Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL): Effects on Bone Structure and Architecture
Catherine M Donlon, Meryl S LeBoff, Sharon H Chou, Nancy R Cook, Trisha Copeland, Julie E Buring, Vadim Bubes, Gregory Kotler, JoAnn E Manson, Catherine M Donlon, Meryl S LeBoff, Sharon H Chou, Nancy R Cook, Trisha Copeland, Julie E Buring, Vadim Bubes, Gregory Kotler, JoAnn E Manson
Abstract
Vitamin D supplements are often used to benefit skeletal health, although data on effects of daily high-dose vitamin D alone on bone density and structure are lacking. The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, randomized, placebo-controlled trial testing effects of high-dose supplemental vitamin D3 (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (FAs; 1 g/day) for the primary prevention of cancer and cardiovascular disease. The study has a mean treatment period of 5 years among 25,874 U.S. men ≥50 years and women ≥55 years old from all 50 states. The ancillary study, VITAL: Effects on Bone Structure and Architecture, is testing effects of vitamin D3 and/or omega-3 FAs on musculoskeletal outcomes and body composition in a subcohort of 771 participants. At in-person visits at the Harvard Catalyst Clinical and Translational Science Center (CTSC), participants completed bone density/architecture, body composition, and physical performance assessments at baseline and two-year follow-up. Baseline characteristics were evenly distributed among treatment groups, suggesting that any uninvestigated confounders will be evenly distributed; sex differences were also analyzed. Future analyses of the two-year follow-up visits will elucidate whether daily high-dose, supplemental vitamin D3 and/or omega-3 FAs improve musculoskeletal outcomes, helping to advance clinical and public health recommendations.
Clinical trial registration number: NCT01747447.
Keywords: Body composition; Bone mineral density; Omega-3 fatty acids; Physical performance; Sex differences; Vitamin D.
Conflict of interest statement
Disclosure Statement: The authors have nothing to disclose.
Copyright © 2018 Elsevier Inc. All rights reserved.
Source: PubMed