Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL): Effects on Bone Structure and Architecture

• Published in: Contemporary clinical trials 2018-04, Vol.67, p.56-67
• Main Authors: Donlon, Catherine M., LeBoff, Meryl S., Chou, Sharon H., Cook, Nancy R., Copeland, Trisha, Buring, Julie E., Bubes, Vadim, Kotler, Gregory, Manson, JoAnn E.
• Format: Article
• Language: English
• Subjects: Absorptiometry, Photon - methods; Biological Availability; Body composition; Body Composition - drug effects; Bone Density - drug effects; Bone mineral density; Cardiovascular Diseases - prevention & control; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Fatty Acids, Omega-3 - administration & dosage; Fatty Acids, Omega-3 - pharmacokinetics; Female; Humans; Male; Middle Aged; Neoplasms - prevention & control; Omega-3 fatty acids; Physical Functional Performance; Physical performance; Primary Prevention; Sex differences; Sex Factors; Vitamin D; Vitamin D - administration & dosage; Vitamin D - pharmacokinetics; Vitamins - administration & dosage; Vitamins - pharmacokinetics
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2018.02.003

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.