Vitamin D and Omega-3 Trial (VITAL)

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.

Conditions

• Cancer
• Cardiovascular Disease

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Office of Dietary Supplements (ODS)

  collaborator NIH

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Pharmavite LLC

  collaborator INDUSTRY

• Pronova BioPharma

  collaborator INDUSTRY

• BASF

  collaborator INDUSTRY

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• JoAnn E. Manson, MD, DrPH · Brigham and Women's Hospital

• Julie E. Buring, ScD · 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

2018-11-10

Completion

2026-05-31

FDA Drug

Yes

Countries

• United States

Study Locations