At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Diabetes Prevention in the Vitamin D and Omega-3 Trial
In Brief
A Phase 3 clinical trial evaluating Vitamin D3, Omega-3 fatty acid (fish oil), and 2 other interventions for Type 2 Diabetes. Completed, enrolled 22,220 participants across 1 site.
Detailed Summary
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) 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 nondiabetic participants in VITAL and will examine whether vitamin D or fish oil prevent type 2 diabetes. Findings from this ancillary study (n=22220 without diabetes at baseline) conducted within the VITAL trial will clarify whether vitamin D and omega-3 fatty acid supplementation reduces risk of type 2 diabetes and thus will inform public health and clinical guidelines for diabetes prevention.
Study Details
Timeline
Interventions
Vitamin D3 (cholecalciferol), 2000 IU per day.
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 placebo
Fish oil placebo