CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18,353 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/NCT01696435
NCT01696435N/ACompleted

VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL

Brigham and Women's Hospital·interventional·Posted Oct 1, 2012·Updated Dec 10, 2025

In Brief

A clinical study evaluating vitamin D3, omega-3 fatty acids (fish oil), and 2 other interventions for Depression and 2 related conditions. Completed, enrolled 18,353 participants across 1 site.

Detailed Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing 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. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil: 1) reduces risk of clinical depressive syndrome, 2) yields better mood scores over time, compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 1, 2012
Enrollment StartJul 1, 2010
Primary CompletionDec 31, 2021
Study CompletionMar 31, 2025
TodayJul 2, 2026
Enrollment to primary: 11.5 yearsPosted 13.8 years ago

Interventions

vitamin D3dietary

Vitamin D3 (cholecalciferol), 2000 IU per day

omega-3 fatty acids (fish oil)drug

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 \[DHA\]).

Fish oil placebodietary

Fish oil placebo

Vitamin D placebodietary

Vitamin D placebo