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VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture


N/A
50 Years
N/A
Open (Enrolling by invite only)
Both
Bone Density, Body Composition, Bone Health

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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 HospitalBoston, Massachusetts  02115