Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL): Effects on Bone Structure and Architecture
| Autor: | Julie E. Buring, JoAnn E. Manson, Trisha Copeland, Vadim Bubes, Nancy R. Cook, Catherine M. Donlon, Meryl S. LeBoff, Gregory Kotler, Sharon H. Chou |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Male
Vitamin medicine.medical_specialty Bone density Biological Availability 030209 endocrinology & metabolism Article 03 medical and health sciences chemistry.chemical_compound Absorptiometry Photon Sex Factors 0302 clinical medicine Double-Blind Method Bone Density Neoplasms Internal medicine Fatty Acids Omega-3 medicine Vitamin D and neurology Humans Pharmacology (medical) 030212 general & internal medicine Vitamin D Dose-Response Relationship Drug business.industry Public health Confounding Vitamins General Medicine Middle Aged Physical Functional Performance Vitamin D and Omega-3 Trial Primary Prevention Clinical trial chemistry Cardiovascular Diseases Dietary Supplements Body Composition Female Cholecalciferol business |
| Zdroj: | Contemporary Clinical Trials. 67:56-67 |
| ISSN: | 1551-7144 |
| DOI: | 10.1016/j.cct.2018.02.003 |
| Popis: | 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 . |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect