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Ensayo controlado aleatorizado2011Financiado por la industria

Financiado en parte por GlaxoSmithKline

Evaluation of ergocalciferol or cholecalciferol dosing, 1,600 IU daily or 50,000 IU monthly in older adults

Binkley N, Gemar D, Engelke J, Gangnon R, Ramamurthy R, Krueger D, Drezner MK

The Journal of clinical endocrinology and metabolism · 118 citas

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Financiado por la industria

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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
Financiado por la industria
Empresa
GlaxoSmithKline
Gobierno
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Gobierno
NIAMS NIH HHS
Subvenciones
National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01 AR027032)

Según 3 financiadores declarados.

Publicación

Publicado
2011-02-03 · J Clin Endocrinol Metab · vol. 96 · número 4 · págs. 981–988
Editorial
Oxford University Press
Citado
175 citas · más que el 99% de estudios similares · 12.8× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
37 trabajos
Acceso
Lectura gratuita
Áreas de investigación
Vitamin D Research Studies · Bone health and osteoporosis research · Parathyroid Disorders and Treatments
Palabras clave
vitamin D2, vitamin D3, 25-hydroxyvitamin D, vitamin D deficiency, older adults, serum calcium, urinary calcium, parathyroid hormone, bone turnover markers, vitamin D toxicity
MeSH
humans, osteoporosis, calcium, cholecalciferol, ergocalciferols, vitamin d, dosage forms, placebos, drug administration schedule, double-blind method, circadian rhythm, dose-response relationship, drug, aged, aged, 80 and over, female, male, bone density conservation agents

7 autores

  • Neil Binkley🇺🇸 · autor de correspondenciaUniversity of Wisconsin–Madison
  • Dessa Gemar🇺🇸University of Wisconsin–Madison
  • Jean A. Engelke🇺🇸University of Wisconsin–Madison
  • Ronald E. Gangnon🇺🇸University of Wisconsin–Madison
  • Rekha Ramamurthy🇺🇸University of Wisconsin–Madison
  • Diane C. Krueger🇺🇸University of Wisconsin–Madison
  • M. K. Drezner🇺🇸University of Wisconsin–Madison

Resumen

El texto original del estudio, en el idioma en que se publicó.

Context

Whether ergocalciferol (D(2)) and cholecalciferol (D(3)) are equally effective to increase and maintain serum 25-hydroxyvitamin D [25(OH)D] concentration is controversial.

Objective

The aim of the study was to evaluate the effect of daily and once monthly dosing of D(2) or D(3) on circulating 25(OH)D and serum and urinary calcium.

Design, setting and participants

In a university clinical research setting, 64 community dwelling adults age 65+ were randomly assigned to receive daily (1,600 IU) or once-monthly (50,000 IU) D(2) or D(3) for 1 yr.

Main outcome measures

Serum 25(OH)D, serum calcium, and 24-h urinary calcium were measured at months 0, 1, 2, 3, 6, 9, and 12. Serum PTH, bone-specific alkaline phosphatase, and N-telopeptide were measured at months 0, 3, 6, and 12.

Results

Serum 25(OH)D was less than 30 ng/ml in 40% of subjects at baseline; after 12 months of vitamin D dosing, levels in 19% of subjects (n = 12, seven receiving daily doses and five monthly doses) remained low, despite compliance of more than 91%. D(2) dosing increased 25(OH)D(2) but produced a decline (P < 0.0001) in 25(OH)D(3). Substantial between-individual variation in 25(OH)D response was observed for both D(2) and D(3). The highest 25(OH)D observed was 72.5 ng/ml. Vitamin D administration did not alter serum calcium, PTH, bone-specific alkaline phosphatase, N-telopeptide, or 24-h urine calcium.

Conclusions

Overall, D(3) is slightly, but significantly, more effective than D(2) to increase serum 25(OH)D. One year of D(2) or D(3) dosing (1,600 IU daily or 50,000 IU monthly) does not produce toxicity, and 25(OH)D levels of less than 30 ng/ml persist in approximately 20% of individuals. Substantial between-individual response to administered vitamin D(2) or D(3) is observed.

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