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

Status Active, not recruiting

Clinical Trial Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) 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 a sub-cohort of 771 participants in VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs. placebo on skeletal health and body composition.

Clinical Trial Description

The VITAL: Effects on Bone Structure and Architecture is an ancillary study of the parent VITAL. This study has enrolled a sub-cohort of 771 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 dual x-ray absorptiometry (DXA); 2) reduces bone turnover as assessed by biomarkers of bone resorption and formation; 3) improves (a) volumetric bone mineral density (vBMD) and measures of bone structure as assessed by peripheral quantitative computed tomography (pQCT) and (b) bone microarchitecture as assessed by high resolution pQCT (HR-pQCT) at the distal radius and tibia as well as trabecular bone score (TBS) at the spine; and 4) results in changes in body composition as 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. We are currently analyzing the effects of daily dietary supplements of fish oil (1 gram of omega-3 fatty acids) vs. placebo on skeletal health and body composition. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01747447
Study type	Interventional
Source	Brigham and Women's Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	August 2012
Completion date	June 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL) — VITAL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms