adjusted 

analysis

RR 0.97 (0.85-

1.11)

NS

>1250-≤1500 8y >1250-

≤1500

248 6,296 Adjusted 

analysis

RR 0.84 (0.72-

0.98)

.05

>1500-≤1750 8y >1500-

≤1750

144 3,983 Adjusted 

analysis

RR 0.76 (0.63-

0.92)

.05

>1750 8y >1750 289 6,645 Adjusted 

analysis

RR 0.91 (0.79-

1.06)

NS

Multivariate-adjusted model controlling for age, energy, history of breast cyst, family history of breast cancer, height, weight gain 

since age 18, alcohol use, race, age at menopause, age at first birth and number of live births, education, mammography history, and 

HRT.
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

16365007 McCullough

2005

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecifie

d 

methods***

was used? 

(y/n)

N

a) Level of 

the 

exposure in 

comparative 

categories 

(e.g. 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement?

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection 

to sample 

analysis 

reported? 

(y/n)

Y

b) Loss to 

follow-up 

<20%? (y/n)

N

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Lot of samples excluded at the analysis phase; no biomarker uses

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

18695076 Melamed 

2008

Cohort 

study

Adults 20 years or older who had a physical exam 

and lab testing at baseline (Oct 1988-Oct 1994) and 

for whom vital status information was known during 

the follow-up period (through Dec 31, 2000)

Did not have 

complete data on the 

study variables of 

interest

Oct 1988-Oct 

1994

NHANES III NIH; PJ 

Schafer CVD 

Research fund

MC

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

18695076 Melamed 

2008

Cohort 

study

nd 

(multiple 

cities in 

US)

13331 13331 44.8 >=20 46 Non-Hispanic 

white: 72.9%, 

non-Hispanic 

black:13.4%, 

Mexican 

American: 5.3%; 

other: 8.4%

Mean BMI: 26.85 Diabetes: 

7.4%

History of 

CVD: 7.9%

HTN: 25%

Use of 

cholesterollowering 

med: 3%

Use of vitamin 

D supplement: 

26.7%

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

18695076 Melamed 

2008

25(OH)D Diasorin 

radioimmunoassay 

(RIA) kit (Diasorin, 

Stillwater, 

Minnesota)

CV from 

quality 

control 

samples, 

13%-19%

nd Winter, JanMar: 25%

Spring, AprJun: 25%

Summer, JulSep: 25%

Fall, Oct-Dec: 

25%

See results

Dietary 

calcium 

intake

nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

18695076 Melamed 

2008

primary All-cause 

mortality

Linked National Death Index records; selected death certificates were reviewed manually to validate the 

process.

Primary

CVD mortality

Cause-specific death was coded according to the ICD-9-CM for deaths occurring between 1988 and 1998, 

and according to the ICD-10 for to deaths occurring in 1999 and 2000.

Including deaths due to hypertensive disease, ischemic heart disease, arrhythmia, heart failure, 

cerebrovascular disease, atherosclerosis or other disease of the arteries.
Primary Cancer mortality Including all malignant neoplasm deaths, deaths as respiratory and intrathoracic organs and genital organs, 

colorectal cancer, breast cancer, and prostate cancer.

primary Infectious 

disease mortality

Including deaths from infectious and parasitic disease, meningitis, acute rheumatic fever, endocarditis, acute 

upper and lower respiratory tract infections including influenza and pneumonia, and urinary tract infections.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including matching 

factors)

Specific comments for 

confounders

18695076 Melamed 

2008

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

Use of vitamin D supplementation

Demographics (e.g., age, gender, race, education)? Yes Age, sex, race, low SES 

status

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions HTN, history of CVD, diabetes

Medication Use of cholesterol-lowering medications

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Season

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes Smoking, physical 

activity level

Other HDL, total cholesterol, estimate GFR categories, serum 

albumin level, log albumin to creatinine ratio, log CRP level

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ 

Total 

N**

Mean

Follow-up

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

18695076 Melamed 

2008

All-cause 

mortality

25(OH)D Q1, 

ng/mL

>32.1 nd nd Median 

8.7 (IRQ 

7.1-10.2) 

yr

adj RR 1

nd

24.4-

32.1

nd nd Adj RR 0.93 0.79-

1.10

17.8-

24.3

nd nd Adj RR 1.06 0.89-

1.24

<17.8 nd nd adj RR 1.26 1.08-

1.46

18695076 Melamed 

2008

CVD 

mortality

25(OH)D Q1, 

ng/mL

>32.1 nd nd adj RR 1 nd

24.4-

32.1

nd nd Adj RR 0.83 0.65-

1.07

17.8-

24.3

nd nd Adj RR 0.88 0.69-

1.14

<17.8 nd nd adj RR 1.20 0.87-

1.64

18695076 Melamed 

2008

Cancer 

mortality

25(OH)D Q1, 

ng/mL

>32.1 nd nd Median 

8.7 (IRQ 

7.1-10.2) 

yr

Adjusted 

for cancer 

and 

external 

causes of 

death 

models 

include 

age, sex, 

race, 

season, 

cigarette 

use, BMI, 

log CRFP, 

serum 

albumin, 

physical 

activity 

level, use 

of vit D 

suppl, and 

low SES

RR 1 nd

24.4-

32.1

nd nd RR 0.8 0.54-

1.19

17.8-

24.3

nd nd RR 1.08 0.8-

1.46

<17.8 nd nd RR 0.91 0.63-

1.31

18695076 Melamed 

2008

Infectious 

disease 

mortality

25(OH)D Q1, 

ng/mL

>32.1 nd nd Median 

8.7 (IRQ 

7.1-10.2) 

adj RR 1
yr

24.4-

32.1

nd nd Adj RR 1.01 0.53-

1.93

17.8-

24.3

nd nd Adj RR 0.87 0.43-

1.74

<17.8 nd nd adj RR 0.84 0.38-

1.86

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

18695076 Melamed 

2008

All-cause mortality

During a median 8.7 years of follow-up (IRQ, 7.1-10.2 years), there were 1806 deaths, of which 777 (43%) were ascribed to 

CVD, 424 (23%) were ascribed to cancers, 105 (6%) were ascribed to infectious causes, and 92 (5%) were ascribed to external 

causes of death. Of those who died of CVD, 590 (76%) died of atherosclerotic CVD, 145 (19%) of cerebrovascular disease, and 

42 (5%) of congestive heart failure. Those who died had a mean age of 66.4 years and 46% were female, 58% were 

hypertensive, 19% had diabetes, and 32% had prior CVD.

18695076 Melamed 

2008

All-cause mortality

25(OH)D deficiency: 

25(OH)D levels <17.8 

ng/mL

In multivariate models, increasing age, female sex, non-white race/ethnicity (particularly non-Hispanic black race/ethnicity), 

diabetes, current smoking and creasing BMI were all independently associated with an increased odds of being 25(OH)D 

deficient (ie, lowest quartile). Physical activity, vitamin D supplementation, and non-winter season were associated with a 

decreased odds of deficiency.

18695076 Melamed 

2008

All-cause mortality

Subgroup analysis by 

CVD (present or 

absent)

The lowest 25(OH)D quartile was more strongly associated with mortality among participants without a history of CVD (MRR, 

1.54; 95% CI, 1.23-1.94) than in those with a history of CVD (MRR, 0.90; 95% CI, 0.66-1.22) (P value for interaction, .006).

18695076 Melamed 

2008

All-cause mortality

Subgroup analysis by 

HTN (present or 

absent)

Stronger associations, although nonsignificant, were found for participants without hypertension (P value for interaction, .09)

18695076 Melamed

2008

All-cause mortality

Subgroup analysis by 

DM (present or absent)

Stronger associations, although nonsignificant, were found for participants without diabetes (P value for interaction, .09)

18695076 Melamed 

2008

All-cause mortality

Subgroup analysis by 

various risk factors of 

low 25(OH)D level

No interaction was observed for age, race, obesity, physical activity level, smoking, or eGFR

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD **

P between 

groups***

P for 

trend****

18695076 Melamed 

2008

All-cause 

mortality

25(OH)D Q1, 

ng/mL – men only

>32.1 1047 6277 adj RR 1 P=0.06 for 

interaction 

between sex

nd

24.4-

32.1

Adj RR 0.82 0.64-

1.05

17.8-

24.3

Adj RR 0.94 0.75-

1.19

<17.8 adj RR 1.04 0.83-

1.30

18695076 Melamed 

2008

All-cause 

mortality

25(OH)D Q1, 

ng/mL – women 

only

>32.1 759 7054 adj RR 1 P=0.06 for 

interaction 

between sex

nd

24.4-

32.1

Adj RR 1.16 0.87-

1.55

17.8-

24.3

Adj RR 1.27 0.97-

1.66

<17.8 adj RR 1.55 1.15-

1.98

18695076 Melamed 

2008

All-cause 

mortality

25(OH)D Q1, 

ng/mL – age ≥65 yr

>32.1 1047 6277 adj RR 1 P=0.014 for 

interaction 

between 

age groups

nd

24.4-

32.1

Adj RR 0.97 0.79-

0.82

17.8-

24.3

Adj RR 0.99 0.82-

1.20

<17.8 adj RR 1.26 1.03-

1.54

18695076 Melamed 

2008

All-cause 

mortality

25(OH)D Q1, 

ng/mL – age <65

>32.1 563 10464 adj RR 1 P=0.014 for 

interaction 

between 

age groups

nd

24.4-

32.1

Adj RR 0.81 0.58-

1.14

17.8-

24.3

Adj RR 1.13 0.81-

1.56

<17.8 adj RR 1.28 0.93-

1.76
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

18695076 Melamed 

2008

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

NA

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

NA

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Insufficient data, number of deaths per 25(OH)D quartile was not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

18827811 Mishra

2008

Cohort 

study

Women from the Medical MRC NSHD, a British national 

representative sample of men and women cohort followed 

from their birth in March 1946.

Men from the 

cohort

Since 1946 at 

birth – ages 53 y 

Medical MRC 

NSHD, UK

Gov GR

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

18827811 Mishra

2008

Cohort 

study

54 N 1471 1161 51.5 ND 0 ND ND ND Intake levels 

available as 

categories for ages 4, 

36, 43, 53

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

18827811 Mishra

2008

25(OH)D

and/or 

1,25(OH)2D

No

18827811 Mishra

2008

Dietary 

calcium 

intake

5-day food 

diaries

McCance and 

Widdowson's 

food table

ND NA N No ND

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome**

Outcome Definition

18827811 Mishra

2008

ND Mammography 

density

Ratio of the absolute area of dense tissue to the sum of the absolute areas of dense and nondense tissues.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year

Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

18827811 Mishra

2008

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes Total energy intake

Demographics (e.g., age, gender, race, education)? Yes age at the time of mammogram; age at 

menarche; social class during adult life

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes at the age of 53 y

Medical conditions Yes Menopausal status at the time of mammogram

Medication Yes Hormonal use

Sunlight exposure and its proxy variables (e.g., seasonal variation 

of 25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes Smoking status

Other Yes Mammographic view

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

intake

mg/d

No. of 

Cases 

(Event)* 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

betwee

n 

groups

***

P for 

trend****

18827811 Mishra

2008

Mammographic 

density at age 

36 y

Q1 ≤523 133 766 ~32 y Adj β 

coefficient

Ref=1 Ref=1

NS

Q2 524 –

648

143 766 ~32 y Adj β 

coefficient

-0.11 -0.33, 

0.10

Q3 652 –

784

156 766 ~32 y Adj β 

coefficient

-0.05 -0.27, 

0.17
Q4 785 –

940

160 766 ~32 y Adj β 

coefficient

-0.04 -0.27, 

0.19

Q5 ≥941 174 766 ~32 y Adj β 

coefficient

-0.08 -0.32, 

0.17

18827811 Mishra

2008

Mammographic 

density at age 

43 y

Q1 ≤611 145 755 ~39 Adj β 

coefficient

Ref=1 Ref=1

NS

Q2 612-

735

156 755 ~39 Adj β 

coefficient

-0.13 -0.35, 

0.09

Q3 736-

859

145 755 ~39 Adj β 

coefficient

-0.06 -0.29, 

0.17

Q4 860-

1020

156 755 ~39 Adj β 

coefficient

-0.11 -0.34, 

0.12

Q5 ≥1021 153 755 ~39 Adj β 

coefficient

-0.16 -0.42, 

0.09

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No.

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

18827811 Mishra

2008

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

n

a) Method 

reported? 

(y/n)

y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

n a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

n

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

na

b) Loss to 

follow-up 

<20%? (y/n)

Y

(<13%)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

n

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

nd b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

n

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Missing table 1 on demographics, baseline exposure data

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

17106437 Mitrou 

2007

Cohort 

study

male smokers (≥5 

cigarettes/d); 50-

69 y

previous history of cancer (except for non-melanoma 

skin cancer or carcinoma in situ); serious diseases 

that limited long term participation; used vit E, A, or βcarotene >pre-defined dose; anticoagulant use

1985-1988 Alpha-Tocopherol, 

Beta-Carotene (ATBC) 

Cancer Prevention 

Study

NIH SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17106437 Mitrou 

2007

Cohort 

study

Finland 

64 N

29133 27028 56.7 

(est.)

nd 100 Caucasians BMI 26.5 (est.) smokers 

at 

baseline

vit D 5.4 μg/d mean 

intake (est.)

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

nd nd

17106437 Mitrou 

2007

Dietary 

calcium 

intake

276 item FFQ 

past 12 mo

database of the 

Natl Public 

Health Institute, 

Finland

Yes, intraclass 

correlation of FFQ 

3 mo apart in a 

sample of 133 

ranged from 0.6 to 

0.7

dietary 

calcium=1513 

mg/d (est.)

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17106437 Mitrou 2007 primary prostate cancer Finnish Cancer Registry (medical records reviewed to confirm diagnosis through 4/1999)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

17106437 Mitrou 

2007

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes total energy intake

Demographics (e.g., age, gender, race, education)? Yes age, education

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI; Ht

Medical conditions Yes type 2 DM

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation 

of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes physical activity; smoke inhalation, number 

of cigarettes

Other Yes FH of prostate cancer; marital status; urban 

residence; intervention group

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Event* 

No. of 

Noncases 

/ Total 

N**

Crude or Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

17106437 Mitrou 

2007

total 

prostate 

cancer

<1000 mg/d 

dietary calcium

nd <1000 

mg

151 nd adjusted (age, 

intervention group, 

physical activity, 

type 2 DM, FH of 

prostate cancer, ht, 

BMI, smoking 

inhalation, 

cigarettes, marital 

status, education, 

urban residence, 

total energy intake)

RR 1.0

<0.0001

1000-1499 1000-

1499

611 nd 1.28 1.07-

1.54

1500-1999 1500-

1999

402 nd 1.38 1.14-

1.67

≥2000 ≥2000 103 nd 1.63 1.27-

2.10

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

17106437 Mitrou 2007 prostate cancer subgroups see Table II in paper for nonadvanced, advanced, low grade, high grade prostate cancer

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17106437 Mitrou 

2007

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

N

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): A

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

16352684 Morley 

2006

Cohort 

study

Pregnant <16 

wk gestation

multiple pregnancies; maternal diseases; dark skin or 

concealing clothing; intention to move from the area in the 

foreseeable future

2002-2003 - government SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

16352684 Morley 

2006

Cohort 

study

Geelong, 

Australia 

38 S

475 374 29 nd 0 99% white Ht 166 cm nd 25(OH)D in winter: 

49.2 nmol/L; 

summer: 62.6 nmol/L 

(~11 wk (median) 

gestation)

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

16352684 Morley

2006

25(OH)D 

and/or 

1,25(OH)2D

RIA y; CV 10.2% nd winter and 

summer

25(OH)D in 

winter: 48.3 

nmol/L; 

summer: 68.9 

nmol/L (28-32 

wk gestation)

Dietary 

calcium 

intake

nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

16352684 Morley 2006 primary birth weight

gestation length

crown-heel length

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

16352684 Morley 

2006

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes infant sex

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes maternal height

Medical conditions parity

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

season of blood drawn

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes smoking

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

**

Final 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P 

between 

groups***

16352684 Morley 

2006 birth 

weight g

maternal vit 

D at 28-32 

wk <28 

nmol/L

adj

27 3397 57 -153 -348, 42 NS

≥28 nmol/L 347 3555 52

crownheel 

length

cm

maternal vit 

D at 28-32 

wk <28 

nmol/L

27 49.8 2.7 -0.6 -1.5, 0.3 NS

≥28 nmol/L 347 50.4 2.4

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

16352684 Morley 2006 no associations between maternal 25(OH)D at recruitment (median 11 wk) and any birth measure (data not shown)

see Table 3 in paper for results on gestation length; knee-heel length, and others

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

16352684 Morley 

2006

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

N

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

N

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

N

b) Analysis 

was planned

when cohort 

was formed? 

(y/n)

Y

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

Y

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): recruited only 475/2470 (19%) of potentially eligible women

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

11262466 Morris

2001

Cohort study pregnant women nd nd Calcium for Preeclampsia Prevention Study (CPEP) NICHHD SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

11262466 Morris

2001

Cohort 

study

Albuquerque, NM; 

Birmingham, AL; 

Cleveland, OH; 

Memphis, TN; 

Portland OR

4314 4157 79% 

age 

17-24

nd 0 51% white; 

46% 

African 

American

38% with BMI ≥ 26 nd dietary calcium 

pre-intervention: 

1121 mg/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

nd nd

11262466 Morris

2001

Dietary 

calcium 

intake

24 h recall nd n dietary calcium 

preintervention: 

1121 mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

11262466 Morris

2001

primary preeclampsia HTN (DBP≥90 mm) and proteinuria (≥300 mg) within 7 d of each other

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

11262466 Morris

2001

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes race

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes smoking

Other health insurance coverage

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

11262466 Morris

2001

preeclampsia dietary calcium 579 ND ND adj RR 1.00 (ref) NS ND

580-

845

ND ND 0.90 0.61-

1.30

846-

1131

ND ND 0.95 0.65-

1.39

1132-

1560

ND ND 0.97 0.65-

1.45

1561 ND ND 0.78 0.49-
1.24

11262466 Morris

2001

Pregnancyinduced 

hypertension 

dietary calcium 579 ND ND adj RR 1.00 (ref) NS

ND

580-

845

ND ND 1.09 0.84-

1.42

846-

1131

ND ND 1.10 0.83-

1.44

1132-

1560

ND ND 1.14 0.85-

1.53

1561 ND ND 1.35 0.98-

1.86

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 
UI Author

Year Outcome Results

UI Author

Year Comments for Results

11262466 Morris

2001

“Because the randomized trial from which the data were obtained did not demonstrate any effect of treatment with supplemental calcium, models were fitted to 

data pooled across both treatment arms.”

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year

Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

11262466 Morris

2001

a) Eligibility 

criteria 

clear? (y/n)

N

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): unclear if the analysis was also adjusted for total energy intake

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

17181890 Moschonis 

2006

RCT Greek 

postmenopausal 

women

Women diagnosed having a T-score lower than – 2.5, taking 

medications (i.e. thiazide diuretics, glucocortocoids) and/or dietary 

supplements (calcium, magnesium, phosphate or vitD) that affect 

bone metabolism, having any kind of degenerative chronic disease 

(i.e. diabetes, nephrolithiasis, heart disease, cancer, hyper-and 

hypothyroidism, impaired renal and liver function), smoking and 

being at menopause for less than 1 y, osteoporotic, or having 

abnormal values on aforementioned blood indices. 

2004 nd Friesland 

Foods 

Hellas

JHL

MC

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17181890 Moschonis 

2006

RCT Greece (Nea 

Smyrni, 

Kalluthea 

and Neo 

Iraklio)

31o N 

112 101 61 (nd) 55-65 0% 100% 

Greek

Weight - 72.9 kg

Height – 157.2 cm

BMI – 29.6 kg/m2

nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17181890 Moschonis 

2006

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd VitD intake 

0.59 μg/d

17181890 Moschonis 

2006

Dietary 

calcium 

intake

24hr recall Database for 

Greek food and 

recipes 

(University of 

Crete)

nd Ca 679.7 

mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

17181890 Moschonis 

2006

Ca group Supplementary Ca (87% of Calcium 

lactate gluconate 13% of Ca carbonate)

600 mg 12 mo

17181890 Moschonis 

2006

Dairy group Advised to consume 3 portions of low-fat 

dairy products (milk and yogurt) fortified 

with Ca and vitD3 on daily basis (1 

portion=250 ml milk, 200g yogurt)

400 mg calcium/portion 

(one portion is equal to

250 ml milk and to 200 g 

yogurt) and 2.5 ug 

vitamin D3 per portion.

Total daily dose = 1200 

mg Ca +7.5 ug vit D3

12 mo Advice to consume dairy products on daily 

basis. In order to avoid excess caloric intake 

subjects were advised to substitute other 

dairy products in their diet with those 

provided

17181890 Moschonis 

2006

Control group No intervention, usual diet Na 12 mo na

Co-intervention(s) *: None

Compliance/Adherence:

Dairy group 93% (assessed via information obtained at the biweekly sessions, combined with data obtained from the nutritional 

assessments conducted at baseline, 5 and 12 months of intervention)

Ca group 95% (assessed by checking for remaining ca tablets in the returned packages but also via weekly phone calls)

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17181890 Moschonis 

2006

primary BMD DXA

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17181890 Moschonis 

2006

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)

No. 

Analyzed Baseline Baseline SE*

Delta 

**

Delta 

CI*

Net 

difference***

Net 

difference 

CI*

P 

between 

groups***

17181890 Moschonis 

2006

Total 

body 

BMD

g/cm2 Control group Crude 12 m 36 1.12 0.014 -0.7 

%

-1.4, 

-0.1 

%

P<0.05, 

dairy vs. 

control

17181890 Moschonis 

2006

Total 

body 

BMD

g/cm2

CalciumSupplemented 

group

Crude 12 m 26 1.077 0.022 0.6 

%

-0.4, 

1.6 

%

P<0.05, 

dairy vs. 

Ca group

17181890 Moschonis 

2006 Total 

body 

BMD

g/cm2

Dairy group 

(1200 mg Ca 

+7.5 ug vit 

D3)

Crude 12 m 39 1.133 0.012 1.5 

%

0.9, 

2.2 

%

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17181890 Moschonis 

2006

RCTParallel Y N N N N Y Y N Y C

Adverse Event(s): ** bloating, constipation and intestinal discomfort apparently related to the calcium supplement

Explanation for Overall Quality Grade (if not Grade A):

No blinding, no adjustment for confounders.

Analyses only included completers: 11 subjects dropped out: 2 from the dairy group dropped out due to 

personal reasons, whereas 4 subjects from the control group either could not be tracked down or were not 

available to participate at follow-up examinations. Furthermore, 4 women from the calcium supplement group 

withdrew, due to complaints of side-effects, such as bloating, constipation and intestinal discomfort apparently 

related to the supplement used.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

19125756 Nagpal 

2009

RCT Male, “apparently 

healthy”, centrally 

obese (waist 

circumference 78 

cm), 35 yrs

Fasting plasma glucose > 7.0 mmol/L, self-reported diabetes, 

insulin or any oral glucose-lowering medication, resting BP > 

140/90 mmHg self-reported hypertensive, antihypertensive 

medication, cholecalciferol or Ca supplementation in last 6 mo., 

chromic renal, hepatic, malignant or intestinal disease or renal 

stones, any medication within the last month that could 

influence insulin secretion, insulin sensitivity, vit D or Ca 

metabolism, febrile illness or infective morbidity in the last 10 

days, grossly deranged liver or kidney function

2006-2007 nd Indian Council 

of Medical 

Research, 

New Delhi

MB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

19125756 Nagpal 

2009

RCT New Delhi, 

India (28 N)

100 71 (ITT 

analysis)

65 (per 

protocol 

analysis)

44 (8) nd 100% Indian BMI = 26.4 (4)

Waist circumference 

(cm) = 91.6 (9)

Waist-hip ratio = 

0.98 (0.06)

“apparently 

healthy”, 

centrally 

obese

Most subjects 

severely vit D 

deficient

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

19125756 Nagpal 

2009

25(OH)D RIA Yes: 5% of 

samples re-run 

for quality 

control. Meancentered coeff 

of variation for 

25(OH)D was 

8.0%

nd nd Mean (nmol/L) 

SD in 

supplemented 

group = 36.5

14.55. In control 

group = 30.0 

12.50

Dietary 

calcium 

intake

nd nd nd nd nd nd Serum Ca 

(mmol/L) SD = 

2.3 0.20

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) Vit D and/or Ca Total Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. 

capsules were taken 2 times a 

day)

19125756 Nagpal 

2009

vit D Calcirol (brand name of cholecalciferol from Cadila 

Pharmaceuticals, Ahmedabad, India)

8571 IU 

cholecalciferol

6 wk 120,000 IU sachets given 3 times, 

every 2 weeks, for 6 weeks

placebo Identical to vit D in color, taste, and external 

appearance and also provided by Cadila 

Pharmaceuticals

- 6 wk Placebo sachets given 3 times, 

every 2 weeks, for 6 weeks

Co-intervention(s) *: Both groups advised to continue their normal diet and exercise.

Compliance/Adherence: Supervised administration of doses by home visits

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

19125756 Nagpal 

2009

2

SBP

Automated OMRON electronic device used – validated in an earlier trial. 3 serial BP recordings from the right arm were 

taken after 10 min rest at 10-min intervals in the sitting posture as per WHO recommendations, and the mean used for 

analysis.

2 DBP Same as SBP

nd 25(OH)D
Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

19125756 Nagpal 

2009

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes – groups matched on age, gender, race, 

education, and income

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes – groups matched on BMI, waist 

circumference, waist-hip ratio

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes – groups matched on smoking, alcohol, 

physical activity

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Delta** Delta 

SD*

Net 

difference

Net 

difference 

SE*

P 

between

19125756 Nagpal 

2009

SBP (ITT 

analysis)

mmHg vit D 1.5 35 124 11 0.60 9.82 +3.95 2.05 0.058

placebo 1.5 36 124 10 -3.35 7.21

SBP (per 

protocol 

analysis)

mmHg vit D 1.5 32 124 11 0.60 9.82 +3.68 2.06 0.079

placebo 1.5 33 124 10 -3.09 7.14

DBP (ITT) mmHg vit D 1.5 35 78 8 0.43 7.66 +1.69 1.64 0.305

placebo 1.5 36 77 9 -1.26 5.97

DBP (per 

protocol)

mmHg vit D 1.5 32 78 8 0.43 7.66 +1.55 1.65 0.353

placebo 1.5 33 77 9 -1.11 5.99

25(OH)D 

(ITT)

nmol/L vit D 1.5 35 36.5 14.55 35.1 27.28 +34.52 4.94 <0.0005

placebo 1.5 36 30.0 12.50 0.60 11.61

25(OH)D 

(per 

protocol)

nmol/L vit D 1.5 32 36.5 14.55 35.1 27.28 +34.44 5.02 <0.0005

placebo 1.5 33 30.0 12.50 0.65 11.78

Weight (ITT) Kg vit D 1.5 35 nd nd +0.03 1.82 +0.42 0.42 0.42

placebo 1.5 36 nd nd -0.38 1.70

Weight (per 

protocol)

vit D 1.5 32 nd nd +0.35 1.60 +0.76 0.41 0.07

placebo 1.5 33 nd nd -0.41 1.73

BMI (ITT) kg/m2vit D 1.5 35 26.7 4.54 -0.02 0.62 +0.02 0.15 0.90

placebo 1.5 36 26.0 3.46 -0.04 0.68

BMI (per 

protocol)

vit D 1.5 32 26.7 4.54 +0.08 0.56 +0.13 0.16 0.40

placebo 1.5 33 26.0 3.46 -0.05 0.69

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 
*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group.

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 
UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

19125756 Nagpal 

2009

RCTparallel Y Y NA N Y Y Y Y YB

(Weight C)

Adverse Event(s): **

Both groups were advised to report any interval morbidity including nausea, vomiting, abdominal pain, urinary 

complaints, or muscle cramps or diagnosis of hypercalcemia during treatment of any illness. No specific data 

on AEs was provided.

Explanation for Overall Quality Grade (if not Grade A):

26% drop-out rate. However, authors claim that there is a low likelihood of loss to follow-up biasing results 

because 1) none of the baseline characteristics was significantly different between those reporting and those 

lost to follow-up, 2) the proportions of subjects lost to follow-up in both groups were comparable, and 3) interval 

morbidity in the two groups did not differ.

No baseline data on weight.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

RCT

RCT-post hoc**

Other intervention study

Cohort study

Case-cohort study

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit D 

or Ca intake ...etc.)

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of 

Dietary 

Assessment? (y/n) 

If Yes, Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data

Time between 

Biomarker 

Sampling and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes/no*

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes/no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 25(OH)D, UV

exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, alcohol 

consumption)

Yes/no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year

Outcome Unit Exposure / 

Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

19158226 Nelson 

2009

RCT Women aged 19-35 y, living in the Bangor, ME area, subjects 

had a BMI 18.5~40kg/m2, have a baseline serum 25(OH)D 

concentration 22.5-175nmol/L, and be free of any disease or 

condition that influences Ca or Vit D, asked not to travel to a 

southern latitude (<35° N latitude) between September and 

March and to refrain from using tanning booths. Had not 

regularly consumed any Ca or Vit D-containing supplement 

within the previous 4 mo and agreed not to take any Ca, Vit D, 

or multivitamin supplements other than those provided during 

the study period. 

Pregnant women, 

Women planned to 

become pregnant, subjects 

taking any medications, 

other than oral 

contraceptives, that affect 

Ca or Vit D 

2005 nd nd JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

19158226 Nelson 

2009

RCT Bangor, ME 112 

women 

86 

women

22.2 

(3.7)

19-35 y 0 Predominantly 

white women 

BMI 25.9 

% body fat 30.1%

Height 164.2 cm

Weight 69.7kg

Healthy ND

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

19158226 Nelson 

2009

25(OH)D 

and/or 

1,25(OH)2D

RIA Y, intra-assay 

and inter-assay 

CV, <10% 

1 month September and 

February

Serum 

25(OH)D 

62.0nmol/L

19158226 Nelson 

2009

Dietary 

calcium 

intake

3-d food 

records

ND n nd nd nd Ca intake 

908.2 mg/d

* Write “nd” if there was no data reported. Please do not leave blank 
**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

19158226 Nelson 

2009

Vit D3 Vit D3 supplement Vit D3 20 μg/d 6 mo One time/day

Nelson 

2009

Placebo

Co-intervention(s) *: Hormonal contraceptive 

Compliance/Adherence: Compliance was assessed by pill counts. No subject had compliance <75%

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

19158226 Nelson 2009 Primary Serum 25(OH)D change

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

19158226 Nelson 2009 The actual mean D3 content of the capsules was 22 μg.

There was a run-in period from Feb until Sep 2005. 

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

19158226

Nelson 

2009

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes VitD intake, Ca intake 

Demographics (e.g., age, gender, race, education)? Yes* Age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* BMI, total body fat %, 

height, weight 

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of

25(OH)D, UV exposure, location)

Yes Summer sun exposure

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other Yes Baseline 25(OH)D

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Delta**

Delta 

CI / SE 

/ SD*

Net 

difference

Net 

difference CI 

/ SE / SD*

P 

between

19158226 Nelson 

2009

25(OH)D nmol/L Vit D3 12 mo 55 62.1 24.0 35.3 23.2 24.4 nd <0.0005

Placebo 12 mo 31 61.9 22.6 10.9 16.9

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

19158226 Nelson 

2009

RCTParallel nd nd NA Y nd y y y y B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Poor reporting of methods 

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort Name

Funding 

Source Extractor

9794175 Nomura 

1998

Case-cohort 

study

men with available blood 

specimen at baseline

baseline prostate cancer; enrollment in 

cardiolipin study; previously thawed sample for 

other studies

1967-1970 Honolulu Heart 

Program

government SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

9794175 Nomura 

1998

Casecohort 

study

Oahu, 

Hawaii 21 N

272 272 58 (nd) 49-70 100 Hawaiian 

Japanese

nd 22 packyears 

smoked

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

9794175 Nomura 

1998

25(OH)D 

and/or 

1,25(OH)2D

proteinbindingIntra-assay CV 

5 to 10%

≥23 y nd all subjects 

live in Hawaii

Dietary 

calcium 

intake

nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

9794175 Nomura 1998 primary prostate cancer biopsy or surgical specimen; discharge records

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

9794175 Nomura 

1998

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

no

Demographics (e.g., age, gender, race, education)? Yes (age, month & year of exam, education)

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions no

Medication no

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

Yes, all from Hawaii

Smoking and other life styles variables Yes (smoking; alcohol use)

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean Vit 

D level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

* 

No. of 

Noncases 

**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

9794175 Nomura 

1998

prostate 

cancer

quartile of 25 OH-D <34 

ng/mL 

(based on 

controls 

freq)

38 34 crude 

(conditional 

logistic)

OR 1.0 (Ref)

0.68

34-40 35 36 0.8 0.4-

1.8

41-47 30 32 0.8 0.4-

1.7

≥48 33 34 0.8 0.4-

1.8

quartile of 1,25 OHD<33 

pg/mL

42 40 crude 

(conditional 

logistic)

1.0 (Ref)

0.87

33-39 32 30 1.0 0.5-

2.1

40-48 28 34 0.7 0.3-

1.6

≥49 34 32 1.0 0.5-

2.1

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Median 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

9794175 Nomura 

1998 Cases: 6-26 y crude 136 41.0 ng/mL 0.66

Control: 6-26 y crude 136 41.6

Duplicate one table per outcome 

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Median 1, 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

9794175 Nomura 

1998 Cases: 6-26 y crude 136 39.0 pg/mL 0.66

Control: 6-26 y crude 136 39.5 0.68

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

9794175 Nomura 1998 prostate cancer 1. Overall results similar in 58 cases ≥75 y to 78 cases <75 y 

2. Regressing the case-control difference on the month of exam showed a coefficient of -0.04 with a P of 0.92

UI Author

Year Outcome Results

9794175 Nomura 1998 prostate cancer by both 25 OH-D and 1,25 OH-D Joint effect odds ratio

1, 25 OH-D tertile

25 OH-D tertile 1 (16-34) 2 (35-46) 3 (47-74)

1 (21-36) 1.0 (Ref) 0.9 (0.3-2.6) 1.0 (0.3-3.4)

2 (37-46) 0.4 (0.1-1.2) 0.7 (0.2-2.2) 1.2 (0.4-3.6)

3 (47-92) 1.5 (0.5-4.7) 0.7 (0.2-2.3) 0.5 (0.2-1.7)

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

9794175 Nomura 

1998

a) Eligibility 

criteria 

clear? (y/n)

N

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

N

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

N

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

N

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

Y

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): unclear what factors were included in conditional logistic analysis; 34/170 cases were not included in the 

analysis because the diagnosis was within 5 years of their examination and had their sera sample thawed

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

17379616 Oh 

2007

Cohort 

study

Registered nurses 30-55y in the Unites States, who returned the 1980 

FFQ, Participants who had no diagnosis of cancer (excluding 

nonmelanoma skin cancer), inflammatory bowel disease, familial 

polyposis, or colorectal polyp prior to 1980, who reported having 

undergone at least one colonoscopy or sigmoidoscopy between 1980 and 

2002

Nd 1976 The 

Nurses’ 

Health 

Study

National 

Institute of 

Health 

JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

17379616 Oh 

2007

Cohort 

study

US (38° N) 121700 48115 nd nd 0% nd BMI 24 nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of 

Dietary 

Assessment? (y/n) 

If Yes, Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17379616 Oh 

2007

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd Nd

17379616 Oh 

2007

Dietary 

calcium 

intake

FFQ USDA Yes, correlation 

coefficient btw 1980 

dietary records and 

the 1984 FFQ: 0.56 

for energy adjusted 

total Ca, 0.51 for 

dietary Ca

Ca 

Quintile 1; 

510mg

Quintile 3:

741mg

Quintile 5:

946mg

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 
***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

17379616 Oh 

2007

nd Colorectal 

adenoma

Reviewed the medical records the histologic type, the anatomic location, and the size of reported polyps, cases 

of distal colorectal adenoma confirmed by histopathologic report 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including matching 

factors)

Specific comments for 

confounders

17379616 Oh 

2007

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy intake

Energy intake, energy-adjusted intakes of fiber, folate, 

phosphorus, and retinol, and red meat intake, vitD intake

Demographics (e.g., age, gender, race, education)? Yes - age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes - BMI

Medical conditions

Medication Postmenopausal hormone use, regular aspirin use

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes - pack –years of smoking, alcohol consumption, vigorous 

physical activity

Other Family history of colorectal cancer, history of previous 

endoscopy, indication for endoscopy

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean Ca 

level / 

dose*****

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

17379616 Oh 

2007

Adenoma Ca quintile 1 584 nd nd Adjusted RR 1

0.06

Ca quintile 2 779 nd nd Adjusted RR 1.05 0.93-

1.20

Ca quintile 3 949 nd nd Adjusted RR 0.96 0.84-

1.11

Ca quintile 4 1139 nd nd Adjusted RR 0.96 0.82-

1.12

Ca quintile 5 1451 nd nd Adjusted RR 0.88 0.74-

1.04

17379616 Oh 

2007

Distal 

colon 

cancer

Ca quintile 1 584 nd nd Adjusted RR 1

0.20

Ca quintile 2 779 nd nd Adjusted RR 1.04 0.90-

1.20

Ca quintile 3 949 nd nd Adjusted RR 0.96 0.82-

1.13

Ca quintile 4 1139 nd nd Adjusted RR 0.97 0.82-

1.16

Ca quintile 5 1451 nd nd Adjusted RR 0.90 0.74-

1.09

17379616 Oh 

2007

Rectum 

cancer

Ca quintile 1 584 nd nd Adjusted RR 1

0.24

Ca quintile 2 779 nd nd Adjusted RR 1.02 0.81-

1.29

Ca quintile 3 949 nd nd Adjusted RR 0.93 0.72-

1.20

Ca quintile 4 1139 nd nd Adjusted RR 0.91 0.69-

1.21

Ca quintile 5 1451 nd nd Adjusted RR 0.85 0.62-

1.16

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 

** ***Median Ca level 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17379616 Oh 

2007

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

N

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Y

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Power calculation not reported; cases, non-cases per calcium category not provided; exposure assessors 

blinding not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

17521921 Oken

2007

Cohort 

study

pregnancy no outpatient medical records; did not complete 1st trimester dietary 

questionnaire; preexisting chronic HTN and did not develop 

preeclampsia; missing covariate information

1999-2002 Project Viva NIH and 

others

SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

17521921 Oken

2007

Cohort 

study

MA 41 – 42

N

1718 1718 68% 

age 30 

to <40

nd 0 72% white; 

12% black

67% prepregnancy 

BMI <24.9

nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

nd nd

17521921 Oken

2007

Dietary 

calcium 

intake

semiquantitative 

FFQ

Harvard 

(based on 

USDA)

n calcium 

(dietary & 

supplement): 

1308 mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17521921 Oken

2007

primary preeclampsia BP >140/90 & proteinuria (dipstick 1+ ≥2 occasions or dipstick 2+) >4 h and ≤7 days apart

gestational HTN

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17521921 Oken

2007

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes age; race; education

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes prepregnancy BMI

Medical conditions 1

st trimester SBP; parity

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year

Outcome Exposure / 

Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

17521921 Oken

2007 Cases: 

preeclampsia

adj for total 

energy 

intake only

59

1270 mg 443

NS

Control: 

normal BP 1540 1309 mg 416

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

17521921 Oken

2007

preeclampsia A multivariate logistic regression did not show an association between calcium (dietary and supplement) intake and preeclampsia (OR 1.03 

per 300 mg of calcium; 95%CI 0.84-1.27).

gestational 

HTN see table 2 in paper for results 

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17521921 Oken

2007

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

N

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

Y

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): did not calibrate the semi-quantitative FFQ for calcium

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

17622244

Otani

2007 

Casecohort 

study

Residents living in several municipalities 

administered by the Japan Public Health 

Center (Aged 40-59y for Cohort 1, Aged 

40-69y for Cohort 2) (n=133323)

Subjects donated blood, returned the 

baseline questionnaire, without diagnosis 

of any cancer (n=38873)

Cases: adenocarcinoma including CIS

Controls: 1:2 matching based on sex, age 

(<3 y), date of blood draw (<3 mo), time 

since last meal (<4 h), study location 

Cases: Nonadenocarcinoma or no 

pathological verification 

(n=25)

1990 

(Cohort 1)

1993 

(Cohort 2) The Japan Public 

Health Centrebased Prospective 

Study

Ministry of 

Health, Labour, 

and Welfare, 

Japan

JHL/TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N enrolled*** N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

17622244 Otani

2007

Casecohort 

study

Japan (~ 

30° – 40° 

N)

Original cohort 

(N=133323),

Subjects donated 

blood, returned the 

baseline 

questionnaire, without 

diagnosis of any 

cancer (N=38873), 

cases (N=375) and 

controls (N=750)

1125 Men 

56.9 (no 

SD)

Women 

56.4 (no 

SD)

40-69 52% (Japanese 

or Asian 

~100%)

BMI

Men: 23.4

Women: 23.6

nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (e.g. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time between 

Biomarker 

Sampling and 

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure 

data

17622244

Otani

2007 

25(OH)D 

and/or 

1,25(OH)2D

Competitive 

proteinbinding assay 

with GcGlobulin 

modification 

Intra-assay 

coefficient of 

variation 

(CV)=8.4% 

(n=9)

