The effect of cholecalciferol supplementation on allograft function in incident kidney transplant recipients: A randomized controlled study
Doi Y, Tsujita M, Hamano T, Obi Y, Namba-Hamano T, Tomosugi T, Futamura K, Okada M, Hiramitsu T, Goto N, Nishiyama A, Takeda A, Narumi S, Watarai Y, Isaka Y
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 8 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
- Japan Society for the Promotion of Science
- Subvenciones
- Japan Society for the Promotion of Science (19K23997)
Según 1 financiador declarado y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2021-02-11 · Am J Transplant · vol. 21 · número 9 · págs. 3043–3054
- Editorial
- Elsevier BV
- Citado
- 11 citas · más que el 79% de estudios similares · 1.3× el promedio de su campo
- Referencias
- 31 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC
- Áreas de investigación
- Pregnancy and Medication Impact · Pancreatitis Pathology and Treatment · Pneumocystis jirovecii pneumonia detection and treatment
- Palabras clave
- Medicine, Cholecalciferol, Placebo, Internal medicine, Clinical endpoint, Vitamin D and neurology, Randomized controlled trial, Renal function, Gastroenterology, Creatinine, Urology, Adverse effect, Pathology
- MeSH
- humans, cholecalciferol, kidney transplantation, double-blind method, dietary supplements, allografts
15 autores
- Yohei Doi🇯🇵The University of Osaka
- Makoto Tsujita🇯🇵Nagoya Memorial Hospital; Japanese Red Cross Nagoya Daini Hospital
- Takayuki Hamano🇯🇵 · autor de correspondenciaNagoya City University; The University of Osaka
- Yoshitsugu Obi🇺🇸University of Tennessee Health Science Center
- Tomoko Namba‐Hamano🇯🇵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
- Akira Nishiyama🇯🇵Kagawa University
- Asami Takeda🇯🇵Japanese Red Cross Nagoya Daini Hospital
- Shunji Narumi🇯🇵Japanese Red Cross Nagoya Daini Hospital
- Yoshihiko Watarai🇯🇵Japanese Red Cross Nagoya Daini Hospital
- Yoshitaka Isaka🇯🇵The University of Osaka
Resumen
El texto original del estudio, en el idioma en que se publicó.
It is unknown whether cholecalciferol supplementation improves allograft outcomes in kidney transplant recipients (KTRs). We conducted a single-center randomized, double-blind, placebo-controlled trial of daily 4000 IU cholecalciferol supplementation in KTRs at 1-month posttransplant. The primary endpoint was the change in eGFR from baseline to 12-month posttransplant. Secondary endpoints included severity of interstitial fibrosis and tubular atrophy (IFTA) at 12-month posttransplant and changes in urinary biomarkers. Of 193 randomized patients, 180 participants completed the study. Changes in eGFR were 1.2 mL/min/1.73 m2 (95% CI; -0.7 to 3.1) in the cholecalciferol group and 1.8 mL/min/1.73 m2 (95% CI, -0.02 to 3.7) in the placebo group, with no significant between-group difference (-0.7 mL/min/1.73 m2 [95% CI; -3.3 to 2.0], p = 0.63). Subgroup analyses showed detrimental effects of cholecalciferol in patients with eGFR 2 (Pinteraction 2 [95% CI; -7.3 to -1.3]). The degree of IFTA, changes in urine albumin-to-creatinine ratio, or adverse events including hypercalcemia and infections requiring hospitalization did not differ between groups. In conclusion, cholecalciferol supplementation did not affect eGFR change compared to placebo among incident KTRs. These findings do not support cholecalciferol supplementation for improving allograft function in incident KTRs. Clinical trial registry: This study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) as UMIN000020597 (please refer to the links below). UMIN-CTR: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023776.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC).
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