Vitamin D + Omega-3 for Diabetes Prevention

Recruiting in Palo Alto (17 mi)

Overseen byYiqing Song, MD, ScD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

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Trial Summary

What is the purpose of this trial?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 proposed study 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.

Eligibility Criteria

This trial is for men and women already participating in the VITAL study without a history of diabetes. It aims to see if taking daily supplements of vitamin D3 or omega-3 fatty acids can prevent type 2 diabetes in those who don't have it.

Inclusion Criteria

I was in the VITAL study and didn't have diabetes when it started.

Participant Groups

The trial tests whether daily doses of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can lower the risk of developing type 2 diabetes among participants with no prior instances of heart disease, cancer, or stroke.

4Treatment groups

Active Control

Placebo Group

Group I: Vitamin D and Omega-3Active Control2 Interventions

Group II: Vitamin D and Omega-3 placeboActive Control2 Interventions

Group III: Vitamin D placebo and Omega-3Active Control2 Interventions

Group IV: Vitamin D placebo and Omega-3 placeboPlacebo Group2 Interventions