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ACTIVE NOT RECRUITING
NCT01169259
PHASE3

Vitamin D and Omega-3 Trial (VITAL)

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25871

Start Date

2010-07

Completion Date

2026-05

Last Updated

2025-11-06

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

vitamin D3

Vitamin D3 (cholecalciferol), 2000 IU per day.

DRUG

omega-3 fatty acids (fish oil)

Omacor, one 1-gram 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 \[DHA\]).

DIETARY_SUPPLEMENT

Vitamin D3 placebo

Vitamin D placebo

DIETARY_SUPPLEMENT

Fish oil placebo

Fish oil placebo

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States