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VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL)
Sponsor: Brigham and Women's Hospital
Summary
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among a sub-cohort of 771 participants in VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs. placebo on skeletal health and body composition.
Official title: VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
771
Start Date
2012-08
Completion Date
2023-08-02
Last Updated
2026-04-28
Healthy Volunteers
Yes
Conditions
Interventions
Vitamin D3 placebo
Vitamin D placebo
Fish oil placebo
Fish oil placebo
omega-3 fatty acids (fish oil)
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States