VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
50 Years
N/A
Both
Bone Density, Body Composition, Bone Health
Trial Information
VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
The VITAL: Effects on Bone Structure and Architecture is an ancillary study of the parent
VITAL. This study will enroll a sub-cohort of 600 VITAL participants at the NIH-sponsored
Harvard Catalyst Clinical and Translational Science Center (CTSC). The following
measurements will be performed at baseline and 2 years post-randomization to determine
whether high-dose vitamin D supplementation vs. placebo: 1) Produces small increases or
reduces bone loss in spine, hip, and total body areal bone density as assessed by DXA; 2)
reduces bone turnover as assessed by biomarkers of bone resorption and formation; 3)
Improves measures of bone structure at the distal radius and tibia; 4) results in changes in
body composition assessed by DXA. Parallel assessments of the effects of omega-3 fatty acids
will be performed. This study may elucidate the mechanisms through which high-dose vitamin D
may prevent age-related fractures and provide new insights into the role of vitamin D on
skeletal health and body composition.
Inclusion Criteria
Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to
participate in this ancillary study:
- Those who are using bisphosphonates currently or within the past 2 years, or other
bone-active medications currently or within the past year are not eligible for this
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:
Bone density
Outcome Description:
To determine whether vitamin D and/or fish oil supplementation produces small increases or reduces bone loss in spine, hip, and total body areal bone density,as assessed by DXA.
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:
2012P000560
NCT ID:
NCT01747447
Start Date:
August 2012
Completion Date:
June 2016
Related Keywords:
- Bone Density
- Body Composition
- Bone Health
Name | Location |
|---|---|
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
