Finnish Vitamin D Trial (FIND)
NCT01463813 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2495
Last updated 2018-10-23
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Vitamin D3
Vitamin D3 40 micrograms (1600 IU) per day
- DIETARY_SUPPLEMENT
-
Vitamin D3
Vitamin D3 80 micrograms (3200 IU) per day
- DIETARY_SUPPLEMENT
-
Placebo
Inactive placebo
Sponsors & Collaborators
-
Academy of Finland
collaborator OTHER -
Juho Vainio Foundation
collaborator OTHER -
Finnish Foundation for Cardiovascular Research
collaborator OTHER -
Finnish Cultural Foundation
collaborator OTHER -
University of Eastern Finland
lead OTHER
Principal Investigators
-
Tomi-Pekka Tuomainen, MD, PhD · University of Eastern Finland
-
Jyrki K Virtanen, PhD · University of Eastern Finland
-
Sari Voutilainen, PhD · University of Eastern Finland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-09-30
- Primary Completion
- 2018-10-31
- Completion
- 2018-10-31
Countries
- Finland
Study Locations
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