Treatment of Vitamin D Insufficiency in Postmenopausal Women: A Randomized Clinical Trial
Hansen KE, Johnson RE, Chambers KR, Johnson MG, Lemon CC, Vo TN, Marvdashti S
JAMA internal medicine · 117 citas
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 independiente
- Gobierno
- Office of Dietary Supplements
- Gobierno
- National Institutes of Health
- Gobierno
- National Institute on Aging
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- NCATS NIH HHS
- Gobierno
- NIA NIH HHS
- Subvenciones
- National Institute on Aging (R01AG028739); National Institutes of Health (UL1TR000427)
Según 6 financiadores declarados.
Publicación
- Publicado
- 2015-08-03 · JAMA Intern Med · vol. 175 · número 10 · pág. 1612
- Editorial
- American Medical Association
- Citado
- 171 citas · más que el 100% de estudios similares · 19.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 106 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Bone health and osteoporosis research · Parathyroid Disorders and Treatments
- Palabras clave
- vitamin D insufficiency, postmenopausal women, vitamin D3, 25-hydroxyvitamin D, calcium absorption, bone mineral density, muscle mass, functional mobility, falls, fall-related injuries, physical activity, musculoskeletal health, osteoporosis prevention
- MeSH
- humans, vitamin d deficiency, calcium radioisotopes, cholecalciferol, vitamin d, radiopharmaceuticals, absorptiometry, photon, drug monitoring, treatment outcome, double-blind method, motor activity, postmenopause, bone density, physical endurance, dose-response relationship, drug, aged, middle aged, female, bone density conservation agents
7 autores
- Karen E. Hansen🇺🇸 · autor de correspondenciaUniversity of Wisconsin–Madison
- Rachael Erin Johnson🇺🇸University of Wisconsin System; Saint Luke's Health System; Saint Luke's Hospital
- Kaitlin R. Chambers🇺🇸University of Wisconsin–Madison
- Michael G. Johnson🇺🇸University of Wisconsin–Madison
- Christina C. Lemon🇺🇸University of Wisconsin–Madison
- Tien Vo🇺🇸University of Wisconsin–Madison
- Sheeva Marvdashti🇺🇸University of Wisconsin–Madison
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Experts debate optimal 25-hydroxyvitamin D (25[OH]D) levels for musculoskeletal health.
Objective
To compare the effects of placebo, low-dose cholecalciferol, and high-dose cholecalciferol on 1-year changes in total fractional calcium absorption, bone mineral density, Timed Up and Go and five sit-to-stand tests, and muscle mass in postmenopausal women with vitamin D insufficiency.
Design, setting, and participants
This randomized, double-blind, placebo-controlled clinical trial was conducted at a single center in Madison, Wisconsin, from May 1, 2010, through July 31, 2013, and the final visit was completed on August 8, 2014. A total of 230 postmenopausal women 75 years or younger with baseline 25(OH)D levels of 14 through 27 ng/mL and no osteoporosis were studied.
Interventions
Three arms included daily white and twice monthly yellow placebo (n=76), daily 800 IU vitamin D3 and twice monthly yellow placebo (n=75), and daily white placebo and twice monthly 50,000 IU vitamin D3 (n=79). The high-dose vitamin D regimen achieved and maintained 25(OH)D levels≥30 ng/mL.
Main outcomes and measures
Outcome measures were 1-year change in total fractional calcium absorption using 2 stable isotopes, bone mineral density and muscle mass using dual energy x-ray absorptiometry, Timed Up and Go and five sit-to-stand tests, functional status (Health Assessment Questionnaire), and physical activity (Physical Activity Scale for the Elderly), with Benjamini-Hochberg correction of P values to control for the false discovery rate.
Results
After baseline absorption was controlled for, calcium absorption increased 1% (10 mg/d) in the high-dose arm but decreased 2% in the low-dose arm (P = .005 vs high-dose arm) and 1.3% in the placebo arm (P = .03 vs high-dose arm). We found no between-arm changes in spine, mean total-hip, mean femoral neck, or total-body bone mineral density, trabecular bone score, muscle mass, and Timed Up and Go or five sit-to-stand test scores. Likewise, we found no between-arm differences for numbers of falls, number of fallers, physical activity, or functional status.
Conclusions and relevance
High-dose cholecalciferol therapy increased calcium absorption, but the effect was small and did not translate into beneficial effects on bone mineral density, muscle function, muscle mass, or falls. We found no data to support experts' recommendations to maintain serum 25(OH)D levels of 30 ng/mL or higher in postmenopausal women. Instead, we found that low- and high-dose cholecalciferol were equivalent to placebo in their effects on bone and muscle outcomes in this cohort of postmenopausal women with 25(OH)D levels less than 30 ng/mL.
Trial registration
clinicaltrials.gov Identifier: NCT00933244.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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