Finnish Vitamin D Trial (FIND)

Study Overview
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Brief Summary
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The Finnish Vitamin D Trial (FIND) is a randomized, double-blind, placebo-controlled, 5-year supplementation study of the benefits and risks of vitamin D in the primary prevention of cardiovascular (CVD) and cancer among 18000 men 60 years or older and women 65 years or older. [Edit 25.3.2015: Due to difficulties in recruitment and funding, the study size is approximately 2500 subjects, with a 550 subject subgroup with more detailed examinations] The participants will be randomized to 3 groups with 6000 in each, with daily supplementation of either: 1) 40 µg/day (1600 IU) of vitamin D3, 2) 80 µg/day (3200 IU) of vitamin D3, or 3) placebo. [Edit 15.3.2015: The 2500 subjects are randomized in 3 groups, approximately 830 subjects per group.] Compliance, use of non-study drugs or supplements, diet, development of endpoints, and CVD and cancer risk factors will be assessed by questionnaires. Blood samples will be collected for assessment of effect modification by baseline 25-hydroxyvitamin D, as well as for future ancillary studies of genetic/biochemical hypotheses. Event data will be obtained by record linkage from the national computerized hospitalization registry.

Detailed Description
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More detailed description available upon request.

Official Title
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Finnish Vitamin D Trial (FIND)

Conditions
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Cardiovascular Diseases, Cancer

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Dietary Supplement: Vitamin D3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men 60 years or older Women 65 years or older Exclusion Criteria: Cardiovascular disease (including myocardial infarction, stroke, transient ischemic attack, angina pectoris, coronary artery bypass grafting, or percutaneous coronary intervention). Cancer (except non-melanoma skin cancer). Any disease or state that raises a vitamin D related safety concern (such as chronic liver, thyroid or kidney disease, hypercalcemia, sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis). Use of supplements yielding vitamin D over 20 µg/day or calcium over 1200 mg/day and unwillingness to discontinue the use.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo, no Vitamin D3 | Dietary Supplement: Placebo<br>* Inactive placebo<br>|
| Experimental: Vitamin D3 80<br>Vitamin D3 80 micrograms (3200 IU) per day | Dietary Supplement: Vitamin D3<br>* Vitamin D3 80 micrograms (3200 IU) per day<br>* Other names: Cholecalciferol;|
| Experimental: Vitamin D3 40<br>Vitamin D3 40 micrograms (1600 IU) per day | Dietary Supplement: Vitamin D3<br>* Vitamin D3 40 micrograms (1600 IU) per day<br>* Other names: Cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular disease | CVD incidence in VitD arms vs. placebo arm. | 5 years | 
| Cancer | Cancer incidence in VitD arms vs.placebo arm | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, bone density conservation agents, cardiovascular disease, cholecalciferol, diabetes mellitus, type 2, dietary supplements, primary prevention, vitamin D