CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 25,871 enrolled
Drug / intervention
omega-3 fatty acids (fish oil) +3 moredrug
Likely dose
omega-3 fatty acids (fish oil) 840 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01169259
NCT01169259Phase 3Active
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Vitamin D and Omega-3 Trial (VITAL)

Brigham and Women's Hospital·interventional·Posted Jul 26, 2010·Updated Nov 6, 2025

In Brief

A Phase 3 clinical trial evaluating vitamin D3, omega-3 fatty acids (fish oil), and 2 other interventions for Cancer and Cardiovascular Disease. Active but no longer recruiting, targeting 25,871 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Cardiovascular Disease
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS), National Institute of Neurological Disorders and Stroke (NINDS), National Center for Complementary and Integrative Health (NCCIH), Pharmavite LLC, Pronova BioPharma, BASF

Timeline

Phase 3ActiveOverdue
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2010
Enrollment StartJul 1, 2010
Primary CompletionNov 10, 2018
Study CompletionMay 1, 2026
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 15.9 years ago

Interventions

vitamin D3dietary

Vitamin D3 (cholecalciferol), 2000 IU per day.

omega-3 fatty acids (fish oil)drug

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 \[DHA\]).

Vitamin D3 placebodietary

Vitamin D placebo

Fish oil placebodietary

Fish oil placebo