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VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL)

NCT01747447 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 771

Last updated 2026-04-28

Study results available
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Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) 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 fish oil (1 gram of omega-3 fatty acids) 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 a sub-cohort of 771 participants in VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs. placebo on skeletal health and body composition.

Conditions

  • Bone Density
  • Body Composition
  • Bone Health

Interventions

DIETARY_SUPPLEMENT

Vitamin D3 placebo

Vitamin D placebo

DIETARY_SUPPLEMENT

Fish oil placebo

Fish oil placebo

DIETARY_SUPPLEMENT

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

Vitamin D3

Vitamin D3 (cholecalciferol), 2000 IU per day.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Meryl S LeBoff, M.D. · 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
2012-08-31
Primary Completion
2017-12-31
Completion
2023-08-02

Countries

  • United States

Study Locations

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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 NCT01747447 on ClinicalTrials.gov