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Ensayo controlado aleatorizado2022Acceso abierto

Cholecalciferol Supplementation Attenuates Bone Loss in Incident Kidney Transplant Recipients: A Prespecified Secondary Endpoint Analysis of a Randomized Controlled Trial

Tsujita M, Doi Y, Obi Y, Hamano T, Tomosugi T, Futamura K, Okada M, Hiramitsu T, Goto N, Isaka Y, Takeda A, Narumi S, Watarai Y

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 24 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

Según la declaración de financiación del texto completo.

Publicación

Publicado
2020-12-01 · J Bone Miner Res · vol. 37 · número 2 · págs. 303–311
Editorial
Oxford University Press
Citado
29 citas · más que el 70% de estudios similares · 0.8× el promedio de su campo
Referencias
43 trabajos
Acceso
Acceso abierto (revista híbrida) · CC-BY-NC
Áreas de investigación
Parathyroid Disorders and Treatments · Pharmacological Effects and Toxicity Studies · Vitamin D Research Studies
Palabras clave
Cholecalciferol, Medicine, Internal medicine, Placebo, Endocrinology, Vitamin D and neurology, Secondary hyperparathyroidism, Parathyroid hormone, Hyperparathyroidism, vitamin D deficiency, Osteopenia, Urology, Osteoporosis, Gastroenterology, Bone mineral, Calcium
MeSH
humans, osteoporosis, vitamin d deficiency, cholecalciferol, parathyroid hormone, vitamin d, kidney transplantation, bone density, dietary supplements

13 autores

  • Makoto Tsujita🇯🇵Nagoya Memorial Hospital; Japanese Red Cross Nagoya Daini Hospital
  • Yohei Doi🇯🇵The University of Osaka
  • Yoshitsugu Obi🇺🇸University of Tennessee Health Science Center
  • Takayuki Hamano🇯🇵 · autor de correspondenciaNagoya City University; The University of Osaka
  • Toshihide Tomosugi🇯🇵Japanese Red Cross Nagoya Daini Hospital
  • Kenta Futamura🇯🇵Japanese Red Cross Nagoya Daini Hospital
  • Manabu Okada🇯🇵Japanese Red Cross Nagoya Daini Hospital
  • Takahisa Hiramitsu🇯🇵Japanese Red Cross Nagoya Daini Hospital
  • Norihiko Goto🇯🇵Japanese Red Cross Nagoya Daini Hospital
  • Yoshitaka Isaka🇯🇵The University of Osaka
  • Asami Takeda🇯🇵Japanese Red Cross Nagoya Daini Hospital
  • Shunji Narumi🇯🇵Japanese Red Cross Nagoya Daini Hospital
  • Yoshihiko Watarai🇯🇵Japanese Red Cross Nagoya Daini Hospital

Resumen

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

Vitamin D deficiency, persistent hyperparathyroidism, and bone loss are common after kidney transplantation (KTx). However, limited evidence exists regarding the effects of cholecalciferol supplementation on parathyroid hormone (PTH) and bone loss after KTx. In this prespecified secondary endpoint analysis of a randomized controlled trial, we evaluated changes in PTH, bone metabolic markers, and bone mineral density (BMD). At 1 month post-transplant, we randomized 193 patients to an 11-month intervention with cholecalciferol (4000 IU/d) or placebo. The median baseline 25-hydroxyvitamin D (25[OH]D) level was 10 ng/mL and 44% of participants had osteopenia or osteoporosis. At the end of the study, the median 25(OH)D level was increased to 40 ng/mL in the cholecalciferol group and substantially unchanged in the placebo group. Compared with placebo, cholecalciferol significantly reduced whole PTH concentrations (between-group difference of -15%; 95% confidence interval [CI] -25 to -3), with greater treatment effects in subgroups with lower 25(OH)D, lower serum calcium, or higher estimated glomerular filtration rate (pint int < 0.05). Changes in serum calcium, phosphate, bone metabolic markers, and BMD at the distal radius were not different between groups. In mediation analyses, change in whole PTH levels explained 39% of treatment effects on BMD change. In conclusion, 4000 IU/d cholecalciferol significantly reduced PTH levels and attenuated LS BMD loss after KTx. This regimen has the potential to eliminate vitamin D deficiency and provides beneficial effects on bone health even under glucocorticoid treatment. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC).

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