Financiado en parte por DSM Nutritional Products
Monthly High-Dose Vitamin D Treatment for the Prevention of Functional Decline: A Randomized Clinical Trial
Bischoff-Ferrari HA, Dawson-Hughes B, Orav EJ, Staehelin HB, Meyer OW, Theiler R, Dick W, Willett WC, Egli A
JAMA internal medicine · 349 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Gobierno
- Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
- Empresa
- DSM Nutritional Products
Según 2 financiadores declarados.
Publicación
- Publicado
- 2016-01-12 · JAMA Intern Med · vol. 176 · número 2 · pág. 175
- Editorial
- American Medical Association
- Citado
- 513 citas · más que el 100% de estudios similares · 58.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 66 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Bone health and osteoporosis research · Exercise and Physiological Responses
- Palabras clave
- Medicine, Calcifediol, Vitamin D and neurology, Body mass index, vitamin D deficiency, Internal medicine, Vitamin, Clinical endpoint, Randomized controlled trial, Cohort, Physical therapy
- MeSH
- lower extremity, humans, vitamin d deficiency, calcifediol, vitamin d, double-blind method, accidental falls, aged, aged, 80 and over, female, male, mobility limitation
9 autores
- Heike Annette Bischoff-Ferrari🇨🇭 · autor de correspondenciaUniversity of Zurich
- Bess Dawson‐Hughes🇺🇸Tufts University; Jean Mayer Human Nutrition Research Center on Aging
- Endel John Orav🇺🇸Harvard University
- Hannes B. Staehelin🇨🇭University of Basel
- Otto W. Meyer🇨🇭University of Zurich
- Robert Theiler🇨🇭University of Zurich
- W. Dick🇨🇭University of Basel
- Walter Churchill Willett🇺🇸Harvard University
- Andreas Egli🇨🇭University of Zurich
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Vitamin D deficiency has been associated with poor physical performance.
Objective
To determine the effectiveness of high-dose vitamin D in lowering the risk of functional decline.
Design, setting, and participants
One-year, double-blind, randomized clinical trial conducted in Zurich, Switzerland. The screening phase was December 1, 2009, to May 31, 2010, and the last study visit was in May 2011. The dates of our analysis were June 15, 2012, to October 10, 2015. Participants were 200 community-dwelling men and women 70 years and older with a prior fall.
Interventions
Three study groups with monthly treatments, including a low-dose control group receiving 24,000 IU of vitamin D3 (24,000 IU group), a group receiving 60,000 IU of vitamin D3 (60,000 IU group), and a group receiving 24,000 IU of vitamin D3 plus 300 μg of calcifediol (24,000 IU plus calcifediol group).
Main outcomes and measures
The primary end point was improving lower extremity function (on the Short Physical Performance Battery) and achieving 25-hydroxyvitamin D levels of at least 30 ng/mL at 6 and 12 months. A secondary end point was monthly reported falls. Analyses were adjusted for age, sex, and body mass index.
Results
The study cohort comprised 200 participants (men and women ≥ 70 years with a prior fall). Their mean age was 78 years, 67.0% (134 of 200) were female, and 58.0% (116 of 200) were vitamin D deficient (<20 ng/mL) at baseline. Intent-to-treat analyses showed that, while 60,000 IU and 24,000 IU plus calcifediol were more likely than 24,000 IU to result in 25-hydroxyvitamin D levels of at least 30 ng/mL (P = .001), they were not more effective in improving lower extremity function, which did not differ among the treatment groups (P = .26). However, over the 12-month follow-up, the incidence of falls differed significantly among the treatment groups, with higher incidences in the 60,000 IU group (66.9%; 95% CI, 54.4% to 77.5%) and the 24,000 IU plus calcifediol group (66.1%; 95% CI, 53.5%-76.8%) group compared with the 24,000 IU group (47.9%; 95% CI, 35.8%-60.3%) (P = .048). Consistent with the incidence of falls, the mean number of falls differed marginally by treatment group. The 60,000 IU group (mean, 1.47) and the 24,000 IU plus calcifediol group (mean, 1.24) had higher mean numbers of falls compared with the 24,000 IU group (mean, 0.94) (P = .09).
Conclusions and relevance
Although higher monthly doses of vitamin D were effective in reaching a threshold of at least 30 ng/mL of 25-hydroxyvitamin D, they had no benefit on lower extremity function and were associated with increased risk of falls compared with 24,000 IU.
Trial registration
clinicaltrials.gov Identifier: NCT01017354.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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