Clinical trial NCT01053481: Using Ca-41 Methodology to Assess the Impact of Different Vitamin D Supplementation Levels on Postmenopausal Bone Health
Official title: Using Ca-41 Methodology to Assess the Impact of Different Vitamin D Supplementation Levels on Postmenopausal Bone Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Osteopenia
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2010-01-21
Enrollment: 25
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether increasing levels of serum 25(OH)Vitamin D as achieved by oral supplementation higher than the current recommendations are associated with a less negative bone calcium balance in post-menopausal Swiss women.

Detailed description: In a substudy - not related to the vitamin D intervention - spot and 24 h urine samples are compared with regard to the assessment of iodine status in Swiss post-menopausal women.

In an short subsequent study using five of the subjects who participated in the original trial, the effect of a 40 d-exercise program (rebounding on a trampoline) on Ca-41 excretion will be observed.

Eligibility criteria: Inclusion Criteria:

* apparently healthy women, at least 5 years post-menopausal
* BMI 18-30
* no HRT
* no regular intake of Ca or vit D supplements
* wiling and able to give written informed consent and to understand, participate and comply with study requirements
* non-smokers
* no long travels (\>3 wk) planned within study period

Exclusion Criteria:

* diseases that predispose to osteoporosis
* history of fragility fractures
* currently on a weight reduction program
* excessive physical activity
* diseases influencing calcium metabolism (thyroid, parathyroid, adrenal disorders etc.)
* regular intake of medication affecting calcium metabolism
* osteoporosis (T-score below -2.5)
* history of psychological illness likely to interfere with the subject's ability to understand the requirements of the study
* participation in concurrent studies

Primary outcomes:
measure: urinary Ca-41/Ca-40 ratio
timeFrame: March 2010 to January 2011
Secondary outcomes:
measure: biomarkers of bone metabolism
timeFrame: March 2010 to January 2011
measure: urinary iodine
timeFrame: August 2009 to December 2010
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich
Study officials:
affiliation: ETH Zurich
name: Michael B Zimmermann, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Denk E, Hillegonds D, Hurrell RF, Vogel J, Fattinger K, Hauselmann HJ, Kraenzlin M, Walczyk T. Evaluation of 41calcium as a new approach to assess changes in bone metabolism: effect of a bisphosphonate intervention in postmenopausal women with low bone mass. J Bone Miner Res. 2007 Oct;22(10):1518-25. doi: 10.1359/jbmr.070617.
citation: Denk E, Hillegonds D, Vogel J, Synal A, Geppert C, Wendt K, Fattinger K, Hennessy C, Berglund M, Hurrell RF, Walczyk T. Labeling the human skeleton with 41Ca to assess changes in bone calcium metabolism. Anal Bioanal Chem. 2006 Nov;386(6):1587-602. doi: 10.1007/s00216-006-0795-5. Epub 2006 Oct 11.
citation: Schild A, Herter-Aeberli I, Fattinger K, Anderegg S, Schulze-Konig T, Vockenhuber C, Synal HA, Bischoff-Ferrari H, Weber P, von Eckardstein A, Zimmermann MB. Oral Vitamin D Supplements Increase Serum 25-Hydroxyvitamin D in Postmenopausal Women and Reduce Bone Calcium Flux Measured by 41Ca Skeletal Labeling. J Nutr. 2015 Oct;145(10):2333-40. doi: 10.3945/jn.115.215004. Epub 2015 Sep 2.