Inferring 9-14 y 

(cohort 2) or 

12-17 y (cohort 

1). (Collected in 

1990-1992 for 

Cohort 1, and 

1993-1995 for 

cohort 2. Last 

follow-up 

12/2003) 

nd VitD intake 

( g/d)

Men: 6.6

Women: 5.3

17622244

Otani

2007 

Dietary 

calcium 

intake

FFQ

(Tsubono et al, 

2003), 44 items 

(cohort 1) and 

52 items 

(cohort 2)

nd nd Ca intake 

(mg/d)

Men: 455.7

Women: 

432.7

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

17622244 Otani

2007

nd Colorectal 

cancer

Adenocarcinoma (Collected for the JPHC cancer registry through local major hospitals, and population-based 

cancer registries) with pathological verification ~95%, death certificates only ~5%. ICD 180-189, 199, and 209 

17622244 Otani

2007

nd Colon cancer See above (ICD180-189 only)

17622244 Otani

2007

nd Rectal cancer See above (ICD199 and 209 only)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

17622244

Otani

2007

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy 

intake

Energy intake, vitamin supplement 

use

Matching factors: sex, age, date of blood draw, time since 

last meal, study location

Further adjustment for n-3 polyunsaturated fatty acid or 

fish intake (results not materially changed [data not 

shown])

Demographics (e.g., age, gender, race, education)? Yes - age, gender

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes - BMI

Medical conditions Family Hx of colorectal cancer

Medication

Sunlight exposure and its proxy variables (e.g., physical 

activity level, occupation, sun exposure, location)

Physical exercise

Smoking and other life styles variables Yes - smoking, alcohol

Other Family history of colorectal cancer, 

cohort

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / SE 

/ SD **

P 

between 

groups***

P for 

trend****

17622244 Otani

2007 

Colorectal 

cancer 

Men

25 (OH)vitaminD –

lowest 

<22.9 43 74 Adjusted RR 1.0 (ref) 0.39

Men

25 (OH)vitaminD –

second

22.9-

27.5 40 85 Adjusted 0.76 0.42-

1.4

Men

25 (OH)vitaminD –

third

27.6-

32.0 36 85 Adjusted 0.76 0.39-1.5
Men

25 (OH)vitaminD –

highest 

32.1+ 44 80 Adjusted 0.73 0.35

-

1.5

17622244 Otani

2007 

Colorectal 

cancer 

Women

25 (OH)vitaminD –

lowest 

<22.9 41 77 Adjusted RR 1.0 (ref) 0.74

Women

25 (OH)vitaminD –

second

22.9-

27.5 34 73 Adjusted 1.0 0.55

-

1.9

Women

25 (OH)vitaminD –

third

27.6-

32.0 44 71 Adjusted 1.2 0.65

-

2.3

Women

25 (OH)vitaminD –

highest 

32.1+ 41 76 Adjusted 1.1 0.50

-

2.3

17622244 Otani

2007 

Colon 

cancer 

Men

25 (OH)vitaminD –

lowest 

<22.9 25 54 Adjusted RR 1.0 (ref) 0.70

Men

25 (OH)vitaminD –

second

22.9-

27.5 27 55 Adjusted 0.98 0.48

-

2.0

Men

25 (OH)vitaminD –

third

27.6-

32.0 29 66 Adjusted 1.0 0.48

-

2.3

Men

25 (OH)vitaminD –

highest 

32.1+ 38 62 Adjusted 1.2 0.51

-

2.7

17622244 Otani

2007 

Colon 

cancer 

Women

25 (OH)vitaminD –

lowest 

<22.9 21 53 Adjusted RR 1.0 (ref) 0.12

Women

25 (OH)vitaminD –

second

22.9-

27.5 27 48 Adjusted 1.7 0.78

-

3.6

Women

25 (OH)vitaminD –

third

27.6-

32.0 27 41 Adjusted 2.1 0.90

-

4.7

Women

25 (OH)vitaminD –

highest 

32.1+ 31 53 Adjusted 2.1 0.78

-

5.6

17622244 Otani

2007 

Rectal 

cancer 

Men

25 (OH)vitaminD –

lowest 

<22.9 18 20 Adjusted RR 1.0 (ref) 0.06

Men

25 (OH)vitaminD –

second

22.9-

27.5 13 30 Adjusted 0.17 0.024

-

1.2

Men

25 (OH)vitaminD –

third

27.6-

32.0

7 19 Adjusted 0.25 0.051

-

1.3

Men 32.1+6 18 Adjusted 0.075 0.0057-
25 (OH)vitaminD –

highest 

0.99

17622244 Otani

2007 

Rectal 

cancer 

Women

25 (OH)vitaminD –

lowest 

<22.9 20 24 Adjusted RR 1.0 (ref) 0.22 0.17

Women

25 (OH)vitaminD –

second

22.9-

27.5 7 25 Adjusted 0.26 0.069-

1.0

Women

25 (OH)vitaminD –

third

27.6-

32.0 17 30 Adjusted 0.46 0.15-1.4

Women

25 (OH)vitaminD –

highest 

32.1+ 10 23 Adjusted 0.33 0.084-

1.3

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

17622244 Otani

2007 

(colorectal) 

Cases: 

Men 10-13 y

Adjusted** 196 27.3*** 22.2-

32.8  0.67

Control: 

Men 

Adjusted**  392 27.6*** 22.9-

32.1 

Otani

2007 

(colorectal) 

Cases: 

Women 10-13 y

Adjusted**  179 22.5*** 18.5-

27.1  0.91

Control: 

Women 

Adjusted**  358 22.3*** 18.7-

27.0 

Otani

2007 

(colon)

Cases: 

Men 10-13 y

Adjusted**  141 28.3 23.0-

35.0

0.25

Control: 

Men 

Adjusted** 282 28.0 23.0-

32.3

Otani

2007 

(colon)

Cases: 

Women 10-13 y

Adjusted** 115 23.3 19.1-

27.3

0.25

Control: 

Women 

Adjusted** 230 22.0 18.5-

27.5

Otani

2007 

(rectal)

Cases: 

Men 10-13 y

Adjusted** 55 24.3 20.2-

29.1

0.0051

Control: 

Men 

Adjusted** 110 26.6 22.9-

31.2

Otani

2007 

(rectal)

Cases: 

Women 10-13 y

Adjusted** 64 20.6 17.8-

25.3

0.093

Control: 

Women 

Adjusted** 128 22.6 19.1-

26.5

Duplicate one table per outcome 

**Tested by extensions of Mantel-Haenszel procedure with matched pairs. 

***median 

****interquartile range 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17622244

Otani

2007 

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(e.g. 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

nd

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

Y

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

nd

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Some poor reporting, no internal calibration of FFQ

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

Comments 
***During follow-up, 9.9% moved away, and 0.2% were lost.
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

17215380 Park 

2007

Cohort 

study

Adults aged 45-75 years from five 

targeted ethnic racial groups: African 

Americans, Native Hawaiians, 

Japanese Americans, Latinos, and 

Whites

Participants who are not in one of the 

targeted ethnic group or who reported 

implausible dietary intakes.

Participants with previous colorectal 

cancer reported on the baseline 

questionnaire or identified from the 

cancer registries of Hawaii and California 

1993-1996 Multiethnic 

Cohort Study

National 

Cancer 

Institute

JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17215380 Park 

2007

Cohort 

study

Hawaii (21° 

N)

Los 

Angeles, 

California 

(34° N)

215,000 191,011 nd nd 45% African 

Americans, 

Native 

Hawaiians, 

Japanese 

Americans, 

Latinos, and 

Whites

nd nd Nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or

Validity) of Dietary 

Assessment? (y/n) 

If Yes, Provide 

Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17215380 Park 

2007

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd VitD intake

335 IU (men)

340 IU 

(women)

17215380 Park 

2007

Dietary 

calcium 

intake

Food 

frequency 

questionnaire

Data base 

developed at 

the cancer 

research center 

of 

Hawaii

Y, quantitative food 

frequency 

questionnaire, 3 

repeated 24-hr 

recalls, correlations 

(Ca: 0.67, VitD: 

0.61)

Ca

960mg (men)

1066mg 

(women)

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

17215380 Park 

2007

nd Colorectal 

cancer 

Identified by means of linkage of to the Surveillance, Epidemiology, End Results cancer registries covering 

Hawaii and California

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including matching 

factors)

Specific comments for 

confounders

17215380 Park 

2007

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Total energy intake, dietary fiber intake

Demographics (e.g., age, gender, race, education)? Yes - ethnicity, age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes - BMI,

Medical conditions

Medication Use of nonsteroidal anti-inflammatory drugs, hormone 

replacement therapy (women); use of multivitamins

Sunlight exposure and its proxy variables (e.g., seasonal variation 

of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes - smoking, family history of colorectal cancer, physical 

activity, history of intestinal polyps

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean Ca 

level / dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Follow 

up, 

mo Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

17215380 Park 

2007

Colorectal 

cancer 

(Men)

Ca quintile 1 <288 

mg/1000kcal/d

342 nd

87.6 Adjusted RR 1.00 0.006

Ca quintile 2

288 -< 369 

mg/1000kcal/d

271 Nd

87.6

Adjusted 1.02 0.86-

1.22

Ca quintile 3 369 -< 457 

mg/1000kcal/d

258 Nd 87.6 Adjusted 1.08 0.89-

1.31

Ca quintile 4 457 -< 611 

mg/1000kcal/d

177 Nd 87.6 Adjusted 0.85 0.68-

1.07

Ca quintile 5 ≥ 611 

mg/1000kcal/d

90 Nd 87.6 Adjusted 0.70 0.52-

0.93

17215380 Park 

2007

Colorectal 

cancer 

(Women)

Ca quintile 1 <288 

mg/1000kcal/d

172 Nd

87.6

Adjusted 1.00

0.003

Ca quintile 2 288 -< 369 

mg/1000kcal/d

175 nd 87.6 Adjusted 0.77 0.60-

0.97

Ca quintile 3 369 -< 457 

mg/1000kcal/d

194 Nd 87.6 Adjusted 0.76 0.60-

0.97

Ca quintile 4 457 -< 611 

mg/1000kcal/d

197 Nd 87.6 Adjusted 0.74 0.57-

0.94

Ca quintile 5 ≥ 611 

mg/1000kcal/d

234 Nd 87.6 Adjusted 0.64 0.50-

0.83

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 

** **Models were also included intakes from food, supplements and foods excluding users of multivitamin or calcium supplements for data analysis.

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 
**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean Ca 

level / dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Follow 

up, 

mo Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

17215380 Park 

2007

Colorectal 

cancer 

(African 

Americans)

Ca quintile 1 <309 

mg/1000kcal/d

126 nd 87.6 Adjusted RR 1.00

0.18

Ca quintile 2 309 -< 410 

mg/1000kcal/d

121 Nd 87.6 Adjusted 0.77 0.58-

1.03

Ca quintile 3 410 -< 558 

mg/1000kcal/d

133 Nd 87.6 Adjusted 1.03 0.77-

1.40

Ca quintile 4 ≥ 558 

mg/1000kcal/d

67 Nd 87.6 Adjusted 0.70 0.48-

1.02
17215380 Park 

2007

Colorectal 

cancer 

(Native 

Hawaiians)

Ca quintile 1 <309 

mg/1000kcal/d

69 Nd 87.6 Adjusted RR 1.00

0.08

Ca quintile 2 309 -< 410 

mg/1000kcal/d

33 Nd 87.6 Adjusted 0.69 0.43-

1.12

Ca quintile 3 410 -< 558 

mg/1000kcal/d

28 Nd 87.6 Adjusted 0.93 0.54-

1.58

Ca quintile 4 ≥ 558 

mg/1000kcal/d

11 Nd 87.6 Adjusted 0.44 0.20-

0.99

17215380 Park 

2007

Colorectal 

cancer 

(Japanese 

Americans)

Ca quintile 1 <309 

mg/1000kcal/d

312 Nd 87.6 Adjusted RR 1.00

0.008

Ca quintile 2 309 -< 410 

mg/1000kcal/d

177 Nd 87.6 Adjusted 0.99 0.80-

1.22

Ca quintile 3 410 -< 558 

mg/1000kcal/d

125 Nd 87.6 Adjusted 0.85 0.66-

1.10

Ca quintile 4 ≥ 558 

mg/1000kcal/d

117 Nd 87.6 Adjusted 0.69 0.52-

0.91

17215380 Park 

2007

Colorectal 

cancer 

(Latinos)

Ca quintile 1 <309 

mg/1000kcal/d

45 Nd 87.6 Adjusted RR 1.00

0.12

Ca quintile 2 309 -< 410 

mg/1000kcal/d

122 Nd 87.6 Adjusted 1.12 0.77-

1.62

Ca quintile 3 410 -< 558 

mg/1000kcal/d

117 Nd 87.6 Adjusted 0.85 0.58-

1.26

Ca quintile 4 ≥ 558 

mg/1000kcal/d

81 Nd 87.6 Adjusted 0.79 0.51-

1.08

17215380 Park 

2007

Colorectal 

cancer 

(Whites)

Ca quintile 1 <309 

mg/1000kcal/d

89 Nd 87.6 Adjusted RR 1.00

0.04

Ca quintile 2 309 -< 410 

mg/1000kcal/d

89 Nd 87.6 Adjusted 0.73 0.54-

1.01

Ca quintile 3 410 -< 558 

mg/1000kcal/d

126 Nd 87.6 Adjusted 0.81 0.60-

1.11

Ca quintile 4 ≥ 558 

mg/1000kcal/d

122 Nd 87.6 Adjusted 0.65 0.46-

0.91
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17215380 Park 

2007

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified

methods***

was used? 

(y/n)

N

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

Y

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Power calculation not reported; blinding assessor not reported; cancer cases not confirmed by histology 

reports; study designed to assess relationship of diet with several cancer sites not specifically between 

calcium and CRC

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

18000020 Park

2007

Cohort 

study

AARP members (50-

71); satisfactory 

dietary data

questionnaires completed by proxy; cancer before baseline 

(except for nonmelanoma skin cancer); self-reported ESRD; 

extreme total energy and calcium (food) intakes (>2x IQR of 

log-transformed intake)

1995-1996 (NIH)-AARP 

Diet & Health 

Study

NCI SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit D 

or Ca intake ...etc.)

18000020 Park

2007

Cohort 

study

CA, FL, LA, 

NJ, NC, PA

339671 293888 nd 50-71 100 92% 

white 

(est.)

BMI 27.2 (est.) nd calcium from non-dairy 

food (346-370 mg/d); 

dairy calcium (211-997 

mg/d); supplemental 

calcium (34-514 mg/d)

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

25(OH)D 

and/or 

1,25(OH)2D

nd nd

18000020 Park

2007

Dietary 

calcium 

intake

124 item FFQ 

past 12 mo

USDA FFQ validated by 

two 24 h recalls in 

1953 participants; 

correlation with 

reference method 

was 0.63

calcium from nondairy food (346-

370 mg/d); dairy 

calcium (211-997 

mg/d); 

supplemental 

calcium (34-514 

mg/d)

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 
***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

18000020 Park

2007

primary incident prostate cancer 8 state cancer registry databases; SSA Death Master File; Natl Death Index Plus

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

18000020 Park

2007

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes tomato, red meat, fish , vit E, α-linolenic 

acid, total energy intake, vit D

Demographics (e.g., age, gender, race, education)? Yes age; race; education

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions Yes DM; PSA screen

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes physical activity; smoking; alcohol

Other Yes marital status; FH prostate cancer

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD **

P between 

groups***

P for 

trend****

18000020 Park

2007

total 

prostate 

cancer

total calcium intake 

(diet + supplement)

<500 

mg/d

767 adj RR 1.01 0.93-

1.10 0.41

500 to 

<750

2927 1.00

750 to 

<1000

2808 0.99 0.93-

1.04

1000 to 

<1500

2572 0.99 0.93-

1.05
1500 to 

<2000

797 0.96 0.88-

1.05

≥2000 309 0.97 0.85-

1.10

18000020 Park

2007

fatal 

prostate 

cancer

total calcium intake 

(diet + supplement)

<500 

mg/d

11 adj RR 0.76 0.38-

1.53 0.99

500 to 

<750

43 1.00

750 to 

<1000

56 1.50 0.97-

2.32

1000 to 

<1500

50 1.42 0.86-

2.35

1500 to 

<2000

18 1.05 0.54-

2.05

≥2000 - - -

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

18000020 Park

2007

nonadvanced and advanced prostate cancer see Table 2 in paper

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

18000020 Park

2007

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

Y

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): A

Explanation for Overall Quality Grade (if not Grade A): excluded 14,495 questionnaires filled out by proxies

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

17925283 Park 

2007

Cohort 

study

Male adults aged 45-75 years from five 

racial and ethnic populations living in 

California and Hawaii: African Americans, 

Native Hawaiians, Japanese Americans, 

Latinos, and Whites

Not in one of the specified ethnic groups 

or reporting implausible dietary intakes.

Participants with prior prostate cancer 

occurrence through questionnaire or 

registry data. Men missing information 

on height, weight, education level, or 

smoking.

1993-1996 Multiethnic 

Cohort Study

National 

Cancer 

Institute

KP/SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N enrolled*** N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

17925283 Park 

2007

Cohort 

study

Hawaii (20° 

N) and 

California 

(32.30°-42° 

N)

Original cohort 

of 215,000 

men and 

women, 

including 

96,958 men 

82,483 Nd 45-75 100% African 

Americans, 

Native 

Hawaiians, 

Japanese 

Americans, 

Latinos, and 

Whites

Nd Nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? (y/n) 

If Yes, Provide 

Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17925283 Park 

2007

25(OH)D 

and/or 

1,25(OH)2D

NA NA NA NA ND

Dietary 

calcium 

intake

Selfadministered 

quantitative 

FFQ

Food composition 

table developed 

by Cancer 

Research Center 

of Hawaii for use 

in Multiethnic 

Cohort Study

Y: calibration study 

comparing to 24-hr 

recall showed 

correlations of 0.67 

and 0.61 

respectively for 

calcium and vitamin 

D respectively.

7% took 

calcium 

supplements 

regularly

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

17925283 Park 

2007

nd Prostate 

cancer

Identified by linkage of cohort to SEER registry, state death files, National Death Index file. Includes all 

prostate cancers except in situ tumors. 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17925283 Park 

2007

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Energy intake

Demographics (e.g., age, gender, race, education)? Yes Ethnicity, education

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions Family history of prostate cancer

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes Smoking

Other Time since cohort entry

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

17925283 Park 

2007

Prostate 

cancer

Total calcium <470 

mg

nd Nd 706 Nd adjusted RR 1.00 Reference Nd 0.69

Total calcium 470-

<692 mg

Nd Nd 925 Nd 1.03 0.93-1.15 Nd

Total calcium 692-

<935 mg

Nd Nd 949 Nd 1.04 0.93-1.17 Nd

Total calcium 935-

<1,300 mg

Nd Nd 936 Nd 1.05 0.93-1.18 Nd

Total calcium 

1,301 mg

nd Nd 888 nd 1.04 0.91-1.20 Nd

17925283 Park 

2007

Prostate 

cancer

Total vit D <66 IU nd Nd 639 Nd adjusted RR 1.00 Reference Nd 0.64

66 - <136 IU Nd Nd 938 Nd 1.15 1.03-1.28 Nd

136 - <256 IU Nd Nd 910 Nd 1.06 0.95-1.19 Nd

256 -<521 IU Nd Nd 940 Nd 1.11 1.00-1.24 Nd

521 IU nd Nd 977 nd 1.09 0.98-1.22 Nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17925283 Park 

2007

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

NA

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

NA

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Incident cases ascertained through registries, unclear if they were verified. Solid dietary assessment 

description; sample size calculations and explanation for if analysis was pre-planned not reported.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

19237724 Park 

2009

Cohort 

study

AARP members in 6 specific 

states and 2 specific 

metropolitan area, age 50 to 

71 (n=?)

Participants who returned 

questionnaires 

(n=567,169)****

GENERAL*****

Provided duplicate 

questionnaires (n=179)

Requested to be withdrawn 

(n=6)

Had moved out of the study 

area or died before 

baseline (n=582)

Proxies for the intended 

respondents (n=15,760)

Any prevalent cancer 

except non-melanoma skin 

cancer at baseline 

(n=51,193)

End-stage renal disease at 

baseline (n=997)

Extreme*** intakes of total 

energy (n=4417)

Extreme*** intakes of total 

calcium (n=1225)

OVARIAN CANCER ONLY 

(in addition to GENERAL)

History of oophorectomy 

(n=43,536)

ENDOMETRIAL CANCER 

ONLY (in addition to 

GENERAL)

History of hysterectomy 

(n=81,025)

1995-1996 NIH-AARP Diet and Health Study 

(NIH-AARP = National Institutes 

of Health-American Association of 

Retired Persons)

NIH (US) TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT 

*** Extreme was defined as “greater than twice the interquartile ranges above the 75th percentile or below the 25th percentile of sex-specific log-transformed intake”

  Unclear how many is the total number of AARP members (=denominator of this number to estimate a response rate) 

** *** At least 13% of questionnaire responders excluded for some reason. 

 
POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled*** N analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat 

...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or 

Ca intake 

...etc.)

19237724 Park 

2009

Cohort 

study

California, 

Florida, 

Louisiana, New 

Jersey, and North 

Carolina (6 

states), and 

Pennsylvania, 

Atlanta, Georgia, 

Detroit, and 

Michigan (2 

metropolitan 

regions) 

N=492,810 

(M=293,907, 

F=198,903)

N=492,810 

(M=293,907, 

F=198,903)

nd 50-71 

(range)

60% White 

(nonHispanic):

M= ~92%

F= ~89%

BMI:

M= ~27.2

F= ~26.7

Family 

history of 

any cancer:

M= ~47%

F= ~51%

Current 

smoker: M= 

~12%

F= ~15%

Antacid user: 

M=~31%

F= ~30%

Hormone 

replacement 

therapy user: 

F= ~40%

Ca-containing 

multivitamin 

user: M=49%, 

F=57%

Ca 

supplement 

user (only 4 or 

more 

times/week): 

M=14%, 

F=41% 

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of 

Dietary 

Assessment? (y/n) If 

Yes, Provide Data

Biomarker 

Assay 

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

25(OH)D 

and/or 

1,25(OH)2D

19237724 Park 

2009

Dietary 

calcium 

intake

FFQ (NCIDHQ)USDA 1994-

1996

Yes (in 1953 

participants against 2 

non-consecutive 24-

hour dietary 

recalls)** *** The 

energy-adjusted 

correlation coefficient 

of dietary Ca intake 

and the reference 

method: M (0.63), F 

(0.64) 

nd Total calcium 

intake (10th to 

90th percentile): 

M=526 to 1530 

mg/d, F=494 to 

1881 mg/d

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

 ONLY biomarker of interest for calcium is calcium balance 

** *** Not explicitly mentioned how they were extracted or if they were representative of the included cohort. 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, orformulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome**

Outcome Definition

19237724 Park 

2009 Nd*** All cancers

Identified thorough a cancer registry database from 11 states by ICD codes (3rd edition). Previous 

study showed that approximately 90% of cases were identified within 2years of cancer occurrence . 

Nd** *

Head and neck 

cancer

The same as all cancer
Nd*** Esophageal cancer The same as all cancer

Nd*** Stomach cancer The same as all cancer

Nd*** Colorectal cancer The same as all cancer

Nd*** Liver cancer The same as all cancer

Nd*** Pancreatic cancer The same as all cancer

Nd*** Lung cancer The same as all cancer

Nd*** Breast cancer The same as all cancer

Nd*** Ovarian cancer The same as all cancer

Nd*** Endometrial cancer The same as all cancer

Nd*** Bladder cancer The same as all cancer

Nd*** Kidney cancer The same as all cancer

Nd*** Thyroid cancer The same as all cancer

Nd*** Brain cancer The same as all cancer

Nd***

Non-Hodgkin 

lymphoma (NHL) Identified through “Surveillance Epidemiology and End Results Program”

Nd*** Leukemia The same as NHL

Nd*** Myeloma The same as NHL

Nd*** “Digestive system” A combined category. See the foot note***** below.

Nd***

“Respiratory system” 

(excluding larynx) A combined category. See the foot note***** below.

Nd*** “Reproductive system” A combined category. See the foot note***** below.

Nd*** “Women” A combined category. See the foot note***** below.

Nd*** “Urinary system” A combined category. See the foot note***** below.

Nd***

“Brain and other nervous 

system” A combined category. See the foot note***** below.

Nd*** “Endocrine system” A combined category. See the foot note***** below.

Nd*** “Others” A combined category excluding above categories (not explicitly stated)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

*** Twenty-six outcomes reported without explicit description of “what is the primary outcome of interest”

  Head and neck (C000-C009, C019-C119, C129-C140, C142-C148, C300-C301, C310-C329, C339-C349, C381-C384, C388, C390, C398, and C399), esophageal (C150-C159), 

stomach (C160-C169), colorectal (C180-C189, C199, C209, and C260), liver (C220 and C221), pancreatic (C250-C259), lung (C340-C349), breast (C500-C509), ovarian (C569), 

endometrial (C540-C549 and C559), prostate (C619), bladder (C670-C679), kidney (C649 and C659), thyroid (C739), and brain (C710-C719) cancer. 

** *** Digestive system (C150-C189, C199, C209-C212, C218, C220-C221, C239-C260, C268-C269, C480-C482, and C488); respiratory system, excluding larynx (C300-C301, C310-

C319, C339-C349, C381-C384, C388, C390, C398, and C399); reproductive system (men: C600-C609, C619-C639; women: C510-C519, C529-C549, C559, and C569-C589); urinary 

system (C649, C659, and C669-C689); brain and other nervous systems (C700-C729); endocrine system (C739-C759, and C379) 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including matching factors) Specific comments

for confounders

19237724 Park 

2009

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total 

energy intake

Yes (intake of fruits and vegetables, red meat, whole grains, tomatoes, 

total fat, protein, folate, linoleic acid, selenium, and total energy

Demographics (e.g., age, gender, race, education)? Yes (race/ethnicity, education

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (body mass index

Medical conditions Yes (family history of cancer, history of hypertension and diabetes, PSA 

test in men, age at menopause; and history of oophorectomy and 

hysterectomy in women)

Medication Yes (antacid use, menopausal hormone therapy and duration, parity; oral 

contraceptive use

Sunlight exposure and its proxy variables (e.g., 

seasonal variation of 25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical 

activity, occupation, alcohol consumption)

Yes (vigorous physical activity, smoking status; time since quitting 

smoking; smoking dose, consumptionof alcohol and total beverages

Other marital status

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Median

total 

Ca 

intake 

(mg/d)

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

Men

19237724 Park 

2009

All 

cancers 

(N=36965)

Q1 526 84 Adj HR

1 Ref

0.74

Q2 498 84 Adj HR 0.99 0.96-

1.03

Q3 857 84 Adj HR 0.99 0.96-

1.03
Q4 1073 84 Adj HR 0.95 0.96

-

1.03

Q5 1530 84 Adj HR 0.99 0.95-

1.03

19237724 Park 

2009

Colorectal 

cancer 

(n=3463)

Q1 526 84 Adj HR

1 Ref

0.001

Q2 498 84 Adj HR 0.89 0.80-

0.98

Q3 857 84 Adj HR 0.83 0.75-

0.93

Q4 1073 84 Adj HR 0.87 0.78-

0.97

Q5 1530 84 Adj HR 0.79 0.70-

0.89

19237724 Park 

2009

Pancreatic 

cancer 

(n=717)

Q1 526 84 Adj HR

1 Ref

0.39

Q2 498 84 Adj HR 0.93 (0.74-

1.16)

Q3 857 84 Adj HR 0.9 (0.72-

1.14)

Q4 1073 84 Adj HR 0.98 (0.78-

1.23)

Q5 1530 84 Adj HR 0.87 (0.68-

1.11)

19237724 Park 

2009

Prostate 

cancer 

(n=17 189)

Q1 526 84 Adj HR

1 ref

0.21

Q2 498 84 Adj HR 0.99 (0.95-

1.04)

Q3 857 84 Adj HR 1.01 (0.96-

1.06)

Q4 1073 84 Adj HR

1

(0.95-

1.05)

Q5 1530 84 Adj HR 1.03 (0.98-

1.08)

Women

19237724 Park 

2009

All 

cancers 

(N=16605)

Q1 494 84 Adj HR

1 Ref

0.23

Q2 717 84 Adj HR 0.98 0.93-

1.03

Q3 969 84 Adj HR 0.94 0.89-

0.99

Q4 1296 84 Adj HR 0.93 0.88-

0.98

Q5 1881 84 Adj HR 0.96 0.91-

1.02
19237724 Park 

2009

Colorectal 

cancer 

(n=1635)

Q1 494 84 Adj HR

1 Ref

0.001

Q2 717 84 Adj HR 0.87 0.75-

1.01

Q3 969 84 Adj HR 0.83 0.71-

0.97

Q4 1296 84 Adj HR 0.71 0.60-

0.84

Q5 1881 84 Adj HR 0.72 0.61-

0.86

19237724 Park 

2009

Pancreatic 

cancer 

(n=384)

Q1 494 84 Adj HR

1 Ref

0.4

Q2 717 84 Adj HR 1.03 0.75-

1.40

Q3 969 84 Adj HR 0.93 0.67-

1.28

Q4 1296 84 Adj HR 0.97 0.71-

1.34

Q5 1881 84 Adj HR 0.88 0.63-

1.24

19237724 Park 

2009

Breast 

cancer 

(n=5856)

Q1 494 84 Adj HR

1 Ref 0.84

Q2 717 84 Adj HR 0.96 0.88-

1.04

Q3 969 84 Adj HR 0.95 0.87-

1.03

Q4 1296 84 Adj HR 0.94 0.86-

1.02

Q5 1881 84 Adj HR 0.98 0.90-

1.07

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***
Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

19237724 Park 

2009

All the presented outcomes:

Men

Cancer category Q1 CI Q2 CI Q3 CI Q4 CI Q5 CI

p for 

trend

All cancers (N=36965) 1 [Reference] 0.99

(0.96-

1.03) 0.99

(0.96-

1.03) 0.95

(0.96-

1.03) 0.99

(0.95-

1.03) 0.74

Head and neck cancer (n=1038) 1 [Reference] 1

(0.83-

1.20) 0.9

(0.74-

1.10) 0.99

(0.82-

1.21) 0.99

(0.81-

1.21) 0.99

Esophageal cancer (n=468) 1 [Reference] 0.98

(0.74-

1.29) 0.84

(0.63-

1.13) 0.89

(0.67-

1.19) 0.84

(0.62-

1.13) 0.23

Stomach cancer (n=512) 1 [Reference] 1.07

(0.81-

1.41) 1.13

(0.86-

1.48) 1.04

(0.79-

1.38) 0.96

(0.72-

1.29) 0.58

Colorectal cancer (n=3463) 1 [Reference] 0.89

(0.80-

0.98) 0.83

(0.75-

0.93) 0.87

(0.78-

0.97) 0.79

(0.70-

0.89) 0.001

Liver cancer (n=311) 1 [Reference] 0.75

(0.52-

1.08) 1.2

(0.87-

1.67) 0.83

(0.58-

1.20) 0.88

(0.61-

1.27) 0.61

Pancreatic cancer (n=717) 1 [Reference] 0.93

(0.74-

1.16) 0.9

(0.72-

1.14) 0.98

(0.78-

1.23) 0.87

(0.68-

1.11) 0.39

Lung cancer (n=4287) 1 [Reference] 1.05

(0.96-

1.15) 1.03

(0.94-

1.13) 1.03

(0.94-

1.13) 1.03

(0.93-

1.13) 0.76
Prostate cancer (n=17189) 1 [Reference] 0.99

(0.95-

1.04) 1.01

(0.96-

1.06) 1

(0.95-

1.05) 1.03

(0.98-

1.08) 0.21

Prostate cancer excluding nonaggressive cases (n=nd) 1 {Reference} 1.00 nd 0.98 nd 0.99 nd 0.96(0.92-

1.02) 0.16

Bladder cancer (n=1417) 1 [Reference] 0.96

(0.82-

1.13) 0.82

(0.69-

0.97) 0.87

(0.73-

1.03) 0.87

(0.73-

1.03) 0.11

Kidney cancer (n=991) 1 [Reference] 0.9

(0.74-

1.10) 0.93

(0.76-

1.14) 0.94

(0.76-

1.15) 0.8

(0.64-

1.01) 0.1

Thyroid cancer (n=170) 1 [Reference] 0.95

(0.58-

1.56) 1.07

(0.66-

1.74) 1.15

(0.71-

1.87) 0.79

(0.46-

1.34) 0.43

Brain cancer (n=390) 1 [Reference] 0.79

(0.57-

1.10) 0.82

(0.59-

1.13) 0.91

(0.66-

1.25) 0.89

(0.65-

1.23) 0.98

Non-Hodgkin lymphoma (n=1267) 1 [Reference] 1.03

(0.86-

1.24) 1.15

(0.96-

1.38) 0.95

(0.79-

1.14) 1.02

(0.85-

1.23) 0.77

Leukemia (n=757) 1 [Reference] 0.93

(0.74-

1.17) 0.95

(0.75-

1.19) 0.96

(0.76-

1.21) 0.88

(0.69-

1.21) 0.38

Myeloma (n=369) 1 [Reference] 1.03

(0.74-

1.43) 1.07

(0.77-

1.48) 0.91

(0.65-

1.28) 0.92

(0.65-

1.30) 0.42

“Digestive system cancer” multivariate HR (Q5 vs Q1) = 0.84 (95%CI, 0.77-0.92); No associations between total Ca intake and other anatomical system 

cancers 

Women

Cancer category Q1 CI Q2 CI Q3 CI Q4 CI Q5 CI

p for 

trend

All cancers (N=16605) 1 [Reference] 0.98

(0.93-

1.03) 0.94

(0.89-

0.99) 0.93

(0.88-

0.98) 0.96

(0.91-

1.02) 0.23

Head and neck cancer (n=325) 1 [Reference] 1.33

(0.97-

1.83) 0.92

(0.64-

1.31) 1.02

(0.71-

1.46) 1.3

(0.91-

1.86) 0.42

Esophageal cancer (n=79) 1 [Reference] 1.47

(0.80-

2.71) 1.14

(0.59-

2.22) 0.56

(0.24-

1.31) 0.83

(0.38-

1.81) 0.18

Stomach cancer (n=143) 1 [Reference] 0.9

(0.54-

1.50) 1.37

(0.85-

2.20) 0.55

(0.30-

1.01) 0.71

(0.40-

1.25) 0.08

Colorectal cancer (n=1635) 1 [Reference] 0.87

(0.75-

1.01) 0.83

(0.71-

0.97) 0.71

(0.60-

0.84) 0.72

(0.61-

0.86) 0.001

Liver cancer (n=86) 1 [Reference] 1.38

(0.73-

2.61) 1.1

(0.55-

2.17) 1.05

(0.52-

2.13) 0.96

(0.46-

2.03) 0.6

Pancreatic cancer (n=384) 1 [Reference] 1.03

(0.75-

1.40) 0.93

(0.67-

1.28) 0.97

(0.71-

1.34) 0.88

(0.63-

1.24) 0.4

Lung cancer (n=2457) 1 [Reference] 0.96

(0.85-

1.08) 0.91

(0.81-

1.03) 0.94

(0.83-

1.07) 1

(0.88-

1.14) 0.95

Breast cancer (n=5856) 1 [Reference] 0.96

(0.88-

1.04) 0.95

(0.87-

1.03) 0.94

(0.86-

1.02) 0.98

(0.90-

1.07) 0.84

Ovarian cancer (n=515) 1 [Reference] 1.04

(0.78-

1.38) 0.99

(0.74-

1.33) 1.05

(0.79-

1.41) 1.14

(0.85-

1.52) 0.34

Endometrial cancer (n=1171) 1 [Reference] 1.11

(0.92-

1.33) 1.01

(0.84-

1.22) 1.1

(0.91-

1.32) 0.99

(0.81-

1.20) 0.66

Bladder cancer (n=264) 1 [Reference] 0.97

(0.67-

1.41) 0.94

(0.64-

1.37) 0.91

(0.61-

1.35) 0.97

(0.65-

1.46) 0.85

Kidney cancer (n=367) 1 [Reference] 0.87 (0.63- 0.81 (0.58- 0.73 (0.51- 0.79 (0.55- 0.21
1.21) 1.13) 1.03) 1.13)

Thyroid cancer (n=199) 1 [Reference] 0.98

(0.63-

1.54) 1.07

(0.69-

1.67) 0.88

(0.55-

1.41) 1.04

(0.65-

1.65) 0.98

Brain cancer (n=160) 1 [Reference] 0.94

(0.59-

1.50) 0.7

(0.42-

1.16) 0.79

(0.48-

1.29) 0.72

(0.43-

1.21) 0.2

Non-Hodgkin lymphoma (n=660) 1 [Reference] 0.96

(0.75-

1.23) 0.89

(0.69-

1.15) 0.99

(0.77-

1.28) 1.24

(0.97-

1.59) 0.03

Leukemia (n=280) 1 [Reference] 0.92

(0.63-

1.35) 1

(0.68-

1.46) 0.92

(0.62-

1.36) 1.25

(0.86-

1.83) 0.17

Myeloma (n=175) 1 [Reference] 1.33

(0.79-

2.24) 1.54

(0.93-

2.57) 1.91

(1.16-

3.15) 1.36

(0.79-

2.36) 0.25

“Digestive system cancer” multivariate HR (Q5 vs Q1) = 0.77 (95%CI, 0.69-0.91); No associations between total Ca intake and other anatomical 

system cancers

(Excerpt from the paper) In nonparametric regression analyses, the HRs for total cancer incidence in women decreased up to approximately 1300 

mg/d of total Ca intake, and no further reduction was observed above 1300 mg/d (Fig 1) 

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

NO data available stratified by age, or other categories of interest 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

19237724 Park 

2009

a) Eligibility 

criteria 

clear? (y/n)

N

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Nd

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

nd

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

Nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

y b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

n

c) Do the 

authors specify 

a primary 

outcome? (y/n)

n

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A):

Many eligible members might have been excluded, no blinded assessment of exposure and outcomes, and 

multiple outcomes collected and assessed without an explicitly stated analyses plan. No independent 

verification of the cases, only registry dependent data.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

11297596 Pfeifer 

2001

RCT 25(OH)D < 50 

nmol/L

-Hypercalcemia or 1

hyperparathyroidism -

fractures of extremities 

due to osteoporosis

-therapy w/ thiazide, 

bisphosphonate, 

calcitonin, vit D3 and 

other vit D metabolites, 

estrogen, antiestrogen in 

the previous 6 months

-therapy w/ fluoride in 

previous 2 yrs.

-known intolerance to 

study meds

-chronic renal failure

-hx of drug or EtOH 

abuse

-nicotine abuse

- > 7 cups coffee daily

-scheduled holiday along 

the geographic longitude 

during the study period

- DM

- severe CVD

- severe HTN (SBP>180 

mm Hg, DBP >95 mm 

Hg

1997 - Strathmann, Inc., which markets vit D and Ca, 

provided the supplements and funding for the 

study.

MB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

11297596 Pfeifer 

2001

RCT Lower 

Saxony, 

Germany 

52 N

148 145 75 ± 4 

yrs.

Age 

range = 

70 – 86 

yrs.

0% nd Mean weight = 65 kg.

Mean height = 162 

cm.

nd 25(OH)D < 50 

nmol/L

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

11297596 Pfeifer 

2001

25(OH)D 

and/or 

1,25(OH)2D

25(OH)D 

and 

1,25(OH)D 

via RIA

Coeffs of 

variation for 

ALL assays 

ranged from 

5.5 – 7.9%

nd Serum 25(OH)D 

= 25 ± 13 

nmol/mL. Serum 

1,25(OH)D = 

36.5 ± 16 ng/L.

Dietary 

calcium 

intake

nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) Vit D and/or Ca Dose Intervention Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

11297596 Pfeifer 

2001

Vit D + calcium Ca carbonate

Vit D3

1200 mg elemental Ca 

and 800 IU vit D3

8 wks Capsules were taken 2x/day (breakfast 

and dinner with a meal)

Calcium Ca carbonate 1200 mg elemental Ca 8 wks Capsules were taken 2x/day (breakfast 

and dinner with a meal)

Co-intervention(s) *:

Compliance/adherence: Assessed by pill counts, 95±12% for the Ca tablets and 96±10% for the Vit D3+Ca tablets, one subject in Ca group excluded for 

non-compliance

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

11297596 Pfeifer 

2001

1° SBP Measured after at least 5 min of supine rest using a sphygmomanometer. Systolic and diastolic blood pressures 

were taken at Korotkov sounds I and V. 

1° DBP Same as SBP

25(OH)D

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

11297596 Pfeifer 2001 32 (47%) of the subjects in the Ca group and 36 (53%) of the subjects in the Ca+D group were on HTN medication.

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups

Please List Name of 

Confounder (including 

matching factors)

Specific comments for confounders

11297596 Pfeifer 

2001

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total 

energy intake

Demographics (e.g., age, gender, race, education)? no

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical 

activity, occupation, alcohol consumption)

no

Other “Both tx groups were comparable concerning age, ht, wt, 

physical activity, concomitant diseases, and concomitant 

medication.”

