Overview

This trial is active, not recruiting.

Condition fractures
Treatments vitamin d3 placebo, fish oil placebo, omega-3 fatty acids (fish oil), vitamin d3
Sponsor Brigham and Women's Hospital
Collaborator National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date July 2010
End date October 2017
Trial size 25875 participants
Trial identifier NCT01704859, 1R01AR060574-01, 2010P002005

Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,874 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 will (1) reduce incident total fractures and (2) reduce incident hip and non-vertebral fractures.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
vitamin d3 placebo
Vitamin D placebo
fish oil placebo
Fish oil placebo
(Active Comparator)
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: Vitamin D3 placebo.
vitamin d3 placebo
Vitamin D placebo
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)
Dietary Supplement: vitamin D3. Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol Dietary Supplement: Fish oil placebo
fish oil placebo
Fish oil placebo
vitamin d3 cholecalciferol
Vitamin D3 (cholecalciferol), 2000 IU per day.
(Active Comparator)
Dietary Supplement: vitamin D3. Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: 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]).
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]).
vitamin d3 cholecalciferol
Vitamin D3 (cholecalciferol), 2000 IU per day.

Primary Outcomes

Measure
Incident total fractures
time frame: 2 years

Secondary Outcomes

Measure
Incident hip and non-vertebral fractures
time frame: 2 years

Eligibility Criteria

Male or female participants at least 50 years old.

All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.

Additional Information

Official title Vitamin D and Omega-3 Fatty Acids (VITAL Trial): Effects on Fractures
Principal investigator Meryl S LeBoff, M.D.
Description The VITAL: Effects on Fracture Study 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 25,874 men and women. Findings from this ancillary study will inform clinical practice on the role(s) of vitamin D and/or omega-3 fatty acid supplements in fracture prevention. Because of the very high prevalence of low vitamin D levels and fractures in older adults, this trial will enable us to prove or disprove whether high-dose vitamin D and/or fish oil supplementation is effective in the primary prevention of age-related osteoporotic fractures in the U.S. These nutritional supplements may offer low-cost preventative interventions and reduce the burden of osteoporotic fractures with the potential for substantial individual and public health benefits.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.