Journal
CONTEMPORARY CLINICAL TRIALS
Volume 41, Issue -, Pages 259-268Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2015.01.007
Keywords
Vitamin D; Fractures; Bone turnover; Omega-3 fatty acids; Bone mineral density; Trabecular bone score
Funding
- National Institute of Arthritis and Musculoskeletal and Skin Diseases [R01AR060574, R01AR59775]
- Harvard University
- Harvard Catalyst - the Harvard Clinical and Translational Science Center (NCRR)
- Harvard Catalyst - the Harvard Clinical and Translational Science Center (NCATS, NIH) [UL1 TR001102]
- [U01CA138962]
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Rationale: Although vitamin D is widely used to promote skeletal health, definitive data on benefits and risks of supplemental vitamin D alone on bone are lacking. Results from large, randomized controlled trials in the general population are sparse. Data on the effects of supplemental omega-3 fatty acids (FAs) on bone are also limited. Design: The VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled trial assessing the role of vitamin D-3 (2000 IU/d) and omega-3 FA (1 g/d) supplements in reducing risks of cancer and cardiovascular disease among U.S. men aged >= 50 and women aged >= 55. To comprehensively test effects of supplemental vitamin D and/or omega-3 FAs on skeletal health, the VITAL: Effects on Fractures ancillary study is determining the effects of these supplements on incident fractures among 25,875 participants enrolled in the parent trial. Study investigators adjudicate fractures through a detailed review of medical records and radiological images (hip and femur). In a complementary ancillary, VITAL: Effects on Structure and Architecture is determining the effects of supplemental vitamin D and/or omega-3 FM on bone with detailed phenotyping during in-person visits. Comprehensive assessments of bone density, turnover, structure/architecture, body composition, and physical performance are being performed at baseline and 2 years post-randomization. Conclusion: Results from these studies will clarify the relationship between supplemental vitamin D and/or omega-3 FM on bone health outcomes, and inform clinical care and public health guidelines on the use of supplemental vitamin D for the primary prevention of fractures in women and men. (C) 2015 Elsevier Inc. All rights reserved.
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