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year

Outcome Unit Exposure / 

Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Final** Final 

SD*

Net 

difference

(CaD – Ca)

Net 

difference CI 

/ SE / SD*

P 

between

11297596 Pfeifer 

2001

SBP mmHg Ca + D 8 wks 73 144.1 20.4 131.0 16.9 -7.4 0.02

Ca 8 wks 72 140.6 14.7 134.9 19.9

DBP mmHg Ca + D 8 wks 73 84.7 7.6 77.5 12.4 -0.3 0.10

Ca 8 wks 72 82.6 6.4 75.7 12.5

25(OH)D nmol/L Ca + D 8 wks 73 25.65 13.63 64.84 25.84 <0.01

Ca 8 wks 72 24.63 12.14 44.36 27.38

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

11297596 Pfeifer 

2001

SBP 60 (81%) of the subjects in the Ca+D group had a decrease in SBP > 5 mmHg compared to 35 (47%) in the Ca group (P = 0.04). 8 (11%) of the 

subjects in the Ca+D group had a increase in SBP > 5 mmHg compared to 29 (39%) in the Ca group (P = 0.05). 

DBP 58 (78%) of the subjects in the Ca+D group had a decrease in DBP > 5 mmHg compared to 36 (49%) in the Ca group (P = 0.1). 21 (28%) of the

subjects in the Ca group had an increase in DBP > 5 mmHg compared to 10 (13%) in the Ca+D group (P = 0.02). 

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

11297596 Pfeifer 

2001

RCT 

parallel nd nd NA Y nd Y Y nd Y B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): No data on randomization technique, allocation concealment, blinded outcome assessment, or assessment for 

confounding

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

10530608 Pietinen

1999 

Cohort study

Based on 

data 

collected 

during an 

RCT

Male smokers, 50-69 years of age at 

entry; recruited from the total male 

population of this age group in 

southwestern Finland; they had to 

smoke at least 5 cigarettes per day 

and to give written consent

History of cancer or other serious 

disease; use of vitamin E, vitamin 

A, or beta-carotene supplements in 

excess of predefined doses; and 

treatment with anticoagulant 

agents

nd Alpha-Tocopherol, 

Beta-Carotene 

Cancer Prevention 

Study (ATBC Study)

US NCI AT

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT
POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race /

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

10530608 Pietinen

1999 

Cohort 

study

Based on 

data 

collected 

during an 

RCT

Southwestern 

Finland

27111 27111 Median, 

cases: 

60.1; 

non 

cases: 

57.1

nd 100 Finish Median BMI 

(kg/m2), cases: 

26.3 ; non 

cases: 26

Physical 

activity 

(moderate), 

cases: 13.9; 

non cases: 

25.8

Median daily 

alcohol 

intake (g), 

cases: 9.6; 

non cases: 

11.2

Median daily 

energy intake 

(kcal), cases: 2731; 

non cases: 2720

Median daily total 

protein intake(g), 

cases: 98; non 

cases: 100

Median daily total 

triglycerides intake 

(g), cases: 100; 

non cases: 101

Median daily 

saturated fatty 

acids intake (g), 

cases: 47.8; non 

cases: 50

Median daily 

monounsaturated 

fatty acids intake 

(g), cases: 35.2; 

non cases: 35

Median daily 

polyunsaturated 

fatty acids intake 

(g), cases: 10.2; 

non cases: 9.6

Median daily trans 

fatty acids intake 

(g), cases: 3; non 

cases: 2.9

Median daily 

dietary fiber intake 

(g), cases: 24.6; 

non cases: 24.2

Median daily 

calcium intake 

(mg), cases: 1286; 

non cases: 1338

Median daily 

vitamin D intake 

(mg), cases: 4.8; 

non cases: 4.8

*Please copy from above
**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

UI Author

Year

Study 

Design*

Location 

(e.g., City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat ...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

10530608 Pietinen

1999 

Cohort 

study

Based on 

data 

collected 

during an 

RCT

Southwestern 

Finland

27111 27111 Median, 

cases: 

60.1; non 

cases: 

57.1

nd 100 Finish Median BMI 

(kg/m2), cases: 

26.3 ; non 

cases: 26

Physical 

activity 

(moderate), 

cases, %: 

25.7

Median daily 

alcohol intake 

(g), cases: 

9.6; non 

cases: 11.2

Median daily 

milk products 

consumption 

(g), cases: 684; 

non cases: 735

Median daily 

whole grain 

products 

consumption 

(g), cases: 216; 

non cases: 212

Median daily 

vegetables 

consumption 

(g), cases: 103; 

non cases: 99

Median daily 

cruciferous 

vegetables 

consumption 

(g), cases: 

16.1; non 

cases: 12.8

Median daily 

fruit 

consumption 

(g), cases: 111; 

non cases: 103

Median daily 

red meat 

consumption 

(g), cases: 125; 

non cases: 128
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of 

Dietary 

Assessment? (y/n) 

If Yes, Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

10530608 Pietinen

1999 

25(OH)D 

and/or 

1,25(OH)2D

na na na na na

10530608 Pietinen

1999 

Dietary 

calcium 

intake

FFQ Food 

composition 

database at the 

National

Public Health 

Institute, Finland; 

fatty acid 

content, fiber 

content of foods: 

analyses carried

out at the 

Department of 

Food Chemistry, 

University of

Helsinki

y

Validation study of 

the dietary method

carried out prior to 

the trial: correlation 

between the 

questionnaire-based, 

energy-adjusted 

intakes and those 

based on 24 days of 

food recording was 

0.66 for calcium

nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

10530608 Pietinen

1999 

Secondary 

outcome Colon cancer or 

rectal cancer

Incid ent cases of colon or rect al cancer (ICD-9) diagnosed bet w een rand om izat ion and 30 Ap ril 

1995, and id ent if ied t hrough t he Finnish Cancer Regist ry. All cases w ere review ed cent rally b y t w o 

oncologist s and a p at hologist checked t he original hist ological sp ecim ens.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

10530608 Pietinen

1999 

In cases of multiple colorectal cancers, the first one was chosen (n = 2), and when the tumors were diagnosed simultaneously, the most invasive one was 

chosen (n = 2). In one case with three simultaneous colorectal cancers, the data were combined, and the ICD-9 code not indicating a specific site within the 

colon was used.

Average follow up: 8 years

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

10530608 Pietinen

1999 

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes (supplement group; calcium intake; energy 

adjustment)

Demographics (e.g., age, gender, race, education)? Yes [age (for 5-year categories); education]

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes [BMI (tertiles)]

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes [smoking years (<35 vs. over); alcohol consumption 

(tertiles); occupational physical activity]

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

Adjusted for age (5-year categories) and supplement group 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI 

**

P 

between 

groups***

P for 

trend****

10530608 Pietinen

1999 

Colorectal 

cancer

1

st quartile, total 

calcium intake, 

median (mg)

856 60 nd

96

adjusted RR 1.0

0.04 2

nd quartile, total 

calcium intake, 

median (mg)

1241 41 nd

96

adjusted RR 0.7 0.4-

1.0

nd
3

rd quartile, total 

calcium intake, 

median (mg)

1484 45 nd

96

adjusted RR 0.7 0.5-

1.1

nd

4

th quartile, total 

calcium intake, 

median (mg)

1789 39 nd

96

adjusted RR 0.6 0.6-

0.9

nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

Adjusted for age (5-year categories), supplement group, smoking years, body mass index, alcohol, education, and physical activity at work, and 

calcium intake 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI 

**

P 

between 

groups***

P for 

trend****

10530608 Pietinen

1999 

Colorectal 

cancer

1

st quartile, total 

calcium intake, 

median (mg)

856 60 nd

96

adjusted RR 1.0

0.04

2

nd quartile, total 

calcium intake, 

median (mg)

1241 41 nd

96

adjusted RR 0.7 0.5-

1.0

nd

3

rd quartile, total 

calcium intake, 

median (mg)

1484 45 nd

96

adjusted RR 0.7 0.5-

1.1

nd

4

th quartile, total 

calcium intake, 

median (mg)

1789 39 nd

96

adjusted RR 0.6 0.6-

0.9

nd

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

10530608 Pietinen

1999 

The analyses were also redone excluding all cases from the first two years of follow-up, but this did not alter the results (data not shown). Type of analyses 

represents a cohort study and not an RCT

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

10530608 Pietinen

1999 

a) Eligibility 

criteria 

clear? (y/n)

y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

n

a) Method 

reported? 

(y/n)

y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

na

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

n

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

n

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

na

b) Loss to 

follow-up 

<20%? (y/n)

y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

n

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Assessor blinding not reported; power calculation not reported; post hoc analyses; number of non-cases 

per calcium quartile is not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

11045788 Platz 

2000

Casecohort 

study

Participants of NHS (i.e., female nurse, age 30-55 y) 

(n=121700)

Volunteer blood sample providers between 05/1989-

06/1991 (n=32826)

Undertook sigmoid- or colonoscopy between1989-

1996 

Free from cancer (except for nonmelanoma skin 

cancer)

Cases: newly diagnosed distal or rectal adenoma 

polyps confirmed by pathology reports (n=326)

Control: 1:1 matching controls by endoscopy during 

the same 2-year period, year of birth (age), 

indication(s) of endoscopy, time period of first and 

most recent endoscopy (n=326)

Cases:

hyperplastic and other 

non-adenoma polyps

adenoma polyps 

reported but not 

confirmed (7% or all 

reports) 

1976 Nurses’ 

health 

study

NIH JHL/TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT 

Undetected proximal polyps can be either cases or controls 

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

11045788 Platz

2000

Casecohort 

study

US, various 

locations

652 652 58.5±6.6 nd 0% nd BMI 25.0 kg/m2

Mean physical 

activity 15.4 METeh/wk

Mean solar 

exposure 352 

langleys/d

Regular 

aspirin use: 

26.1%

Hormone 

replacement: 

35.5%

Prior negative 

endoscopy: 

34.4%

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (e.g. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical Validity 

of Biomarker Data 

Reported? (y/n) If 

Yes, Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure data

11045788 Platz 

2000

25(OH)D 

and/or 

1,25(OH)2D

RIA Intrapair coefficient 

of variation (CV)

1,25(OH)2D=9.9%

25(OH)D=7.5%

Nd ~6-

~11 

y(earliest 

should be 

1996 latest 

should be 

2000)

Nd (but 

stratified 

analyses 

based on 

season of 

blood draw 

performed)

1,25(OH)2D=31.9 

pg/ml

25(OH)D=26.6 

pg/ml

Vit D=323 IU/d

11045788 Platz

2000

Dietary 

calcium 

intake

SFFQ nd nd 984.5mg/d

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

11045788 Platz 2000 nd (distal) colorectal polyps Adenomatous polyps by review of histopathological reports.

11045788 Platz 2000 nd (distal) colon polyps Same as above

11045788 Platz 2000 nd Rectal polyps Same as above

11045788 Platz 2000 nd “high-risk” (distal) colorectal polyps Large (1 cm or larger), villous or tubulovillous adenoma

11045788 Platz 2000 nd “low-risk” (distal) colorectal polyps Small (<1 cm), tubular adenoma

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

Data on “low-risk” (distal) colorectal polyps were not extracted. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups

Please List Name of 

Confounder (including 

matching factors)

Specific comments for confounders

11045788 Platz 

2000

Other nutrients or dietary factors (e.g., certain 

food consumption), including supplement use 

and total energy intake

Yes: Intake of red meat and 

methionine, 1980 folic acid 

Matching factors: endoscopy during the same 2-year period, year of birth, 

indication(s) for endoscopy, time period of first or most recent endoscopy 

excluding the one in the current time period, and date of blood draw

Stratified analyses on: use of Vit D or Ca supplement, total intake of Vit D 

or Ca, daily solar UV irradiation, season of blood draw

Demographics (e.g., age, gender, race, 

education)?

Yes – matched on age

Anthropometrics (e.g., BMI, body weight, % 

body fat)?

Yes - BMI

Medical conditions No

Medication Yes: Aspirin use, 1990 

postmenopausal hormone use 

Sunlight exposure and its proxy variables 

(e.g., physical activity level, occupation, sun 

exposure, location)

Yes: physical activity

Smoking and other life styles variables Yes - smoking, alcohol 

consumption

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean Vit 

D level / 

dose*****

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

11045788 Platz 

2000

Distal 

colorectal 

adenoma

1,25(OH)2D 

quartile 1

22.3 

pg/ml

97 80 Adjusted OR 1.00 (ref)

0.4

quartile 2 29.0 

pg/ml

71 84 0.64 0.41-

1.02

quartile 3 33.9 

pg/ml

84 80 0.80 0.50-

1.30

quartile 4 40.9 

pg/ml

74 82 0.71 0.43-

1.15
11045788 Platz 

2000

Distal 

colorectal 

adenoma

25(OH)D

quartile 1

16.3 

pg/ml

103 82 Adjusted OR 1.00 (ref)

1.0

quartile 2 22.6 

pg/ml

62 80 0.64 0.41-

1.00

quartile 3 28.3 

pg/ml

61 82 0.58 0.36-

0.95

quartile 4 38.0 

pg/ml

100 82 1.04 0.66-

1.66

11045788 Platz 

2000 

Rectal 

adenoma 

1,25(OH)2D 

quartile 1

22.3 

pg/ml

16 17 AdjustedOR 1.00 (ref) 0.9

quartile 2 29.0 

pg/ml

18 14 1.35 0.41-

4.43

quartile 3 33.9 

pg/ml

13 16 0.58 0.16-

2.09

quartile 4 40.9 

pg/ml

18 18 1.06 0.30-

3.73

11045788 Platz 

2000

Rectal 

adenoma 

25(OH)D

quartile 1

16.3 

pg/ml

24 18 Adjusted OR 1.00 (ref) 0.9

quartile 2 22.6 

pg/ml

7 16 0.38 0.12-

0.19

quartile 3 28.3 

pg/ml

10 13 0.34 0.08-

1.42

quartile 4 38.0 

pg/ml

24 18 1.59 0.50-

5.03

11045788 Platz 

2000

Distal 

colon 

adenoma 

1,25(OH)2D 

quartile 1

22.3 

pg/ml

81 63 Adjusted OR 1.00 (ref)

0.2

quartile 2 29.0 

pg/ml

53 70 0.51 0.30-

0.86

quartile 3 33.9 

pg/ml

71 64 0.78 0.45-

1.34

quartile 4 40.9 

pg/ml

56 64 0.60 0.34-

1.04

11045788 Platz 

2000

Distal 

colon 

adenoma 

25(OH)D

quartile 1

16.3

pg/ml

79 64 Adjusted OR 1.00 (ref)

1.0

quartile 2 22.6 

pg/ml

55 64 0.71 0.43-

1.18

quartile 3 28.3 

pg/ml

51 69 0.60 0.35-

1.02

quartile 4 38.0 

pg/ml

76 64 1.02 0.60-

1.73

11045788 Platz 

2000

Distal 

colorectal 

adenoma

25(OH)D nd nd nd Adjusted 

(after 2 

years from 

blood draw 

only) 

OR 1.00 (ref) nd Nd 

“comparable 

to main 

analysis”

0.73 nd
0.85 nd

0.96 nd

11045788 Platz 

2000

Distal 

colorectal 

adenoma

1,25(OH)D

quartile 1

nd nd nd Adjusted 

(season of 

blood draw 

taken into 

account) 

OR 1.00 (ref) nd Nd 

“comparable 

to main 

analysis”

quartile 2 0.64 nd

quartile 3 0.75 nd

quartile 4 0.68 nd

11045788 Platz 

2000

“high-risk” 

distal 

colon 

cancer 

25(OH)D

quartile 1

16.3 45 36 Adjusted OR 1.00 (ref) 0.9

quartile 2 22.6 24 37 0.54 0.25-

1.16

quartile 3 28.3 26 35 0.67 0.31-

1.44

quartile 4 38.0 47 34 1.30 0.59-

2.86

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 

** ***median 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

SD*

P 

between 

groups

11045788 Platz 

2000 Cases: -7y Adjusted 326 31.6 pg/ml

8.4 0.3

Control: -7y (matching) 326 32.2 

pg/ml

8.6

11045788 Platz 

2000 Cases: Adjusted 326 977 mg/d 334 0.6

Control: (matching) 326 992 mg/d 332

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

11045788 Platz 

2000

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(e.g. 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

nd

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Some unclear reporting (inclusion and blinding) and retrospective analyses of an existing cohort, no 

internal calibration of SFFQ

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

11045788 Platz 

2000

Casecohort 

study

Participants of NHS (i.e., female nurse, age 30-55 y) 

(n=121700)

Volunteer blood sample providers between 05/1989-

06/1991 (n=32826)

Undertook sigmoid- or colonoscopy between1989-

1996 

Free from cancer (except for nonmelanoma skin 

cancer)

Cases: newly diagnosed distal or rectal adenoma 

polyps confirmed by pathology reports (n=326)

Control: 1:1 matching controls by endoscopy during 

the same 2-year period, year of birth (age), 

indication(s) of endoscopy, time period of first and 

most recent endoscopy (n=326)

Cases:

hyperplastic and other 

non-adenoma polyps

adenoma polyps 

reported but not 

confirmed (7% or all 

reports) 

1976 Nurses’ 

health 

study

NIH JHL/TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT 

Undetected proximal polyps can be either cases or controls 

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

11045788 Platz

2000

Casecohort 

study

US, various 

locations

652 652 58.5±6.6 nd 0% nd BMI 25.0 kg/m2

Mean physical 

activity 15.4 METeh/wk

Mean solar 

exposure 352 

langleys/d

Regular 

aspirin use: 

26.1%

Hormone 

replacement: 

35.5%

Prior negative 

endoscopy: 

34.4%

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical Validity 

of Biomarker Data 

Reported? (y/n) If 

Yes, Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure data

11045788 Platz 

2000

25(OH)D 

and/or 

1,25(OH)2D

RIA Intrapair coefficient 

of variation (CV)

1,25(OH)2D=9.9%

25(OH)D=7.5%

Nd ~6-

~11 

y(earliest 

should be 

1996 latest 

should be 

2000)

Nd (but 

stratified 

analyses 

based on 

season of 

blood draw 

performed)

1,25(OH)2D=31.9 

pg/ml

25(OH)D=26.6 

pg/ml

Vit D=323 IU/d

11045788 Platz

2000

Dietary 

calcium 

intake

SFFQ nd nd nd nd 984.5mg/d

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

11045788 Platz 2000 nd (distal) colorectal polyps Adenomatous polyps by review of histopathological reports.

11045788 Platz 2000 nd (distal) colon polyps Same as above

11045788 Platz 2000 nd Rectal polyps Same as above

11045788 Platz 2000 nd “high-risk” (distal) colorectal polyps Large (1 cm or larger), villous or tubulovillous adenoma

11045788 Platz 2000 nd “low-risk” (distal) colorectal polyps Small (<1 cm), tunular adenoma

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

Data on “low-risk” (distal) colorectal polyps were not extracted. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups

Please List Name of 

Confounder (including 

matching factors)

Specific comments for confounders

11045788 Platz 

2000

Other nutrients or dietary factors (e.g., certain 

food consumption), including supplement use 

and total energy intake

Yes: Intake of red meat and 

methionine, 1980 folic acid 

Matching factors: endoscopy during the same 2-year period, year of birth, 

indication(s) for endoscopy, time period of first or most recent endoscopy 

excluding the one in the current time period, and date of blood draw

Stratified analyses on: use of Vit D or Ca supplement, total intake of Vit D 

or Ca, daily solar UV irradiation, season of blood draw

Demographics (e.g., age, gender, race, 

education)?

Yes – matched on age

Anthropometrics (e.g., BMI, body weight, % 

body fat)?

Yes - BMI

Medical conditions No

Medication Yes: Aspirin use, 1990 

postmenopausal hormone use 

Sunlight exposure and its proxy variables 

(e.g., physical activity level, occupation, sun 

exposure, location)

Yes: physical activity

Smoking and other life styles variables Yes - smoking, alcohol 

consumption

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean Vit 

D level / 

dose*****

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

11045788 Platz 

2000

Distal 

colorectal 

adenoma

1,25(OH)2D 

quartile 1

22.3 

pg/ml

97 80 Adjusted OR 1.00 (ref)

0.4

quartile 2 29.0 

pg/ml

71 84 0.64 0.41-

1.02

quartile 3 33.9 

pg/ml

84 80 0.80 0.50-

1.30

quartile 4 40.9 

pg/ml

74 82 0.71 0.43-

1.15
11045788 Platz 

2000

Distal 

colorectal 

adenoma

25(OH)D

quartile 1

16.3 

pg/ml

103 82 Adjusted OR 1.00 (ref)

1.0

quartile 2 22.6 

pg/ml

62 80 0.64 0.41-

1.00

quartile 3 28.3 

pg/ml

61 82 0.58 0.36-

0.95

quartile 4 38.0 

pg/ml

100 82 1.04 0.66-

1.66

11045788 Platz 

2000 

Rectal 

adenoma 

1,25(OH)2D 

quartile 1

22.3 

pg/ml

16 17 Adjusted OR 1.00 (ref) 0.9

quartile 2 29.0 

pg/ml

18 14 1.35 0.41-

4.43

quartile 3 33.9 

pg/ml

13 16 0.58 0.16-

2.09

quartile 4 40.9 

pg/ml

18 18 1.06 0.30-

3.73

11045788 Platz 

2000

Rectal 

adenoma 

25(OH)D

quartile 1

16.3 

pg/ml

24 18 Adjusted OR 1.00 (ref) 0.9

quartile 2 22.6 

pg/ml

7 16 0.38 0.12-

0.19

quartile 3 28.3 

pg/ml

10 13 0.34 0.08-

1.42

quartile 4 38.0 

pg/ml

24 18 1.59 0.50-

5.03

11045788 Platz 

2000

Distal 

colon 

adenoma 

1,25(OH)2D 

quartile 1

22.3 

pg/ml

81 63 Adjusted OR 1.00 (ref)

0.2

quartile 2 29.0 

pg/ml

53 70 0.51 0.30-

0.86

quartile 3 33.9 

pg/ml

71 64 0.78 0.45-

1.34

quartile 4 40.9 

pg/ml

56 64 0.60 0.34-

1.04

11045788 Platz 

2000

Distal 

colon 

adenoma 

25(OH)D

quartile 1

16.3 

pg/ml

79 64 Adjusted OR 1.00 (ref)

1.0

quartile 2 22.6 

pg/ml

55 64 0.71 0.43-

1.18

quartile 3 28.3 

pg/ml

51 69 0.60 0.35-

1.02

quartile 4 38.0 

pg/ml

76 64 1.02 0.60-

1.73

11045788 Platz 

2000

Distal 

colorectal 

adenoma

25(OH)D nd nd nd Adjusted 

(after 2 

years from 

blood draw 

only) 

OR 1.00 (ref) nd Nd 

“comparable 

to main 

analysis”

0.73 nd
0.85 nd

0.96 nd

11045788 Platz 

2000

Distal 

colorectal 

adenoma

1,25(OH)D

quartile 1

nd nd nd Adjusted 

(season of 

blood draw 

taken into 

account) 

OR 1.00 (ref) nd Nd 

“comparable 

to main 

analysis”

quartile 2 0.64 nd

quartile 3 0.75 nd

quartile 4 0.68 nd

11045788 Platz 

2000

“high-risk” 

distal 

colon 

cancer 

25(OH)D

quartile 1

16.3 45 36 Adjusted OR 1.00 (ref) 0.9

quartile 2 22.6 24 37 0.54 0.25-

1.16

quartile 3 28.3 26 35 0.67 0.31-

1.44

quartile 4 38.0 47 34 1.30 0.59-

2.86

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 

** ***median 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

SD*

P 

between 

groups

11045788 Platz 

2000 Cases: -7y Adjusted 326 31.6 pg/ml

8.4 0.3

Control: -7y (matching) 326 32.2 

pg/ml

8.6

11045788 Platz 

2000 Cases: 

Adjusted 326 977 mg/d 334 0.6

Control: (matching) 326 992 mg/d 332

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

11045788 Platz 

2000

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

nd

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Some unclear reporting (inclusion and blinding) and retrospective analyses of an existing cohort, no 

internal calibration of SFFQ

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

15090720 and 

17440943

Platz 2004 

and Mikhak 

2007

Casecohort 

study

available blood 

specimen, white 

male (Mikhak)

cancer prior to blood drawn (except 

for nonmelanoma skin cancer); T1a 

prostate cancer

1993-95 Health 

Professionals 

Follow-up Study

government SI, KP (for 

Mikhak study)

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N enrolled*** N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

15090720 Platz 

2004

Casecohort 

study

NE, S, W, 

Midwest US

920 (460 cases 

and 460 

controls)

920 66.5 

(7.4)

nd 100 6% nonwhiteBMI 22.8 18% 

smoker; 

DM 3.6%

448 IU/d of vit D; 

962 mg/d of 

calcium

17440943 Mikhak 

2007

Casecohort 

study

NE, S, W, 

Midwest US

51,529 in original 

cohort, 1408 in 

case-control 

(704 each for 

cases and 

controls)

1366 66 (7) nd 100 100% 

white 

nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

15090720 Platz 

2004

25(OH)D 

and/or 

1,25(OH)2D

RIA y; 2 separate 

analytical runs; 

intrapair CV 

5.4%, 5.6% for 

25OH-D; 5.3%, 

7.3% for 1,25 

OH-D

nd nd;

but cases 

matched to 

controls for 

season of 

blood drawn

Vit D (IU/day): 

cases = 

459(268) 

;controls = 

436(271)

17440943 Mikhak 

2007

25(OH)D 

and/or 

1,25(OH)2D

RIA for 

25(OH)D, 

radioceptor 

assay with 

calf thymus 

receptors for 

1,25(OH)D

nd nd nd nd

15090720 Platz 

2004

Dietary 

calcium 

intake

nd nd nd Calcium 

(mg/day): 

cases= 

975(474); 

controls = 

950(455)

17440943 Mikhak 

2007

Dietary 

calcium 

intake

Nd Nd Nd Nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

15090720 Platz 2004 primary prostate cancer deaths, diagnosis or self-reported

17440943 Mikhak 2007 Nd Prostate cancer Deaths, diagnosis, or self-reported

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors) Specific comments for confounders

15090720 Platz 

2004

Other nutrients or dietary factors (e.g., certain 

food consumption), including supplement use 

and total energy intake

yes; intake of energy, red meat, fish, 

lycopene, fructose and α-linolenic acid, vit E, 

Se, Ca and vit D

Demographics (e.g., age, gender, race, 

education)?

Yes

Anthropometrics (e.g., BMI, body weight, % body 

fat)?

Yes

Medical conditions DM; vasectomy

Medication

Sunlight exposure and its proxy variables (e.g., 

physical activity level, occupation, sun exposure, 

location)

yes; season, location

Smoking and other life styles variables Yes; smoking

Other

17440943 Mikhak 

2007

Other nutrients or dietary factors (e.g., certain 

food consumption), including supplement use 

and total energy intake

Yes Total intake of tomato sauce, alcohol, energy, fish, 

calcium, retinol, alpha linolenic acid, vitamin E 

supplement use, selenium supplement use

Demographics (e.g., age, gender, race, 

education)?

Yes Age (match), race

Anthropometrics (e.g., BMI, body weight, % body 

fat)?

Yes BMI

Medical conditions Family history of prostate cancer

Medication

Sunlight exposure and its proxy variables (e.g., 

physical activity level, occupation, sun exposure, 

location)

Yes Region of residence

Smoking and other life styles variables Yes Smoking status

Other History of PSA test before blood draw 

(match), quadrant of day of blood draw 

(match), year of blood draw (match)

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95%

CI

P 

btw Result 95% CI

P 

btw

17440943 Mikhak 

2007

Total 

prostate 

cancer

25(OH)D <= 15 

ng/ml

Nd 627 1231 OR: 25(OH)D deficient/nondeficient0.63 0.44-

0.90

nd 0.62 0.43-

0.91

0.01

25(OH)D > 15 

ng/ml

Nd 57 145

Total 

prostate 

cancer

1,25(OH)D <= 

26 pg/ml

Nd 565 1151 OR: 1,25(OH)D deficient/nondeficient1.22 0.89-

1.65

nd 1.25 0.91-

1.73

nd

1,25(OH)D > 26 

pg/ml

Nd 119 225

*Example: OR Ca/placebo 

Note: unadjusted model still matched for matching factors as listed in confounder table 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI 

/ SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

15090720 Platz 

2004

Prostate 

cancer

25 OH-D; Quartile* 

(separate cut points 

by analytical run 

(there were 2); 

Quartile 

1

109 114 mutually 

adjusted for 1,25 

and 25-OH-D 

using conditional 

OR 1.00 (Ref)

0.41
season of the year 

and distributions 

among control, see 

Table 3 in paper)

logistic 

regression

Quartile 2115 113 1.05 0.71-

1.54

Quartile 394 120 0.82 0.56-

1.20

Quartile 4142 113 1.27 0.86-

1.86

Quartile 1109 114 mutually 

adjusted for 1,25 

and 25-OH-D; 

FH; ht; physical 

activity; DM; 

vasectomy; 

smoking, diet; vit 

E, Se 

supplements 

using conditional 

logistic 

regression

OR 1.00 (Ref)

0.59

Quartile 2115 113 1.00 0.67-

1.49

Quartile 394 120 0.77 0.51-

1.15

Quartile 4142 113 1.19 0.79-

1.79

1,25 OH-D Quartile 1102 110 mutually 

adjusted for 1,25 

and 25-OH-D 

using conditional 

logistic 

regression

1.00 (Ref) 0.16

Quartile 2103 115 0.99 0.67-

1.45

Quartile 3120 122 1.08 0.73-

1.61

Quartile 4135 113 1.25 0.83-

1.88

Quartile 1102 110 mutually 

adjusted for 1,25 

and 25-OH-D; 

FH; ht; physical 

activity; DM; 

vasectomy; 

smoking, diet; vit 

E, Se 

supplements 

using conditional 

1.00 (Ref) 0.16
logistic 

regression

Quartile 

2

103 115 0.93 0.62-

1.39

Quartile 

3

120 122 1.04 0.69-

1.56

Quartile 

4

135 113 1.25 0.82-

1.90

*From Platz 2004, table 3 footnotes: 

Medians for each quartile: Among controls matched to cases diagnosed between date of blood draw and 1/1996: 25(OH)D - summer: 20.1, 24.1,27.6,32.9; fall: 14.9,22.4,25.4,31.1; 

spring: 12.0, 16.6,20.9,24.5; winter: 9.3, 15.8, 19.9,24.6. I,25(OH)D - summer: 27.0, 31.0, 35.7, 42.6; fall: 26.8, 30.1, 34.4, 39.9; spring: 25.6, 28.9, 33.7, 37.1; winter: 19.1 

27.1,33.5,39.2. Ratio (xIO-3) - summer: 0.89,1.25,1.38,1.90; fall: 0.99,1.20, 1.54,2.11; spring: 1.00, 1.54, 1.88,2.78; winter: 1.06, 1.42, 1.81,2.84. Among controls matched to cases 

diagnosed 2/1996 - 1/1998: 25(OH)D in ng/ml- summer: 17.4,23.8,28.4,36.5; fall: 16.8,22.0,27.7,38.2; spring: 13.9, 19.7,24.0,29.9; winter: 13.8, 19.4,21.8,26.9. 1,25(OH)D in pg/ml - 

summer: 25.5, 30.6, 37.3, 45.2; fall: 27.5, 31.9, 36.7,44.0; spring: 25.0, 30.0, 34.3, 38.8; winter: 27.6, 31.7, 36.8, 39.9. Ratio (xI0-3) - summer: 0.88; 1.11, 1.47, 1.96; fall: 0.95, 1.14, 

1.54,2.10; spring: 0.91, 1.33, 1.56,2.19; winter: 1.14, 1.50, 1.84,2.70. 

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

15090720 Platz 

2004 Cases: 2.2 ± 1.2 y crude 460 24.6 ng/mL 

7.7 0.20

Control: 460 23.9 

ng/mL 

8.2

Duplicate one table per outcome 

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

1,25(OH)D 

Level

Vit D 

level 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

15090720 Platz 

2004 Cases: 2.2 ± 1.2 y crude 460 34.3 pg/mL 7.1 0.06

Control: 460 33.5 pg/mL 7.1

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

17440943 Mikhak 2007 Prostate cancer No significant differences in 25(OH)D or 1,25(OH)D between cases and matched controls, as well as no differences in quintile trend.

UI Author

Year Comments for Results

15090720 Platz 2004 mean time between blood drawn and diagnosis was 2.2 ± 1.2 y

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

15090720 

and 

17440943

Platz 

2004 

and 

Mikhak 

2007

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

N

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Y

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Platz did not adjust for calcium intake (Mikhak did), Mikhak does not describe how cancer cases and 

staging were ascertained, nor do the total cases match up from text to result table (Table 3).

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

15827103 Reid 

2005

RCT 5 y postmenopausal, age 

>55 y

Osteoporosis therapy, Ca supplement, major ongoing disease, 

25(OH)D<10 μg/L (25 nmol/L), metabolic bone disease, regular 

users of HRT, anabolic steroids, glucocorticoids, 

bisphosphonates, LS bone density z score<-2

~2000 Same as 

Bolland 

2008

Govt (suppl 

supplied by 

industry)

EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled*** N analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

15827103 Reid 

2005

RCT Auckland, 

New Zealand

(36.5°S)

1471 1471 (ITT), 

153 

withdrew 

prior to 30 

months

74 

(~4.2)

≥55 y 0 nd BMI 26.4 healthy 25(OD)D≥25 

nmol/L

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

nd nd

15827103 Reid 

2005

Dietary 

calcium 

intake

nd nd nd Dietary 

calcium 857 

mg/d 

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

18198394 Reid 

2005

Ca supplement Calcium citrate (Citracal) 1 g (elemental) 5 years 2 x 200 mg before breakfast; 3 x 200 mg 

evening

Identical placebo

Co-intervention(s) *: None

Compliance/Adherence: Calcium: 396 (54%) alive, continuing followup, continuing intervention at 5 years. Overall compliance 55%

Placebo: 443 (60%) alive, continuing followup, continuing intervention at 5 years. Overall compliance 58%

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

18198394 Reid 2005 2° Weight Kg, BMI

2° BP SBP, DBP

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups

Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

18198394 Reid 

2005

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? No

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Delta**

Final or 

Delta 

SE

Net 

difference

Net 

difference CI 

/ SE / SD*

P 

between

18198394 Reid 

2005

Weight Kg Calcium 30 732 66.9 11.5 -0.368 0.132 0 0.93

Placebo 739 67.1 11.8 -0.369 0.134

BMI kg/m2 Calcium 30 732 26.5 4.3 +0.01 0.05 -0.01 0.83

Placebo 739 26.4 4.2 +0.02 0.05

SBP mm 

Hg

Calcium 30 732 134.9 22.6 0.0 0.9 -2.4 0.14

Placebo 739 133.9 22.9 +2.4 0.9

DBP mm 

Hg

Calcium 30 732 70.1 10.7 -0.2 0.4 -1.0 0.13

Placebo 739 69.6 10.0 +0.8 0.4

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

18198394 Reid 

2005 RCT Y Y NA Y nd Y Y N Y B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Since these are 2° outcomes (from original study perspective), fully adjusted analyses should have been 

performed

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

12869397 Rodriguez 

2003

Cohort 

study

-residing in one of 21 

states with populationbased state cancer 

registries

-men with a history of cancer

-incomplete dietary information

-loss to follow-up from baseline through August 

31, 1999

-those with prevalent cancer at baseline, except 

nonmelanoma skin cancer

-those whose self report of prostate cancer 

could not be confirmed

-extreme values of energy intake reported

-leaving 15% or more of FFQ items blank, four 

or more out of seven dairy food questions blank, 

uninterpretable responses to calcium or 

multivitamin questions.

1992-1993 Cancer 

Prevention Study 

II Nutrition Cohort

Nd KP/SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N enrolled*** N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

12869397 Rodriguez 

2003

Cohort 

study

United 

States 

(various)

86,404 male 

participants in 

the CPS-II 

Nutrition 

Cohort

65,321 nd 50-74 100% Nd BMI mean = 26.1 Nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subject selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

12869397 Rodriguez 

2003

25(OH)D 

and/or 

1,25(OH)2D

Nd Nd Nd Nd -Intake <700 

mg/day of 

calcium: mean 

vitamin D intake 

= 168.2 IU/day

-Intake <700 

mg/day of 

calcium: mean 

vitamin D intake 

= 168.2 IU/day

Dietary 

calcium 

intake

FFQ 

(modified 

Block)

Diet Analysis 

System 

version 3.8a

Y, energyadjusted 

correlation 

controlling for 

day-to-day 

variations in 24-

hour recalls is 

0.68

Nd

6547130

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

12869397 Rodriguez 

2003

Nd Prostate 

cancer

Incident cases identified through self-report, verified through medical records or linkage with state cancer 

registries. Also through death certificates among cohort members not reporting cancer at enrollment.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

12869397 Rodriguez 

2003

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Total energy intake, total fat intake, 

phosphorous, total vitamin D

Demographics (e.g., age, gender, race, education)? Yes Age at entry, education, 

race

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other Family history of prostate cancer in brother 

or father

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

12869397 Rodriguez 

2003

Prostate 

cancer

Total calcium 

intake <700 

mg/day

nd nd 1323 23,653 147,858 

personyears

adjusted RR 1 Reference Nd

0.02

Total calcium 

intake 700-999 

mg/day

nd nd 1293 Nd 137,184 

personyears

1.0 0.9-1.1 Nd

Total calcium 

intake 1000-

1499 mg/day

nd nd 835 Nd 88,023 

personyears

1.0 0.9-1.1 Nd

Total calcium 

intake 1500-

1999 mg/day

nd nd 265 nd 23,174 

personyears

1.3 1.1-1.5 Nd

Total calcium 

intake ≥2000 

mg/day

nd nd 95 1,330 8,152 

personyears

1.2 1.0-1.6 Nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups
Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

12869397 Rodriguez 

2003

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Y

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): A

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

17315319 Rohrmann

2007

Cohort 

study

men; 

completed 

FFQ

<35 y in 1989; baseline cancer; skipped >32 items in FFQ; 

<3 food items consumed per day; total energy intake outside 

the range of 800-5000 Kcal

1989 CLUE II 

study

government SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17315319 Rohrmann

2007

Cohort 

study

Washington 

County, 

Maryland

5620 3892 53.8 

(nd)

nd 100 99% 

white

BMI 27.2 nd 25% used calcium 

supplements

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

nd nd

17315319 Rohrmann

2007

Calcium 

intake 

(dietary and 

supplement)

60 item Block 

FFQ

nd n 25% used 

calcium 

supplements

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17315319 Rohrmann

2007

primary incident prostate cancer Cancer Registry; death certificates; Natl Death Index

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17315319 Rohrmann

2007

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

energy intake; tomato; 

saturated fat

Demographics (e.g., age, gender, race, education)? Yes age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI at age 21

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean Ca 

dose (diet & 

suppl 

combined)

No. of 

Event* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

17315319 Rohrmann incident 

prostate 

cancer

tertile 1 <685.77 

mg/d

58 nd adj HR 1.00

0.99

tertile 2 685.77 to 

957.58 mg/d

65 nd 0.98 0.72-

1.47

tertile 3 >957.58 

mg/d

76 nd 0.99 0.70-

1.41

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 
**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

17315319 Rohrmann

2007

low-stage and high-stage prostate cancer see Table 2 in paper

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17315319 Rohrmann

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

N

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Calcium intake is from combined diet and supplement; only 25% of participants used supplement; not all

relevant confounders adjusted

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort Name

Funding 

Source Extractor

9236416 Ross 

1997

Case-cohort 

study

Men 45-64 yo at screening

Cases: Fatal stroke

Controls: 5 per case, matched for age, month of interview, 

neighborhood, alive at time of death of index case

History of 

cancer

1986-89 None NCI EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

9236416 Ross 

1997

Casecohort 

study

Shanghai, 

China

31° N

18,244 245 

cases

1225 

controls

nd 45-64 100% Chinese BMI quartiles:

<20, 20-<22, 22-

<24.2, ≥24.2

nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

nd nd

9236416 Ross 

1997

Dietary 

calcium 

intake

FFQ Chinese Food 

Composition 

Tables

nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

9236416 Ross 1997 1° Fatal stroke

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

9236416 Ross 

1997

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes Age matched

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions Yes HTN

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes Cigarettes, alcohol

Other Yes Education, marital status

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

F/up

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI

**

P between 

groups***

P for 

trend****

9236416 Ross 

1997

Fatal 

stroke

Calcium tertile 1 12 

years

nd 103 460 Adjusted RR 1.0 -- NS

Calcium tertile 2 nd 68 369 0.8 0.6, 

1.6

NS

Calcium tertile 3 nd 74 396 1.0 0.8, 

1.4

NS

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / SE 

/ SD*

Mean 

Ca 

intake

Ca CI 

/ SE / 

SD*

P 

between 

groups

9236416 Ross 

1997 Cases: 12 years Crude 245 228 mg 0.38

Control: 1225 241 mg

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

9236416 Ross 

1997

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

N

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

Y

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

?

