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

NCT01696435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18353

Last updated 2025-12-10

Study results available
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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.

Conditions

Interventions

DIETARY_SUPPLEMENT

vitamin D3

Vitamin D3 (cholecalciferol), 2000 IU per day

DRUG

omega-3 fatty acids (fish oil)

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 \[DHA\]).

DIETARY_SUPPLEMENT

Fish oil placebo

Fish oil placebo

DIETARY_SUPPLEMENT

Vitamin D placebo

Vitamin D placebo

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Olivia I Okereke, MD, SM · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2021-12-31
Completion
2025-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01696435 on ClinicalTrials.gov