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Vitamin D and Omega-3 Fatty Acids (VITAL Trial): Effects on Fractures


N/A
50 Years
N/A
Open (Enrolling by invite only)
Both
Fractures

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Trial Information

Vitamin D and Omega-3 Fatty Acids (VITAL Trial): Effects on Fractures


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 10,000 men and 10,000 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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Incident total fractures

Outcome Description:

To determine whether vitamin D and/or fish oil supplementation will reduce incident total fractures according to annual questionnaires, medical record review, and fracture adjudication.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Meryl S LeBoff, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital

Authority:

United States: Institutional Review Board

Study ID:

2010P002005

NCT ID:

NCT01704859

Start Date:

July 2010

Completion Date:

June 2016

Related Keywords:

  • Fractures
  • fracture
  • Fractures, Bone

Name

Location

Brigham and Women's HospitalBoston, Massachusetts  02115