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): No data on tertile ranges. Unclear why some factors adjusted for and not others. Unclear if all stroke 

fatalities captured. No data on blinding.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name Funding Source Extractor

15531500 Sambrook

2004

Cohort 

study

≥65 y; resides in nursing 

homes or hostels; ≥16 

mo follow-up; available 

25OH-D data

bedridden; bilateral amputees; nonEnglish speaking; 1o 

hyperparathyroidism; severe renal 

impairment (serum Cr >300 μmol/L)

1999 Fracture Risk 

Epidemiology in the 

Elderly (FREE)

nd SI

16598375 Sambrook 

2006

Cohort 

study

All individuals from 

FREE study in whom 

serum samples were 

available for biochemical 

analysis

Patients with primary 

hyperparathyroidism were excluded 

from the analysis

June 1999 

and Jan 2003

Fracture Risk 

Epidemiology in the 

frail Elderly (FREE) 

Study

National Health and 

Medical Research 

Council of Australia 

and Arthritis 

Australia

MC

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI

Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

15531500 Sambrook

2004

Cohort 

study

N. Sydney, 

Australia

842 842 85 

(nd)

nd 22 nd 60 Kg 7.2% DM; 

62% HTN

nd

16598375 Sambrook 

2006

Cohort 

study

North 

Sydney, 

Australia

33° 55’ 

South

2005 

(original 

cohort)

1112 86.0 

(6.9)

65-104 

(data for 

2005 

enrolled 

only)

21.2 nd Mean weight: 59.6 

kg

Mean 

number of 

medication: 

6.8

“frail elderly”; 

7.8% had hip 

fracture

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (e.g. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

15531500

16598375

Sambrook 

2004

Sambrook 

2006

25(OH)D Diasorin 

radioimmunoassay 

kit (Stillwater, MN, 

US)

Intra-assay 

CV=7.6%; 

Inter-assay 

CV=9.0%.

nd nd Mean (SD) = 

25 (18-37) nM

vit D 

supplement 

(100-1000 IU 

daily) in 6.6% 

men; 10% 

women

Dietary 

calcium 

intake

nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

16598375 Sambrook 

2006

Secondary (assumed because primary outcome of the 

original cohort was falls and fractures)

Total 

mortality

Mortality and cause of death were ascertained from death certificates and 

chart review during regular visits to institutions

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

15531500 Sambrook

2004 This paper described first 865 subjects who had completed at least 16 months follow-up from FREE study

16598375 Sambrook 

2006

Backward elimination was used to select confounders to be included in the final multivariate regression analyses. 25(OH)D was not selected. Therefore, 

only results of univariate analysis were extracted here.

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

15531500 Sambrook

2004

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

No

Demographics (e.g., age, gender, race, education)? Yes age; gender

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions illness severity

Medication no

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

no

Smoking and other life styles variables no

Other serum PTH, albumin, phosphate and calcium; 

bone U/S attenuation; Cr clearance 

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

16598375 Sambrook 

2006

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy intake

See above comments. Only results of 

univariate analysis were extracted here

Demographics (e.g., age, gender, race, education)? no

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

15531500 Sambrook

2004 Cases: 

345 16-53 mo

adjusted for 

age and 

gender

345 24.9

14.4

0.006

Control: 

497 16-53 mo

adjusted for 

age and 

gender

1112 27.9

15.7

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

15531500 Sambrook

2004

Total 

mortality

After adjustment for age and gender, log 25OH-D was a significant predictor of mortality (HR 0.990 (0.982-0.998), P=0.001). In multivariate 

analysis that included serum PTH, 25OH-D and bone U/S attenuation, only PTH, Cr clearance, albumin, gender & illness severity remained 

significant predictors of mortality.

16598375 Sambrook 

2006

Total 

mortality

Over a median follow-up of 817 days (mean, 852 days; range: 4–2028 days), a total of 559 (50.3%) subjects died.

Causes of death were cardiac (n=184), cerebrovascular (n=94), infections (mainly pneumonia; n=157), other

(n=120: renal failure 19, cancer 24, respiratory 16, dementia 29, and others 32), and undetermined (n= 4). Eighty eight hip fractures 

occurred in 87 subjects during the period of follow-up.

Result from univariate analysis for potential risk factors for total mortality:

Using Log 25(OH)D as the independent variable, HR (95%CI) of total mortality was 0.87 (0.75-1.01), p=0.07 (n=1112)

UI Author Comments for Results
Year

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

15531500 Sambrook

2004

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(e.g. 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

N

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

N

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): did not adjust for dietary factors, anthropometrics and additional variables relevant to vitamin D
QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

16598375 Sambrook 

2006

a) Eligibility 

criteria 

clear? (y/n)

N

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(e.g. 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

NA

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

N

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

N

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Very selected subgroup of individuals from original cohort; 25(OH)D was not selected to enter final 

multivariate model. Therefore, only results of univariate analysis were used (no confounding was 

controlled).

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

10362125 Schuurman 

1999

Case-cohort 

study

-male -Hx of cancer (except skin cancer)

-incomplete or inconsistent dietary 

data

1986-1992 Netherlands Cohort 

Study

Dutch Cancer 

Society

MB/SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and Country, 

latitude)

N enrolled*** N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat ...etc)

Health 

Status

Specific

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or 

Ca intake 

...etc.)

10362125 Schuurman 

1999

Casecohort 

study

Netherlands, 

52.30 N

2392 (original 

cohort size = 

58279. 704 cases 

derived from 

entire cohort. 

Random 

subcohort sample 

of 1688 men used 

to estimate 

accumulated 

person years at 

risk)

2167 (642 

cases, 

1525 

controls)

Cases: 

63.9±3.8

Controls: 

61.4±4.2

Range: 

55-69 

yrs

100% nd nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

10362125 Schuurman 

1999

25(OH)D 

and/or 

1,25(OH)2D

nd nd

Dietary 

calcium 

intake

SFFQ (given at 

baseline to 

estimate 

consumption 

during the year 

preceding start 

of study)

Dutch food 

composition 

table

N nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify)

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

10362125 Schuurman 1999 nd Prostate cancer Computerized record linkage with all nine cancer registries in The Netherlands,

and with the Dutch national data base of pathology reports

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups

Please List Name of 

Confounder (including 

matching factors)

Specific comments for confounders

10362125 Schuurman 

1999

Other nutrients or dietary factors (e.g., 

certain food consumption), including 

supplement use and total energy intake

Yes Intake of Ca adjusted for energy. Total energy intake-adjusted. Mean 

intake of fresh meat, fish, cured meat, milk and milk products, cheese, 

eggs, calcium and protein did not differ among cases and subcohort 

members.

Demographics (e.g., age, gender, race, 

education)?

Yes Age-adjusted

Anthropometrics (e.g., BMI, body weight, % 

body fat)?

No

Medical conditions No

Medication No

Sunlight exposure and its proxy variables 

(e.g., seasonal variation of 25(OH)D, UV 

exposure, location)

No

Smoking and other life styles variables (e.g., 

physical activity, occupation, alcohol 

consumption)

No

Other Yes Adjusted for family hx of prostate cancer and SES

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI

Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year

Outco

me

Quintiles [Median 

Ca intake (mg/d) 

/cutpoint]

Mea

n Vit 

D 

level 

/ 

dose

Mea

n Ca 

level 

/ 

dose

No. of 

Cases 

(Event)

* 

Pers

onyears

Mean

Follow-up

,

mo

Crude or 

Adjusted 

analysis

?

Outcom

e Metric 

(e.g. OR, 

RR, HR, 

%)

Outcom

e effect 

size

CI 

P 

betwe

en 

group

s***

P for 

trend***

*

1036212

5

Schuurma

n 1999

Prostat

e 

cancer

602/709 (reference 

group)

120 1821 75 Adjusted RR 1.0 N/A

780/848 126 1845 75 Adjusted RR 1.10 0.80-

1.51

>0.05

911/984 127 1840 75 Adjusted RR 1.04 0.76-

1.42

>0.05

1064/1164 140 1817 75 Adjusted RR 1.21 0.89-

1.66

>0.05

1329/nd 129 1800 75 Adjusted RR 1.09 0.79-

1.50

>0.05 p=0.34

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 
QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

1036212

5

Schuurma

n 1999

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome 

info? (y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecifie

d 

methods***

was used? 

(y/n)

NA

a) Level 

of the 

exposure 

in 

comparati

ve 

categorie

s (eg 

quartiles) 

is given 

(ranges)? 

(y/n) 

applicabl

e for 

categoric

al 

analyses 

only

N

a) Adjusted 

or matched 

for ANY 

confounder

s (other 

than age 

and 

sex)?** 

(y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment

? (y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of 

population 

random or 

consecutive

? (y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement

? (y/n)

Y

b) Food 

compositio

n database 

or suppl 

compositio

n 

reported? 

(y/n)

Y

Time from 

sample 

collection 

to sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justificatio

n of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors 

specify a 

primary 

outcome? 

(y/n)

N

c) 

Justification 

of sample 

size 

(includes 

sample size 

calculations)

? (y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Unclear the proportion of questionnaire validated against the 9-day diet record; accumulated person 

years at risk in the total cohort are estimated using a subcohort; no 1o outcome specified.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment Years Trial or Cohort 

Name

Funding 

Source Extractor

7498100 Scragg 

1995

RCT -Subjects recruited from general 

practitioner registers

-63 – 76 yrs

-vit D 

medication/supplements

-antihypertensive med

Dec. 1991 – Jan. 

1992

None nd MB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT 

for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

7498100 Scragg 

1995

RCT Cambridge, 

UK 52°N

191 189 69.6 

(nd)

Age 

range: 

63 – 76 

yrs.

46% nd Mean weight = 70.3 

kg.

Mean BMI = 25.8

Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

7498100 Scragg 

1995

25(OH)D 

and/or 

1,25(OH)2D

25(OH)D 

competitive 

protein 

binding 

assay

Y, intra-assay 

coefficient of 

variation 2.7%

nd At baseline: Tx 

group mean = 

13.8 ng/mL

Control group 

mean = 12.9 

ng/mL

7498100 Scragg 

1995

Dietary 

calcium 

intake

nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or 

Ca Dose Intervention Duration Intervention Frequency (e.g. capsules were taken 2 times a day)

7498100 Scragg 

1995

Cholecalciferol Prepared in Arachis oil by a hospital and 

checked for bioactivity

2.5 mg 

(100,000 IU)

Follow-up assessment 5 

wks post drink

One time drink taken in presence of 

interviewer

7498100 Scragg 

1995

Placebo Prepared in Arachis oil by a hospital and 

checked for (lack of) bioactivity

One time drink taken in presence of 

interviewer

Co-intervention(s) *: None

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

7498100 Scragg 1995 1 SBP BP was measured twice pre and post intervention with a Hg sphygmomanometer and averaged 

7498100 Scragg 1995 1 DBP BP was measured twice pre and post intervention with a Hg sphygmomanometer and averaged

7498100 Scragg 1995 2 25(OH)D As measured by competitive protein binding assay

 

 

 

 

 

 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

7498100 Scragg 1995 Complete trial performed during winter with goal of eliminating UV exposure as a confounder

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

7498100 Scragg 

1995

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? no NS diff. in age between groups

Anthropometrics (e.g., BMI, body weight, % body fat)? no NS diff. In BMI and body weight 

between groups

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

Smoking and other life styles variables no NS diff in % smokers between 

groups

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Delta** Delta 

SD*

Net 

difference

Net 

difference CI / 

SE / SD*

P 

between

7498100 Scragg 

1995

SBP mmHg Vit D 5 wks 95 149 22 -5 13 0 0.81

placebo 5 wks 94 147 23 -5 16

DBP Vit D 5 wks 95 82 12 -1 9 0 0.92

placebo 5 wks 94 82 10 -1 9

25(OH)D ng/mL Vit D 5 wks 95 13.8 5.9 +7.2 3.8 8.6 0.0001

placebo 5 wks 94 12.9 5.4 -1.4 1.1

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

7498100 Scragg 

1995

RCT 

Parallel Y nd NA Y Y Y Y N Y A

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): possible confounders not accounted for

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort Name Funding Source Extractor

12208895 Shin 2002 Cohort study Registered nurses from 11 states in the 

United Sates, women who completed 

the 1980 dietary questionnaire, did not 

have implausible values for total energy 

intake (<500 kcal or >3500kcal), had not 

left more than 10 food items blank, and 

had not been diagnosed with cancer by 

1980

nd 1980 Nurses’ Health 

Study

National cancer 

institute, national 

institutes of health, 

department of 

health and human 

services; American 

cancer society 

international union 

against cancer; 

and the Korean 

science and 

engineering 

foundation 

JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

12208895 Shin 

2002

Cohort 

study

US 88691 88381 46.7 

(nd)

Nd 0 nd Mean BMI at age 

18y: 21.4, Mean 

height: 64.5 in.

History of 

osteoporosis: 

1.2%

Current 

smokers: 

28.9%

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subject selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the

biomarker 

samples were 

drawn

Background 

exposure 

data

12208895 Shin 

2002

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd Total Vit D 

intake 

306.7 IU/d

12208895 Shin 

2002

Dietary 

calcium 

intake

(1980) 61 item 

FFQ, (1984, 

1986, 1990, and 

1994) 

approximately 

130 foods - FFQ

USDA Nutrient 

data base

Y (see other 

article, Willett et 

al. 1988, Salvini et 

al. 1989)

Total Ca 

intake

773.7 mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

12208895 Shin 

2002

nd Breast 

cancer

Medical records were obtained for breast cancer cases identified by either self-report or vital records, and more 

than 99% of these records confirmed the self-report. 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

12208895 Shin 

2002

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total 

energy intake

Total energy intake, total fat intake, 

glycemic index, β-carotene intake, total 

active vit E intake, 

For the analysis of postmenopausal women, age at 

menopause and postmenopausal hormone use were 

added.

Demographics (e.g., age, gender, race, education)? Yes - age, BMI at age 18

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes - height, weight change since age 18, 

age at menarche,

Medical conditions History of benign breast disease, family 

history of breast cancer, 

Medication

Sunlight exposure and its proxy variables (e.g., 

seasonal variation of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical 

activity, occupation, alcohol consumption)

Yes - physical activity, alcohol intake, 

Other Time period, parity, age at first birth

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

12208895 Shin 

2002

Premenopausal 

women -

Breast cancer 

Total Ca group 1 ≤ 500 142 192 Adjusted RR 1.00

0.05

Total Ca group 2 >500-

≤600

106 192 Adjusted RR 0.88 0.68-

1.13

Total Ca group 3 >600-

≤700

133 192 Adjusted RR 0.97 0.76-

1.24

Total Ca group 4 >700-

≤800

119 192 Adjusted RR 0.95 0.74-

1.22

Total Ca group 5 >800-

≤1000

161 192 Adjusted RR 0.82 0.64-

1.05

Total Ca group 6 >1000-

≤1250

104 192 Adjusted RR 0.75 0.57-

0.99

Total Ca group 7 >1250 62 192 Adjusted RR 0.80 0.58-

1.12

12208895 Shin 

2002

Postmenopausal 

women -

Breast cancer 

Total Ca group 1 ≤ 500 240 192 Adjusted RR 1.00

0.70

Total Ca group 2 >500-

≤600

216 192 Adjusted RR 0.86 0.72-

1.04

Total Ca group 3 >600-

≤700

293 192 Adjusted RR 0.94 0.79-

1.12

Total Ca group 4 >700-

≤800

292 192 Adjusted RR 0.92 0.77-

1.10

Total Ca group 5 >800-

≤1000

518 192 Adjusted RR 0.93 0.79-

1.10

Total Ca group 6 >1000-

≤1250

433 192 Adjusted RR 0.90 0.76-

1.07

Total Ca group 7 >1250 353 192 Adjusted RR 0.93 0.77-

1.12

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

12208895 Shin 

2002

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

N

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

nd

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Poor reporting

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort Name

Funding 

Source Extractor

17019716 Shin

2006

Cohort 

study

Women between the 

ages of 40 and 70 years 

were recruited in urban 

Shanghai

Subjects who had a previous history of cancer at 

baseline; those who reported an implausible total calorie 

intake (<500 or >3500 kcal/day); and those who moved 

away from Shanghai immediately after the baseline 

survey

March 1997 to 

May 2000

Shanghai 

Women’s 

Health Study

NIH AT

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit D 

or Ca intake ...etc.)

17019716 Shin

2006

Cohort 

study

urban 

Shanghai, 

China

(31° 14' N)

73314 73314 Cases: 

59 

(8.5); 

noncases: 

52 (9.1)

nd 0 Chinese BMI, average 

(Kg/m2): 24

Waist to hip ratio, 

average: 0.81

Menopause: 

49%

CRC in first 

degree 

relatives: 

2.2%

Ever 

sm oked 

regularly: 

2.8%

Ever drank 

alcohol 

regularly: 

2.3%

Ever 

exercised 

regularly: 

35%

Ever used 

hormone 

replacement: 

2%

Fruit s/veget ab les 

int ake (g/d ay), 

average: 567.7

Meat int ake 

(g/d ay), average: 

50.1

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 
***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of 

Dietary Assessment? 

(y/n) If Yes, Provide 

Data

Biomarker 

Assay****

Analytical 

Validity of

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17019716 Shin

2006

25(OH)D 

and/or 

1,25(OH)2D

na na na na na

17019716 Shin

2006

Dietary 

calcium 

intake

FFQ The Chinese 

Food 

Composition

Table was used 

to estimate the 

intake level of 

major nutrients 

for the study 

participants

y

Intake levels of major 

nutrients and food 

obtained from the FFQ 

compared with those 

derived from multiple 

24-hr dietary recalls. 

The correlation 

coefficients between 

FFQ and 24-hr dietary 

recalls were 0.54 for 

calcium

nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

17019716 Shin

2006

primary Colorectal 

cancer Cohort members have been followed by a combination of biennial follow-up surveys and record linkage to the Shanghai 

Cancer Registry and the Shanghai Vital Statistics Registry. The matching criteria used for linkage to identify cancer cases 

and deceased subjects in the cohort were citizen identification number, name, date of birth and address. International 

Classification of Diseases-9 (ICD-9) codes 153 and 154 were used to identify colon and rectal cancer cases, respectively. 

All possible matches were checked manually and verified through home visits.

secondary Colon 

cancer

secondary Rectal 

cancer

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

17019716 Shin

2006

Subjects were followed until diagnosis of cancer, death or June 30, 2004, whichever came first. If the subjects’ in-person contact occurred between June 30, 

2004 and December 31, 2004, the date of contact was used as a last follow-up date.

Mean values for the total sample were calculated by the mean values given for cases and non-cases respectively in the paper

Median follow up: 5.75 years

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

17019716 Shin

2006

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes (vitamin supplement use and total energy intake)

Demographics (e.g., age, gender, race, education)? Yes (age at recruitment, education)

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions Yes (menopausal status, family history of colorectal 

cancer among first degree relatives)

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes (cigarette smoking, alcohol consumption, 

physically active during past 5 years)

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)
All cases included (event = 283) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

17019716 Shin

2006

Colorectal 

cancer

1

st quintile, 

median (mg/day)

≤ 

291.9

nd nd Median, 

68.9

adjusted RR 1.0

0.484

Colorectal 

cancer

2

nd quintile, 

median (mg/day)

≤ 

389.9

nd nd Median, 

68.9

adjusted RR 1.0 0.7–

1.4

nd

Colorectal 

cancer

3

rd quintile, 

median (mg/day)

≤ 

488.2

nd nd Median, 

68.9

adjusted RR 1.0 0.7–

1.4

nd

Colorectal 

cancer

4

th quintile, 

median (mg/day)

≤ 

610.8

nd nd Median, 

68.9

adjusted RR 0.9 0.6–

1.3

nd

Colorectal 

cancer

5

th quintile, 

median (mg/day)

> 

610.8

nd nd Median, 

68.9

adjusted RR 0.9 0.6–

1.3

nd

Exclude first 2 years of follow-up (event = 220) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

17019716 Shin

2006

Colorectal 

cancer

1

st quintile, 

median (mg/day)

≤ 

291.9

nd nd nd adjusted RR 1.0

0.023

Colorectal 

cancer

2

nd quintile, 

median (mg/day)

≤ 

389.9

nd nd nd adjusted RR 0.9 0.6–

1.3

nd

Colorectal 

cancer

3

rd quintile, 

median (mg/day)

≤ 

488.2

nd nd nd adjusted RR 0.8 0.5–

1.2

nd

Colorectal 

cancer

4

th quintile, 

median (mg/day)

≤ 

610.8

nd nd nd adjusted RR 0.7 0.4–

1.1

nd

Colorectal 

cancer

5

th quintile, 

median (mg/day)

> 

610.8

nd nd nd adjusted RR 0.6 0.3–

1.0

nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 
UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

17019716 Shin

2006

Additional analyses were performed after excluding the first year or first 2 years of follow-up periods to evaluate whether undiagnosed cancer cases at the 

baseline survey may affect the results.

After excluding the first year of follow-up, higher intakes of calcium were associated with a decreased risk of colorectal cancer (P for trend = 0.058, data not 

shown).

In the subgroup analyses, similar associations were observed for colon and rectal cancer (data not shown). After excluding the first 2 years of follow-up, higher 

calcium intake significantly decreased the risk of colon cancer (p for trend = 0.030), but failed to reach any statistical significance for rectal cancer (P for trend = 

0.345).

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
Exclude first 2 years of follow-up (colon cancer, N = 129; rectal cancer, N = 91) 

UI

Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR,

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

17019716 Shin

2006

Colon 

cancer

1

st quintile, 

median (mg/day)

≤ 

291.9

nd nd nd adjusted RR 1.0

0.030

2

nd quintile, 

median (mg/day)

≤ 

389.9

nd nd nd adjusted RR 1.0 0.6–

1.0

nd

3

rd

quintile, 

median (mg/day)

≤ 

488.2

nd nd nd adjusted RR 0.6 0.4–

1.1

nd

4

th quintile, 

median (mg/day)

≤ 

610.8

nd nd nd adjusted RR 0.6 0.3–

1.0

nd

5

th quintile, 

median (mg/day)

> 

610.8

nd nd nd adjusted RR 0.6 0.3–

1.1

nd

Rectal 

cancer

1

st quintile, 

median (mg/day)

≤ 

291.9

nd nd nd adjusted RR 1.0

0.345

2

nd quintile, 

median (mg/day)

≤ 

389.9

nd nd nd adjusted RR 0.8 0.4–

1.5

nd

3

rd quintile, 

median (mg/day)

≤ 

488.2

nd nd nd adjusted RR 1.2 0.6–

2.1

nd

4

th quintile, 

median (mg/day)

≤ 

610.8

nd nd nd adjusted RR 0.9 0.5–

1.8

nd

5

th quintile, 

median (mg/day)

> 

610.8

nd nd nd adjusted RR 0.6 0.6–

1.4

nd
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17019716 Shin

2006

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

Y

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): Assessor blinding not reported; power calculation not reported; number of cases and non-cases per 

calcium quintile intake are not reported; confirmation of cases by histology not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

16985031 Skinner 

2006

Cohort 

study

Nurses’ Healthy Study (NHS): initiated in 1976 

when 121,701 US female registered nurses ages 

30 to 55 years responded to a mailed 

questionnaire

Health Professionals Follow-up (HPFS): began in 

1986 when 51,529 US male health professionals 

ages 40 to 75 years responded to a mailed 

questionnaire

Prior cancers, except 

nonmelanoma skin cancer; 

missing dietary information

NHS: 1984

HPFS: 1986

1. NHS

2. HPFS

NIH and 

NHS’s 

grant

MC

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

16985031 Skinner 

2006

Cohort 

study

Multiple 

cities in US

NHS: 

121,701

HPFS: 

51,529

NHS: 

75,427

HPFS: 

46,771

NHS: 

51 (nd)

HPFS: 

55 (nd)

NHS: 

30-55

HPFS: 

40-75

NHS:

0

HPFS: 

100

nd Mean BMI -

NHS: 24

HPFS: 25

Diabetic 

–

NHS: 

3%

HPFS: 

1%

Residence in 

northern state –

NHS: 50%

HPFS: 74%

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

16985031 Skinner 

2006

25(OH)D 

and/or 

1,25(OH)2D

nd nd

16985031 Skinner 

2006

Dietary 

calcium 

intake

FFQ (Willet, 

1990)

Harvard 

University Food 

Composition 

Database, 

derived from 

USDA

Pearson r between 

FFQ and 4 1-week 

diet records for 

energy-adjusted 

calcium intake = 

0.56 (HPFS cohort)

See results

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

16985031 Skinner 

2006

nd

Pancreatic 

cancer

Self-reported diagnosis in the 2-year period before each questionnaire. Some permitted to confirm through medical 

records. Additionally, primary case of death by pancreatic cancer was used. Because no material differences were 

observed between these two types of cases, both cases with and without medical records were included in final 

analyses.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

16985031 Skinner 2006 This article gave a pooled analysis of HPFS and NHS cohorts and separate data for each cohort. Only data from each cohort were extracted

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

16985031 Skinner 

2006

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total energy intake

Use of multivitamin supplement, 

dietary intake of vitamin D

Two statistical models: with and without 

adjustment for vitamin D were reported

Demographics (e.g., age, gender, race, education)? Yes age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI, height

Medical conditions History of DM

Medication

Sunlight exposure and its proxy variables (e.g., seasonal 

variation of 25(OH)D, UV exposure, location)

Region of residence (south, north)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes smoking

Other Parity (for women only)

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

16985031 Skinner 

2006

Pancreatic 

cancer

Total daily calcium 

intake (mg) in 

HPFS (men, 1986-

2000)

<500 17 Personyear:

59,963

Adjusted 

(but no 

dietary 

vitamin D)

RR 1

0.19

500-

999

119 372,213 Adjusted 

(but no 

dietary 

vitamin D)

RR 1.10 0.66-

1.81

≥1000 51 179,381 Adjusted RR 0.85 0.49-
(but no 

dietary 

vitamin D)

1.49

16985031 Skinner 

2006

Pancreatic 

cancer

Total daily calcium 

intake (mg) in 

HPFS (men, 1986-

2000)

<500 17 Personyear:

59,963

Adjusted 

(including 

dietary 

vitamin D)

RR 1 0.86

500-

999

119 372,213 Adjusted 

(including 

dietary 

vitamin D)

RR 1.28 0.76-

2.18

≥1000 51 179,381 Adjusted 

(including 

dietary 

vitamin D)

RR 1.23 0.67-

2.25

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

16985031 Skinner 

2006

Pancreatic 

cancer

Total daily calcium 

intake (mg) in NHS 

(women, 1984-

2000)

<500 24 Personyear:

156,300

Adjusted 

(but no 

dietary 

vitamin D)

RR 1

0.04

500-

999

109 665,099 Adjusted 

(but no 

dietary 

vitamin D)

RR 1.01 0.65-

1.58

≥1000 45 340,595 Adjusted 

(but no 

dietary 

vitamin D)

RR 0.69 0.42-

1.15

16985031 Skinner 

2006

Pancreatic 

cancer

Total daily calcium 

intake (mg) in NHS 

(women, 1984-

2000)

<500 24 Personyear:

156,300

Adjusted 

(including 

dietary 

vitamin D)

RR 1 0.09

500-

999

109 665,099 Adjusted 

(including 

dietary 

vitamin D)

RR 1.09 0.69-

1.73

≥1000 45 340,595 Adjusted 

(including 

dietary 

vitamin D)

RR 0.75 0.43-

1.30

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 
***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

16985031 Skinner 

2006

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): A

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

8478144 Slob 

1993

Cohort 

study

All civil servants in 

Amsterdam, aged between 

40 and 65 years, and their 

spouses

Subjects without information on survival status or cause of 

death, with missing information on calcium intake and other 

potential confounding variables, with extremely low energy 

intake (i.e., for men <1500kcal, for women <1250kcal)

1953-1954 nd nd JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

8478144 Slob 

1993

Cohort 

study

Amsterdam

(52°18' N)

3091 2591 Men 

53(7.3)

Women 

52 (7.2)

40-65y 50.9% nd BMI

Men 24.7 (2.7)

Women 26.4 (3.7)

nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

8478144 Slob 

1993

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd nd

8478144 Slob 

1993

Dietary 

calcium 

intake

FFQ (oneweek recall)Dutch food 

tables

n Men 

929±415mg/d

Women 

660±283mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

8478144 Slob 

1993

nd Gastrointestinal 

cancer mortality

The residence at death and the municipal death registration number were obtained from the Dutch Central 

Bureau of Genealogy. The combination of residence at death, date at death and municipal death registration 

number enabled linkage with the cause of death in the records of the Dutch Central Bureau of Statistics.

8478144 Slob 

1993

nd

Cancer mortality

The residence at death and the municipal death registration number were obtained from the Dutch Central 

Bureau of Genealogy. The combination of residence at death, date at death and municipal death registration 

number enabled linkage with the cause of death in the records of the Dutch Central Bureau of Statistics.

8478144 Slob 

1993

nd

All-cause mortality

The residence at death and the municipal death registration number were obtained from the Dutch Central 

Bureau of Genealogy. The combination of residence at death, date at death and municipal death registration 

number enabled linkage with the cause of death in the records of the Dutch Central Bureau of Statistics.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

8478144 Slob 

1993

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Energy intake, dietary fiber

Demographics (e.g., age, gender, race, education)? Yes - age

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Followup 

Duration

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

8478144 Slob 

1993 All cause 

mortality – Men

Ca quintile 1 28 yr ≤585 nd nd Adjusted OR 1.1 0.7-

1.6

nd nd

Ca quintile 2 585<,

≤725

nd nd Adjusted OR 1.1 0.7-

1.6

nd nd

Ca quintile 3 725<, 

≤935

nd nd Adjusted OR 0.8 0.5-

1.2

nd nd

Ca quintile 4 935<, 

≤1245

nd nd Adjusted OR 0.9 0.6-

1.3

nd nd
Ca quintile 5 >1245 nd nd Adjusted OR 1.0 nd nd

8478144 Slob 

1993 Total cancer 

mortality – Men

Ca quintile 1 28 yr ≤585 232 (total 

cases)

1321 

(total)

Adjusted OR 1.0 0.6-

1.6

nd nd

Ca quintile 2 585<,

≤725

nd nd Adjusted OR 1.0 0.6-

1.6

nd nd

Ca quintile 3 725<, 

≤935

nd nd Adjusted OR 1.0 0.6-

1.5

nd nd

Ca quintile 4 935<, 

≤1245

nd nd Adjusted OR 0.8 0.5-

1.3

nd nd

Ca quintile 5 >1245 nd nd Adjusted OR 1.0 nd nd

8478144 Slob 

1993

Gastrointestinal 

cancer 

mortality– Men

Ca quintile 1 28 yr ≤585 nd nd Adjusted OR 1.5 0.7-

3.2

nd nd

Ca quintile 2 585<,

≤725

nd nd Adjusted OR 1.1 0.5-

2.3

nd nd

Ca quintile 3 725<, 

≤935

nd nd Adjusted OR 1.1 0.5-

2.2

nd nd

Ca quintile 4 935<, 

≤1245

nd nd Adjusted OR 0.6 0.3-

1.4

nd nd

Ca quintile 5 >1245 nd nd Adjusted OR 1.0 nd nd

8478144 Slob 

1993

All cause 

mortality –

Women

Ca quintile 1 28 yr ≤445 nd nd Adjusted OR 1.2 0.8-

1.9

nd nd

Ca quintile 2 445<,

≤540

nd nd Adjusted OR 1.1 0.7-

1.7

nd nd

Ca quintile 3 540<, 

≤640

nd nd Adjusted OR 1.3 0.9-

2.0

nd nd

Ca quintile 4 640<, 

≤850

nd nd Adjusted OR 1.1 0.7-

1.7

nd nd

Ca quintile 5 >850 nd nd Adjusted OR 1.0 nd nd

8478144 Slob 

1993

Total cancer 

mortality –

Women

Ca quintile 1 28 yr ≤445 127 (total 

cases)

1270 

(total)

Adjusted OR 1.1 0.6-

2.1

nd nd

Ca quintile 2 445<,

≤540

nd nd Adjusted OR 0.8 0.4-

1.5

nd nd

Ca quintile 3 540<, 

≤640

nd nd Adjusted OR 1.6 0.9-

2.8

nd nd

Ca quintile 4 640<, 

≤850

nd nd Adjusted OR 1.4 0.7-

2.5

nd nd

Ca quintile 5 >850 nd nd Adjusted OR 1.0 nd nd

8478144 Slob 

1993

Gastrointestinal 

cancer 

mortality–

Women

Ca quintile 1 28 yr ≤445 nd nd Adjusted OR 3.1 0.8-

12.3

nd nd

Ca quintile 2 445<,

≤540

nd nd Adjusted OR 1.6 0.4-

7.2

nd nd

Ca quintile 3 540<, 

≤640

nd nd Adjusted OR 3.8 1.0-

13.9

nd nd
Ca quintile 4 640<, 

≤850

nd nd Adjusted OR 1.8 0.4-

7.7

nd nd

Ca quintile 5 >850 nd nd Adjusted OR 1.0 nd nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

8478144 Slob 

1993

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

N

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Y

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): No internal calibration of dietary assessment (FFQ). No data on number of cases per calcium intake 

category.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

19056900 Sneve 

2008

RCT -men and 

women

-21-70 yrs 

old

-BMI 

between 

28.0 and 

47.0 kg/m2

- diabetes, hx of MI, angina pectoris, stroke, renal stone disease, 

sarcoidosis

-wt loss of more than 10% of total body wt during the last 6 mos., those 

using antidepressant drugs or wt reducing drugs, participation in an 

organized wt loss program, pregnant or lactating women, women 

planning to become pregnant in the next 12 mos., women below the 

age of 50 yrs without adequate contraception, subjects with serum Ca > 

2.55 mmol/L, males with serum creatinine > 129 micromol/L, and 

females with serum creatinine > 104 micromol/L

2005-2007 nd The Northern 

Norway 

Regional 

Health 

Authority

MB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI

Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit D or 

Ca intake ...etc.)

19056900 Sneve 

2008

RCT North 

Norway 

(latitude = 

70 N)

445 334 47.6 

(11.4)

nd 36% nd Weight(kg)=100.1

(14.2)

BMI=34.8(3.9)

% body fat=43.0

(7.5)

waist hip ratio=0.97

(0.09)

Overweight 

or obese, 

22% 

smokers

Serum 

Ca(mmol/L)=2.31(0.11)

Serum 25(OH)D 

(nmol/L)=53.1(16.9)

Calorie intake 

(J/day)=9161(2887)

Ca intake 

(mg/day)=940(398)

Vit D intake 

(mcg/day)=8.9(6.6)

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration 

(or Validity) 

of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure data

19056900 Sneve 

2008

25(OH)D electrochemiluminescence Yes: 

according to 

producer, the 

assay has, for 

total analytical 

precison, a 

coeff of

variation 

7.8% as 

judged in any 

of three 

different 

concentrations 

(48.6 – 73.8 –

177.0 nmol/L)

nd nd Vit D intake 

(mcg/day)=8.9(6.6)

Serum 25(OH)D 

(nmol/L)=53.1(16.9)

Dietary 

calcium 

intake

FFQ nd nd Serum Ca was measured 

at baseline and at 3, 6, 9, 

and 12 months. Urine for 

measurement of Ca 

excretion was collected for 

24 hr at baseline and at 

the end of the study.

nd nd Ca intake 

(mg/day)=940(398)

Serum 

Ca(mmol/L)=2.31(0.11)

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca 

Total Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

19056900 Sneve 

2008

Vit D + Ca Vit D capsules from Jenapharm, Jena, Germany.

Ca supplement – Nycoplus Ca, Nycomed, Oslo, 

Norway)

5714 IU 

cholecalciferol + 

500 mg Ca

1 yr 2 capsules each containing 20,000 IU 

cholecalciferol taken twice a week (Monday 

and Thursday). Ca supplement taken daily

Vit D + Ca + 

placebo

Vit D capsules from Jenapharm, Jena, Germany. 

Ca supplement – Nycoplus Ca, Nycomed, Oslo, 

Norway). Placebo capsules, purchased from 

Hasco-lek, Wroclaw, Poland, were identical to the 

vit D capsules

2857 IU 

cholecalciferol + 

500 mg Ca

1 yr 1 capsule containing 20,000 IU 

cholecalciferol taken once a week (Monday or 

Thursday). One placebo capsule taken each 

week (Monday or Thursday). Ca supplement 

taken daily.

Ca + placebo Ca supplement – Nycoplus Ca, Nycomed, Oslo, 

Norway. Placebo capsules, purchased from 

Hasco-lek, Wroclaw, Poland, were identical to the 

vit D capsules

500 mg Ca 1 yr 2 placebo capsules taken each week 

(Monday and Thursday). Ca supplement 

taken daily.

Co-intervention(s) *:

At the baseline visit, any supplements with Ca and vit D were discontinued. Participants were given written recommendations on healthy 

diet and physical activity.

Compliance/Adherence:

If participant missed a capsule on assigned day, it could be taken another day. If a whole week was missed, double dose could be taken 

the next week. The compliance rate for cholecalciferol/placebo capsules were 95% in all 3 groups, and for the calcium tablets 81, 85, and 

83% in the vitD+Ca, vitD+Ca+placebo, and Ca+placebo groups respectively.

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

19056900 Sneve 2008 1 weight

2 BMI

2 Serum 25(OH)D

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

19056900 Sneve 

2008

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes – 3 groups matched on vit D intake, Ca 

intake, calorie intake

Demographics (e.g., age, gender, race, education)? Yes – 3 groups matched on age, adjusted for sex

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes – 3 groups matched on BMI, body weight, % 

body fat, and waist hip ratio

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes – 3 groups matched on % smokers and 

physical activity score

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) (SEE COMMENTS FOR RESULTS SECTION BELOW)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)

No. 

Analyzed Baseline Baseline SD*

Delta** Delta 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

19056900 Sneve 

2008 weight kg Vit D + Ca crude 12 116 101 14.5 +0.1 3.8

vs. 

Ca+placebo 

group = -0.4

NS

Vit D + Ca + 

placebo crude 12 106 98.6 14.3 +0.3 3.2

vs. 

Ca+placebo 

group = -0.2

NS

Ca + 

placebo crude 12 112 100.6 13.9 +0.5 3.9 NS

19056900 Sneve 

2008 BMI Kg/m2 Vit D + Ca crude 12 116 35.0 4.1 0.0 1.3

vs. 

Ca+placebo 

group = -0.2

NS

Vit D + Ca + 

placebo crude 12 106 34.4 3.9 +0.1 1.1

vs. 

Ca+placebo 

group = -0.1

NS

Ca + 

placebo crude 12 112 35.1 3.8 +0.2 1.4 NS

19056900 Sneve 

2008 Serum 

25(OH)D nmol/L Vit D + Ca crude 12 116 54.5 16.7 +59.8 21.1

vs. 

Ca+placebo 

group = +62.1

P<0.05 

versus 

Ca+placebo 

group

Vit D + Ca + 

placebo crude 12 106 51.4 18.4 +37.8 15.7

vs. 

Ca+placebo 

group = +40.1

P<0.05 

versus 

Ca+placebo 

group

Ca + 

placebo crude 12 112 53.2 15.4 -2.3 9.5 NS

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

19056900 Sneve 2008 In results above, baseline values are for all 445 subjects randomized but the delta values are for the 334 subjects who completed the study.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

19056900 Sneve 

2008

RCT -

parallel nd Y NA N nd Y Y Y Y B

Adverse Event(s): **

2 subjects were diagnosed with 1 hyperparathyroidism during the study and 1 subject had an increase in 

serum Ca to 2.62 mmol/L. All 3 subjects were excluded from the study. 4 subjects had transient increases in 

serum Ca > 2.59 mmol/L and remained in the study. 317 other adverse events were recorded, most of them 

related to GI discomfort. There were no significant differences between the treatment groups regarding 

adverse events.

Explanation for Overall Quality Grade (if not Grade A): Dropout rate greater than 20%. No explanation for high non-completion rate. Randomization technique not 

described. 

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

2311461 Stemmermann

1990

Cohort 

study

Men of Japanese ancestry born in 

the years 1900 through 1919 and 

living on the Hawaiian island of 

Oahu in 1965

Men excluded because of prevalent 

colorectal cancer; or because the subject 

considered his intake in the previous 24 

hours to be atypical

1965 - 1968 Japan 

Hawaii 

Cancer 

Study

NCI AT

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

2311461 Stemmermann

1990

Cohort 

study

Hawaiian 

island of 

Oahu

(21° 19'N)

8006 8006 nd nd 100 Japanese nd nd Average calcium 

intake (mg/day): 

503.23

Average fat intake 

(g/day): 85.58

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

2311461 Stemmermann

1990

25(OH)D 

and/or 

1,25(OH)2D

na na na na na

2311461 Stemmermann

1990

Dietary 

calcium 

intake

24h diet recall 

interview was 

administered to 

each subject by 

dieticians; food 

models and 

serving utensils 

were used to 

illustrate portion 

sizes

y

Food 

composition 

tables were 

compiled from 

the best 

available 

sources to 

calculate 

individual 

intakes of 

nutrients

nd nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

2311461 Stemmermann

1990

primary Colon cancer

Ascertainment of incident cancers was conducted by a periodic review of hospital discharge records for the 

island of Oahu. A computerized record linkage was performed between the study file and files of the Hawaii 

Tumor Registry to reduce the possibility of missing incidence cases. Each case of carcinoma was confirmed by 

histologic examination. The number of cancer cases identified by subsites of the large bowel were as follows: 

cecum and ascending colon (ICD-8: 153.0); transverse (ICD-8: 153.1) and descending colon (ICD-8: 153.2); 

sigmoid colon (ICD-8: 153.3); rectosigmoid (ICD-8: 154.0); and rectal (ICD-8: 154.1)

primary Cecum /ascending 

colon cancer

primary Transverse 

/descending colon 

cancer

primary Sigmoid colon 

cancer

primary Rectal cancer

primary Rectosigmoid 

cancer

primary Rectum cancer

secondary Large bowel 

cancer

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

2311461 Stemmermann

1990 max follow up: 22 years

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

2311461 Stemmermann

1990

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

No

Demographics (e.g., age, gender, race, education)? Yes (age)

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI 

**

P 

between 

groups***

P for 

trend****

2311461 Stemmermann

1990

All colon 

tumors

High tertile nd 58 2403 nd adjusted RR 1.0

0.16 Medium tertile nd 57 2399 nd adjusted RR 1.0 0.7-

1.4

nd

Low tertile nd 74 2392 nd adjusted RR 1.3 0.9-

1.8

nd

Cecum 

/ascending 

colon 

cancer

High tertile nd 16 2403 nd adjusted RR 1.0

0.76

Medium tertile nd 9 2400 nd adjusted RR 0.6 0.2-

1.3

nd

Low tertile nd 18 2392 nd adjusted RR 1.0 0.6-

2.2

nd

Transverse 

/descending 

colon 

cancer

High tertile nd 14 2403 nd adjusted RR 1.0

0.20

Medium tertile nd 11 2399 nd adjusted RR 0.8 0.4-

1.7

nd

Low tertile nd 8 2392 nd adjusted RR 0.6 0.2-

1.3

nd

Sigmoid 

colon 

cancer

High tertile nd 28 2403 nd adjusted RR 1.0

0.02

Medium tertile nd 37 2399 nd adjusted RR 1.3 0.8-

2.2

nd

Low tertile nd 48 2392 nd adjusted RR 1.7 1.1-

2.8

nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) NOTE: for this specific study (cohort study) this type of analysis may be considered inappropriate

Colon cancer

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

SE*

P 

between 

groups

2311461 Stemmermann

1990

Cases: 

189

nd adjusted 189 481.50 21.97

ns Control: 

7195

nd adjusted 7195 502.76 3.56

Duplicate one table per outcome 

Cecum /ascending colon cancer

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

SE*

P 

between 

groups

2311461 Stemmermann

1990 Cases: 43 nd adjusted 43 518.90 46.05

ns Control: 

7195

nd adjusted 7195 502.76 3.56

Transverse /descending colon cancer

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

SE*

P 

between 

groups

2311461 Stemmermann

1990 Cases: 33 nd adjusted 33 551.55 52.56

ns Control: 

7195

nd adjusted 7195 502.76 3.56

Sigmoid colon cancer

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

SE*

P 

between 

groups

2311461 Stemmermann

1990

Cases: 

113

nd adjusted 113 446.86 28.40

0.05 Control: 

7195

nd adjusted 7195 502.76 3.56
Rectal cancer

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

SE*

P 

between 

groups

2311461 Stemmermann

1990 Cases: 88 nd adjusted 88

524.48 32.21

ns Control: 

7195

nd adjusted 7195 502.76 3.56

Rectosigmoid cancer

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / 

SE /

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

SE*

P 

between 

groups

2311461 Stemmermann

1990 Cases: 39 nd adjusted 39 495.23 48.34

ns Control: 

7195

nd adjusted 7195 502.76 3.56

Rectum cancer

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

SE*

P 

between 

groups

2311461 Stemmermann

1990 Cases: 49 nd adjusted 49 547.87 43.16

ns Control: 

7195

nd adjusted

7195 502.76 3.56

Large bowel cancer 

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI / 

SE / 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

SE*

P 

between 

groups

2311461 Stemmermann

1990

Cases: 

277

nd adjusted 277 495.14 18.16

ns Control: 

7195

nd adjusted 7195 502.76 3.56

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 
UI Author

Year Outcome Results

UI Author

Year Comments for Results

2311461 Stemmermann

1990

Besides total calcium intake, results were also given as subgroup analyses for dairy calcium intake and non-dairy calcium intake

Rectosigmoid and rectum cancer were not associated with calcium intake (data not shown)

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 
QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

2311461 Stemmermann

1990

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

N

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive?

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

Y

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Study designed to compare cancer events in large bowel subsites between group with dairy calcium intake 

and group with non-dairy calcium intake; assessor blinding not reported; confounding factors not included in 

the analyses; power calculations not reported; results are not reported for all the outcomes (large bowel 

cancer per subsite); use of 24h recall interview instead of FFQ

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

19208842 Stolzenberg, 

2009

Casecohort 

study

Men and women, aged 55 to 74 y, from the 

Prostate, Lung, ovarian, and Colorectal 

Cancer Screening Trial (PLCO).

Cases: All incident cases of pancreatic 

adenocarcinomas occurred between 1994 

and 2006 (follow-up to 11.7 y; median, 5.4 

y)

Controls: selected from all PLCO study 

participants with serum samples and who 

were alive at the time the case was 

diagnosed. Two controls were matched to 

each case by age (±5 y), race, sex, and 

calendar date of blood draw in 2-mo 

blocks.

A personal history of one of the 4 

PLCO cancers or those currently 

undergoing treatment for any cancer, 

except nonmelanoma of the skin, as 

well as subjects who had been 

screened fro prostate or colorectal 

cancer during the prior 3 y 

November 

1993 – July 

2001

PLCO NIH MC

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat 

...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or 

Ca intake 

...etc.)

19208842 Stolzenberg, 

2009

Casecohort 

study

Multicenters in 

the US: 

Birmingham, 

AL; Denver, 

CO; Detroit, 

MI; Honolulu, 

HI; Marshfield, 

WI; 

Minneapolis, 

MN; 

Pittsburgh, PA; 

Salt lake City, 

UT; St. Louis 

MO; and 

Washington, 

DC)

Original 

RCT 

participants: 

152,810

Cases: 184

Controls: 

368

Cases: 

184

Controls: 

368

Cases: 

66

Controls: 

66

Cases:

IQR 59-

72

Controls: 

IQR 58-

72

65.2 90.2% 

White, 

3.3% 

Black, 

1.6% 

Hispanic, 

4.9% 

Asian

Mean (IQR) BMI 

–

Cases: 26.7 

(22.3-32.7)

Controls: 26.3 

(22.0-33.0)

DM: 10.5%

Gallbladder 

disease: 

13.2%

Vit D 

inadequacy 

(<40 nol/L): 

14%

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 
***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

19208842 Stolzenberg, 

2009

25(OH)D RIA 

(Heartland 

Assays lab)

Yes

Overall CV = 

4.7%

Within 2 hr calendar date of 

blood draw in 2-

mo blocks was 

matching factor to 

control for 

seasonal 

variation in the 

analysis

Residential 

sum exposure 

at study entryLow sun: 47%

Moderate sun 

45%

High sun: 8%

19208842 Stolzenberg, 

2009

Dietary 

calcium 

intake

137 item FFQ 

(Deeb, 2007)

nd nd N/A Median (IQR) 

total calcium 

intake –

Cases: 1091 

(710-1942) 

mg/d

Controls: 

1133 (732-

1776) mg/d

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

19208842 Stolzenberg, 

2009 Pancreatic 

cancer

Vital status of cohort participants and pancreatic cancer cases was identified by self-report survey, state cancer 

registries, death certificates, physician referrals, and reports from next of kin for deceased individuals. Medical and 

pathologic records related to pancreatic cancer diagnosis and supporting doc were obtained. 90.2% of pancreatic 

cancer cases were confirmed through medical review.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

19208842 Stolzenberg, 2009 2.5% had family history of pancreatic cancer. No differences between cases and controls.

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

19208842 Stolzenberg, 

2009

Other nutrients or dietary factors (e.g., certain food 

consumption), including supplement use and total 

energy intake

Demographics (e.g., age, gender, race, 

education)?

Yes*

Anthropometrics (e.g., BMI, body weight, % body 

fat)?

Yes* BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., 

seasonal variation of 25(OH)D, UV exposure, 

location)

Seasonal variation of 25(OH)D, and 

residential sun exposure (low, 

moderate or high)

Seasonal variation of 25(OH)D was one of the matching 

factor; residential sun exposure was treated as effect 

modifier (stratified analyses)

Smoking and other life styles variables (e.g., 

physical activity, occupation, alcohol consumption)

Yes* smoking

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

19208842 Stolzenberg, 

2009

Pancreatic 

cancer

25(OH)D 

quintiles, nmol/L

≤45.9 44 74 Median 5.4 

y (up to 

11.7 y)

Adjusted OR 1 (ref) nd

0.49

>45.9 

and 

≤60.3

40 74 0.97 0.47-

1.98

>60.3 

and 

≤69.5

27 73 0.86 0.40-

1.84
>69.5 

and 

≤82.3

31 74 0.84 0.39-

1.80

>82.3 42 73 1.45 0.66-

3.15

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
19208842 Stolzenberg, 

2009

Pancreatic 

cancer

25(OH)D, nmol/L (quartile) P 

interaction

<49.3 >49.3 and 

<65.2

>65.2 and 

<78.4

>78.4

Residential sum exposure, low* Case/control, n 

(91/167)

22/44 22/42 21/43 26/38

Adj OR (95% CI) 1 (ref) 2.52 (0.92-

6.90)

2.33 (0.83-

6.48)

4.03 (1.38-

11.79)

0.015

Residential sum exposure, 

moderate/high*

Case/control, n 

(93/201)

33/48 15/50 18/49 24/54

Adj OR (95% CI) 1.97 (0.80-

4.82)

0.66 (0.22-

2.01)

0.91 (0.31-

2.71)

1.45 (0.53-

3.96)

*Residential regions based on ranges of UV radiation levels obtained from annual R-B meter in states in which screening centers are 

located: low sun (R-B≤105, Detroit, MI; Minneapolis, MN; Marshfield, WI), moderate/high sun (R-B=113-134, Pittsburgh, PA; St. Louis, 

MO; Denver, CO; Washington, DC; Salt Lake City, UT, and R-B≥154, Brimingham, AL; Honolulu, HI)

19208842 Stolzenberg, 

2009

Pancreatic 

cancer

The adjusted Ors for each respective quartile compared with the first after the exclusion of the cases that occurred during the first 2 years 

(n=153 cases in analysis) were 0.78, 0.98 and 1.47 (95%Ci, 0.70-2.99, p trend=0.3) and 5 years (n=105 cases in analysis) were 0.52, 

1.27 and 2.21 (95% CI, 0.92-5.30; p trend-0.06)

UI Author

Year Comments for Results

19208842 Stolzenberg, 2009 There was no significant interaction of 25(OH)D status and pancreatic cancer by smoker status, sex, physical activity, or total vitamin A intake.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

Blood drawn in fall and winter season 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

19208842 Stolzenberg, 

2009

Pancreatic 

cancer

25(OH)D 

quintiles, nmol/L

≤45.9 25 50 Median 5.4 

y (up to 

11.7 y)

Adjusted OR 1 (ref) nd

0.10

>45.9 

and 

≤60.3

15 37 1.95 0.72-

5.27

>60.3 

and 

≤69.5

10 26 1.82 0.56-

5.96

>69.5 

and 

13 29 1.06 0.35-

3.27
≤82.3

>82.3 14 12 3.91 1.19-

12.85

Blood drawn in spring and summer season 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

19208842 Stolzenberg, 

2009

Pancreatic 

cancer

25(OH)D 

quintiles, nmol/L

≤45.9 19 24 Median 5.4 

y (up to 

11.7 y)

Adjusted OR 1 (ref) nd

0.55

>45.9 

and 

≤60.3

25 37 0.39 0.13-

1.23

>60.3 

and 

≤69.5

17 47 0.38 0.13-

1.14

>69.5 

and 

≤82.3

18 45 0.44 0.14-

1.35

>82.3 28 61 0.59 0.20-

1.75
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

19208842 Stolzenberg, 

2009

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment?

(y/n)

y

a) 

Prospective 

collection of 

data? (y/n)

y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

n

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

y

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

n Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

y

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

n

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

n b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

n

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

n

OVERALL Grade (A/B/C): A

Explanation for Overall Quality Grade (if not Grade A): Small number of cases in some subgroup analyses; analyses were not planned when trial was formed. 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

17047087 StolzenbergSolomon

2006

Casecohort 

study

All cases of p ancreat ic cancer d iagnosed 

b et w een January 1985 and Decem b er 

2001 w ere id ent if ied t hrough t he Finnish 

Cancer Regist ry am ong 29,133 eligible 

m en in sout hw est ern Finland, ages 50 t o 

69 years, w ho sm oked at least 5 

cigaret t es p er d ay, w ere rand om ized 

Alp ha-Tocopherol, Bet a-Carot ene Cancer

Prevent ion St udy

Cont rols: participants from the same study who 

were alive at the time the case was diagnosed 

and free from cancer (except nonmelanoma skin 

cancer) as of December 2001.

1) hist ory of 

m alignancy ot her 

t han nonm elanom a 

cancer of t he skin 

or

carcinom a in sit u

2) severe angina on 

exert ion, 

3) chronic renal 

insuf f iciency

4) liver cirrhosis, 5) 

chronic alcoholism , 

or ot her m ed ical 

cond it ions t hat 

m ight

lim it long-t erm 

p art icip at ion, 

6) ant icoagulant 

t herap y

7) used 

sup p lem ent s 

cont aining vit am in 

E (> 20 m g/d ), 

vit am in A (> 20,000

IU/d ), or β-carot ene 

(> 6 m g/d )

Trial enroll: 

1985 – 1988

Cases 

ascertained: 

1985 - 2001

Alp haTocop herol, 

Bet a-Carot ene 

Cancer

Prevent ion 

St ud y

NIH GR

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT
POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17047087 StolzenbergSolomon

2006

Casecohort 

study

Finland

64° N

200 

cases

400 

controls

200 

cases

400 

controls

58 54-62 100% Caucasian BMI 26 kg/m2 Diabetes 

9%

Bronchial 

asthma 4%

Mean BP = 

140/90

Smoking 

h/o both 

case and 

controls = 

90%

Vit D food 5μg

Supplement 8% 

yes

Serum 

25(OH)vitamin D 

(D2 and D3), 

nmol/L 49 in cases, 

46 in controls

Vitamin D 

inadequacy (<40 

nmol/L), 28% in 

cases, 37.2% in 

controls

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

Background Diet*

UI Author

Year

Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17047087 StolzenbergSolomon

2006

25(OH)D 

and/or 

1,25(OH)2D

RIA Y

int rab at ch 

and 

int erb at ch 

coef f icient 

of variat ion

p ercent of 

t he 25(OH)D 

assay w as 

16.5%.

The int erval 

b et w een 

serum 

collect ion 

and

d iagnosis 

w as up t o 

16 years 

(m ed ian 

f ollow -up 

t im e, 11.8 

years).

Energy Kcal 

2700

Fish 33g

Eggs 47 g

Milk 763 g

Alcohol 9 g

n-3 fatty 

acids 2 g

saturated fat 

54 g

Folate 330 

μg

17047087 StolzenbergSolomon

2006

Dietary 

calcium 

intake

nd nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 
***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

17047087 StolzenbergSolomon

2006

Cancer Pancreatic 

cancer

od d s rat ios (OR) f or p ancreat ic cancer w it h sub ject s in t he low est q uint ile as t he 

ref erence cat egory

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

17047087 Stolzenberg-Solomon

2006

Data also available according to the seasonal variations of vit D

Data also available after exclusion of cases by 5 years and 10 years

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17047087 StolzenbergSolomon

2006

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Y serum ret inol

Demographics (e.g., age, gender, race, education)? Yes ed ucat ion,

occup at ional act ivit y

m at ching b ased on age

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions N

Medication N

Sunlight exposure and its proxy variables (e.g., physical activity 

level, occupation, sun exposure, location)

N Subgroup analyses based on 

seasonal variation

Matching based on month of blood 

draw

Smoking and other life styles variables Yes/no sm oking int ensit y and 

d urat ion, report ing t o

have q uit sm oking > 3 

consecut ive visit s

Other N

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Adjusted 

analysis

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / SE / SD

**

P 

between 

groups***

P for 

trend****

17047087 StolzenbergSolomon

2006

pancreatic 

cancer

< 32 Na Na 27 80 Age and 

multivariable 

adjusted OR 

of baseline 

fasting 

25(OH)vitamin 

D (D2 and D3) 

OR 1.00 (ref erence)

0.001
status

17047087 StolzenbergSolomon

2006

Pancreatic 

cancer

> 32 and 

< 41.1

34 80 OR 1.30 (0.70-2.40) 0.001

17047087 StolzenbergSolomon

2006

Pancreatic 

cancer

> 41.1 and 

< 51.1

47 80 OR 2.12 (1.15-3.90) 0.001

17047087 StolzenbergSolomon

2006

Pancreatic 

cancer

> 51.1 and 

< 65.5

35 81 OR 1.50 (0.81-2.76) 0.001

17047087 StolzenbergSolomon

2006

Pancreatic 

cancer

> 65.5 57 79 OR 2.92 (1.56-5.48) 0.001

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

17047087 Stolzenberg-Solomon

2006

Pancreatic cancer Data according to seasonal variation and quintile available

UI Author

Year Comments for Results

17047087 Stolzenberg-Solomon

2006 Data after excluding cases at 5 y and 10 y are available

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17047087 StolzenbergSolomon

2006 a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(e.g. 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

Y

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): A

Explanation for Overall Quality Grade (if not Grade A): mostly well conducted 

study

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

9242478 Tangrea 

1997

Post-hoc Case-cohort study 

on a lung cancer prevention 

RCT on alpha-tocopherol 

and beta-carotene 

Participants of ATBC study

Male

Age 50-69 y

Current smoker (> 5 per day)

Residents in southwestern Finland

Cases (colorectal cancer): ICD-9-153 

(colon) or 154 (rectum) by Finish cancer 

registry

Controls: 2 age, study clinic, date of 

blood draw matching controls (including 

9 patients of another cancer) by 

incidence-density sampling 

No serum controls (2 

controls for 2 

independent cases were 

excluded)

1985-1993 ATBC 

study

nd TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year Study Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

9242478 Tangrea 

1997

Post-hoc Casecohort study on 

a lung cancer 

prevention RCT 

on alphatocopherol and 

beta-carotene

Southwestern 

Finland (~ 60° 

N)

438 (146 

cases, 

292 

controls)

436 (146 

cases, 

290 

controls)

Median 

60

50-69 100 nd Wt=79.1

BMI=26.3

nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (e.g. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure 

data

9242478 Tangrea 

1997

25(OH)D 

and/or 

1,25(OH)2D

RIA with I125

[25(OH)D]

Radioreceptor 

assay 

[1,25(OH)2D]

Intraset Coeff of 

Va: 9.5% 

[25(OH)D] and 

7.5% 

[1,25(OH)2D]

nd~9 to ~12 

y inferred)

nd Vit D intake: 

5.3 g/d (4% 

supplement 

user)

9242478 Tangrea 

1997

Dietary 

calcium 

intake

FFQ nd nd Ca=1.3 g/d

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

9242478 Tangrea 

1997

nd Colorectal 

cancer

Diagnosis of primary adenocarcinoma through the Finish cancer registry supplemented by medical records 

and pathology reports with pathological review 

nd Colon cancer Diagnosis of primary adenocarcinoma (see above for details)

nd Rectal cancer Diagnosis of primary adenocarcinoma (see above for details)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section.
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

9242478 Tangrea 

1997

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes (fat, fiber, protein, calcium, cholesterol, 

alpha-tocopherol, beta-carotene)

Demographics (e.g., age, gender, race, education)? Yes (matched on age, education)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (BMI)

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Yes (residence)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes (physical activity, marital status, smoking 

history)

Other Yes (Tx allocation of alpha-tocopherol and betacarotene)

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR ALL 

OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure /Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

9242478 Tangrea 

1997

Colorectal 

cancer

[25(OH)D] Q1 -9.8 nd 46 72 crude RR 1.0 - nd

0.13

Q2 >9.8-

13.9

35 73 0.7 0.4-

1.3

Q3 >13.9-

19.3

36 73 0.8 0.4-

1.3

Q4 >19.3 29 72 0.6 0.3-

1.1

9242478 Tangrea Colon [25(OH)D]Q1 -9.8 nd 30 47 crude RR 1.0 - 0.69
1997 cancer Q2 >9.8

-

13.9

18 47 0.6 0.3-

1.2

Q3 >13.9-

19.3

22 45 0.8 0.4-

1.6

Q4 >19.3 21 42 0.8 0.4-

1.6

9242478 Tangrea 

1997

Colon 

cancer 

(excluding 

the 2 y RCT 

period) 

[25(OH)D] Q1-9.8 nd 19 38 crude RR 1.0- nd 0.58

Q2 >9.8-

13.9

13 35 0.8 0.3-

1.8

Q3 >13.9-

19.3

19 32 1.2 0.5-

2.8

Q4 >19.3 17 31 1.2 0.5-

2.8

9242478 Tangrea 

1997

Rectal 

cancer

[25(OH)D] Q1-9.8 nd 16 25 crude RR 1.0- nd 0.06

Q2 >9.8-

13.9

17 26 0.9 0.4-

2.4

Q3 >13.9-

19.3

14 28 0.8 0.3-

2.0

Q4 >19.38 30 0.4 0.1-

1.1

9242478 Tangrea 

1997

Rectal 

cancer 

(excluding 

the 2 y RCT 

period) 

[25(OH)D] Q1-9.8 nd 12 15 crude RR 1.0- nd 0.04

Q2 >9.8-

13.9

13 16 0.8 0.2-

2.4

Q3 >13.9-

19.3

7 21 0.4 0.1-

1.3

Q4 >19.37 25 0.3 0.1-

1.1
UI Author

Year

Outcome Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

9242478 Tangrea 

1997

Colorectal 

cancer

[1,25(OH)2D] Q1 -31.7 nd 32 72 crude RR 1.0 - nd 0.76

Q2 >31.7-

37.3

43 72 1.3 0.8-

2.4

Q3 >37.3-

43.1

41 74 1.2 0.7-

2.2

Q4 >43.1 30 72 0.9 0.5-

1.7

9242478 Tangrea 

1997

Colon 

cancer

[1,25(OH)2D]Q1 -31.7 nd 20 51 crude RR 1.0 - 0.80

Q2 >31.7-

37.3

29 44 1.7 0.8-

3.4

Q3 >37.3-

43.1

20 41 1.2 0.6-

2.6

Q4 >43.1 22 45 1.2 0.6-

2.6

9242478 Tangrea 

1997

Colon 

cancer 

(excluding 

the 2 y RCT 

period) 

[1,25(OH)2D]Q1 -31.7 nd 12 21 crude RR 1.0 - nd 0.39

Q2 >31.7-

37.3

14 28 0.7 0.3-

2.2

Q3 >37.3-

43.1

21 33 1.0 0.4-

2.5

Q4 >43.1 8 27 0.5 0.2-

1.5

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline 

Exposure and 

Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

CI 

Mean Ca 

intake or 

Ca 

balance

Ca 

CI / 

SE / 

SD*

P 

between 

groups

9242478 Tangrea 

1997

[25(OH)D]

Cases: 

Nd Crude

146 12.2 11.2-

13.2 nd Nd <0.01

Control: 290 13.8 13.1-

14.5

9242478 Tangrea 

1997

[1,25(OH)2D]

Cases: 

nd crude

146 36.5 35.2-

37.8 nd nd NS

Control: 290 36.7 35.7-

37.7

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

9242478 Tangrea 

1997

Only univariate/crude analysis (controlled only for matching factors) was reported as the results based on multivariate model were comparable to nonadjusted analysis.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

9242478 Tangrea 

1997

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(e.g. 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Post-hoc assessment of a cohort of another RCT with multiple subgroup analyses. Family history not 

considered in adjustment.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

12467133 Terry

2002

Cohort 

study

Women born between 1914-

1948 who received invitation to 

participate in mammography 

screening program and also 

completed and returned a sixpage questionnaire including 

items about age, weight (kg), 

height (cm), education, and diet 

Women > 76 years old; women whose 

questionnaires had missing or incorrect 

national identification numbers, were nit 

properly dated or lacked the date the woman 

moved out of the study area; women whose 

date of death were verified through the 

Swedish Death Registry; women with answers 

in the dietary portion of the questionnaire 

suggesting they had extreme energy intakes (3 

SD below or above the mean value for natural 

logarithmically transformed calories using cut 

points of 417 and 3729 kcal) or had carelessly 

completed the dietary questionnaire; women 

with a previous cancer diagnosis (by linkage to 

the Swedish Cancer Registry)

1987-1990 Swedish 

Mammography 

Screening 

Cohort

Swedish 

Cancer 

Society and 

Swedish 

Research 

Council

AT

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N enrolled*** N 

analyzed

Mean (SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

12467133 Terry

2002

Cohort 

study

Vastmanland 

county 

(59°45'N) and 

Uppsala county 

(59°53'N), 

Sweden

61463

This number is 

smaller than 

the number of 

women 

reported at the 

baseline data 

table

61463 According to 

calcium 

intake 

quartile

Age:

1

st

quartile:53; 

2

nd quartile: 

52; 3rd

quartile: 52; 

4

th quartile: 

53

nd 0 Swedish According to 

calcium intake 

quartile

BMI (Kg/m2) 

(unclear whether it 

is mean or 

median):

1

st quartile:24.2; 

2

nd quartile: 24; 3rd

quartile: 24.1; 4th

quartile: 24.5

nd Calcium intake, 

median 

(mg/day): 688 

(IQR 486-914)

Vitamin D 

intake, median 

(μg/day): 3.2 

(IQR 2.9-3.7)

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
UI Author

Year

Study 

Design*

Location 

(e.g., City and 

Country, 

latitude)

N enrolled*** N 

analyzed

Mean (SD) 

Age, yr

Age 

Range 

/ IQR

Male, %Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

12467133 Terry

2002

Cohort 

study

Vastmanland 

county and 

Uppsala 

county, 

Sweden

61463

This number is 

smaller than 

the number of 

women 

reported at the 

basely data 

table

61463 According to 

calcium 

intake 

quartile

Mean age: 1

st

quartile:53; 2

nd quartile: 

52; 3rd

quartile: 52; 4

th quartile: 

53

nd0 Swedish According to 

calcium intake 

quartile

BMI (Kg/m

2

) 

(unclear whether it 

is mean or 

median): 1

st quartile:24.2; 

2

nd quartile: 24; 3rd

quartile: 24.1; 4th

quartile: 24.5

nd According to 

calcium intake 

quartile

Energy 

(kcal/day): 1

st quartile:1266; 

2

nd quartile: 

1331; 3rd

quartile: 1349; 4

th quartile: 1265

Total fat (g/day): 1

st quartile: 42.2; 

2

nd quartile: 42.2; 

3

rd quartile: 42.7; 

4

th quartile: 42.8

Dietary fiber 

(g/day): 1

st quartile: 16.6; 

2

nd quartile: 16; 

3

rd quartile: 15.6; 

4

th quartile: 14.9

Vitamin C 

(mg/day): 1

st quartile: 58.8; 

2

nd quartile: 58.9; 

3

rd quartile: 58.1; 

4

th quartile: 56.2

Folic acid (μg/day): 1

st quartile:170;

2

nd quartile: 176; 

3

rd quartile: 180; 

4

th quartile: 186
UI Author

Year

Study 

Design*

Location 

(e.g., City and 

Country, 

latitude)

N enrolled*** N 

analyzed

Mean (SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

12467133 Terry

2002

Cohort 

study

Vastmanland 

county and 

Uppsala 

county, 

Sweden

61463

This number is 

smaller than 

the number of 

women 

reported at the 

basely data 

table

61463 According to 

calcium 

intake 

quartile

Age:

1

st

quartile:53; 

2

nd quartile: 

52; 3rd

quartile: 52; 

4

th quartile: 

53

nd 0 Swedish According to 

calcium intake 

quartile

BMI (Kg/m2) 

(unclear whether it 

is mean or 

median):

1

st quartile:24.2; 

2

nd quartile: 24; 3rd

quartile: 24.1; 4th

quartile: 24.5

nd According to 

calcium intake 

quartile

Fruit and 

vegetables 

(servings/wk):

1

st quartile:25.3; 

2

nd quartile: 26.7; 

3

rd quartile: 26.2; 

4

th quartile: 24.8

Red meat 

(servings/wk):

1

st quartile:5.1; 

2

nd quartile: 5.1; 

3

rd quartile: 4.6; 

4

th quartile: 4.1

Alcohol 

(drinks/wk):

1

st quartile: 2.1; 

2

nd quartile: 2.2; 

3

rd quartile: 2.3; 

4

th quartile: 2

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration (or 

Validity) of Dietary 

Assessment? (y/n) If 

Yes, Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

12467133 Terry

2002

25(OH)D 

and/or 

1,25(OH)2D

na na na na na

12467133 Terry

2002

Dietary 

calcium 

intake

Self 

administered 

FFQ

Swedish 

National Food 

Administration 

Data

y

Validity evaluated for 

129 of the 213 women 

who weighed and 

recorded what they 

consumed during 4 7-

nd
day periods at 3 to 4 

month intervals. Validity 

estimates for dietary 

calcium intake: 0.5 

(Pearson’s correlation 

coefficient between FFQ 

and Food records)

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

12467133 Terry

2002

primary

Colorectal 

cancer

Matching two independent sources: computerized Regional Cancer Registries and a list of all pathology reports 

from the two pathology departments covering the study area (until December 31, 1998)

For the last two years of follow up (through December 31, 2000) matching with computerized Regional Cancer 

Registry only

secondary Colon cancer Cancer occurring above the peritoneal delineation of the abdominal cavity

secondary Rectal cancer Cancer occurring below the peritoneal delineation of the abdominal cavity

secondary Proximal colon 

cancer

Cancer occurring from the cecum through the splenic flexure

secondary Distal colon 

cancer

Cancer occurring from the descending colon through the sigmoid colon

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

12467133 Terry

2002

Average duration of follow up: 11.3 years.

Age, BMI, nutrition status are given as mean, or median per calcium intake quartile at baseline. Median values for the total cohort are given only for calcium 

intake and vitamin D. 

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including matching 

factors)

Specific comments for 

confounders

12467133 Terry

2002

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes (red meat, energy adjusted folic acid and vitamin C 

consumption quartiles, energy adjusted nutrients)

Demographics (e.g., age, gender, race, education)? Yes (age: in 5 year age groups; education level: less than 

high school, high school, university)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (BMI in quartiles)

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal variation 

of 25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes (alcohol consumption)

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model) 

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

Age adjusted model 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca level 

/ dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

12467133 Terry

2002

CRC 1

st total calcium 

intake quartile 

(median±SD, 

mg/day)

486±79 156 nd 135.6 adjusted RR 1.00

0.04

CRC 2

nd quartile total 

calcium intake 

(median±SD, 

mg/day)

631±34 149 nd 135.6 adjusted RR 0.97 0.77-

1.21

nd

CRC 3

rd quartile total 

calcium intake 

(median±SD, 

mg/day)

747±37 145 nd 135.6 adjusted RR 0.96 0.77-

1.21

nd

CRC 4

th quartile total 

calcium intake 

(median±SD, 

mg/day)

914±136 122 nd 135.6 adjusted RR 0.77 0.61-

0.98

nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

Multivariate model including age, BMI, education level, red meat intake, alcohol consumption, energy adjusted saturated fat, folic acid, vitamin C, 

and vitamin D intake 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca level 

/ dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

12467133 Terry

2002

CRC 1

st quartile total 

calcium intake 

(median±SD, 

mg/day)

486±79 156 nd 135.6 adjusted RR 1.00

0.02 CRC 2

nd quartile total 

calcium intake 

(median±SD, 

mg/day)

631±34 149 nd 135.6 adjusted RR 0.97 0.77-

1.21

nd
CRC 3

rd quartile total 

calcium intake 

(median±SD, 

mg/day)

747±37 145 nd 135.6 adjusted RR 0.95 0.75-

1.20

nd

CRC 4

th quartile total 

calcium intake 

(median±SD, 

mg/day)

914±136 122 nd 135.6 adjusted RR 0.72 0.56-

0.93

nd

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

Age adjusted model 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca level 

/ dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

12467133 Terry

2002

Colon 

cancer

1

st quartile 

(median±SD, 

mg/day)

486±79 100 nd 135.6 adjusted RR 1.00

0.17

2

nd quartile 

(median±SD, 

mg/day)

631±34 97 nd 135.6 adjusted RR 0.98 0.74-

1.30

nd

3

rd quartile 

(median±SD, 

mg/day)

747±37 92 nd 135.6 adjusted RR 0.95 0.72-

1.27

nd

4

th quartile 

(median±SD, 

mg/day)

914±136 82 nd 135.6 adjusted RR 0.81 0.61-

1.09

nd

Rectal 

cancer

1

st quartile 

(median±SD, 

mg/day)

486±79 55 nd 135.6 adjusted RR 1.00 nd

0.11

2

nd quartile 

(median±SD, 

mg/day)

631±34 48 nd 135.6 adjusted RR 0.90 0.61-

1.32

nd

3

rd quartile 

(median±SD, 

mg/day)

747±37 49 nd 135.6 adjusted RR 0.92 0.62-

1.36

nd

4

th quartile 

(median±SD, 

mg/day)

914±136 39 nd 135.6 adjusted RR 0.70 0.46-

1.06

nd
Multivariate model including age, BMI, education level, red meat intake, alcohol consumption, energy adjusted saturated fat, folic acid, vitamin C, 

and vitamin D intake 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca level 

/ dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

12467133 Terry

2002

Colon 

cancer

1

st quartile 

(median±SD, 

mg/day)

486±79 100 nd 135.6 adjusted RR 1.00

0.06

2

nd quartile 

(median±SD, 

mg/day)

631±34 97 nd 135.6 adjusted RR 0.97 0.74-

1.30

nd

3

rd quartile 

(median±SD,

mg/day)

747±37 92 nd 135.6 adjusted RR 0.93 0.70-

1.24

nd

4

th quartile 

(median±SD, 

mg/day)

914±136 82 nd 135.6 adjusted RR 0.74 0.54-

1.01

nd

Rectal 

cancer

1

st quartile 

(median±SD, 

mg/day)

486±79 55 nd 135.6 adjusted RR 1.00 nd

0.12

2

nd quartile 

(median±SD, 

mg/day)

631±34 48 nd 135.6 adjusted RR 0.89 0.60-

1.32

nd

3

rd quartile 

(median±SD, 

mg/day)

747±37 49 nd 135.6 adjusted RR 0.94 0.63-

1.39

nd

4

th quartile 

(median±SD, 

mg/day)

914±136 39 nd 135.6 adjusted RR 0.70 0.45-

1.09

nd
Women < 55 years old vs. women ≥ 55 years old

Multivariate model including age, BMI, education level, red meat intake, alcohol consumption, energy adjusted saturated fat, folic acid, vitamin C, 

and vitamin D intake 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI**

P 

between 

groups***

P for 

trend****

12467133 Terry

2002

Colon 

cancer

Women < 55 

years 1st quartile 

(mg/day)

176 

to 

<568

nd nd 135.6 adjusted RR 1.00

0.92

Colon 

cancer

Women < 55 

years 2nd quartile 

(mg/day)

568 

to 

<688

nd nd 135.6 adjusted RR 1.32 0.75-

2.30

nd

Colon 

cancer

Women < 55 

years 3rd quartile 

(mg/day)

688 

to 

<816 

nd nd 135.6 adjusted RR 1.02 0.55-

1.85

nd

Colon 

cancer

Women < 55 

years 4th quartile 

(mg/day)

816 

to 

1300

nd nd 135.6 adjusted RR 1.11 0.60-

2.05

nd

Rectal 

cancer

Women < 55 

years 1st quartile 

(mg/day)

176 

to 

<568

nd nd 135.6 adjusted RR 1.00

0.75

Rectal 

cancer

Women < 55 

years 2nd quartile 

(mg/day)

568 

to 

<688

nd nd 135.6 adjusted RR 0.33 0.34-

1.59

nd

Rectal 

cancer

Women < 55 

years 3rd quartile 

(mg/day)

688 

to 

<816 

nd nd 135.6 adjusted RR 1.30 0.66-

2.56

nd

Rectal 

cancer

Women < 55 

years 4th quartile 

(mg/day)

816 

to 

1300

nd nd 135.6 adjusted RR 0.70 0.31-

1.62

nd

Colorectal 

cancer

Women < 55 

years 1st quartile 

(mg/day)

176 

to 

<568

nd nd 135.6 adjusted RR 1.00

0.77

Colorectal 

cancer

Women < 55 

years 2nd quartile 

(mg/day)

568 

to 

<688

nd nd 135.6 adjusted RR 1.06 0.68-

1.66

nd

Colorectal 

cancer

Women < 55 

years 3rd quartile 

(mg/day)

688 

to 

<816 

nd nd 135.6 adjusted RR 1.11 0.71-

1.73

nd

Colorectal 

cancer

Women < 55 

years 4th quartile 

(mg/day)

816 

to 

1300

nd nd 135.6 adjusted RR 0.91 0.56-

1.48

nd

Colorectal 

cancer

Women ≥ 55 

years 1st quartile 

(mg/day)

176 

to 

<568

nd nd 135.6 adjusted RR 1.00

0.008
Colorectal 

cancer

Women ≥ 55 

years 2nd quartile 

(mg/day)

568 

to 

<688

nd nd 135.6 adjusted RR 0.93 0.71-

1.21

nd

Colorectal 

cancer

Women ≥ 55 

years 3rd quartile 

(mg/day)

688 

to 

<816 

nd nd 135.6 adjusted RR 0.89 0.68-

1.17

nd

Colorectal 

cancer

Women ≥ 55 

years 4th quartile 

(mg/day)

816 

to 

1300

nd nd 135.6 adjusted RR 0.66 0.49-

0.89

nd

Colon 

cancer

Women ≥ 55 

years 1st quartile 

(mg/day)

176 

to 

<568

nd nd 135.6 adjusted RR 1.00

0.02

Colon 

cancer

Women ≥ 55 

years 2nd quartile 

(mg/day)

568 

to 

<688

nd nd 135.6 adjusted RR 0.89 0.64-

1.23

nd

Colon 

cancer

Women ≥ 55 

years 3rd quartile 

(mg/day)

688 

to 

<816 

nd nd 135.6 adjusted RR 0.91 0.65-

1.26

nd

Colon 

cancer

Women ≥ 55 

years 4th quartile 

(mg/day)

816 

to 

1300

nd nd 135.6 adjusted RR 0.64 0.44-

0.92

nd

Rectal 

cancer

Women ≥ 55 

years 1st quartile 

(mg/day)

486 nd nd 135.6 adjusted RR 1.00

0.15

Rectal 

cancer

Women ≥ 55 

years 2nd quartile 

(mg/day)

631 nd nd 135.6 adjusted RR 0.96 0.61-

1.52

nd

Rectal 

cancer

Women ≥ 55 

years 3rd quartile 

(mg/day)

747 nd nd 135.6 adjusted RR 0.79 0.48-

1.29

nd

Rectal 

cancer

Women ≥ 55 

years 4th quartile 

(mg/day)

914 nd nd 135.6 adjusted RR 0.70 0.42-

1.19

nd
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed?

(y/n)

Y

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Number of women when baseline data are presented is inconsistent (larger) with the sample size reported 

in the methods section; blinding assessor not reported; number of non-cases per calcium intake quartile is 

not given; also number of cases and non-cases in the subgroup analyses by age; statistical methods to 

compare all different subgroups per cancer type, in the analysis by age, are not applied; power calculations 

are not reported; confirmation of cases by histology not reported for al participants

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

3307307 Thomsen 

1987

RCT Early post-menopausal women without history of diseases or 

receiving drugs known to influence calcium metabolism or the 

cardiovascular system.

nd nd nd nd KP

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

3307307 Thomsen 

1987

RCT Copenhagen, 

Denmark

55°40’ N

28 28 nd nd 0% nd nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

3307307 Thomsen 

1987

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd nd

3307307 Thomsen 

1987

Dietary 

calcium 

intake

nd nd nd nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca 

Total Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

3307307 Thomsen 

1987

Calcium Sandoz (calcium lactate-gluconate, 

calcium carbonate)

2,000 mg One year nd

placebo

Co-intervention(s) *:

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design.

