Spots Global Cancer Trial Database for Finnish Vitamin D Trial (FIND)

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Trial Identification

Brief Title: Finnish Vitamin D Trial (FIND)

Official Title: Finnish Vitamin D Trial (FIND)

Study ID: NCT01463813

Conditions

Cardiovascular Diseases

Cancer

Interventions

Vitamin D3

Placebo

Study Description

Brief Summary: 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: More detailed description available upon request.