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Ensayo controlado aleatorizado2008

Cholecalciferol (vitamin D3) therapy and vitamin D insufficiency in patients with chronic kidney disease: a randomized controlled pilot study

Chandra P, Binongo JN, Ziegler TR, Schlanger LE, Wang W, Someren JT, Tangpricha V

Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 96 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
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Gobierno
National Center for Advancing Translational Sciences
Gobierno
NIAMS NIH HHS
Gobierno
NCATS NIH HHS
Subvenciones
National Center for Advancing Translational Sciences (UL1 TR000454); National Institute of Arthritis and Musculoskeletal and Skin Diseases (K23 AR054334)

Según 4 financiadores declarados.

Publicación

Publicado
2008-01-01 · Endocr Pract · vol. 14 · número 1 · págs. 10–17
Editorial
Elsevier BV
Citado
142 citas · más que el 98% de estudios similares · 10.1× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
62 trabajos
Acceso
Acceso abierto (copia en repositorio)
Áreas de investigación
Parathyroid Disorders and Treatments · Vitamin D Research Studies · Dialysis and Renal Disease Management
Palabras clave
vitamin D3, vitamin D3 supplementation, vitamin D insufficiency, chronic kidney disease, 25-hydroxyvitamin D, parathyroid hormone, secondary hyperparathyroidism, 1,25-dihydroxyvitamin D, bone turnover markers
MeSH
humans, vitamin d deficiency, calcium, cholecalciferol, collagen type i, parathyroid hormone, acid phosphatase, alkaline phosphatase, isoenzymes, vitamin d, peptides, placebos, pilot projects, double-blind method, adolescent, adult, aged, aged, 80 and over, middle aged, renal insufficiency, chronic, tartrate-resistant acid phosphatase

7 autores

  • Prakash Chandra🇺🇸Emory University
  • José Binongo
  • Thomas R. Ziegler🇺🇸Emory University
  • Lynn E. Schlanger🇺🇸Emory University
  • Wenli Wang🇺🇸Emory University
  • James T. Someren🇺🇸Emory University
  • Vin Tangpricha🇺🇸 · autor de correspondenciaEmory University

Resumen

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

Objective

To investigate the efficacy of cholecalciferol (vitamin D3) in raising serum 25-hydroxyvitamin D (25[OH)]D) levels and reducing parathyroid hormone (PTH) levels in patients with chronic kidney disease (CKD).

Methods

In this double-blind, randomized controlled pilot study, participants with CKD stage 3 and 4 (estimated glomerular filtration rate, 15-59 mL/min/1.73 m2), vitamin D insufficiency (serum 25[OH]D 70 pg/mL were randomly assigned to receive either 50 000 IU of cholecalciferol or placebo once weekly for 12 weeks. Primary outcomes (25[OH]D and PTH levels) were measured at baseline, week 6, and week 12. Secondary outcomes (1,25-dihydroxvitamin D and bone turnover markers) were measured at baseline and week 12. Because of skewed data distribution, statistical analyses were performed on a logarithmic scale. The difference between the group means was exponentiated to provide the geometric mean ratio. A linear mixed model using an unstructured variance-covariance matrix was used to examine change in the primary and secondary outcomes over time.

Results

Geometric mean serum 25(OH)D concentrations of the study groups were similar at baseline (P = .77). At week 6, a significant difference between the treatment and placebo groups was detected (P = .001); this difference was maintained at week 12 (P = .002). Among cholecalciferol-treated participants, serum 25(OH)D concentration increased on average from 17.3 ng/mL (95% confidence interval [CI], 11.8-25.2) at baseline to 49.4 ng/mL (95% CI, 33.9-72.0) at week 12. As-treated analysis indicated a trend toward lower PTH levels among cholecalciferol-treated participants (P = .07).

Conclusion

Weekly cholecalciferol supplementation appears to be an effective treatment to correct vitamin D status in patients with CKD.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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