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

3307307 Thomsen 1987 nd Bodyweight Change in kg/yr

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

3307307 Thomsen 

1987

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? No

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final 

or 

Delta 

CI / SE 

/ SD*

Net 

difference

Net 

difference 

CI / SE / 

SD*

P 

between

3307307 Thomsen 

1987

Bodyweight 

change

Kg Calcium 1 yr 14 60.6 SD = 5.4 61.0 SD = 

5.1

-0.2 ND Not 

significant

placebo 1 yr 14 66.4 SD = 13.8 67.0 SD = 

14.0

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 
**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

3307307 Thomsen 

1987

RCTparallel Y nd nd nd nd nd nd N Y C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): Poorly described methods and demographics. Large baseline difference in weight.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

12609940 Trivedi 

2003

RCT Men & women***

65-85 years***

The British doctor study register or 

the sex-age register of a GP in 

Ipswich, Suffolk***

Already Vit D supplements takers

Contraindication to Vit D (eg, renal 

stone, sarcoidosis, malignancy)

06/96-03/97 Nd Medical 

Research 

Council, UK

TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT 

***Registry participants to which a recruit mail sent (n=11120), who agreed to participate (n=3504 [32%]) 

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

12609940 Trivedi 

2003

RCT UK (Oxford 

[52°N] & 

Ipswich 

[52°N])

2686 2686 75 (5) 65-

85****

76 nd BMI=24.4 Hx of CAD: 16%

Hx of stroke: 4%

Hx of CVD: 28%

Hx of cancer

Steroids user: 

5%

Hormone 

replacement 

therapy 

(female): 7% 

Physically active 

(>moderately): 

84%

Mean total Ca 

intake at 4 year 

after start of the 

intervention: 742 

mg/d 

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Inclusion criteria 

CAD = coronary artery disease/ischemic heart disease; CVD = cardiovascular disease comprising CAD, stroke, and other cardiac diseases 
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure data

12609940 Trivedi 

2003

25(OH)D at 4 

years after the 

intervention in 

the placebo 

group (n=114 

only)

nd nd nd nd 53.4 nmol/L

12609940 Trivedi 

2003

Dietary 

calcium intake

nd nd nd NA NA Mean total Ca 

intake at 4 year 

after start of the 

intervention: 

742 mg/d

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) Vit D Total Daily Dose Intervention Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

12609940 Trivedi 

2003

Vit D Vit D3 (cholecalciferol) 100,000 IU q 4 months 

(~833 IU/d)

5 years (15 total 

doses)

1 cap q 4 mo

Placebo Matching placebo

Co-intervention(s) *: Participants continued any usual medications (only data on steroids and hormone replacement therapy reported) 

Compliance/Adherence: 76% with at least 80% compliance; 66% at last dose (80% if excluding deaths)

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

*Cardiovascular disease=ICD-9 codes 390.0-459.9; ischaemic heart disease=410.0-414.0; cerebrovascular disease=430.0-438.0; all cancers=140.0-239.9; colorectal 

cancer=153.0-154.8; respiratory cancer=160.0-165.9; breast cancer=174.0-175.0 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

***None of the causes were verified independently (e.g. by medical charts or pathology reports) 

UI Author

Year

Primary / Secondary 

Outcome**

Outcome Definition

12609940 Trivedi 

2003

Secondary All cause mortality Death certificate (based on ICD-9*) by investigators blinded to the 

intervention***

Secondary Cardiovascular disease mortality same as above

Secondary Ischemic heart disease mortality same as above

Secondary Cerebrovascular disease mortality same as above

Secondary All cancers mortality same as above

Secondary Colorectal caner mortality same as above

Secondary Respiratory cancer mortality same as above

Secondary Breast cancer mortality (female) same as above

Secondary Cardiovascular disease incidence Death certificate (ICD-9*) and self-reported questionnaire data***

Secondary Ischemic heart disease incidence same as above

Secondary Cerebrovascular disease 

incidence same as above

Secondary All cancers incidence same as above

Secondary Colorectal cancer incidence same as above

Secondary Respiratory cancer incidence same as above

Secondary Breast cancer incidence (female) same as above

Secondary Falls incidence same as above
UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

12609940 Trivedi 

2003

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

No

Demographics (e.g., age, gender, race, education)? Yes (Age, gender [subgroup])

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions No

Medication No

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other None

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Max

Followup, mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, 

RR, HR, %) and direction 

of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI P btw

12609940 Trivedi 

2003

Mortality

Men and Women

All Causes

Vit D 60-69 224 1345 HR

0.88

0.74-

Placebo 247 1341 1.06 0.18

Cardiovascular 

Disease

Vit D 60-69 101 1345 HR

Placebo 117 1341 0.84 0.65-1.1 0.2

Ischaemic Heart 

Disease

Vit D 60-69 42 1345 HR 0.84 0.56-1.27 0.41
Placebo 49 1341

Cerebrovascular 

Disease

Vit D 60-69 28 1345 HR

Placebo 26 1341 1.04 0.61-1.77 0.89

All Cancers

Vit D 60-69 63 1345 HR

Placebo 72 1341 0.86 0.61-1.2 0.37

Colorectal

Vit D 60-697 1345 HR

Placebo 11 1341 0.62 0.24-1.6 0.33

Respira-ry

Vit D 60-69 10 1345 HR

Placebo 11 1341 0.89 0.38-2.09 0.78

Mortality Men

All Causes

Vit D 60-69 199 1019 HR

Placebo 220 10180.88 0.73-1.07 0.19

Cardiovascular 

Disease

Vit D 60-69 90 1019 HR

Placebo 106 1018 0.83 0.62-1.1 0.19

Ischaemic Heart 

Disease

Vit D 60-69 38 1019 HR

Placebo 45 1018 0.83 0.54-1.28 0.4

Cerebrovascular 

Disease

Vit D 60-69 24 1019 HR

Placebo 25 1018 0.92 0.52-1.61 0.77

All Cancers

Vit D 60-69 56 1019 HR

Placebo 59 1018 0.93 0.64-1.34 0.69

Colorectal

Vit D 60-697 1019 HR

Placebo7 1018 0.97 0.34-2.78 0.96

Respiratory

Vit D 60-69 10 1019 HR

Placebo9 1018 1.08 0.44-2.65 0.87

Mortality Women

All Causes

Vit D 60-69 25 326 HR

Placebo 27 323 0.91 0.53-1.56 0.73

Cardiovascular 

Disease

Vit D 60-69 11 326 HR

Placebo 11 323 0.99 0.43-2.3 0.99

Ischaemic Heart 

Disease

Vit D 60-694 326 HR

Placebo4 323 0.99 0.25-3.96 0.99

Cerebrovascular 

Disease

Vit D 60-694 326 HR

3.98

0.44-

Placebo1 323 35.64 0.22

All Cancers

Vit D 60-697 326 HR

Placebo 13 323 0.53 0.21-1.33 0.18

Colorectal

Vit D 60-690 326 HR

Placebo4 323 NA 0.04

Respiratory

Vit D 60-690 326 HR

Placebo2 323 NA 0.16

Breast

Vit D 60-690 326 HR

Placebo0 323 NA NA

Incidence Men & 

Women
Cardiovascular 

Disease

Vit D 60-69 477 1345

HR 0.9 0.77-1.06 0.22

Placebo 503 1341

IschaemicHeart 

Disease

Vit D 60-69 224 1345

HR 0.94 0.77-1.15 0.57

Placebo 233 1341

Cerebrovascular 

Disease

Vit D 60-69 105 1345

HR 1.02 0.77-1.36 0.87

Placebo 101 1341

All Cancers Vit D 60

-69 188 1345 HR 1.09 0.86

-1.36 0.47

Placebo 173 1341

Cancer Excluding 

Skin

Vit D 60-69 144 1345

HR 1.11 0.86-1.42 0.43

Placebo 130 1341

Colorectal Cancer Vit D 60

-69 28 1345 HR 1.02 0.60

-1.74 0.94

Placebo 27 1341

Respiratory 

Cancer

Vit D 60-69 17 1345

HR 1.12 0.56-2.25 0.75

Placebo 15 1341

Self Reported 

Falls

Vit D 60-69 254 1027

HR 0.93 0.76-1.14 0.5

Placebo 261 1011

Incidence Men

Cardiovascular 

Disease

Vit D 60-69 392 1019

HR 0.91 0.76-1.09 0.3

Placebo 412 1018

Ischaemic Heart 

Disease

Vit D 60-69 191 1019

HR 0.98 0.78-1.22 0.86

Placebo 193 1018

Cerebrovascular 

Disease

Vit D 60-69 86 1019

HR 0.99 0.72-1.36 0.96

Placebo 85 1018

All Cancers Vit D 60

-69 163 1019 HR 1.11 0.87

-1.42 0.39

Placebo 147 1018

Cancer Excluding 

Skin

Vit D 60-69 129 1019

HR 1.17 0.89-1.54 0.26

Placebo 111 1018

Colorectal Cancer Vit D 60

-69 25 1019 HR 1.18 0.65

-2.12 0.59

Placebo 21 1018

Respiratory 

Cancer

Vit D 60-69 17 1019

HR 1.29 0.62-2.68 0.49

Placebo 13 1018

Self Reported 

Falls

Vit D 60-69 154 757

HR 0.87 0.68-1.12 0.27

Placebo 169 756

Incidence 

Women
Cardiovascular 

Disease

Vit D 60-69 85 326

HR 0.89 0.63-1.27 0.52

Placebo 91 323

Ischaemic Heart 

Disease

Vit D 60-69 33 326

HR 0.79 0.48-1.29 0.35

Placebo 40 323

Cerebrovascular 

Disease

Vit D 60-69 19 326

HR 1.19 0.60-2.37 0.62

Placebo 16 323

All Cancers Vit D 60-69 25 326 HR 0.95 0.54-1.68 0.85

Placebo 26 323

Cancer Excluding 

Skin

Vit D 60-69 15 326

HR 0.77 0.39-1.55 0.47

Placebo 19 323

Colorectal Cancer Vit D 60-69 3 326 HR 0.49 0.12-1.98 0.32

Placebo 6 323

Respiratory 

Cancer

Vit D 60-69 0 326

HR NA 0.16

Placebo 0.6 323

Breast Cancer

Vit D 60-69 4 326

Placebo 4 323 HR 0.99 0.25-3.99 0.99

Self Reported 

Falls

Vit D 60-69 100 270

HR 1.03 0.72-1.48 0.86

Placebo 92 255

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI 

/ SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

Outcome 

effect 

size

CI / 

SE 

/ 

SD

P 

between 

groups***

P for 

trend 
Groups N**  %) **

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

12609940 Trivedi 

2003 RCT nd nd nd

y y y y NA y B

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

No independent verification of cases identified through the death certificates and self-reported data and 

suboptimal reporting of methodology of randomization.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

15883441 Tseng 

2005

Cohort 

study

Diagnosis of prostate 

cancer at or before the 

1982-1984 baseline 

interview

1982-1984 National Health and Nutrition 

Examination Survey (NHANES I) 

Epidemiologic Follow-up Study 

(NHEFS)

NIH, American Cancer Society, 

Department of Defense, 

Commonwealth of Pennsylvania

KP/SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean (SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

15883441 Tseng 

2005

Cohort 

study

United States 

various, 

excluding 

Hawaii, 

Alaska, and 

Native 

American 

lands

14407 3779 57.8(14.6) 25-74 100% White 88%, 

Black 11%, 

Other 1%

nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

15883441 Tseng 

2005

25(OH)D 

and/or 

1,25(OH)2D

NA NA NA NA Vitamin D 

dietary intake 

172(101) IU/d

15883441 Tseng 

2005

Dietary 

calcium 

intake

FFQ No specific 

information, but 

reference to 

Ursin 1993

N Calcium 

730(347) mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 
****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

15883441 Tseng 

2005

Nd Prostate 

cancer

Confirmation through histopathology reports or medical records deemed “definite” case status. “Probable” case 

status given when confirmation could only be confirmed through death certificates or interview.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year

Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

15883441 Tseng 

2005

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Energy intake, recreational and usual level of 

physical activity

Demographics (e.g., age, gender, race, education)? Yes Age, race, education

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

US region, rural/urban/suburban residence, 

recreational sun exposure

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes Smoking status, current 

alcohol intake

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / SE / 

SD **

P 

between 

groups***

P for 

trend****

15883441 Tseng 

2005

Prostate 

cancer

Tertile 1: 

Calcium median 

intake 455.4 

mg/d

nd nd 28 Nd 7.7 yrs Adjusted RR 1.0 Reference Nd

0.001

Tertile 2: 

Calcium median 

intake 642.1 

mg/d

nd nd 37 Nd 7.7 yrs 1.0 0.6-1.7 Nd

Tertile 3: 

Calcium median 

intake 920.6 

mg/d

nd nd 66 Nd 7.7 yrs 2.2 1.4-3.5 nd
UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

15883441 Tseng 

2005

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Part of dietary estimates derived from recall data based on NHANES II conducted ~4 y earlier; only ~65% 

cases were “definite” (confirmed by histopathology or medical records), rest were “probable”.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding 

Source Extractor

14618623 Tuohimaa

2004

Case-cohort 

study

enrolled in heart studies; 

available blood sample

1973; 1981-82; 

1985-ongoing

Helsinki Heart Study; Janus Project; 

Vasterbotten Intervention Project

non-profit SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

14618623 Tuohimaa

2004

Casecohort 

study

Helsinki, 

Finland; 

Norway; 

Northern 

Sweden

2073 2073 nd <40 to 

>60

100 nd nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

14618623 Tuohimaa

2004

25(OH)D RIA, 

Incstar, MN

y; intraassay 

8.5%; 

interassay 16%

nd nd nd

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

14618623 Tuohimaa

2004

primary prostate cancer national cancer registries

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

14618623 Tuohimaa

2004

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

nd

Demographics (e.g., age, gender, race, education)? yes age

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions nd

Medication nd

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

yes region

Smoking and other life styles variables no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases

*

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD **

P between 

groups***

P for 

trend****

14618623 Tuohimaa

2004

prostate 

cancer

≤19 19 nd conditional 

logistic

OR 1.5 0.8-

2.7

20-39 169 nd 1.3 0.98-

1.6

40-49 

(ref)

229 nd 1

60-79 138 nd 1.2 0.9-

1.5

≥80 67 nd 1.7 1.1-
2.4

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

14618623 Tuohimaa

2004 used conditional logistic regression analysis to maintain matching status, but unclear which factors were matched
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

14618623 Tuohimaa

2004

a) Eligibility 

criteria 

clear? (y/n)

N

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

N

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

N

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A): unclear if additional relevant confounders were also adjusted for in analysis

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

17301263 Tuohimaa

2007

Case-cohort study prostate cancer nd 1981-82 Helsinki Heart Study non-profit SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

17301263 Tuohimaa

2007

Casecohort 

study

Helsinki, 

Finland

588 588 51 

(3.7)

nd 100 nd BMI 26.3 subjects 

enrolled in 

gemfibrozil 

trial

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17301263 Tuohimaa

2007

25(OH)D 

and/or 

1,25(OH)2D

RIA 

(Incstar 

Corp., MN)

intraassay CV: 

8.5%; 

interassay CV: 

16%

10.8 y nd most sample 

collected 

during winter 

months

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17301263 Tuohimaa

2007

Primary prostate cancer from Finnish Cancer Registry

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17301263 Tuohimaa

2007

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

no

Demographics (e.g., age, gender, race, education)? Yes

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes

Medical conditions Yes, BMI >28; SBP >150; HDL-C ≤1.05

Medication Yes

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

nd

Smoking and other life styles variables no*

Other specimens were accidentally thawed or not 54/132 (41%) accidentally 

thawed

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention

Groups

Mean Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

No. of 

Noncases

/ Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

17301263 Tuohimaa

2007

prostate 

cancer

132 

(total)

456 

(total)

<40 nmol/L crude OR 1.93 1.19-

3.13

40-59 

(reference)

1

≥60 crude 1.32 0.69-

2.56

<40 nmol/L adjusted OR 1.88 1.15-
3.08

40-59 

(reference)

1

≥60 adjusted 1.25 0.64-

2.43

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI

Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

17301263 Tuohimaa some data reported in Tuohimaa 2004
2007 UI 14618623

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17301263 Tuohimaa

2007

a) Eligibility 

criteria 

clear? (y/n)

N

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

N

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Y

b) Food 

composition

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

Y

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

41% of the specimens were accidentally thawed; no explicit information provided for adjustment for 

additional factors relevant to vitamin D

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

16339476 Umesawa 2006 Cohort study 40-79 y Stroke, CHD, cancer, valid FFQ 1988-1990 Japan Collaborative Cohort Gov’t EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

16339476 Umesawa 

2006

Cohort 

study

Japan, 

various

53,387 53,387 56 40-79 39% Japanese Men 22.7

Women 22.9

Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

16339476 Umesawa 

2006

Dietary 

calcium 

intake

FFQ Japan Food 

Table v4

No (data from 

other study 

reported)

nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

16339476 Umesawa 2006 1° Total stroke mortality Death certificates (ICD-9 & 10)

specific stroke data not extracted

2° Coronary heart disease mortality Death certificates (ICD-9 & 10)

2° Total CVD mortality Death certificates (ICD-9 & 10), “total CVD” not defined

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

16339476 Umesawa 

2006

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes K intake, total energy intake

Demographics (e.g., age, gender, race, education)? Yes Age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions Yes HTN, DM

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes Smoking, EtOH

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Median 

Ca 

intake

No. of 

Cases 

(Event)* 

Total N 

(person 

years)

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

MEN

16339476 Umesawa 

2006

Total 

stroke 

death

Calcium intake 

quintile 1

250 61 4623 8.9 y Adjusted 

“multivariate”

RR 1.0 -- --

0.13

quintile 2 363 76 4624 1.14 0.76 

,1.70

NS

quintile 3 449 69 4623 0.90 0.56, 

1.45

NS

quintile 4 536 59 4624 0.69 0.40, 

1.18

NS

quintile 5 665 57 4623 0.68 0.37, 

1.26

NS

WOMEN

16339476 Umesawa 

2006

Total 

stroke 

death

Calcium intake 

quintile 1

266 70 7121 8.9 y Adjusted 

“multivariate”

RR 1.0 -- --

.01

quintile 2 379 82 7122 1.38 0.95, 

2.01

NS

quintile 3 462 73 7122 1.24 0.79, 

1.95

NS

quintile 4 545 42 7122 0.69 0.40, 

1.18

NS

quintile 5 667 55 7122 0.94 0.51, 

1.72

NS

MEN

16339476 Umesawa 

2006

CHD 

death

Calcium intake 

quintile 1

250 37 4623 8.9 y Adjusted 

“multivariate”

RR 1.0 -- -- 0.43

quintile 2 363 26 4624 0.84 0.47, 

1.50

NS

quintile 3 449 33 4623 1.20 0.62, 

2.30

NS

quintile 4 536 32 4624 1.27 0.60, 

2.68

NS

quintile 5 665 20 4623 0.92 0.37, 

2.29

NS

WOMEN

16339476 Umesawa 

2006

CHD 

death

Calcium intake 

quintile 1

266 38 7121 8.9 y Adjusted 

“multivariate”

RR 1.0 -- -- 0.50

quintile 2 379 21 7122 0.88 0.48, 

1.62

NS
quintile 3 462 25 7122 1.28 0.62, 

2.61

NS

quintile 4 545 17 7122 0.84 0.35, 

2.02

NS

quintile 5 667 15 7122 0.87 0.31, 

2.45

NS

MEN

16339476 Umesawa 

2006

CVD 

death

Calcium intake 

quintile 1

250 140 4623 8.9 y Adjusted 

“multivariate”

RR 1.0 -- -- 0.95

quintile 2 363 141 4624 0.98 0.75, 

1.30

NS

quintile 3 449 135 4623 0.93 0.67, 

1.29

NS

quintile 4 536 135 4624 0.92 0.64, 

1.32

NS

quintile 5 665 134 4623 0.97 0.64, 

1.48

NS

WOMEN

16339476 Umesawa 

2006

CVD 

death

Calcium intake 

quintile 1

266 153 7121 8.9 y Adjusted 

“multivariate”

RR 1.0 -- -- 0.14

quintile 2 379 156 7122 1.29 0.99, 

1.67

NS

quintile 3 462 136 7122 1.24 0.90, 

1.69

NS

quintile 4 545 98 7122 0.92 0.64, 

1.34

NS

quintile 5 667 101 7122 1.14 0.74, 

1.74

NS

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 
**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

16339476 Umesawa 

2006

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

#

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

N

##

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

?

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): A (B for total CVD mortality)

Explanation for Overall Quality Grade (if not Grade A): Definition of CVD mortality implied only

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

# Median only

## CVD
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

18635855 Umesawa

2008

Cohort 

Study

40-59 y MI, angina, stroke, cancer at 

baseline

1990 Japan Public Health Center (JPHC)–

based study (cohort I)

Gov’t EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

18635855 Umesawa

2008

Cohort 

Study

4 areas 

Japan

Okinawa 

(24°) to Akita 

(40°)

41,526 41,526 ~49 

(nd)

40-59 48% Japanese ~23.5 Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

18635855 Umesawa

2008

Dietary 

calcium 

intake

FFQ nd Yes

Spearman rank 

correlation 

coefficient 0.41

nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome**

Outcome Definition

18635855 Umesawa

2008

1° Stroke incidence (also stroke 

subtypes)

Participant reporting and hospital medical record review (National Survey of 

Stroke criteria)

18635855 Umesawa

2008

1° Fatal stroke Death certificates & medical records

18635855 Umesawa

2008

2° Coronary heart disease MI, sudden cardiac death, per participant reporting and medical record review 

(standard criteria)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

18635855 Umesawa

2008

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes Na intake, K intake, n-3 fa 

intake

Demographics (e.g., age, gender, race, education)? Yes Age, sex

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions Yes DM, HTN

Medication Yes for hypercholesterolemia

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes Smoking, EtOH

Other Yes Menopause

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Median 

Ca 

intake

No. of 

Cases 

(Event)* 

N 

(Personyr)

Mean

Follow-up,

mo

Crude or Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

18635855 Umesawa

2008

Total 

stroke

Ca intake 

Quintile 1

233 314 ~8305 

(112,018)

13 y Adjusted 

(“multivariable+HTN)

HR 1.00 -- -- .02

Quintile 2 344 257 ~8305 

(106,354)

0.94 0.79, 

1.13

NS

Quintile 3 439 252 ~8305 

(106,435)

0.79 0.65, 

0.97

<0.05

Quintile 4 603 247 ~8305 

(104,697)

0.78 0.63, 

0.96

<0.05

Quintile 5 753 251 ~8305 

(104,186)

0.71 0.56, 

0.89

<0.05

18635855 Umesawa

2008

CHD Ca intake 

Quintile 1

233 72 ~8305 

(112,018)

Adjusted 

(“multivariable+HTN)

HR 1.00 -- -- NS

Quintile 2 344 72 ~8305 

(106,354)

1.18 0.83, 

1.68

NS

Quintile 3 439 56 ~8305 

(106,435)

0.91 0.60, 

1.37

NS

Quintile 4 603 58 ~8305 

(104,697)

1.08 0.71, 

1.65

NS

Quintile 5 753 64 ~8305 

(104,186)

0.93 0.58, 

1.50

NS

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

18635855 Umesawa

2008

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of 

population 

random or 

consecutive

? (y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

?

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): A

Explanation for Overall Quality Grade (if not Grade A): Well conducted. Generally well reported.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

3788835 Van 

Beresteyn 

1986

RCT Female dietetic students 20-23 yrs of age, 49-76 kg 

bodyweight, not receiving any medical treatment at 

time of recruitment

nd nd Nd Netherlands Institute 

for Dairy Research

KP

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

3788835 Van 

Beresteyn

RCT Netherlands

(52°N)

58 58 21(1.0) 20-23 0% Nd Bodyweight = 49-76 

kg

Nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc. 

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported?

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

3788835 Van 

Beresteyn

25(OH)D 

and/or 

1,25(OH)2D

Nd Nd Nd Nd nd

Dietary 

calcium 

intake

Specially 

developed 

questionnaire 

(CIVO/TNO 

Department for 

Toxicology and 

Nutrition, Zeist, 

The Netherlands)

Dutch 

computerized 

food 

composition 

table

N nd

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or 

Ca Total Daily 

Dose

Intervention 

Duration

Intervention Frequency (e.g. 

capsules were taken 2 times 

a day)

3788835 Van 

Beresteyn

Calcium Calcium powder containing calcium carbonate, citric acid, 

sodium-hydrogen carbonate, dextrose, and corn flour. Powders 

were consumed with lemonade or apple juice.

1500 mg Ca++ 6 weeks Three times a day

placebo Placebo powder containing citric acid, sodium-hydrogen 

carbonate, dextrose, and corn flour. Powders were consumed 

with lemonade or apple juice.

0 mg Ca++ 6 weeks Three times a day

Co-intervention(s) *: NA

Compliance/Adherence: nd

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

3788835 Van Beresteyn Secondary Body weight Body weight in kg

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups

Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

3788835 Van 

Beresteyn

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? No

Anthropometrics (e.g., BMI, body weight, % body fat)? no

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final 

or 

Delta 

CI / SE 

/ SD*

Net 

difference

Net 

difference 

CI / SE / 

SD*

P 

between

3788835 Van 

Beresteyn

Body 

weight

Kg Calcium 6 weeks 29 61.8 SD = 6.9 Final = 

61.5

Final 

SD = 

6.4

0.8 Nd Not 

significant

placebo 6 weeks 29 62.5 SD = 6.9 Final = 

63.0

Final 

SD = 

6.6

BMI Kg/m2 Calcium 6 weeks 29 20.8 SD = 2.0 Final = 

20.7

Final 

SD = 

1.9

0.2 Nd Not 

significant

placebo 6 weeks 29 21.0 SD = 1.9 Final = 

21.1

Final 

SD = 

1.8

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

Outcome 

effect 

size

CI / 

SE 

/ 

SD

P 

between 

groups***

P for 

trend 
Groups N**  %) **

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

3788835 Van 

Beresteyn

RCTparallel nd nd nd Y nd nd Y N Y B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): No information on blinding, dropouts (or lack thereof)

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding Source Extractor

18065592 van der 

Pols

2007

Cohort study Residence 

in England 

and 

Scotland

Subjects could not identified through the 

National Health Service Central Register, 

censored before 1948, lost to follow-up

1937-1939 The Boyd 

Orr cohort

The World Cancer 

Research Fund, 

The National Health and 

Medical Research 

Council of Australia

JHL

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

18065592 van der 

Pols

2007

Cohort 

study

England (54° 

N)

Scotland (55° 

57' N)

1343 

families

4374 

children

7.6 

(sd, 

nd)

4-11 yr 49.5% nd Height z score: -0.01

BMI z score: 0.01

nd Nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide 

Data

Time 

between 

Biomarker

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

18065592 van der 

Pols

2007

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd nd

18065592 van der 

Pols

2007

Dietary 

calcium 

intake

7-d 

household 

inventory 

method

Diet in, data-out program 

(DIDO software; Medical 

Research Council Human 

Nutrition Research 

Center, Cambridge, 

United Kingdom), Fruit 

and vegetable 

consumption (McCance 

and Widdowson’s The 

Composition of Foods)

Prewar food tables were 

used to adapt the 

database if the 

composition of 1930s

foods was very different 

from that of foods today, 

or if there was no 

modern-day equivalent.

nd Ca 547.82 

mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

18065592 van der 

Pols

2007

nd

Colorectal 

cancer 

Derived from the presence of a cancer code anywhere on the death certificate or from the first cancer 

that was registered.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

18065592 van der 

Pols

2007

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Energy, fruit intakes

Demographics (e.g., age, gender, race, education)? Yes* - age, gender

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes/no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes/no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year

Outcome Exposure / 

Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

18065592 van der 

Pols

2007

Colorectal 

cancer Ca intake did not have a clear independent association with colorectal cancer risk in this population (multivariate adjusted OR for highest 

vs. lowest intake: 1.91; 95% CI: 0.84. 4.32; P for trend=0.18) CRC cases =76

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 
QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical

Analysis Outcome Design

18065592 van 

der 

Pols

2007

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

N

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

N

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Per capita food and nutrient intake were calculated by dividing daily total intake by the total number of 

household members. Childhood diet was based on household rather than individual consumption. 7 day diet 

inventory instead of FFQ; cases not confirmed by histology reports blinding not reported; power calculation 

not reported; blinding not reported

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

1544755 van der 

Vijver 1992

Cohort 

study

Civil servants or 

spouses

40-65 yo

nd on survival or cause of death, Ca intake, men 

<1500 Kcal/day, women <1250 Kcal/day

1953-54 Dutch civil 

servants

Heart 

foundation

EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

1544755 van der 

Vijver 

1992

Cohort 

study

Amsterdam, 

Netherlands

52°

2925 (incl 

those with 

nd)

2605 52 40-65 51% White 

(implied)

Men 24.6

Women 26.3

All nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

1544755 van der 

Vijver 

1992

Dietary 

calcium 

intake

1 week FFQ Dutch Food 

Composition 

Tables

N Ca intake

Men 928±413 

mg

Women 

660±283 mg

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods,

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

1544755 van der Vijver 1992 1° CVD mortality Death certificates, national records of cause of death

ICD codes

1544755 van der Vijver 1992 1° CHD mortality same

1544755 van der Vijver 1992 2° All cause mortality same

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

1544755 van der Vijver 

1992

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes Age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes smoking, EtOH

Other Yes SBP, cholesterol

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean

Follow-up

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

Total 

N

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, %)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

1544755 van der 

Vijver 

1992

All cause 

mortality, 

men

Quintile 1 28 y ≤585 nd 271 Adjusted OR 1.1 0.7-1.5 NS

Quintiles 2-4 585-

1245

nd 798 0.9 0.7-1.2 NS

Quintile 5 >1245 nd 271 1.0 --

All cause 

mortality, 

women

Quintile 1 28 y ≤445 nd 258 Adjusted OR 1.3 0.8-2.0 NS

Quintiles 2-4 445-

850

nd 750 1.2 0.8-1.8 NS

Quintile 5 >850 nd 257 1.0 --

CVD 

mortality, 

men

Quintile 1 28 y ≤585 31.9% 

(age adj)

271 Adjusted OR 1.3 0.8-1.9 NS

Quintiles 2-4 585-

1245

26.7% 798 1.1 0.8-1.5 NS

Quintile 5 >1245 24.9% 271 1.0 --

CVD 

mortality, 

women

Quintile 1 28 y ≤445 14.6% 

(age adj)

258 Adjusted OR 1.1 0.6-2.0 NS

Quintiles 2-4 445-

850

14.4% 750 1.1 0.7-1.7 NS

Quintile 5 >850 12.6% 257 1.0 --

CHD 

mortality, 

men

Quintile 1 28 y ≤585 16.6% 

(age adj)

271 Adjusted OR 0.9 0.6-1.6 NS

Quintiles 2-4 585-

1245

15.1% 798 1.0 0.6-1.5 NS

Quintile 5 >1245 14.5% 271 1.0 --

CHD 

mortality, 

women

Quintile 1 28 y ≤445 6.2% 

(age adj)

258 Adjusted OR 1.1 0.5-2.5 NS

Quintiles 2-4 445-

850

6.3% 750 1.2 0.6-2.3 NS

Quintile 5 >850 4.4% 257 1.0 --

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

1544755 van der Vijver 1992 Same outcomes Similar results at 15 y follow-up, results not shown.

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

1544755 van 

der 

Vijver 

1992

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

?

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Analyses simplistic. More complete analyses were not performed.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

16960177 Visser

2006

Cohort study

(posthoc)

representative Dutch older 

population (≥65 y); born before 

1930; has blood sample

not living independently; no 

blood sample; missing contact 

information

1996 Longitudinal Aging 

Study Amsterdam

government SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

16960177 Visser

2006

Cohort 

study

W, NE, S of the 

Netherlands

1260 1260 ≥65 y 65 to 

≥80 y

51 nd BMI <25 to ≥30 31-41% 

with CVD; 

44-59% 

with 

arthritis

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

16960177 Visser

2006

25(OH)D Competitive 

protein-binding 

(Nichols 

Diagnostics, 

CA)

Y

interassay CV 

<15%

1-2 y nd nd

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

16960177 Visser

2006

primary mortality by death certificate

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

16960177 Visser

2006

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes* age, sex, education

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes/no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

Smoking and other life styles variables Yes* frailty indicators and lifestyle variables

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

16960177 Visser

2006

mortality

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

cases

(events)*

Total 

N

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

16960177 Visser

2006

mortality published cutoffs

25(OH)D

<25 

nmol/L

66 127 adjusted for 

sex, age, 

education

HR 1.61 1.09-

2.37 0.0058

25-49.9 42 462 1.17 0.85-

1.62

50-74.9 30 440 0.93 0.67-

1.29

≥75 29 231 1.0

16960177 Visser mortality published cutoffs <25 66 127 adjusted for 1.54 1.04- 0.021
2006 25(OH)D above plus 

chronic 

diseases, 

serum 

creatinine, 

cognition, 

depressive 

symptoms

2.29

25-49.9 42 462 1.11 0.80-

1.54

50-74.9 30 440 0.95 0.68-

1.32

≥75 29 231 1.0

16960177 Visser

2006

mortality published cutoffs

25(OH)D

<25 66 127 adjusted for 

above plus 

lifestyle 

variables

1.47 0.99-

2.19 0.046

25-49.9 42 462 1.08 0.78-

1.51

50-74.9 30 440 0.95 0.68-

1.32

≥75 29 231 1.0

16960177 Visser

2006

mortality published cutoffs

25(OH)D

<25 66 127 adjusted for 

above plus 

frailty indicators

1.28 0.85-

1.92 0.19

25-49.9 42 462 1.00 0.72-

1.40

50-74.9 30 440 0.91 0.65-

1.26

≥75 29 231 1.0

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 
**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

16960177 Visser

2006

mortality association did not differ significantly between men and women or between subjects aged <70, 70-79, and ≥80 y (P>0.33); subjects who were 

excluded from this study were more likely to die (59.4%) than the ones included (30.2%).

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

16960177 Visser

2006

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

N

a) One of 

the 

prespecified 

methods 

was used? 

(y/n)

N

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

N

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

Y

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

posthoc analysis; reported results are likely biased because selected only subjects with available blood 

sample and subjects who were excluded from this study were more likely to die than the ones included

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding 

Source Extractor

16481636 WactawskiWende 20061. RCT (for 

supplement 

part of study)

2. Casecohort***

RCT part:

Postmenopausal women 

(aged 50-79) (n=36282)

Case-cohort part:

Cases: invasive colorectal 

cancer (n=317; although 

322 cases were found in 

the entire study...)

Controls: 1:1 matching 

colorectal cancer free 

participants by age, 

center, race, ethnic group 

(n=317)

RCT part:

Predicted survival of 

less than three 

3years

a history of renal 

calculi or 

hypercalcemia

current use of oral 

corticosteroids

current daily use of at 

least 600IU of 

supplemental vitamin 

D or calcitriol

Case-cohort part:

Cases: carcinoma in 

situ and primary 

cancers of other sites

Inadequate serum (11 

pairs [cases+controls])

1993-1998 (after 1-

year run-in period 

followed, patients 

were randomized in 

between 1995-2000) 

1. Women’s Health 

Initiative randomized 

trials 2. Ca+VitD 

supplementation trial

NHLBI, 

DHHS

JHL/TTe

18092326 Ding 2008 RCT

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

***After a review of initial findings, a nested case-control study was proposed to determine whether the serum 25-hydroxyvitaminD level at baseline modified the outcome. 
POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat 

...etc)

Health 

Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or 

Ca intake 

...etc.)

16481636 WactawskiWende 

2006

1. RCT (for 

supplement

part of 

study)

2. Casecohort

US

(38 ̊ N)

RCT part: 

36282 

(Ca+vitD 

supplements 

n=18176, 

placebo 

n=18106)

Case-cohort 

part: 634 

(cases 

n=317, 

controls 

n=317)

RCT part:

36282 

Casecohort 

part: 612 

(cases 

n=306, 

controls 

n=306)

nd 50-79y 0% White 83.1%

Black 9.1%

Hispanic 4.2%

Indian/Alaskan 

Native 0.4%

Asian or 

Pacific 

Islander 2.0%

Unknown 

1.2%

nd Previous 

polyps: 8%

Family Hx: 

15%

Aspirin: 

19.4%

HRT: 68.3%

Participants 

of other 

trials:

WHI 

hormone 

therapy 

trial: 56%

WHI dietary 

modification 

trial: 31% 

nd

18092326 Ding 2008 RCT N=16089

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples 

were drawn

Background 

exposure data

16481636

18092326

WactawskiWende

2006

Ding 2008

25(OH)D 

and/or 

1,25(OH)2D

RIA Y, interassay 

coefficient of 

variation=11.8%

nd nd nd

16481636

18092326

WactawskiWende 

2006

Ding 2008

Dietary 

calcium 

intake

nd nd nd Ca 

(supplements+diet)

<800mg/d(%)=34

800-

<1200mg/d(%)=26.3

≥1200mg/d(%)=39.6

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or 

Ca Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

16481636

18092326

WactawskiWende 2006

Ding 2008

VitD+Ca VitD – GlaxoSmithKline

Ca – calcium carbonate

VitD 400 IU

Ca 1000 mg

7y 200IU of VitD twice daily

500mg of Ca twice daily

placebo “identical appearing placebo tablet” NA 7y Taken twice daily

Co-intervention(s) *:

54%of the participants enrolled in the trial of dietary modification, 69% enrolled in the trial of dietary modification and 14% 

participated in the both trials.

Compliance/Adherence: During year 1, 60% of the participants took at least 80% of their study medication, and this % remained stable through year 6, 

with small differences between groups. At least 70 % took 50% or more of their study medication through year 6.

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

16481636 & 

18092326

Wactawski-Wende 

2006 & Ding 2008

Secondary 

(primary: hip 

fracture)

(Invasive) 

colorectal 

cancer

Verified in a blinded fashion and coded with the use of the surveillance, epidemiology, and end results 

system; 99.4% of reported cancers were centrally confirmed. A total of 339 colorectal cancers. Of 

these, 9 were in situ and 8 were primary cancers of other sites. (Excluded in situ and primary cancers 

of other sites)

16481636 Wactawski-Wende 

2006

nd (Invasive) 

colon cancer Excluded in situ and primary cancers of other sites

16481636 Wactawski-Wende 

2006

nd (invasive) 

rectal cancer Excluded in situ and primary cancers of other sites

16481636 Wactawski-Wende 

2006

nd All cause 

mortality nd

16481636 Wactawski-Wende 

2006

nd Death from 

colorectal 

cancer

Death from colorectal cancer

16481636 Wactawski-Wende 

2006

nd Intestinal 

polyps Intestinal polyps based on participants’ self-report not centrally verified. 

16481636 Wactawski-Wende 

2006

nd Kidney stone Kidney stone based on participants’ self-report not centrally verified.

16481636 Wactawski-Wende 

2006

nd Total cancer 

incidence Intestinal polyps based on participants’ self-report not centrally verified. 

16481636 Wactawski-Wende 

2006

nd Cancer related 

mortality Kidney stone based on participants’ self-report not centrally verified.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups

Please List Name of 

Confounder 

(including matching 

factors)

Specific comments for confounders

16481636

18092326

WactawskiWende 2006

Ding 2008

Other nutrients or dietary factors 

(e.g., certain food consumption), 

including supplement use and 

total energy intake

No significant interactions were found with any baseline characteristic examined. ([Shown 

in Figure 1] Baseline characteristics: age at screening, race or ethnic group, education, 

first-degree relative with colorectal cancer, history of poly removal, BMI, physical activity, 

total energy intake, energy from saturated fat, total calcium intake, total vitD intake, region 

according to solar irradiance, multivitamin use, smoking status, NSAID use, hormone 

therapy use, enrollment in WHI hormone therapy trials, enrollment in WHI dietary 

modification trail)

Demographics (e.g., age, gender, 

race, education)?

Yes (age)

Anthropometrics (e.g., BMI, body 

weight, % body fat)?

Yes

Medical conditions History of colorectal 

cancer

Medication

Sunlight exposure and its proxy 

variables (e.g., seasonal variation 

of 25(OH)D, UV exposure, 

location)

Smoking and other life styles 

variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes

Other Clinical center

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author Year Outcome Exposure / 

Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, 

RR, HR, %) and direction 

of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

16481636 WactawskiWende 2006Invasive 

colorectal 

cancer

VitD 400 IU +

Ca 1000 mg

84 168 18176 HR Vit D+Ca / placebo 1.08 0.86-

1.34

0.51

Placebo 84 154 18106

16481636 WactawskiWende 2006Invasive colon 

cancer

VitD 400 IU +

Ca 1000 mg

84 128 18176 HR Vit D+Ca / placebo 1.00 0.78-

1.28

0.99

Placebo 84 126 18106

16481636 WactawskiWende 2006Invasive rectal 

cancer 

VitD 400 IU +

Ca 1000 mg

84 44 18176 HR Vit D+Ca / placebo 1.46 0.92-

2.32

0.11

Placebo 84 30 18106

16481636 WactawskiWende 2006Death from 

colorectal 

cancer 

VitD 400 IU +

Ca 1000 mg

84 34 18176 HR Vit D+Ca / placebo 0.82 0.52-

1.29

0.39

Placebo 84 41 18106

16481636 WactawskiWende 2006All cause 

mortality 

VitD 400 IU +

Ca 1000 mg

84 744 18176 HR Vit D+Ca / placebo 0.91 0.83-

1.01

0.07

Placebo 84 807 18106

16481636 WactawskiWende 2006Total cancer VitD 400 IU +

Ca 1000 mg

84 1634 18176 HR Vit D+Ca / placebo 0.98 0.91-

1.05

0.53

Placebo 84 1655 18106

16481636 WactawskiWende 2006Cancer 

mortality

VitD 400 IU +

Ca 1000 mg

84 344 18176 HR Vit D+Ca / placebo 0.89 0.77-

1.03

0.12

Placebo 84 382 18106

16481636 WactawskiWende 2006Kidney stone 

(UL)

VitD 400 IU +

Ca 1000 mg

84 449 18176 HR Vit D+Ca / placebo 1.17 1.02-

1.34

0.02

Placebo 84 381 18106

16481636 WactawskiWende 2006Intestinal 

Polyp

VitD 400 IU +

Ca 1000 mg

84 2983 18176 HR Vit D+Ca / placebo 0.99 0.94-

1.04

0.71

Placebo 84 2997 18106

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between
Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 
OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

18092326 Ding 

2008

Colorectal 

cancer

While Ca + vitamin D supplementation among women concurrently assigned to estrogen therapies suggested increased risk (HR=1.5, 95% 

CI: 0.96, 2.33), among women concurrently assigned to placebo arms of the estrogen trials, Ca + vitamin D indicated suggestive benefits 

(HR=0.71, 95% CI=0.46-1.09) (p-for-estrogen-interaction=0.018)

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

Nested Case-Control study 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean Vit D 

level / dose

Mean 

Ca 

level 

/ 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

16481636 WactawskiWende 

2006

Invasive 

colorectal 

cancer 

25-

hydroxyvitaminD

group 1

≥58.4nmol/liter 60 93 Adjusted OR 1.00

0.02

25-

hydroxyvitaminD

group 2

42.4-

58.3nmol/liter

78 73 Adjusted OR 1.96 1.18-

3.24

25-

hydroxyvitaminD

group 3

31.0-

42.3nmol/liter

80 73 Adjusted OR 1.95 1.18-

3.24

25-

hydroxyvitaminD

group 4

<31.0nmol/liter 88 67 Adjusted OR 2.53 1.49-

4.32
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

16481636

WactawskiWende 

2006

RCTparallel Y Y NA Y Y Y Y Y Y B

Adverse Event(s): ** Kidney stones

Explanation for Overall Quality Grade (if not Grade A):

Original study was designed for assessing the risks and benefits of hormone therapy and dietary modification. 

