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

August 7, 2023 updated by: Meryl LeBoff, Brigham and Women's Hospital
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25871

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D + fish oil
Dietary supplement: Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Other Names:
  • cholecalciferol
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]).
Active Comparator: Vitamin D + fish oil placebo
Dietary supplement: Fish oil placebo
Fish oil placebo
Dietary supplement: Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Other Names:
  • cholecalciferol
Active Comparator: Vitamin D placebo + fish oil
Dietary supplement: Vitamin D3 placebo
Vitamin D placebo
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]).
Placebo Comparator: Vitamin D placebo + fish oil placebo
Dietary supplement: Vitamin D3 placebo
Vitamin D placebo
Dietary supplement: Fish oil placebo
Fish oil placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

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

Investigators

  • Principal Investigator: Meryl S LeBoff, M.D., Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 9, 2012

First Posted (Estimated)

October 12, 2012

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010P002005
  • 1R01AR070854-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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