Vitamin D + Omega-3 for Cancer and Cardiovascular Disease
(VITAL Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJulie E. Buring, ScD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Brigham and Women's Hospital

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The VITamin D and OmegA-3 TriaL (VITAL) 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 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. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.

Eligibility Criteria

The VITAL study is for U.S. adults without past heart disease, stroke, or cancer (except skin cancer). Men must be over 50 and women over 55. Participants shouldn't take more than small doses of vitamin D or calcium supplements, no fish oil supplements, and have no severe illnesses like kidney failure or liver disease.

Inclusion Criteria

No other serious illness that would preclude participation

Consuming no more than 800 IU of vitamin D from all supplemental sources combined, or willing to decrease or forego such use during the trial

Consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or willing to decrease or forego such use during the trial

+5 more

Participant Groups

This trial tests if daily vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can prevent cancer, heart disease, and stroke in healthy individuals. It's a randomized study where participants unknowingly get either the real supplement or a placebo.

4Treatment groups

Active Control

Placebo Group

Group I: Vitamin D placebo + fish oilActive Control2 Interventions

Group II: Vitamin D + fish oilActive Control2 Interventions

Group III: Vitamin D + fish oil placeboActive Control2 Interventions

Group IV: Vitamin D placebo + fish oil placeboPlacebo Group2 Interventions