Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial
Sanders KM, Stuart AL, Williamson EJ, Simpson JA, Kotowicz MA, Young D, Nicholson GC
JAMA · 911 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 Health and Medical Research Council
- Subvenciones
- National Health and Medical Research Council (251682)
Según 1 financiador declarado.
Publicación
- Publicado
- 2010-05-11 · JAMA · vol. 303 · número 18 · pág. 1815
- Editorial
- American Medical Association
- Citado
- 1,381 citas · más que el 100% de estudios similares · 72.9× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 45 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Bone health and osteoporosis research · Balance, Gait, and Falls Prevention
- Palabras clave
- vitamin D supplementation, vitamin D3, falls, fracture, older women, vitamin D status, adherence to supplementation, 25-hydroxyvitamin D3, parathyroid hormone
- MeSH
- humans, cholecalciferol, treatment failure, administration, oral, drug administration schedule, risk factors, double-blind method, seasons, accidental falls, aged, aged, 80 and over, female, male, bone density conservation agents, fractures, bone
7 autores
- Kerrie M. Sanders🇦🇺 · autor de correspondenciaBarwon Health; Royal Children's Hospital; The University of Melbourne; Murdoch Children's Research Institute
- Amanda L. Stuart🇦🇺Barwon Health; Royal Children's Hospital; The University of Melbourne; Murdoch Children's Research Institute
- Elizabeth Williamson🇦🇺Barwon Health; Royal Children's Hospital; The University of Melbourne; Murdoch Children's Research Institute
- Julie Anne Simpson🇦🇺Barwon Health; Royal Children's Hospital; The University of Melbourne; Murdoch Children's Research Institute
- Mark A. Kotowicz🇦🇺Barwon Health; Royal Children's Hospital; The University of Melbourne; Murdoch Children's Research Institute
- Doris Yee Ling Young🇦🇺Barwon Health; Royal Children's Hospital; The University of Melbourne; Murdoch Children's Research Institute
- Geoffrey C. Nicholson🇦🇺Barwon Health; Royal Children's Hospital; The University of Melbourne; Murdoch Children's Research Institute
Resumen
El texto original del estudio, en el idioma en que se publicó.
Context
Improving vitamin D status may be an important modifiable risk factor to reduce falls and fractures; however, adherence to daily supplementation is typically poor.
Objective
To determine whether a single annual dose of 500,000 IU of cholecalciferol administered orally to older women in autumn or winter would improve adherence and reduce the risk of falls and fracture.
Design, setting, and participants
A double-blind, placebo-controlled trial of 2256 community-dwelling women, aged 70 years or older, considered to be at high risk of fracture were recruited from June 2003 to June 2005 and were randomly assigned to receive cholecalciferol or placebo each autumn to winter for 3 to 5 years. The study concluded in 2008.
Intervention
500,000 IU of cholecalciferol or placebo.
Main outcome measures
Falls and fractures were ascertained using monthly calendars; details were confirmed by telephone interview. Fractures were radiologically confirmed. In a substudy, 137 randomly selected participants underwent serial blood sampling for 25-hydroxycholecalciferol and parathyroid hormone levels.
Results
Women in the cholecalciferol (vitamin D) group had 171 fractures vs 135 in the placebo group; 837 women in the vitamin D group fell 2892 times (rate, 83.4 per 100 person-years) while 769 women in the placebo group fell 2512 times (rate, 72.7 per 100 person-years; incidence rate ratio [RR], 1.15; 95% confidence interval [CI], 1.02-1.30; P = .03). The incidence RR for fracture in the vitamin D group was 1.26 (95% CI, 1.00-1.59; P = .047) vs the placebo group (rates per 100 person-years, 4.9 vitamin D vs 3.9 placebo). A temporal pattern was observed in a post hoc analysis of falls. The incidence RR of falling in the vitamin D group vs the placebo group was 1.31 in the first 3 months after dosing and 1.13 during the following 9 months (test for homogeneity; P = .02). In the substudy, the median baseline serum 25-hydroxycholecalciferol was 49 nmol/L. Less than 3% of the substudy participants had 25-hydroxycholecalciferol levels lower than 25 nmol/L. In the vitamin D group, 25-hydroxycholecalciferol levels increased at 1 month after dosing to approximately 120 nmol/L, were approximately 90 nmol/L at 3 months, and remained higher than the placebo group 12 months after dosing.
Conclusion
Among older community-dwelling women, annual oral administration of high-dose cholecalciferol resulted in an increased risk of falls and fractures.
Trial registration
anzctr.org.au Identifier: ACTRN12605000658617; isrctn.org Identifier: ISRCTN83409867.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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