Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults
LeBoff MS, Chou SH, Ratliff KA, Cook NR, Khurana B, Kim E, Cawthon PM, Bauer DC, Black D, Gallagher JC, Lee IM, Buring JE, Manson JE
The New England journal of medicine · 224 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute on Aging
- Gobierno
- National Cancer Institute
- Gobierno
- National Institute of Arthritis and Musculoskeletal and Skin Diseases
- Gobierno
- National Center for Complementary and Integrative Health
- Gobierno
- NCCIH NIH HHS
- Gobierno
- NIAMS NIH HHS
- Gobierno
- NCI NIH HHS
- Gobierno
- NIA NIH HHS
- Subvenciones
- National Cancer Institute (U01CA138962); National Institute on Aging (R01AG071611); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01 AR060574); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR070854); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR059775); National Cancer Institute (R01CA138962); National Center for Complementary and Integrative Health (R01AT011729)
Según 8 financiadores declarados.
Publicación
- Publicado
- 2022-07-27 · N Engl J Med · vol. 387 · número 4 · págs. 299–309
- Editorial
- Massachusetts Medical Society
- Citado
- 305 citas
- Referencias
- 37 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Bone health and osteoporosis research · Nutrition and Health Studies
- Palabras clave
- vitamin D supplementation, fracture prevention, hip fracture, non-vertebral fractures, middle-aged and older adults, omega-3 fatty acids, VITAL trial, bone health, osteoporosis
- MeSH
- humans, osteoporosis, vitamin d deficiency, hip fractures, cholecalciferol, fatty acids, omega-3, double-blind method, dietary supplements, aged, middle aged, female, male, fractures, bone
13 autores
- Meryl Susan LeBoff🇺🇸Brigham and Women's Hospital; Harvard University; University of California, San Francisco
- Sharon Hsiao-Han Chou🇺🇸Brigham and Women's Hospital; Harvard University; University of California, San Francisco
- Kristin A. Ratliff🇺🇸Brigham and Women's Hospital; Harvard University; University of California, San Francisco
- Nancy R. Cook🇺🇸Brigham and Women's Hospital; Harvard University; University of California, San Francisco
- Bharti Khurana🇺🇸Brigham and Women's Hospital; Harvard University; University of California, San Francisco
- Eun‐Jung Kim🇺🇸Brigham and Women's Hospital; Harvard University; University of California, San Francisco
- Peggy Mannen Cawthon🇺🇸Brigham and Women's Hospital; Harvard University; University of California, San Francisco; California Pacific Medical Center
- Douglas C. Bauer🇺🇸Brigham and Women's Hospital; Harvard University; University of California, San Francisco
- Dennis M. Black🇺🇸Brigham and Women's Hospital; Harvard University; University of California, San Francisco
- Gallagher JA🇺🇸Creighton University; Brigham and Women's Hospital; Harvard University; University of California, San Francisco
- I‐Min Lee🇺🇸Brigham and Women's Hospital; Harvard University; University of California, San Francisco
- Julie E. Buring🇺🇸Brigham and Women's Hospital; Harvard University; University of California, San Francisco
- JoAnn E. Manson🇺🇸Brigham and Women's Hospital; Harvard University; University of California, San Francisco
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Vitamin D supplements are widely recommended for bone health in the general population, but data on whether they prevent fractures have been inconsistent.
Methods
In an ancillary study of the Vitamin D and 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 and 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 vitamin D deficiency, low bone mass, or osteoporosis. Incident fractures were reported by participants on annual questionnaires and adjudicated by centralized medical-record review. The primary end points were incident total, nonvertebral, and hip fractures. Proportional-hazards models were used to 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% Black [5106 of 25,304]), we confirmed 1991 incident fractures in 1551 participants over a median follow-up of 5.3 years. Supplemental vitamin D3, as compared with placebo, did not have a significant effect on total fractures (which occurred in 769 of 12,927 participants in the vitamin D group and in 782 of 12,944 participants in the placebo group; hazard ratio, 0.98; 95% confidence interval [CI], 0.89 to 1.08; P = 0.70), nonvertebral fractures (hazard ratio, 0.97; 95% CI, 0.87 to 1.07; P = 0.50), or hip fractures (hazard ratio, 1.01; 95% CI, 0.70 to 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 and 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.).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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