27 Jul Brigham Study of Supplemental Vitamin D and Risk of Bone Fractures Reported in NEJM
MedicalResearch.com Interview with:
Meryl S. LeBoff, MD
Chief, Calcium and Bone SectionDirector of the Skeletal Health and Osteoporosis CenterDirector, Bone Density UnitDistinguished Chair in Skeletal Health and Osteoporosis
Professor of Medicine, Harvard Medical School
Endocrinology, Diabetes and Hypertension, Women’s Health
Brigham And Women’s Hospital
JoAnn E. Manson, MD, DrPH
Professor, Epidemiology, Harvard T.H. Chan School Of Public Health
Michael and Lee Bell Professor of Women’s Health, Medicine, Harvard Medical School
Chief, Preventive Medicine, Brigham And Women’s Hospital
Co-Director, Womens Health, Brigham And Women’s Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Osteoporosis is a major public health problem. Although supplemental vitamin D has been widely used to reduce the risk of fractures in the general population, studies of the effects of vitamin D on fractures, the most important bone health outcome, have been conflicting.
Randomized controlled trials, the highest quality studies, from around the world have shown benefit, no effect, or even harm of supplemental vitamin D on risk of fractures. Some of the trials used bolus dosing, had small samples sizes or short study duration, and co-administered calcium. No large RCTS of this scale tested whether daily supplemental vitamin D (without co-administration with calcium) prevented fractures in the US population.
To fill these knowledge gaps, we tested the hypothesis in this ancillary study to VITAL, whether daily supplemental vitamin D3 reduced the risk of incident total, non-spine and hip fractures in women and men in the US.
MedicalResearch.com: Are there potential risks of high dose Vitamin D supplementation?
Response: Supplemental vitamin D (2000 IU/d) over a median of 5.3 years was safe and there were no differences between the supplemental vitamin D and placebo groups in risk of hypercalcemia, kidney stones or kidney disease. A Data Safety Monitoring Board carefully monitored the safety of this intervention in the main VITAL study.
MedicalResearch.com: What should readers take away from your report?
Response: In this, the largest placebo-controlled randomized clinical trial including 25,871 participants enrolled from 50 states and a median follow-up of 5.3 years, supplemental vitamin D3 (2000 IU/d) did not reduce fracture risk in generally healthy, midlife and older women and men, not preselected for vitamin D deficiency or osteoporosis.
Our results do not support the use of vitamin D supplements to prevent fractures in generally healthy US men and women. These results do not apply to older adults in residential communities or those with severe vitamin D deficiency, low bone mass or osteoporosis
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Our ongoing studies are focusing on whether free vitamin D levels or genetic variation in vitamin D absorption, metabolism, or receptor function will provide information about individuals who may benefit from supplemental vitamin D on musculoskeletal health.
MedicalResearch.com: Is there anything else you would like to add?
Response: We would like to thank the NIH for supporting this VITAL ancillary study. Acknowledgments are included in the NEJM manuscript.
Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults
M.S. LeBoff and Others
N Engl J Med 2022;387:299-309
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