Vitamin D and Omega-3 Fatty Acids (VITAL Trial): Effects on Fractures
This trial is active, not recruiting.
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
Incident total fractures
time frame: 2 years
Incident hip and non-vertebral fractures
time frame: 2 years
Male or female participants at least 50 years old.
All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.
|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.|
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