Once-weekly dose of 8400 IU vitamin D(3) compared with placebo: effects on neuromuscular function and tolerability in older adults with vitamin D insufficiency
Lips P, Binkley N, Pfeifer M, Recker R, Samanta S, Cohn DA, Chandler J, Rosenberg E, Papanicolaou DA
The American journal of clinical nutrition · 91 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2010-02-04 · Am J Clin Nutr · vol. 91 · número 4 · págs. 985–991
- Editorial
- Elsevier BV
- Citado
- 116 citas · más que el 98% de estudios similares · 7.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 34 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Balance, Gait, and Falls Prevention · Bone health and osteoporosis research
- Palabras clave
- vitamin D3 supplementation, vitamin D insufficiency, older adults, postural stability, mediolateral sway, muscle strength, Short Physical Performance Battery, 25-hydroxyvitamin D, parathyroid hormone, tolerability, hypercalcemia, falls
- MeSH
- humans, vitamin d deficiency, cholecalciferol, parathyroid hormone, vitamins, vitamin d, drug administration schedule, double-blind method, movement, dietary supplements, aged, aged, 80 and over, female, male, postural balance
9 autores
- Paul T.A.M. Lips🇳🇱Vrije Universiteit Amsterdam; Amsterdam UMC Location Vrije Universiteit Amsterdam
- Neil Binkley🇺🇸University of Wisconsin–Madison
- Michael A. Pfeifer
- Robert R. Recker
- Suvajit Samanta🇺🇸Merck & Co., Inc., Rahway, NJ, USA (United States)
- Dosinda Cohn🇺🇸Merck & Co., Inc., Rahway, NJ, USA (United States)
- Julie Chandler🇺🇸Merck & Co., Inc., Rahway, NJ, USA (United States)
- Elizabeth Rosenberg🇺🇸Merck & Co., Inc., Rahway, NJ, USA (United States)
- Dimitris A. Papanicolaou🇺🇸Merck & Co., Inc., Rahway, NJ, USA (United States)
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Vitamin D insufficiency, which is prevalent in older individuals, is associated with bone and muscle weakness and falls.
Objective
We examined the effects of a weekly dose of 8400 IU vitamin D(3) on postural stability, muscle strength, and safety.
Design
In this double-blind trial, subjects aged > or =70 y with serum 25-hydroxyvitamin D [25(OH)D] concentrations or =6 ng/mL were randomly assigned to receive a weekly dose of 8400 IU vitamin D(3) (n = 114) or a placebo (n = 112). Mediolateral body sway with eyes open (assessed with the AccuSway(PLUS) platform; Advanced Medical Technology Inc, Watertown, MA) was the primary endpoint. Secondary endpoints included the short physical performance battery (SPPB) and serum 25(OH)D concentrations. An analysis of covariance model was used for treatment comparisons. Safety and tolerability were monitored.
Results
Serum 25(OH)D concentrations rose significantly (from 13.9 to 26.2 ng/mL, P or = 0.46 compared with <0.46 cm), treatment with 8400 IU vitamin D(3) significantly reduced sway compared with treatment with placebo (P = 0.047) in patients with elevated baseline sway but not in patients with normal baseline sway. Adverse experiences and incidences of hypercalcemia, hypercalciuria, and elevated creatinine were similar with both treatments. In patients treated with 8400 IU vitamin D(3), but not in placebo-treated patients, parathyroid hormone decreased significantly.
Conclusions
Weekly treatment with 8400 IU vitamin D(3) raised 25(OH)D concentrations in elderly, vitamin D-insufficient individuals. Treatment with 8400 IU vitamin D(3) did not reduce mediolateral sway significantly compared with treatment with placebo in this population, although in post hoc analysis, treatment with 8400 IU vitamin D(3) reduced sway in the subgroup of patients who had elevated sway at baseline. Weekly treatment with 8400 IU vitamin D(3) was well tolerated. This trial was registered at clinicaltrials.gov as NCT00242476.
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