At the time the study ended, 352 women assigned to calcium with vitamin D supplements and 332 women 

assigned to placebo had withdrawn; 144 and 152, respectively, had been lost to follow-up.

This study was downgraded to B because there are very serious problems with WHI as a study reporting no 

association of Ca+D on endpoints. The most prominent problem with the trial as evidence for no association 

for Ca+D is the poor compliance with study treatment. Another serious problem is the allowance in the trial of 

use of supplements. The trial is a B when reporting no association because non-compliance and the 

“contamination” of the non-intervention group would cause bias to the null.

It was the consensus among the Tufts EPC that overall, the methodological quality of the trial was B, 

particularly when the trial is being used to guide decisions about DRI, as opposed to decisions about whether 

to actively recommend supplementation for an individual woman.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

18092326 Ding 

2008

RCTparallel Y Y NA Y Y Y Y Y Y B

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A):

The reduced sample size (<50%) of the original WHI power calculations assuming no interaction with estrogen 

therapies

It was the consensus among the Tufts EPC that overall, the methodological quality of the trial was B, 

particularly when the trial is being used to guide decisions about DRI, as opposed to decisions about whether 

to actively recommend supplementation for an individual woman.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 
QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

17661565 Wagner

2006

RCT Fully lactating mothers within 1 

mo postpartum

DM; HTN; parathyroid disease; 

uncontrolled thyroid disease

nd - academic; 

NIH

SI

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

17661565 Wagner

2006

RCT Charleston, SC

32°47'N

19 19 29 0 89% 

white

dietary calcium 

intake: 1125 mg/d; 

dietary vit D 273 

IU/d

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17661565 Wagner

2006

25(OH)D 

and/or 

1,25(OH)2D

RIA n dietary vit D 

273 IU/d

17661565 Wagner

2006

Dietary 

calcium 

intake

Block 1998.2 

FFQ

n calcium 

intake: 1125 

mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

17661565 Wagner

2006

United Research Labs, PA

RXChoice®, NY

mom: 400 IU vit D3

infant: 300 IU vit D3/d

6 mo one prenatal vitamin and two placebo study 

tablets qd

17661565 Wagner

2006

United Research Labs, PA; 

Tishcon Corp., NY

mom: 400 IU + 6000 

IU vit D3

infant: placebo drops

one prenatal vitamin and two vitamin D 

study tablets qd

Co-intervention(s) *:

Compliance/Adherence: ≥80% for mom; as low as 61% for infants

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

17661565 Wagner

2006

primary 25(OH)D level in mom

17661565 Wagner

2006 vit D3 level in mom

17661565 Wagner

2006 25(OH)D level in infant

17661565 Wagner

2006 anti-rachitic activity in milk vit D3 and 25 (OH)D in milk converted into biological activity using reference data

17661565 Wagner

2006 infant weight and length

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

17661565 Wagner

2006 subjects compensated with gift cards

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17661565 Wagner

2006

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes* age, race

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes* changes in skin pigmentation

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes* outdoor activities

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final or 

Delta**

Final 

or 

Delta 

CI / SE 

/ SD*

Net 

difference

Net 

difference 

CI / SE / 

SD*

P 

between

17661565 Wagner

2006

mom 25 

(OH)D at 1 

mo

ng/mL mom 400 10 32.2 nd

mom 6400 9 34

at 2 mo mom 400 10 35.1

mom 6400 9 47.1

at 3 mo mom 400 10 35.1

mom 6400 9 48.4

at 4 mo mom 400 10 28.9

mom 6400 9 45

at 5 mo mom 400 10 25.9

mom 6400 9 50.6

at 6 mo mom 400 10 33.5

mom 6400 9 51.9

at 7 mo mom 400 10 38.4

mom 6400 9 58.8

17661565 Wagner

2006

mom vit D3 

level at 1 mo

ng/mL mom 400 10 2.2 nd

mom 6400 9 4.1

at 2 mo mom 400 10 2.8

mom 6400 9 30.3

at 3 mo mom 400 10 3.5

mom 6400 9 32.4

at 4 mo mom 400 10 2.8

mom 6400 9 39.2
at 5 mo mom 400 10 3.7

mom 6400 9 49.6

at 6 mo mom 400 10 5.3

mom 6400 9 43.9

at 7 mo mom 400 10 4

mom 6400 9 49.7

17661565 Wagner

2006

antirachitic 

activity in 

milk at 1 mo

IU mom 400 10 59.6 nd

mom 6400 9 82.4

at 2 mo mom 400 10 71.2

mom 6400 9 387

at 3 mo mom 400 10 78.6

mom 6400 9 370.5

at 4 mo mom 400 10 45.7

mom 6400 9 374.4

at 5 mo mom 400 10 68.3

mom 6400 9 555.2

at 6 mo mom 400 10 69.9

mom 6400 9 624.5

at 7 mo mom 400 10 76.3

mom 6400 9 873.5 <0.0003

17661565 Wagner

2006

infant 25 

(OH)D at 1 

mo

ng/mL infant 300 10 13 nd

infant placebo 9 14

at 2 mo infant 300 10 33

infant placebo 9 36

at 7 mo infant 300 10 43

infant placebo 9 46

infant weight 

at 1 mo

Kg infant 300 10 4.7 0.4 0.80

infant placebo 9 4.6 0.7

at 4 mo infant 300 10 6.7 0.5 0.91

infant placebo 9 6.6 0.8

at 7 mo infant 300 10 7.6 0.8 0.30

infant placebo 9 8.4 1.1

infant length 

at 1 mo

cm infant 300 10 54.6 1.1 0.29

infant placebo 9 55.9 2.9

at 4 mo infant 300 10 62.4 1.7 0.75

infant placebo 9 62.8 1.9

at 7 mo infant 300 10 65.5 1.8 0.06

infant placebo 9 69.3 2.9

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

17661565 Wagner

2006 RCT Y Y NA Y N Y N N N C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): pilot study, small sample size, details of analysis not reported; up to 39% of infants might not have received the 

intended intervention

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

18259007 Wang 

2008

Cohort 

Study

Women US health 

professionals, ≥45 y

CVD, Nonmelanoma cancer, insufficient completion of FFQ, 

implausible total energy intake (not defined), Baseline HTN 

(self reported MD diagnosis, SBP≥140, DBP≥90, or 

antihypertensive drug)

1992-1995 Women’s 

Health 

Study

Gov’t EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry data 

(e.g., BMI, weight, 

or %body fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low Vit 

D or Ca intake 

...etc.)

18259007 Wang 

2008

Cohort 

Study

US various 28,886 28,886 53.8 

(~6.5)

≥45 y 0% ~94% 

white

~25.1±~4.5 Healthy nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

nd

18259007 Wang 

2008

Dietary 

calcium 

intake

FFQ Harvard 

School of 

Public Health

No, but in “similar 

cohorts of health 

professionals” data 

provided

nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

18259007 Wang 

2008

1° Incident 

HTN

At least 1 of: self report of new physician diagnosis; self-report starting antihypertensive drug; self-report SBP≥140 

mm Hg; self-report DBP≥90 mm Hg (censored on the date of CVD diagnosis)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

18259007 Wang 

2008

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes Total energy intake; fruit, vegetable, whole 

grain, red meat intake 

Demographics (e.g., age, gender, race, education)? Yes Age, Race

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions Yes DM, hypercholestolemia

Medication Yes randomization to aspirin, vitamin E, 

multivitamin use

Sunlight exposure and its proxy variables (e.g., seasonal variation 

of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes Smoking, EtOH, physical activity

Other Menopausal status

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Median 

(range) 

Vit D 

dose

Median 

(range) 

Ca 

intake

No. of 

Cases 

(Event)* 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

18259007 Wang 

2008

Incident 

HTN

Dietary Calcium 

Quintile 1

483.5 

(189-

557.9)

1860 5777 10 y Adjusted 

(“multivariate)

HR 1.00 --

<.0001

Quintile 2 620.4 

(558-

678.9)

1778 5777 0.96 0.90, 

1.03

NS

Quintile 3 739.6 

(679-

801.9)

1626 5777 0.89 0.83, 

0.95

<.05

Quintile 4 883.5 

(802-

999.9)

1634 5777 0.89 0.83, 

0.95

<.05

Quintile 5 1170.4 

(1000-

2559)

1631 5777 0.87 0.81, 

0.93

<.05

18259007 Wang 

2008

Incident 

HTN

Supplement Vit D 

Quartile 1

0 (0) 5745 nd 10 y Adjusted 

(“multivariate)

HR 1.00 --

Quartile 2 228 (2-

249)

951 nd 1.00 0.93, 

1.09

NS

Quartile 3 400 

(250-

399)

1648 nd 1.03 0.96, 

1.11

NS

Quartile 4 800 

(400-

2000)

185 nd 1.09 0.93, 

1.27

NS

0.27

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***
Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

18259007 Wang 

2008

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

Y a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

?

c) Internal

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N# b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): Calcium: A

Vit D: C

Explanation for Overall Quality Grade (if not Grade A):

Good methods and analysis of Calcium. 

Vitamin D analysis poorly described. Minor errors in text regarding methods for Vit D analysis. Report that 

vitamin D analyzed in 4 “quintiles” (sic), but bottom quintile is no vitamin D supplement and nd given on 

numbers of participants in each group.
QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 

# Data reported for similar studies
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment Years Trial or Cohort 

Name

Funding 

Source Extractor

18180395 Wang

2008

Cohort study Framingham Offspring

25(OH)D measured 1996-

2000

Prevalent CVD or

CKD

1996-2000 (originally 

1971)

Framingham 

Offspring

nd EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location (e.g., 

City and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

18180395 Wang

2008

Cohort 

study

Probably mostly 

still around 

Framingham, 

MA

42°

1739

(Originally 

5124)

1739 59 (9) nd 45% White 

100%

BMI 28.1 No 

CVD, 

CKD

Vit D supplement 

4%

Multivitamin 41%

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

18180395 Wang

2008

25(OH)D 

and/or 

1,25(OH)2D

RIA 

(DiaSorin)

Yes

CoV 8.5% 

(intraassay); 

13.2% 

(interassay)

≤3 yr nd

Dietary 

calcium 

intake

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome**

Outcome Definition

18180395 Wang

2008

Primary First cardiovascular 

event

MI, coronary insufficiency, angina, stroke, TIA, claudication, heart failure (all defined per 

Framingham study criteria)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

18180395 Wang

2008

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Yes Use of Vit D containing 

supplements

Demographics (e.g., age, gender, race, education)? Yes Age, sex, education (<12 y)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes BMI

Medical conditions Yes DM

Medication Yes anti-HTNive

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

Yes Season of blood draw

Physical activity

Smoking and other life styles variables Yes Smoking

Other Yes SBP, TC/HDL, SCr, 

(CRP, analysis not included 

here)

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, 

HR, %) and direction of 

comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

18180395 Wang

2008

CV event 25(OH)D <15 

ng/mL

5.4 yr 50 481 Unadjusted: Rate (age and sex 

adjusted)

Adjusted: HR

8.9% 5.5, 

12.2

nd 1.70 1.08, 

2.67

.02

25(OH)D ≥15 

ng/mL

70 1258 4.4% 2.8, 

5.9

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases

(Event)*

No. of 

Noncases / 

Total 

N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE / 

SD **

P between 

groups***

P for 

trend****

18180395 Wang

2008

CV event Severe deficiency <10 

ng/mL

nd nd Adjusted† HR 1.80 1.05, 

3.08

<.05 .01

Deficiency 10-<15 

ng/mL

nd nd Adjusted† HR 1.53 1.00, 

2.36

P=.05

Referent ≥15 

ng/mL

70 1258 Adjusted†

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

† Not adjusted for physical activity, vit D suppl, educational attainment, season. 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 
UI Author

Year Outcome Results

18180395 Wang

2008

CV event Multivariable Cox with continuous 25(OH)D and regression splines with nonlinear relationship:

Suggest increased hazard at 25(OH)D levels below 15-20 ng/mL (see figure 2, page 508).

UI Author

Year Comments for Results

18180395 Wang

2008 There are also analyses based on prespecified subgroups analyses by HTN status.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year

Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

18180395 Wang

2008

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

nd

a) Method 

reported? 

(y/n)

NA a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

NA Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

Y

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

NA b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): A (though C for 3 category results)

Explanation for Overall Quality Grade (if not Grade A):

Rigorous, appropriate adjustments (except for 3 category results, which were not fully adjusted, particularly 

including season), well analyzed and reported.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

18988909 Weng 

2008

Cohort 

study

> 40 yrs old (n=3282)

Total energy intake range 

between 500 to 5500 

kcal/d for men and 500 to 

4000 kcal/d for women

Hx of cancer, stroke which may have changed their 

dietary habits (n=84), and people who had missing 

values for FFQ (n=613), for other variables (n=797), 

or was lost to follow-up (n=11). Also excluded those 

with extreme dietary data (n=5)

1989-2002 CVDFACTSNational Health 

Research 

Institutes in 

Taiwan

MB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean (SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat 

...etc)

Health Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or 

Ca intake 

...etc.)

18988909 Weng 

2008

Cohort 

study

Taiwan 3282 1772 Stroke group = 

62.6(8.1)

Nonevent 

group=56.1(9.8)

nd 44% nd Mean BMI stroke 

group=25.3(3.4)

Mean BMI 

nonevent 

group=24.4(3.3)

10.5% diabetics, 

4.2% self-report 

heart disease, 

17% use 

antihypertensive 

medication

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? (y/n) 

If Yes, Provide 

Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

18988909 Weng 

2008

Dietary 

calcium 

intake

FFQ nd N (but authors state 

that the FFQ was 

validated previously 

by comparing to 15-

days food records)

no nd nd

* Write “nd” if there was no data reported. Please do not leave blank 
**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

18988909 Weng 2008 nd stroke Self-reported and cross-checked by medical records or death certificates

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

18988909 Weng 

2008

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes Matched on gender, adjusted for age

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions Yes Adjusted for DM, htn, heart disease, 

hypertriglceridemia

Medication Yes Adjusted for use of htn meds

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes Matched on smoking hx, EtOH habits, 

physical activity

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

18988909 Weng 

2008

stroke Quartile 3 + 

Quartile 4

>591.50 

mg

127 adjusted HR reference

Quartile 2 451.24-

591.50 

mg

127 adjusted HR 1.49 0.99-

2.24

Quartile 1 <451.24 127 adjusted HR 1.52 0.98-

2.35 0.031
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 
Please copy the appropriate table above for all subgroup analyses of interest. 

QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 
QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

18988909 Weng 

2008

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Nd

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

Nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): No data on exposure assessor blinded to outcome or outcome assessor blinded to exposure. Food 

composition database not reported.

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study Design*

Inclusion Exclusion Enrollment Years Trial or Cohort Name Funding Source Extractor

9022561 Whelton, 1997 RCT Healthy, 30-54 yo

DBP 80-89 mm Hg

Treatment with antihypertensive 1987-88 TOHP nd EB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

9022561 Whelton, 

1997

RCT 10 sites 471 445 43~+/-

6.6

30-54 68% 86% 

white

~83 Kg

BMI ~27

Healthy

Borderline 

DBP

nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

9022561 Whelton, 

1997

Dietary 

calcium 

intake

none NA NA none

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, 

foods, or formulation) 

Vit D and/or Ca 

Total Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

9022561 Whelton, 

1997

Ca supplement Ca carbonate 1 g 18 mo 500 mg 2x/day

Placebo

Co-intervention(s) *: None

Compliance/Adherence: nd for Ca vs Placebo arms

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

9022561 Whelton, 1997 1° Change in SBP/DBP

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

9022561 Whelton, 

1997

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? No

Anthropometrics (e.g., BMI, body weight, % body fat)? No

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

No

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Final or 

Delta**

Final or 

Delta CI 

/ SE / 

SD*

Net 

difference

Net 

difference CI 

/ SE / SD*

P 

between

9022561 Whelton, 

1997

SBP mm 

Hg

Ca 

supplement

18 mo 221 126.0 7.7 nd nd ~-0.5 

(figure)

~0.75 NS

Placebo 224 125.4 8.8 nd nd

9022561 Whelton, 

1997

DBP mm 

Hg

Ca 

supplement

18 mo 221 84.1 2.9 nd nd ~+0.3 

(figure)

~0.5 NS

Placebo 224 83.9 2.8 nd nd

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 
****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

9022561 Whelton, 

1997 RCT nd nd NA Y nd nd probably N N C

Adverse Event(s): ** nd

Explanation for Overall Quality Grade (if not Grade A): No data on background diet. Ca vs Placebo analysis very poorly reported. Primary outcome of HTN incidence 

not reported. Clear results data not presented. Results not in text of results section.

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

3620314 Wu, 

1987

Cohort 

study

Residents who moved into the Large retirement community 

between June, 1981 and June 1982 were mailed a questionnaire 

on June 1982. A total of 11,888 (625) of the 19,752 residents 

returned the questionnaire.

Pre-existing CRC 

were excluded from 

the analysis

1982 nd nd MC

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age Range / 

IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

3620314 Wu, 

1987

Cohort 

study

About 50 

miles south 

of Los 

Angeles, 

California

[21° N]

11,888 11,644 nd nd (to adjust 

for age, the 

cohort were 

divided into 4 

age strata: 

<=64, 65-74, 

75-84, >=85)

~33% 100% 

Caucasian

(upper-middle 

socioeconomic 

class)

nd nd nd

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

25(OH)D 

and/or 

1,25(OH)2D

3620314 Wu, 

1987

Dietary 

calcium 

intake

FFQ – 56 

foods and 

coffee

USDA N nd

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 
****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year Intervention(s) Source (e.g., brand name, foods, or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / 

Secondary 

Outcome**

Outcome Definition

3620314 Wu, 

1987

nd Colorectal 

cancer

Pathological diagnosis of cancer from local hospitals was available among 85% study participants. In addition, all 

participants are sent a follow-up questionnaire on a biennial basis. All residents were followed until the diagnosis of 

CRC, death or March 31, 1985 whichever occurred first.

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

3620314 Wu, 1987 No main result for calcium and CRC. Only subgroup analysis results by gender.

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

3620314 Wu, 

1987

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Yes*

Anthropometrics (e.g., BMI, body weight, % body fat)? no*

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

no*

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, 

HR, %)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

UI

Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI 

**

P 

between 

groups***

P for 

trend****

3620314 Wu, 

1987

CRC -

male

Calcium intake

Tertile 1 (low)

nd nd nd nd* Personyrs= 13875adjusted RR 1 nd nd

Tertile 2 nd nd nd nd* Personyrs= 13840adjusted RR 1.19 0.6, 

2.2

Tertile 3 (high) nd nd nd nd* Personyrs= 13611adjusted RR 0.86 0.4, 

1.7

3620314 Wu, 

1987

CRC -

female

Calcium intake

Tertile 1 (low)

nd nd nd nd* 4.5 yr

Personyrs= 13875

adjusted RR 1 nd nd

Tertile 2 nd nd nd nd* Personyrs= 13840adjusted RR 0.9 0.5, 

1.6

Tertile 3 (high) nd nd nd nd* Personyrs= 13611adjusted RR 0.89 0.5, 

1.6

*Total number of subjects (both male and female) per tertile: tertile 1=3865, tertile 2=3873; tertile 3=3828 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse events. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

3620314 Wu, 

1987

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

nd

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

N

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

N

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

Y

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

nd

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

nd

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

N

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Poor reporting of baseline characteristics and exposures’ data. No adjustment for confounding other than 

age and sex. Confirmation by histology not performed for all cases; number of cases, non-cases per gender 

not provided

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name

Funding 

Source Extractor

11904316 Wu

2002

Cohort 

study 1: 

HPFS

Cohort 

study 2:

NHS

HPFS: male dentists, podiatrists, 

pharmacists, optometrists, osteopaths, and 

veterinarians who were 40-75 years old and 

completed a mailed questionnaire requesting 

information on various exposures and 

medical diagnosis in 1986; and also 

completed a 131-item semi-quantitative FFQ 

at the same year (1986) (follow up FFQ 

included were mailed during the years: 1990, 

1994)

NHS: registered US nurses who were 30-55 

years old and completed a mailed 

questionnaire requesting information on 

various exposures and medical diagnosis in 

1976; and completed a 61-item semiquantitative FFQ in 1980 (follow up FFQ 

included 121-134 items during the years: 

1984, 1986, 1990, 1994)

HPFS: men who failed to fill in the 

FFQ at baseline or left a large 

number of items blank (>70); men 

with unreasonably high (>4200 

kcal/day or low (<800 kcal/day) total 

energy intake; men with history of 

previous cancer (except for

nonmelanoma skin cancer), and

ulcerative colitis

NHS: women who failed to fill in the 

FFQ at baseline or left a large 

number of items blank (>10); women 

with unreasonably high (>3500 

kcal/day or low (<600 kcal/day) total 

energy intake; women with history of 

previous cancer (except for 

nonmelanoma skin cancer), and 

ulcerative colitis

HPFS: 1986

NHS: 1980

HPFS: Health 

Professionals 

Follow-up Study

NHS: Nurses’ 

Health Study

HPFS: 

NCI

NHS: 

NCI

AT

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT
POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat ...etc)

Health Status

Specific 

Nutrition 

Status Data 

(e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

11904316 Wu

2002

Cohort 

study 1 

(HPFS)

Cohort 

study 2 

(NHS)

HPFS: nd

NHS: US

HPFS: 

47344

NHS: 

87998

HPFS: 

47344

NHS: 

87998

HPFS:

54.4

(nd)

NHS: 

46.6 

(nd)

HPFS: 

nd

NHS: 

nd

HPFS: 

100

NHS: 

0

HPFS: 

nd

NHS: nd

HPFS: Average 

BMI (kg/m2): 25.5

NHS: Average 

BMI (kg/m2): 24.4

HPFS: %current 

smokers: 9.6; %aspirin 

users: 29.3; %family 

history CRC: 10; 

%history of polyps: 

3.5; %previous 

endoscopy: 25.8; 

%current multivitamin 

supplementation: 41.6

NHS: %current 

smokers: 28.9; 

%aspirin users: 32.8; 

%family history CRC: 

8.4; %history of 

polyps: 0.8; %previous 

endoscopy: 9.8; 

%current multivitamin 

supplementation: 34.1; 

%menopausal women: 

33

HPFS: Average 

total energy 

intake 

(kcal/day): 

1985; average 

vitamin D intake 

(IU/day): 363; 

average calcium 

intake (mg/day): 

897

NHS: Average 

total energy 

intake 

(kcal/day): 

1566; average 

vitamin D intake 

(IU/day): 292; 

average calcium 

intake (mg/day): 

733

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal Calibration 

(or Validity) of 

Dietary 

Assessment? (y/n) If 

Yes, Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

11904316 Wu

2002

25(OH)D 

and/or 

1,25(OH)2D

NA NA NA NA NA

11904316 Wu

2002

Dietary 

calcium 

intake

HPFS: FFQ

NHS: FFQ

HPFS: USDA 

and others 

(REF 33-36) 

NHS: USDA 

and others 

(REF 33-36)

y (REF 33-36)

HPFS: Pearson 

correlation coefficient 

(energy adjusted) 

between calcium 

intake computed from 

the FFQ and average 

calcium intake of two 

1-week diet records 

for 127 men: 0.53 

(with supplements and 

without supplements)

NHS: Pearson 

correlation coefficient 

(energy adjusted) 

between calcium 

intake computed from 

the FFQ and average

calcium intake of two 

1-week diet records 

for 191 women: 0.63 

(with supplements); 

and 0.70 (without 

supplements)

NA

* Write “nd” if there was no data reported. Please do not leave blank 

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 
INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome**

Outcome Definition

11904316 Wu

2002

primary Primary 

adenocarcinoma

Reported as diagnosis of colon or rectal cancer by the patients and confirmed by reviewing medical 

records of pathology reports. Data extracted from pathology reports included: histology, anatomic location, 

and sage of cancer

primary Proximal (right sided) 

colon cancer Colon cancer located in cecum, ascending colon, or transverse colon

primary Distal (left sided) colon 

cancer

Colon cancer located in descending colon, or sigmoid colon

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

11904316 Wu

2002

86 cases with colorectal cancer in HPFS and 97 cases with colorectal cancer in NHS were included in the analyses with missing information on anatomic site. 

These additional cases were confirmed by medical records, by autopsy, or death reports, or by reconfirming the self-reported diagnosis from the patients. 

Exclusion of these cases yielded similar results.

Death was confirmed by the National Death Index or reports from family members
-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder (including 

matching factors)

Specific comments for 

confounders

11904316

Wu

2002

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes (red meat consumption)

Demographics (e.g., age, gender, race, education)? Yes (Age)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (BMI)

Medical conditions Yes (family history CRC; for NHS only: menopausal 

status)

Medication Yes (aspirin use; for NHS only: post-menopausal 

hormone use)

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes (physical activity; pack-years of smoking before 

age 30; alcohol consumption)

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %)

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

HPFS: adjusted for age, BMI, family history CRC, aspirin use, red meat consumption, physical activity; pack-years of smoking before age 30, 

alcohol consumption (5 out of 313 confirmed cancer case subjects were excluded for cancer from subsite analyses because of insufficient 

information on cancer location)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

11904316 Wu

2002

Primary 

adenocarcinoma 

(CRC)

Cumulative 

average calcium 

intake (mg)

≤ 500 47 nd nd adjusted RR 1.00 nd

0.17
Cumulative 

average calcium 

intake (mg)

501-

600

48 nd nd adjusted RR 0.69 0.46-

1.04

nd

Cumulative 

average calcium 

intake (mg)

601-

700

58 nd nd adjusted RR 0.69 0.47-

1.01

nd

Cumulative 

average calcium 

intake (mg)

701-

800

51 nd nd adjusted RR 0.60 0.40-

0.90

nd

Cumulative 

average calcium 

intake (mg)

801-

100

81 nd nd adjusted RR 0.67 0.47-

0.97

nd

Cumulative 

average calcium 

intake (mg)

1001-

1250

84 nd nd adjusted RR 0.62 0.42-

0.92

nd

Cumulative 

average calcium 

intake (mg)

>1250 60 nd nd adjusted RR 0.64 0.43-

0.95

nd

Proximal (right 

sided) colon 

cancer

Cumulative 

average calcium 

intake (mg)

≤ 500 12 nd nd adjusted RR 1.00 nd

0.91

Cumulative 

average calcium 

intake (mg)

501-

600

15 nd nd adjusted RR 0.84 0.39-

1.81

nd

Cumulative 

average calcium 

intake (mg)

601-

700

19 nd nd adjusted RR 0.87 0.42-

1.79

nd

Cumulative 

average calcium 

intake (mg)

701-

800

22 nd nd adjusted RR 0.98 0.48-

1.99

nd

Cumulative 

average calcium 

intake (mg)

801-

100

34 nd nd adjusted RR 1.06 0.54-

2.07

nd

Cumulative 

average calcium 

intake (mg)

1001-

1250

24 nd nd adjusted RR 1.01 0.50-

2.05

nd

Cumulative 

average calcium 

intake (mg)

>1250 24 nd nd adjusted RR 0.92 0.45-

1.87

nd

Distal (left 

sided) colon 

cancer

Cumulative 

average calcium 

intake (mg)

≤ 500 22 nd nd adjusted RR 1.00 nd

0.12

Cumulative 

average calcium 

intake (mg)

501-

600

25 nd nd adjusted RR 0.77 0.43-

1.37

nd

Cumulative 

average calcium 

intake (mg)

601-

700

25 nd nd adjusted RR 0.64 0.36-

1.14

nd

Cumulative 701- 16 nd nd adjusted RR 0.41 0.21- nd
average calcium 

intake (mg)

800 0.78

Cumulative 

average calcium 

intake (mg)

801-

100

28 nd nd adjusted RR 0.51 0.29-

0.91

nd

Cumulative 

average calcium 

intake (mg)

1001-

1250

18 nd nd adjusted RR 0.46 0.24-

0.86

nd

Cumulative 

average calcium 

intake (mg)

>1250 24 nd nd adjusted RR 0.58 0.32-

1.05

nd
NHS: adjusted for age, BMI, family history CRC, aspirin use, red meat consumption, physical activity; pack-years of smoking before age 30, 

alcohol consumption, post-menopausal hormone use, menopausal status

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. 

of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI **

P 

between 

groups***

P for 

trend****

11904316 Wu

2002

Primary 

adenocarcinoma 

(CRC)

Cumulative 

average calcium 

intake (mg)

≤ 500 70 nd nd adjusted RR 1.00 nd 0.35
Cumulative 

average calcium 

intake (mg)

501-

600

79 nd nd adjusted RR 1.19 0.86-

1.64

nd

Cumulative 

average calcium 

intake (mg)

601-

700

83 nd nd adjusted RR 1.07 0.77-

1.47

nd

Cumulative 

average calcium 

intake (mg)

701-

800

90 nd nd adjusted RR 1.18 0.86-

1.63

nd

Cumulative 

average calcium 

intake (mg)

801-

100

130 nd nd adjusted RR 1.04 0.77-

1.40

nd

Cumulative 

average calcium 

intake (mg)

1001-

1250

106 nd nd adjusted RR 1.05 0.77-

1.44

nd

Cumulative 

average calcium 

intake (mg)

>1250 68 nd nd adjusted RR 0.94 0.66-

1.33

nd

Proximal (right 

sided) colon 

cancer

Cumulative 

average calcium 

intake (mg)

≤ 500 27 nd nd adjusted RR 1.00 nd

0.32

Cumulative 

average calcium 

intake (mg)

501-

600

25 nd nd adjusted RR 0.92 0.53-

1.61

nd

Cumulative 

average calcium 

intake (mg)

601-

700

37 nd nd adjusted RR 1.18 0.72-

1.96

nd

Cumulative 

average calcium 

intake (mg)

701-

800

46 nd nd adjusted RR 1.55 0.96-

2.52

nd

Cumulative 

average calcium 

intake (mg)

801-

100

56 nd nd adjusted RR 1.13 0.70-

1.81

nd

Cumulative 

average calcium 

intake (mg)

1001-

1250

50 nd nd adjusted RR 1.28 0.79-

2.08

nd

Cumulative 

average calcium 

intake (mg)

>1250 35 nd nd adjusted RR 0.28 0.75-

2.16

nd

Distal (left 

sided) colon 

cancer

Cumulative 

average calcium 

intake (mg)

≤ 500 33 nd nd adjusted RR 1.00 nd

0.06

Cumulative 

average calcium 

intake (mg)

501-

600

37 nd nd adjusted RR 1.24 0.77-

2.00

nd

Cumulative 

average calcium 

intake (mg)

601-

700

40 nd nd adjusted RR 1.16 0.72-

1.85

nd

Cumulative 701- 33 nd nd adjusted RR 0.98 0.60- nd
average calcium 

intake (mg)

800 1.61

Cumulative 

average calcium 

intake (mg)

801-

100

46 nd nd adjusted RR 0.78 0.49-

1.25

nd

Cumulative 

average calcium 

intake (mg)

1001-

1250

40 nd nd adjusted RR 0.91 0.56-

1.48

nd

Cumulative 

average calcium 

intake (mg)

>1250 24 nd nd adjusted RR 0.73 0.41-

1.27

nd

NHS: adjusted for age, BMI, family history CRC, aspirin use, red meat consumption, physical activity; pack-years of smoking before age 30, 

alcohol consumption, post-menopausal hormone use, menopausal status

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca level 

/ dose

No. of 

Cases 

(Event)* 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

11904316

Wu

2002

Primary 

adenocarcinoma 

(CRC)

Total calcium 

intake at 

baseline 

(mg/day)

Lowest 

category

nd 20,599 nd adjusted RR 1.00

nd 11904316

Wu

2002

Primary 

adenocarcinoma 

(CRC)

Total calcium 

intake at 

baseline 

(mg/day)

Highest 

category

nd 5636 nd adjusted RR 0.83 0.64-

1.09

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
HPFS and NHS: pooled analysis adjusted for age, BMI, family history CRC, aspirin use, red meat consumption, physical activity; pack-years of 

smoking before age 30, alcohol consumption, post-menopausal hormone use, menopausal status

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD

**

P 

between 

groups***

P for 

trend****

11904316 Wu

2002

Proximal 

(right 

sided) 

colon 

cancer

Cumulative 

average calcium 

intake (mg)

≤ 500 70 nd nd adjusted RR 1.00 nd

0.41
Cumulative 

average calcium 

intake (mg)

501-

600

79 nd nd adjusted RR 0.90 0.57-

1.04

nd

Cumulative 

average calcium 

intake (mg)

601-

700

83 nd nd adjusted RR 1.07 0.71-

1.62

nd

Cumulative 

average calcium 

intake (mg)

701-

800

90 nd nd adjusted RR 1.33 0.87-

2.04

nd

Cumulative 

average calcium 

intake (mg)

801-

100

130 nd nd adjusted RR 1.10 0.75-

1.63

nd

Cumulative 

average calcium 

intake (mg)

1001-

1250

106 nd nd adjusted RR 1.19 0.80-

1.77

nd

Cumulative 

average calcium 

intake (mg)

>1250 68 nd nd adjusted RR 0.14 0.72-

1.81

nd

Distal (left 

sided) 

colon 

cancer

Cumulative 

average calcium 

intake (mg)

≤ 500 70 nd nd adjusted RR 1.00 nd

0.01

Cumulative 

average calcium 

intake (mg)

501-

600

79 nd nd adjusted RR 1.01 0.64-

1.59

nd

Cumulative 

average calcium 

intake (mg)

601-

700

83 nd nd adjusted RR 0.88 0.50-

1.57

nd

Cumulative 

average calcium 

intake (mg)

701-

800

90 nd nd adjusted RR 0.65 0.28-

1.53

nd

Cumulative 

average calcium 

intake (mg)

801-

100

130 nd nd adjusted RR 0.65 0.44-

0.98

nd

Cumulative 

average calcium 

intake (mg)

1001-

1250

106 nd nd adjusted RR 0.67 0.34-

1.30

nd

Cumulative 

average calcium 

intake (mg)

>1250 68 nd nd adjusted RR 0.65 0.43-

0.98

nd

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between

groups***
Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

11904316 Wu

2002

HPFS: follow up years, 1986-1996; multivariate adjustment did not substantially alter the age specific estimates; results were similar when baseline total 

calcium intake was used without updating dietary information.

NHS: follow up years, 1980-1996; multivariate adjustment did not substantially alter the age specific estimates; the inverse association between CRC and 

baseline total calcium intake (without updating dietary information) was stronger 

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

HPFS 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

11904316 Wu

2002

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A):

Assessor blinding not reported; post-hoc analyses; power calculation not reported; results are not 

reported completely; data on several analyses are not shown
NHS

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

11904316 Wu

2002

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c)

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A):

Assessor blinding not reported; post-hoc analyses; power calculation not reported; results are not

reported completely; data on several analyses are not shown

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

17623801 Wu 

2007 

Casecohort 

study

Male US health professionals 

(N=51,129)

subjects provided a blood sample in 

1993 -1995 (N=18,225)

Cases: colorectal cancer diagnosed 

between 1993-01/2002

Controls: 1:2 matching by age (<2 y), 

year of enrollment, month of blood 

donation (<1 mo) 

nd 1986 Health Professionals 

Follow-up Study (HPFS) 

cohort

National Cancer 

Institute, National 

Institutes of Health

(DiaSorin Corp (Maker 

of Vit D assay kit))

JHL/TTe

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N enrolled*** N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, 

low Vit D or Ca 

intake ...etc.)

17623801 Wu 

2007 

Casecohort 

study

US, 

various

Original cohort 

(N=51,129), 

subjects provided 

a blood sample 

(N=18,225), 

cases (N=179) 

and controls 

(n=356)

535 66.2 nd 100 nd BMI 25.7 Aspirin use in 

1994: 40%

Current 

smoking: 5%

Previous 

colonoscopy: 

65%

Vit D: 455.7 IU/d

Ca: 939 mg/d 

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker Data 

Reported? (y/n) 

If Yes, Provide 

Data

Time between

Biomarker 

Sampling and

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

17623801 Wu 

2007 

25(OH)D RIA Intrapair 

coefficient of 

variation 

(CV)=10.1% 

(n=15 triplets [1 

case and 2 

matching 

controls])

~7 to 14 y 

(based on 

blood 

collection, last 

follow-up, 

submission)

Winter: 28%

Spring/Fall: 

21%

Summer: 52%

455.7 IU/d

17623801 Wu 

2007 

Dietary 

calcium 

intake

FFQ nd nd 939 mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

17623801 Wu 2007 nd Colorectal cancer

The vast majority of colorectal cancers (>90%) confirmed through medical records; the 

remaining cases confirmed by corroborating information on cancer diagnosis from 

participants.

