D&B LÀ GÌ

List of authors.Meryl S. LeBoff, M.D., Sharon H. Chou, M.D., Kristin A. Ratliff, B.A., Nancy R. Cook, Sc.D., Bharti Khurana, M.D., Eunjung Kim, M.S., Peggy M. Cawthon, Ph.D., M.P.H., Douglas C. Bauer, M.D., Dennis Black, Ph.D., J. Chris Gallagher, M.D., I-Min Lee, M.B., B.S., Sc.D., Julie E. Buring, Sc.D., và JoAnn E. Manson, M.D., Dr.P.H.et al.

Abstract

Background

Vitamin D supplements are widely recommended for bone health in the general population, but data on whether they prevent fractures have been inconsistent.

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Methods

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Download a PDF of the Research Summary.

In an ancillary study of the vitamin D và Omega-3 Trial (VITAL), we tested whether supplemental vitamin D3 would result in a lower risk of fractures than placebo. VITAL was a two-by-two factorial, randomized, controlled trial that investigated whether supplemental vitamin D3 (2000 IU per day), n−3 fatty acids (1 g per day), or both would prevent cancer và cardiovascular disease in men 50 years of age or older and women 55 years of age or older in the United States. Participants were not recruited on the basis of vi-ta-min D deficiency, low bone mass, or osteoporosis. Incident fractures were reported by participants on annual questionnaires & adjudicated by centralized medical-record review. The primary over points were incident total, nonvertebral, and hip fractures. Proportional-hazards models were used khổng lồ estimate the treatment effect in intention-to-treat analyses.

Results

Among 25,871 participants (50.6% women <13,085 of 25,871> and 20.2% đen <5106 of 25,304>), we confirmed 1991 incident fractures in 1551 participants over a median follow-up of 5.3 years. Supplemental vi-ta-min D3, as compared with placebo, did not have a significant effect on total fractures (which occurred in 769 of 12,927 participants in the vi-ta-min D group and in 782 of 12,944 participants in the placebo group; hazard ratio, 0.98; 95% confidence interval , 0.89 lớn 1.08; P=0.70), nonvertebral fractures (hazard ratio, 0.97; 95% CI, 0.87 to lớn 1.07; P=0.50), or hip fractures (hazard ratio, 1.01; 95% CI, 0.70 khổng lồ 1.47; P=0.96). There was no modification of the treatment effect according to baseline characteristics, including age, sex, race or ethnic group, body-mass index, or serum 25-hydroxyvitamin D levels. There were no substantial between-group differences in adverse events as assessed in the parent trial.

Conclusions

Vitamin D3 supplementation did not result in a significantly lower risk of fractures than placebo among generally healthy midlife và older adults who were not selected for vitamin D deficiency, low bone mass, or osteoporosis. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases; VITAL ClinicalTrials.gov number, NCT01704859.)

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Supported by grants (R01 AR060574, R01 AR070854, & R01 AR059775, khổng lồ Dr. LeBoff) from the National Institute of Arthritis & Musculoskeletal and Skin Diseases. The VITAL parent trial is supported by grants (U01 CA138962, R01 CA138962, and R01AT011729, khổng lồ Drs. Manson và Buring) from the National Cancer Institute, the National Heart, Lung, & Blood Institute, the Office of Dietary Supplements, the National Institute of Neurological Disorders & Stroke, & the National Center for Complementary & Integrative Health.

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Disclosure forms provided by the authors are available with the full text of this article at oered.org.


A data sharing statement provided by the authors is available with the full text of this article at oered.org.


From the Division of Endocrinology, Diabetes, and Hypertension (M.S.L., S.H.C., K.A.R.), the Division of Preventive Medicine (N.R.C., E.K., I.-M.L., J.E.B., J.E.M.), and the Department of Radiology (B.K.), Brigham và Women’s Hospital, Harvard Medical School (M.S.L., S.H.C., N.R.C., B.K., I.-M.L., J.E.B., J.E.M.), and the Department of Epidemiology, Harvard T.H. Chan School of Public Health (N.R.C., I.-M.L., J.E.B., J.E.M.) — all in Boston; California Pacific Medical Center Research Institute (P.M.C.), và the Departments of Epidemiology và Biostatistics (P.M.C., D.C.B., D.B.) & Medicine (D.C.B.), University of California, San Francisco — both in San Francisco; and the Department of Endocrinology, Creighton University School of Medicine, Omaha, NE (J.C.G.).


Dr. LeBoff can be contacted at or at the Division of Endocrinology, Diabetes, và Hypertension, Brigham and Women’s Hospital, 221 Longwood Ave., Boston, MA 02115.