Skip to main content
OpenTrials
Completed

NCT Number: NCT01704859

VITamin D and OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers

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 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 (1) whether vitamin D reduces incident total, non-vertebral fractures, and hip fractures and (2) whether this reduction is modified by vitamin D levels

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fractures Fractures, Bone Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

The VITAL: Vitamin D, Fractures, and Genetic Markers is an ancillary study of the parent VITAL trial (VITamin D and OmegA-3 TriaL). The study will require the adjudication of all self-reported incident fracture events among 25,871 men and women. Findings from this ancillary study will inform clinical practice on the role(s) of vitamin D supplements in fracture prevention. This proposal will generate important positive or informative negative results about effects of supplemental vitamin D3 alone on fracture risk, while also elucidating the relative importance of vitamin D biomarkers and genetic variations in vitamin D-related pathways on bone. Findings from the proposed ancillary study have the potential for major clinical as well as public health impact for both men and women in the U.S.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

All participants from the VITAL parent study (NCT01169259) were enrolled in this ancillary study.

Treatment and study plan

Vitamin D3 placebo

Dietary Supplement

Vitamin D placebo

Fish oil placebo

Dietary Supplement

Fish oil placebo

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]).

Vitamin D3

Dietary Supplement

Vitamin D3 (cholecalciferol), 2000 IU per day.

Other names: cholecalciferol

Primary outcomes

  1. Incident total, non-vertebral, and hip fractures

    Time frame: 5 years

    To determine whether vitamin D supplementation will reduce incident total, non-vertebral, and hip fractures according to annual questionnaires, medical record review, and fracture adjudication.

Secondary outcomes

  1. Incident total, non-vertebral, and hip fractures

    Time frame: 5 years

    To determine whether baseline vitamin D levels and genetic variation in vitamin D-related pathways modify effects of vitamin D supplements on fractures.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2012
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.