17623801 Wu 2007 nd Colon cancer

17623801 Wu 2007 nd Proximal colon cancer

17623801 Wu 2007 nd Distal colon cancer

17623801 Wu 2007 nd Rectal cancer

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

17623801 Wu 

2007

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Intakes of folate, calcium, retinol, meat intake

Demographics (e.g., age, gender, race, education)? Yes - age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes - BMI

Medical conditions Family history of colorectal cancer

Medication Aspirin use

Sunlight exposure and its proxy variables (e.g., physical activity level, 

occupation, sun exposure, location)

physical activity

Smoking and other life styles variables Yes - smoking, alcohol intake

Other Fasting status, month of blood donation

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean Vit 

D level / 

dose*****

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR,

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

17623801 Wu 2007 Colorectal 

cancer 

25(OH)D – quintile

1

18.4 45 71 Adjusted OR 1.0 (ref) 0.24

25(OH)D – quintile

2

25.0 44 71 Adjusted 0.97 0.55-

1.70

25(OH)D – quintile

3

29.1 30 68 Adjusted 0.66 0.35-

1.24

25(OH)D – quintile

4

33.3 23 74 Adjusted 0.51 0.27-

0.97

25(OH)D – quintile 39.4 37 72 Adjusted 0.83 0.45-
5 1.52

17623801 Wu 2007 Colon 

cancer

25(OH)D –

quartile 1

19.3 49 66 Adjusted OR 1.0 (ref) 0.005

25(OH)D –

quartile 2

26.7 44 68 Adjusted 0.74 0.42-

1.33

25(OH)D –

quartile 3

32.0 17 68 Adjusted 0.29 0.14-

0.59

25(OH)D –

quartile 4

38.8 29 74 Adjusted 0.46 0.24-

0.89

17623801 Wu 2007 Proximal 

colon 

cancer

25(OH)D –

quartile 1

19.3 20 30 Adjusted OR 1.0 (ref)

0.36

25(OH)D –

quartile 2

26.7 21 36 Adjusted 0.84 0.29-

2.41

25(OH)D –

quartile 3

32.0 10 35 Adjusted 0.35 0.11-

1.09

25(OH)D –

quartile 4

38.8 18 35 Adjusted 0.69 0.23-

2.08

17623801 Wu 2007 Distal 

colon 

cancer

25(OH)D –

quartile 1

19.3 19 27 Adjusted OR 1.0 (ref)

0.29

25(OH)D –

quartile 2

26.7 16 22 Adjusted 0.93 0.34-

2.55

25(OH)D –

quartile 3

32.04 21 Adjusted 0.31 0.07-

1.36

25(OH)D –

quartile 4

38.88 24 Adjusted 0.71 0.21-

2.39

17623801 Wu 2007 Rectal 

cancer

25(OH)D – tertile 

1

21.2 11 30 Adjusted OR 1.0 (ref) 0.08

25(OH)D – tertile 

2

29.3 15 28 Adjusted 1.74 0.61-

5.00

25(OH)D – tertile 

3

37.4 14 22 Adjusted 3.32 0.87-

12.69

17623801 Wu 2007 Colorectal 

cancer

(only >2y 

since 

blood 

donation) 

25(OH)D – quintile

1

18.4 36 58 Adjusted OR 1.0 (ref)

0.31

25(OH)D – quintile

2

25.0 38 55 Adjusted 1.29 0.66-

2.51

25(OH)D – quintile

3

29.1 22 56 Adjusted 0.63 0.31-

1.28

25(OH)D – quintile

4

33.3 20 60 Adjusted 0.63 0.30-

1.29

25(OH)D – quintile

5

39.4 29 59 Adjusted 0.84 0.41-

1.72

17623801 Wu 2007 Colon 

cancer

25(OH)D –

quartile 1

19.3 40 55 Adjusted OR 1.0 (ref) 0.008
(only >2y 

since 

blood 

donation)

25(OH)D –

quartile 2

26.7 37 52 Adjusted 0.91 0.46-

1.78

25(OH)D –

quartile 3

32.0 16 59 Adjusted 0.32 0.15-

0.69

25(OH)D –

quartile 4

38.8 20 58 Adjusted 0.43 0.20-

0.94

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

 P value for testing the linear trend of the OR/RR across different categories or doses 

** ***medians were calculated among control subject only. 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. 

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level 

SD*

Mean Ca 

intake or 

Ca 

balance

Ca 

SD*

P 

between 

groups

17623801 Wu 

2007 Cases: 8y Crude 179 28.7 9.2 917 419 0.07*

17623801 Wu 

2007 Control: 8y Crude 356 29.4 8.6 950 422

Duplicate one table per outcome 

*p value for plasma 25(OH)D concentrations 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results
UI Author

Year

Comments for Results

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean Vit 

D level / 

dose*****

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases**

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE / 

SD **

P 

between 

groups***

P for 

trend****

17623801 Wu 

2007 

Age<65y

Colorectal 

cancer 

25(OH)D – quartile 

1

19.3 25 34 Adjusted OR 1.0 (ref)

0.13

25(OH)D – quartile 

2

26.7 15 28 Adjusted 1.03 0.36-

2.91

25(OH)D – quartile 

3

32.0 9 30 Adjusted 0.38 0.12-

1.26

25(OH)D – quartile 

4

38.8 14 36 Adjusted 0.45 0.15-

1.40

17623801 Wu 

2007 

Age≥65y

Colorectal 

cancer 

25(OH)D – quartile 

1

19.3 34 55 Adjusted OR 1.0 (ref)

0.34

25(OH)D – quartile 

2

26.7 36 61 Adjusted 0.97 0.50-

1.87

25(OH)D – quartile 

3

32.0 19 58 Adjusted 0.56 0.27-

1.15

25(OH)D – quartile 

4

38.8 27 54 Adjusted 0.83 0.39-

1.75
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

17623801 Wu 

2007 

a) Eligibility 

criteria 

clear? (y/n)

nd

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

Y

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

Y

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

nd

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

nd

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

N

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

N

b) Loss to 

follow-up 

<20%? (y/n)

NA

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

N

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

N

b)

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

N

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): B

Explanation for Overall Quality Grade (if not Grade A): Some poor reporting on inclusion criteria, blinding. 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years Trial or Cohort Name Funding Source Extractor

7795837 Yamamoto 

1995

RCT -high-normal DBP (80 to 90 mm 

Hg) and not taking 

antihypertensive drugs

-BMI < 36.15 kg/m2

-black or white

-preexisting cardiovascular or 

life-threatening conditions

-conditions requiring or 

contraindicating and of the study 

interventions

-intent to become pregnant 

during the study period

-consuming more than 21 

alcohol-containing drinks weekly

nd Trials of Hypertension 

Prevention (TOHP)

NHLBI

NIH

MB

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health 

Status

Specific Nutrition 

Status Data (e.g., 

malnourish, low 

Vit D or Ca intake 

...etc.)

7795837 Yamamoto 

1995

RCT US, various 471 447 at 3 

mo.

438 at 6 

mo.

43±6.5 Age 

range: 

30-54

69% 86% 

white

10.5% 

black

BMI=27.4±3.7 “healthy” Ca intake= 

970mg/d

24-hr urinary 

Ca=189 mg

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

7795837 Yamamoto 

1995

25(OH)D 

and/or 

1,25(OH)2D

nd nd nd nd nd

7795837 Yamamoto 

1995

Dietary 

calcium 

intake

24-hr diet 

recall, FFQ

nd n Ca 970mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 
****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules 

were taken 2 times a day)

7795837 Yamamoto 

1995

Ca Calcium carbonate 1 g Ca 6 mo. Pills were taken 2 times a day

7795837 Yamamoto 

1995

placebo nd N/A 6 mo. Pills were taken 2 times a day

Co-intervention(s) *:

Compliance/Adherence:

Eligibility for randomization required consumption of at least two-thirds of 6 wks of supplement placebo dosing. During the study, 

pill counts were similar among race-gender subgroups and averaged 95% (with three-fourths taking at least 95% of their 

supplements). 

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 

LIST OF ALL OUTCOMES 

UI Author

Year Primary / Secondary Outcome** Outcome Definition

7795837 Yamamoto 1995 1o Δ in DBP

1o Δ in SBP

nd BMI

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

7795837 Yamamoto 

1995

Eligibility blood pressures (baseline) were calculated from the average of 9 seated readings taken over 3 visits, 10 to 30 days apart. Final pressures were 

calculated from 9 readings at 6 months. Blood pressure was taken by certified technicians using standardized techniques with a Hawksley random-zero 

sphygmomanometer. Pressures were taken at the visit’s start after the subject had been seated for 5 minutes. The first and fifth Korotkoff sounds were 

recorded.

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

7795837 Yamamoto 

1995

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Demographics (e.g., age, gender, race, education)? Ca/placebo groups similar age, 

race/gender, and education

Anthropometrics (e.g., BMI, body weight, % body fat)? Ca/placebo group similar BMI

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation 

of 25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Ca/placebo groups similar % current 

smokers and EtOH intake

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Delta** Delta 

SD*

Net 

difference

Net 

difference CI 

/ SE / SD*

P 

between

7795837 Yamamoto 

1995

BMI kg/m

2 Ca 6 mo. 217 27.4 3.7 +0.07 0.95 -0.05 NS

placebo 6 mo. 218 27.0 3.7 +0.12 1.02

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total N**

Crude or 

Adjusted 

analysis?

Outcome 

Metric (e.g. 

OR, RR, HR, 

%)

Outcome 

effect size

CI / 

SE / 

SD

**

P between 

groups***

P for 

trend****

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 
MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

7795837 Yamamoto 

1995

Overall, active treatment and placebo groups showed no significant differences for DBP or SBP after 3 or 6 months of Ca supplementation. Black men 

taking Ca showed BP increases, but CIs were wide. 

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Final or 

Delta**

Final 

or 

Delta 

CI / SE 

/ SD*

Net 

difference

Net 

difference 

CI / SE / 

SD*

P 

between

7795837 Yamamoto 

1995

DBP in 

white 

women

mmHg Ca 6 mo 62 83.8 2.9 -1.89 < 0.05

placebo 6 mo 60 83.5 2.9

7795837 Yamamoto 

1995

SBP in 

white 

women

mmHg Ca 3 mo 62 126.3 8.1 -3.68 < 0.05

placebo 3 mo 60 124.2 9.1

7795837 Yamamoto 

1995

SBP in 

white 

women

mmHg Ca 6 mo 62 126.3 8.1 -2.99 = 0.06

placebo 6 mo 60 124.2 9.1

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)
UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P 

between 

groups***

7795837 Yamamoto 

1995

SBP in 

white 

women

mmHg

20.3-124.9 

mg urinary 

Ca

Adjusted

3 mo. -8

P < 0.05 

(vs. 

placebo)

125.0-169.0 3 mo.

169.1-235.9 3 mo.

236-606.4 3 mo.

7795837 Yamamoto 

1995

DBP in 

white 

women

20.3-124.9 6 mo. -5

P < 0.01 

(vs. 

placebo)

125.0-169.0 6 mo.

169.1-235.9 6 mo.

236-606.4 6 mo.

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline SD*

Delta** Delta 

SD*

Net 

difference

Net 

difference CI 

/ SE / SD*

P 

between

7795837 Yamamoto 

1995

BMI in 

white men

kg/m2 Ca 6 mo. 130 27.6 3.5 -0.04 0.84 -0.02 NS

placebo 6 mo. 129 27.1 3.5 -0.02 1.05

BMI in 

black men

Ca 6 mo. 12 28.0 4.0 +0.58 0.46 +0.64 NS

placebo 6 mo. 11 28.4 4.9 -0.06 1.30

BMI in 

white 

women

Ca 6 mo. 59 27.5 3.9 +0.19 1.18 -0.14 NS

placebo 6 mo. 55 26.6 3.9 +0.33 0.96

BMI in 

black 

women

Ca 6 mo. 7 25.7 4.3 +0.28 1.00 -0.34 NS

placebo 6 mo. 13 27.3 3.6 +0.62 0.64

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

7795837 Yamamoto 

1995

RCTparallel Y Y NA Y nd N Y Y Y A

Adverse Event(s): ** For the Ca group compared to the placebo group, excessive gas and bloating were more frequently reported by white women

at 3 months and by whites, in general, at 6 months, and white men reported more loose stools at 6 months.

Explanation for Overall Quality Grade (if not Grade A): No major problems

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive?

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design* Inclusion Exclusion Enrollment 

Years

Trial or 

Cohort 

Name

Funding 

Source Extractor

9521437 Zheng

1998

Cohort 

study

Women 55-69 years old who 

completed a mailed questionnaire in 

January 1986 and were followed for 

mortality and cancer incidence for 9 

years

Baseline history of cancer, including melanoma; 

30 or more blanks on the dietary questionnaire; 

determined to have extreme total energy intake 

(<600 or ≥5000 kcal/day); not postmenopausal

1986 Iowa 

Women’s 

Health 

Study

US NCI AT

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or 

%body fat ...etc)

Health Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

9521437 Zheng

1998

Cohort 

study

Iowa, US

(40°23′ -

40°30′ N)

34702 34702 nd 55-59 years 

old: 107377 

person-yr; 

60-64 years 

old: 104081 

person-yr; 

≥65 years 

old: 81632 

person-yr

0 nd nd Pack-yr of 

smoking: Never 

192,062 personyr; <30 pack-yr; 

54,287 person-yr; 

≥30 pack-yr 

40,695 person-yr

Hormone 

replacement 

therapy: Never 

179,130 personyr; <5 years 

79,408 3 personyr; ≥5 years 

31,946 person-yr

Postmenopausal: 

100%

Total energy 

intake (tertile, 

kcal/day)

<1499.1: 97428 

person-yr; 1499.1-

1970.3: 97685 

person-yr; 

≥1940.4: 97987 

person-yr

Total fat intake 

(tertile, g/day)

<54.6: 97319 

person-yr; 54.6-

75.9: 97506 

person-yr; 

≥76.0: 98266 

person-yr

Total fruit and 

vegetable intake 

(tertile, 

servings/week)

<33.5: 96744 

person-yr; 33.5-

48.5: 98806 

person-yr; ≥48.6 

97540 person-yr

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 
***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.

Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

9521437 Zheng

1998

25(OH)D 

and/or 

1,25(OH)2D

NA NA NA NA NA

9521437 Zheng

1998

Dietary 

calcium 

intake

Semiquantitative 

FFQ (by Willet)

USDA Nutrient 

Database

y

For validity and 

reliability see 

Munger et al. Am J 

Epidemiol, 1992

Pearson’s 

correlation 

coefficients of

nutrient intake 

from FFQ with 

those from

five 24-h dietary 

recalls is 0.67 for 

calcium

Ca mg/d

< 800.8 

(n=56),

800.8-1278.8

(n=52),

> 1278.7

(n=36)

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, 

or formulation) 

Vit D and/or Ca Total 

Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. capsules were 

taken 2 times a day)

Co-intervention(s) *:

Compliance/Adherence:

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

9521437 Zheng

1998

secondary Rectal 

cancer

State Health Registry of Iowa, part of the Surveillance, Epidemiology, and End Results Program of the National Cancer 

Institute; cancer of the rectum (International Classification of Diseases-Oncology, code = 154)

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

9521437 Zheng

1998 Primary outcome: mortality; cancer incidence

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors) Specific comments for confounders

9521437 Zheng

1998

Other nutrients or dietary factors (e.g., certain food consumption), 

including supplement use and total energy intake

Yes (total energy intake)

Demographics (e.g., age, gender, race, education)? Yes (age)

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes (body mass index, fat and protein 

intake)

in some analyses

Medical conditions No

Medication Yes (use of hormone replacement 

therapy)

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

No

Smoking and other life styles variables (e.g., physical activity, 

occupation, alcohol consumption)

Yes (smoking status, pack-years of 

smoking)

in some analyses also: alcohol 

consumption , physical activity

Other

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline Baseline CI / SE / SD*

Final or 

Delta**

Final or 

Delta CI / 

SE / SD*

Net 

difference

Net difference 

CI / SE / SD*

P 

between

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level 

/ 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases 

/ 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI

P 

between 

groups***

P for 

trend****

9521437 Zheng

1998

Rectal 

cancer

Low total calcium 

intake tertile 

(mg/day)

<800.8 56 nd 108 adjusted RR 1.00

0.02 9521437 Zheng

1998

Rectal 

cancer

Intermediate total 

calcium intake 

tertile (mg/day)

800.8-

1278.7 

52 nd 108 adjusted RR 0.90 0.61-

1.33

nd
9521437 Zheng

1998

Rectal 

cancer

High total 

calcium intake 

tertile (mg/day)

≥1278.7 36 nd 108 adjusted RR 0.59 0.37-

0.94

nd

Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis? Mean

Follow-up 

(months)

No. 

Analyzed Baseline

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 

Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

UI Author

Year Comments for Results

9521437 Zheng

1998

Follow up: 9 years.

Subgroup analysis was also conducted based on intake sources of calcium (supplement vs. no supplement group)
-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

Adverse Event(s): **

Explanation for Overall Quality Grade (if not Grade A):

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 

QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

9521437 Zheng

1998

a) Eligibility 

criteria 

clear? (y/n)

Y

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

N

a) Method 

reported? 

(y/n)

Y

a) One of 

the 

prespecified 

methods***

was used? 

(y/n)

NA

a) Level of 

the 

exposure in 

comparative 

categories 

(eg 

quartiles) is 

given 

(ranges)? 

(y/n) 

applicable 

for 

categorical 

analyses 

only

Y

a) Adjusted 

or matched 

for ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

Y

a) Clear 

definition of 

outcome, 

including time 

of 

ascertainment? 

(y/n)

Y

a) 

Prospective 

collection of 

data? (y/n)

Y

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

N

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

N

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Y

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

NA

b) Loss to 

follow-up 

<20%? (y/n)

Y

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

Y

c) Internal 

calibration 

of method 

perform (if 

FFQ)? 

(y/n/NA)

Y

b) 

Justification 

of final 

adjusted 

model 

selection? 

(y/n)

Y

c) Do the 

authors specify 

a primary 

outcome? (y/n)

Y

c) 

Justification 

of sample 

size (includes 

sample size 

calculations)? 

(y/n)

N

OVERALL Grade (A/B/C): C

Explanation for Overall Quality Grade (if not Grade A):

Study designed for cancer incidence and mortality; not specifically for rectal cancer; power calculation for 

rectal cancer not stated; number of women without cancer per calcium tertile not reported; blinding for 

assessors not reported; confirmation of cancer cases by histology not reported 

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers 

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author

Year

Study 

Design*

Inclusion Exclusion Enrollment 

Years

Trial or Cohort 

Name Funding Source Extractor

18089701 Zhu 

2008

RCTpost hocSubstudy of the larger Calcium Intake 

Fracture Outcome Study (N=1500). The 

first 120 sequential patients presenting in 

September 1998 (end of winter in Western 

Australia) enrolled in this substudy.

Aged 70 yr old, and not receiving bone 

active agent

nd 1998 Substudy of 

Calcium Intake 

Fracture 

Outcome Study

Healthway Health Promotion 

Foundation of Western Australia, the 

Australian Menopause Society, and 

the Australian National Health and 

Medical Research Council

JHL

MC

*Leave appropriate choice of study design and delete all others 

**Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCT

POPULATION (BASELINE)**

UI Author

Year

Study 

Design*

Location 

(e.g., City 

and 

Country, 

latitude)

N 

enrolled***

N 

analyzed

Mean 

(SD) 

Age, 

yr

Age 

Range 

/ IQR

Male, 

%

Race / 

Ethnicity

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc)

Health Status

Specific 

Nutrition Status 

Data (e.g., 

malnourish, low 

Vit D or Ca 

intake ...etc.)

18089701 Zhu 

2008

RCT Western 

Australia 

120 120 74.8 

(2.6)

nd 0% nd nd nd (some 

subjects, unclear 

how many 

developed 

cancer or 

vascular disease 

during the study)

“living in sunny 

climate”

*Please copy from above

**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. 

***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. For case-cohort study, please 

report as detailed as possible information on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (eg. blood sample or dietary 

assessment), number of subjects had outcome data ...etc.
Background Diet*

UI Author

Year Exposure

Dietary 

Assessment 

Method**

Food 

Composition 

Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data

Time 

between 

Biomarker 

Sampling 

and 

Analysis

Season/Date 

when the 

biomarker 

samples were 

drawn

Background 

exposure 

data

18089701 Zhu 

2008

25(OH)D 

and/or 

1,25(OH)2D

25(OH)D -

competitive 

protein 

biding essay

n nd September 

1998 (end of 

winter in 

Western 

Australia) 

68.0 (28.7) 

nmol/liter

18089701 Zhu 

2008

Dietary 

calcium 

intake

Semiquantitative

food frequency 

questionnaire

nd nd 1010 mg/d

* Write “nd” if there was no data reported. Please do not leave blank

**Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief name described in the table 

***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Country-specific food tables, Other 

nutrient analysis (please specify) 

****ONLY biomarker of interest for calcium is calcium balance 

INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY 

UI Author

Year

Vit D and/or Ca 

Intervention(s)

Source (e.g., brand name, foods, or 

formulation) 

Vit D and/or Ca 

Total Daily Dose

Intervention 

Duration

Intervention Frequency (e.g. 

capsules were taken 2 times a day)

18089701 Zhu 

2008

Ca group + Placebo 

vitD 

Ca (Caltrate; Wyeth Consumer Healthcare, 

Baulkham Hills, New South Wales, Australia)

Ca 1200 mg 5y 600 mg of Ca twice/day

Placebo vitD (nd)

18089701 Zhu 

2008

CaD group Ca (Caltrate; Wyeth Consumer Healthcare, 

Baulkham Hills, New South Wales, Australia)

Ca 1200 mg

VitD2 1000 IU

5y 600 mg of Ca twice/day

1000 IU of vitD2 once/day

VitD2 (Ostelin; Boots Healthcare, North Ryde, 

New South Wales, Australia)

18089701 Zhu 

2008

Placebo group Placebo Ca (nd)

Placebo vitD (nd)

5y

Co-intervention(s) *: None

Compliance/Adherence: Measured by counting tablets returned every 12 months, so significant differences among 3 groups, Ca or placebo in the Ca, CaD, 

and control groups (80.9, 80.7, and 86.9% respectively), for vitD or placebo (84.2, 86.9, and 89.8% respectively)

Duplicate one row per intervention, including control intervention. 

*Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitamin D and/or calcium. 

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. 
LIST OF ALL OUTCOMES 

UI Author

Year

Primary / Secondary 

Outcome** Outcome Definition

18089701 Zhu 

2008

Secondary 25(OH)D Measured by competitive protein binding essay after column extraction

18089701 Zhu 

2008

Primary BMD Measured at the hip with an Acclaim 4500A fan beam densitometer (Hologic Corp., Waltham, MA) ay baseline yr 

1,3, and 5 using an identical protocol. 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 

**Must have been explicitly stated in the original paper. Otherwise, please enter “nd”

UI Author

Year Comments

-----Confounders: Please report all confounders controlled in the analyses reported in the following result section 

(adjusted results) 

UI Author

Year Confounder Groups Please List Name of Confounder 

(including matching factors)

Specific comments for 

confounders

18089701 Zhu 

2008

Other nutrients or dietary factors (e.g., certain food consumption), including 

supplement use and total energy intake

Baseline calcium intake and vitamin D status

Demographics (e.g., age, gender, race, education)? Yes* - Age

Anthropometrics (e.g., BMI, body weight, % body fat)? Yes * - height, body weight

Medical conditions

Medication

Sunlight exposure and its proxy variables (e.g., seasonal variation of 

25(OH)D, UV exposure, location)

Smoking and other life styles variables (e.g., physical activity, occupation, 

alcohol consumption)

Yes/no*

Other VitD status

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLECTION TABLE FOR 

ALL OUTCOMES OF INTEREST 

-----Main Analyses (For analyses that adjusted for confounders, choose the “best” model)

2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) 

UI Author 

Year Outcome Exposure / Intervention

Mean 

Follow-up, 

mo

N 

Event

N 

Total

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted Adjusted

Result 95% 

CI

P 

btw Result 95% CI

P 

btw

*Example: OR Ca/placebo 

2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author 

Year Outcome Unit Exposure / Intervention

Mean

Follow-up,

mo 

No. 

Analyzed Baseline*** Baseline SD*

Delta**

Delta 

CI / SE 

/ SD*

Net 

difference

Net 

difference 

SD*

P 

between

18089701 Zhu 

2008

Hip BMD mg/cm2 Ca group + Vit 

D

60 39 / 33 782.9 88.8 nd 2.2 % 1.1 % 0.05

Placebo 60 41 / 36 827.8 125.4 nd

18089701 Zhu 

2008

Hip BMD mg/cm2 Ca group + Vit 

D2

12 39 / 33 782.9 88.8 0.19 nd 1.2 % 0.6 % 0.04

Placebo 12 41/ 36 827.8 125.4 -1.27

18089701 Zhu 

2008

Hip BMD mg/cm2 Ca group + 

Placebo vit D

12 40 / 38 833.9 92.9 -0.17 nd 1.5 % 0.5 % 0.007

Placebo 12 41 / 36 827.8 125.4 -1.27

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Baseline data are for all subjects enrolled 

≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death)

UI Author

Year Outcome

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups

Mean 

Vit D 

level / 

dose

Mean 

Ca 

level / 

dose

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean

Follow-up,

mo

Crude or 

Adjusted 

analysis?

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%)

Outcome 

effect 

size

CI / 

SE 

/ 

SD

**

P 

between 

groups***

P for 

trend****
Duplicate one row per exposure category or intervention group. 

*Number of subjects with outcome 

**Please choose one and delete the others

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

****P value for testing the linear trend of the OR/RR across different categories or doses 

≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP)

UI Author

Year Outcome Unit

Exposure 

Category / 

Intervention 

Group

Crude or 

Adjusted 

analysis?

Mean

Follow-up 

(months)

No. 

Analyzed Baseline Baseline SD*

Final 

**

Final 

SD*

Net 

difference***

Net 

difference 

CI / SE / 

SD*

P between 

groups***

18089701 Zhu 

2008 25(OH)D nmol/liter Ca groupyear 1

Crude 12 37 66.6 25.9 64.5 26.5 nd nd NS

Ca group 

year 3

Crude 36 35 66.6 25.9 74.6 23.8 nd nd NS

Ca group 

year 5

Crude 60 34 66.6 25.9 63.7 28.7 nd nd NS

18089701 Zhu 

2008 25(OH)D nmol/liter CaD group 

year 1

Crude

12 34 70.2 25.6 97.8 31.8 nd nd

P < 0.001 

vs. Ca or 

control 

group

CaD group 

year 3

Crude

36 32 70.2 25.6 118.4 44.38 nd nd

P < 0.001 

vs. Ca or 

control 

group

CaD group 

year 5

Crude

60 29 70.2 25.6 106.4 29.0 nd nd

P < 0.001 

vs. Ca or 

control 

group

18089701 Zhu 

2008 25(OH)D nmol/liter Control group year 1

Crude 12 38 67.3 34.2 59.7 28.8 nd nd NS

Control 

group year 3

Crude 36 32 67.3 34.2 63.6 32.3 nd nd NS

Control 

group year 5

Crude 60 30 67.3 34.2 61.5 23.0 nd nd NS

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK.

*Please choose one and delete the others 

**Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 

***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 

MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH DISEASE) AND 

CONTROLS (WITHOUT DISEASE) 

UI Author

Year

Outcome 

Group

Time between 

Baseline Exposure 

and Outcome 

Assessments

Crude or 

Adjusted 

analysis?

No. 

Analyzed

Mean 

25(OH)D 

Level

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance

Ca CI 

/ SE / 

SD*

P 

between 

groups

Cases: 

Control: 
Duplicate one table per outcome 

OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE 

UI Author

Year Outcome Results

18089701 Zhu 

2008

Hip BMD Both Ca and CaD groups had significantly better maintenance of hip BMD than the control group at yr 1 (Ca-control: 1.5±0.5%, p=0.007; CaDcontrol: 1.2±0.6%, p=0.04). However, only the CaD group had significantly better maintenance of hip BMD, compared with the control group, at 

yr3 (CaD-control: 2.8±1.1%, p=0.01) and 5 (CaD-control: 2.2±1.1%, P=0.05). In the CaD group, there was no bone loss over the 5 yr of the study. 

The results were unchanged after adjusted for baseline age, height, and body weight.

UI Author

Year Comments for Results

18089701 Zhu 2008 No year-5 net change BMD data for Ca vs. placebo group but the net difference was not statistically significant.

This is a sub study of the larger Calcium Intake Fracture Outcome Study, a 5-yr double-blinded, randomized, controlled calcium

supplementation study, in which 1500 community-living ambulant women over the age of 70 yr were randomized to received either 1200mg

Calcium per day or identical placebo.

-----Subgroup Analyses 

Please copy the appropriate table above for all subgroup analyses of interest. 

UI Author

Year Outcome Results

18089701 Zhu 

2008

Hip BMD Further analysis was carried out by grouping subjects according to the median of the baseline 25OHD values (68nmol/liter). In those patients with 

25OHD concentrations below the median, the hip BMD was maintained, compared with controls, whereas in those with higher baseline 25OHD 

levels, there was no treatment effect. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author

Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA)

Allocation 

Concealment 

(y/n/nd/NA)

Appropriate 

Washout 

Period 

(y/n/nd/NA)

Dropout 

Rate 

<20%

Blinded 

Outcome 

Assessment 

(y/n/nd)

Intention 

to Treat 

Analysis 

(y/n/nd)

Appropriate 

Statistical 

Analysis**

(y/n)

Assessment 

for 

Confounding 

(y/n/nd/NA)

Clear 

Reporting 

with No 

Discrepancies

(y/n)

OVERALL 

Grade

18089701 Zhu 

2008

RCTparallel Y Y NA Y Y Y Y Y Y B

Adverse Event(s): ** No significant differences among the three groups in the rate of incident cancer or vascular disease. No case of kidney stones was reported.

Explanation for Overall Quality Grade 

(if not Grade A):

Differential dropout rates between groups. During the study, 2 patients withdrew from the Ca group, 6 from CaD group, and 5 from the control 

group. The reasons for the two withdrawals in the Ca group were concurrent illnesses or health concerns; in the CaD group, the reasons for 

withdrawal were personal reasons not related to the study (n=3), concurrent illnesses or health concerns (n=2), and investigator’s decision (n =1). 

In the control group, the reasons for withdrawal were personal reasons not related to the study (n=1), death (n=2), and investigator’s decision 

(n=2).

Not sure if all subjects had hip BMD measurements (not shown in table or figure, but assumed complete data for BMD in this data extraction form 

(excluding withdraws). ITT analyses.

Not all subjects had 25(OH)D data. Crude analysis for curve 4 data only. Grade C for curve 4 data.

No information on food composition database 

NA=not applicable 

*Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, RCT – Cluster, quasi-RCT, 

Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) 

**Please do not leave blank. Type nd if there was no data on adverse. 
QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES 

UI Author

Year Population Exposure (All) Dietary assessment*

Biomarkers* Comparator Statistical 

Analysis Outcome Design

a) Eligibility 

criteria clear? 

(y/n)

a) Exposure 

assessor 

blinded to 

outcome info? 

(y/n)

a) Method 

reported? 

(y/n)

a) One of the 

prespecified 

methods***

was used? 

(y/n)

a) Level of the 

exposure in 

comparative 

categories (eg 

quartiles) is 

given (ranges)? 

(y/n) 

applicable for 

categorical 

analyses only

a) Adjusted or 

matched for 

ANY 

confounders 

(other than 

age and 

sex)?** (y/n)

a) Clear 

definition of 

outcome, 

including time of 

ascertainment? 

(y/n)

a) Prospective 

collection of 

data? (y/n)

b) Sampling 

of population 

random or 

consecutive? 

(y/n)

b) Outcome 

assessor 

blinded to 

exposure 

measurement? 

(y/n)

b) Food 

composition 

database or 

suppl 

composition 

reported? 

(y/n)

Time from 

sample 

collection to 

sample 

analysis 

reported? 

(y/n)

b) Loss to 

follow-up <20%? 

(y/n)

b) Analysis 

was planned 

when cohort 

was formed? 

(y/n)

c) Internal 

calibration of 

method 

perform (if 

FFQ)? 

(y/n/NA)

b) 

Justification of 

final adjusted 

model 

selection? 

(y/n)

c) Do the 

authors specify 

a primary 

outcome? (y/n)

c) Justification 

of sample size 

(includes 

sample size 

calculations)? 

(y/n)

OVERALL Grade (A/B/C):

Explanation for Overall Quality Grade (if not Grade A):

*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers

**We will judge in the end if the set of confounders is adequate 

***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence 
ELIGIBILITY CRITERIA AND OTHER CHARACTERISTICS 

UI Author 

Year 

Study 

Design* Inclusion Exclusion Enrollment Years Trial o

Coho

Name 

18410225 Zhu, 

2008 

RCT Women between 70 and 90 yr of age were 

recruited from three sources: patients attending the emergency departments of teaching hospitals, patients receiving services from the local community home nursing service (Silver Chain) for management of falls, and the Electoral roll, which lists >98% of women of this age. The inclusion criteria were a plasma 25(OH)D <60 nM and a history of >1 fall in the previous 12 mo. 

Current vitamin D consumption, current consumption of bone or mineral active agents apart from calcium, a BMD Z-score at the total hip site of less than -2.0, medical conditions or disorders that influence bone mineral metabolism including lab evidence of renal insufficiency (creatinine >2-fold above 

the normal value), a fracture in the past 6 mo, and a Mini Mental State Exam score <24 or the presence of significant neurological conditions likely to substantially impair balance or physical activity such as stroke and Parkinson’s disease. 

April 2003 and October 2004 

nd 

*Leave appropriate choice of study design and delete all others **Post hoc analyses of an existing RCT for outcomes that were not planned in the original RCTPOPULATION (BASELINE)**

UI Author Year Study Design*

Location 

(e.g., City 

and 

Country, 

latitude) 

N 

enrolled***

N 

analyzed 

Mean 

(SD) 

Age, 

yr 

Age 

Range 

/ IQR 

Male, 

% 

Race / 

Ethnicity 

Anthropometry 

data (e.g., BMI, 

weight, or %body 

fat ...etc) 

Health 

18410225 Zhu, 

2008 

RCT Perth, 

Australia (32 °S) 

302 256 77 

(4.5) 

70 to 90 

0 nd Mean BMI = 29 nd (based 

inclusion exclusion assume swere not vhealthy buphysical functionin

*Please copy from above**Report baseline data for all subjects: preferred data for subjects actually analyzed than for subjects that enrolled in the study. ***For RCT, N enrolled is the number of subjects randomized. For cohort study, N enrolled is the total number of subjects fulfilled study inclusion criteria. 

report as detailed information as possible on subjects selection. For example, original cohort sample size, number of subjects provided exposure data (egassessment), number of subjects had outcome data ...etc. 
Background Diet*

UI Author Year Exposure Dietary Assessment Method** Food Composition Database***

Internal 

Calibration (or 

Validity) of 

Dietary 

Assessment? 

(y/n) If Yes, 

Provide Data 

Biomarker 

Assay****

Analytical 

Validity of 

Biomarker 

Data 

Reported? 

(y/n) If Yes, 

Provide Data 

Time 

between 

Biomarker 

Sampling 

and 

Analysis 

Sea

w

bio

sam

d

18410225 Zhu, 

2008 

25(OH)D RIA 

(DiaSorin, Stillwater, MN, USA) 

no nd nd 

Dietary calcium intake 

FFQ NUTTAB 90 no no 

* Write “nd” if there was no data reported. Please do not leave blank **Please refer to common dietary assessment method table. If other method was used, please describe the detail. Otherwise, please simply use the brief ***USDA Nutrient Database, Minnesota Food and Nutrient Database (NDSR), Food product manufacturer, McCance and Widdowson's food table, Count

nutrient analysis (please specify) ****ONLY biomarker of interest for calcium is calcium balance INTERVENTION(S), SKIP IF OBSERVATIONAL STUDY UI Author Year Intervention(s) Source (e.g., brand name, foods, or formulation) Vit D and/or Ca Total Daily Dose Intervention Duration Inter

capsule

18410225 Zhu, 

2008 

Vitamin D2 + Calcium 

Ostelin; Boots Healthcare, North Ryde, Australia 1000 IU vit D2 + 

1000 mg/d Ca 

1 yr Consume 

Calcium + placebo Calcium citrate (Citracal; Mission Pharmacal, 

Key Pharmaceutical, Phodes, Ausralia) 

1000 mg/d 1 yr Consume 

Co-intervention(s) *: None Compliance/Adherence: Tablet counting, 86.7% and 86.8% in the vitamin D and the control groups. Duplicate one row per intervention, including control intervention. *Report the non-vit D or Ca intervention(s) (e.g., other drug intervention, or background low-fat diet). We are interested in only independent effect of vitam

Therefore, describe how effects of co-intervention(s) were controlled for in the analyses or study design. LIST OF ALL OUTCOMES 

UI Author Year Primary / Secondary Outcome** Outcome Definition 

18410225 Zhu, 2008 primary BMD Hip and total body. DXA 

Secondary 25(OH)D 

Duplicate one row per outcome of interest. Only need to list outcomes that were included in the result section. 
**Must have been explicitly stated in the original paper. Otherwise, please enter “nd” 

UI Author 

Year Comments 

-----Confounders: Please report all confounders controlled in the analyses reported in the follow

(adjusted results) 

UI Author 

Year Confounder Groups Please List Name of Confounder (including matching factors) 

Other nutrients or dietary factors (e.g., certain food consumption), including supplement use and total energy intake 

Demographics (e.g., age, gender, race, education)? Yes/no*Anthropometrics (e.g., BMI, body weight, % body fat)? Yes/no*Medical conditions Medication Sunlight exposure and its proxy variables (e.g., seasonal variation of 25(OH)D, UV exposure, location) Smoking and other life styles variables (e.g., physical activity, occupation, alcohol consumption) 

Yes/no*

Other 

*Please choose “yes” if any one of the confounders in this group was controlled in the analysis 
FOLLOWING IS RESULT SECTION. PLEASE CHOOSE APPROPRIATE TYPE OF DATA COLLEC

ALL OUTCOMES OF INTEREST -----Main Analyses (For analyses that adjusted for confounders, choose the “best” model) 2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) UI Author Year Outcome Exposure / Intervention Mean Follow-up, 

mo 

N 

Event 

N 

Total 

Outcome Metric (e.g. OR, RR, HR, %) 

and direction of comparison*

Unadjusted 

Result 95% CI 

b

*Example: OR Ca/placebo 2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author Year Outcome Unit Exposure / Intervention Mean Follow-up, 

mo 

No. 

Analyzed Baseline Baseline SD* Delta** Delta SD* Net difference 

18410225 Zhu, 

2008 

25(OH)D nmol/L Vit D2 + Ca 12 123 44.8 12.7 34% nd 34% 

Ca 12 133 43.7 12.9 0% nd 

18410225 Zhu, 

2008 

Hip BMD mg/cm2 Vit D2 + Ca 12 123 851 127 0.5% 0.3 0.3% 

Ca 12 133 826 129 0.2% 0.2 

Baseline=baseline value; Final=final value; Delta=change value from baseline, which is Final-Baseline value; Net difference=differences in deltas 

*Enter outcome metric reported in the unadjusted or adjusted result section **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 ≥2 ARMS/GROUPS: DICHOTOMOUS OUTCOMES (e.g. OR, RR, %death) UI Author Year Outcome 

Exposure 

Categories(e.g., 

Tertiles) / 

Intervention 

Groups 

Mean 

Vit D 

level / 

dose 

Mean 

Ca 

level / 

dose 

No. of 

Cases 

(Event)* 

No. of 

Noncases / 

Total 

N**

Mean 

Follow-up, 

mo 

Crude or 

Adjusted 

analysis? 

Outcome 

Metric 

(e.g. OR, 

RR, HR, 

%) 

Outcome 

effect 

size 

Duplicate one row per exposure category or intervention group. *Number of subjects with outcome **Please choose one and delete the others ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 ****P value for testing the linear trend of the OR/RR across different categories or doses 
≥2 ARMS/GROUPS: CONTINOUS OUTCOMES (e.g. BMD, BP) 

UI Author Year Outcome Unit 

Exposure 

Category / 

Intervention 

Group 

Crude or 

Adjusted 

analysis? Mean Follow-up 

(months) 

No. 

Analyzed Baseline 

Baseline 

CI / SE / 

SD*

Final 

or 

Delta**

Final 

or 

Delta 

CI / 

SE / SD*

Net 

difference**

Duplicate one row per exposure category or intervention group. Please write “nd” if there was no data reported. DO NOT LEAVE BLANK. *Please choose one and delete the others **Delta value is preferred than the Final value. Please report the direction for the change by using “+” or “-“ sign: e.g. +2.8 or -2.8 ***Specify the comparison. For example group 1 vs. 3 = -6; group 1 vs. 2 = -8 MEAN DATA. THIS SHOULD ONLY APPLY TO CASE-COHORT STUDIES THAT COMPARE BASELINE VIT D / CA LEVELS BETWEEN CASES (WITH 

CONTROLS (WITHOUT DISEASE) UI Author Year Outcome Group 

Time between 

Baseline Exposure 

and Outcome 

Assessments 

Crude or 

Adjusted 

analysis? 

No. 

Analyzed 

Mean 

25(OH)D 

Level 

Vit D 

level CI 

/ SE / 

SD*

Mean Ca 

intake or 

Ca balance 

Ca CI 

/ SE / 

SD*

P 

between 

groups 

Cases: Control: 

Duplicate one table per outcome OTHER RESULTS. ONLY USE THE FOLLOWING BOX WHEN THE TYPE OF RESULT DATA DO NOT FIT THE TABLES PROVIDED ABOVE UI Author Year Outcome Results UI Author 

Year Comments for Results 

-----Subgroup Analyses Please copy the appropriate table above for all subgroup analyses of interest. 
QUALITY of INTERVENTIONAL STUDIES 

UI Author Year Design*

Appropriate 

Randomization 

Technique 

(y/n/nd/NA) 

Allocation 

Concealment 

(y/n/nd/NA) 

Appropriate 

Washout 

Period 

(y/n/nd/NA) 

Dropout 

Rate 

<20% 

Blinded 

Outcome 

Assessment 

(y/n/nd) 

Intention 

to Treat 

Analysis 

(y/n/nd) 

Appropriate 

Statistical 

Analysis**

(y/n) 

Assessm

for 

Confoun

(y/n/nd/

18410225 Zhu, 

2008 RCT yes yes NA yes nd yes yes no 

Adverse Event(s): ** There were no significant differences between the vitamin D and the cont

cancer and vascular disease (ischemic heart disease and stroke). There wvitamin D and the control groups, respectively. One participant in the vitamhypercalcemia one occasion. No case of renal calculus was reported. 1 participant was deceased during the study. 

Explanation for Overall Quality Grade (if not Grade A):NA=not applicable *Please do not copy the 4 categories of study designs from above sections. Specify the exact study design: RCT – Parallel, RCT – Cross-over, Non-randomized, but controlled trial, before-and-after trial, other interventional design (please explain in detail) **Please do not leave blank. Type nd if there was no data on adverse events. QUALITY of COHORT OR NESTED CASE-CONTROL STUDIES UI Author Year Population Exposure (All) Dietary assessment* Biomarkers* Comparator Statistical Analysis Outco

a) Eligibility criteria clear? (y/n) 

a) Exposure assessor blinded to outcome info? (y/n) 

a) Method reported? (y/n) 

a) One of the prespecified methods***was used? (y/n) 

a) Level of the exposure in comparative categories (eg quartiles) is given (ranges)? (y/n) applicable for categorical analyses only 

a) Adjusted or matched for ANY confounders (other than age and sex)?** (y/n) 

a) Clear definition of outcome, including timascertainme(y/n) 

b) Sampling of population random or consecutive? (y/n) 

b) Outcome assessor blinded to exposure measurement? (y/n) 

b) Food composition database or suppl composition reported? (y/n) 

Time from 

sample collection to sample analysis reported? (y/n) 

b) Loss to follow-up <2(y/n) 

c) Internal calibration of method perform (if FFQ)? (y/n/NA) 

b) Justification of final adjusted model selection? (y/n) 

c) Do the authors spea primary outcome? (

OVERALL Grade (A/B/C): Explanation for Overall Quality Grade (if not Grade A):*Check “NA” and skip all questions if study did not use dietary assessment or biomarkers **We will judge in the end if the set of confounders is adequate ***Prespecified methods: HPLC, RIA kits, LC-MS/MS; EIA/Chemiluminescence