The effect of cholecalciferol supplementation on allograft function in incident kidney transplant recipients: A randomized controlled study

Doi, Yohei; Tsujita, Makoto; Hamano, Takayuki; Obi, Yoshitsugu; Namba-Hamano, Tomoko; Tomosugi, Toshihide; Futamura, Kenta; Okada, Manabu; Hiramitsu, Takahisa; Goto, Norihiko; Nishiyama, Akira; Takeda, Asami; Narumi, Shunji; Watarai, Yoshihiko; Isaka, Yoshitaka

doi:https://doi.org/10.1111/ajt.16530

The effect of cholecalciferol supplementation on allograft function in incident kidney transplant recipients: A randomized controlled study

Doi, Yohei; Tsujita, Makoto; Hamano, Takayuki et al.

American Journal of Transplantation, 2021, 21(9), 3043-3054

Number of Access:2,030（2025-09-12 08:37 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/92482

Link to primary information

File	Format	Terms of use	Size	Views	Date.Available	Description	information
AmJTransplant_21_9_3043	pdf	None	982 KB	148	2023.09.04

Creative Commons : Attribution - NonCommercial

Item Information

Output File Export EndNote Basic Export Mendeley

Title	The effect of cholecalciferol supplementation on allograft function in incident kidney transplant recipients: A randomized controlled study
Creator	NRID 1000030846382 1000030846382 ORCID 0000-0002-5165-291X 0000-0002-5165-291X researchmap permalink DOI-YOHEI DOI-YOHEI CreatorName Doi, Yohei
	CreatorName Tsujita, Makoto
	CreatorName Hamano, Takayuki
	CreatorName Obi, Yoshitsugu
	NRID 1000030734420 1000030734420 researchmap permalink namba-handai3857 namba-handai3857 Scopus Author ID 8577526800 8577526800 CreatorName Namba-Hamano, Tomoko
	CreatorName Tomosugi, Toshihide
	CreatorName Futamura, Kenta
	CreatorName Okada, Manabu
	CreatorName Hiramitsu, Takahisa
	CreatorName Goto, Norihiko
	NRID 1000010325334 1000010325334 CreatorName Nishiyama, Akira
	CreatorName Takeda, Asami
	CreatorName Narumi, Shunji
	CreatorName Watarai, Yoshihiko
	NRID 1000000379166 1000000379166 researchmap permalink isaka-handai3857 isaka-handai3857 Scopus Author ID 16207611100 16207611100 ORCID 0000-0002-0820-7167 0000-0002-0820-7167 CreatorName Isaka, Yoshitaka
Subject	clinical research/practice
	clinical trial
	kidney (allograft) function/dysfunction
	kidney transplantation/nephrology
Description	Doi Y., Tsujita M., Hamano T., et al. The effect of cholecalciferol supplementation on allograft function in incident kidney transplant recipients: A randomized controlled study. American Journal of Transplantation 21, 3043 (2021); https://doi.org/10.1111/ajt.16530.
Abstract	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 <45 mL/min/1.73 m2 (Pinteraction <0.05, between-group difference; −4.3 mL/min/1.73 m2 [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.
Publisher	John Wiley and Sons Inc
Source Title	American Journal of Transplantation
Volume (Issue)	21(9)
Page	3043-3054
Date of Issued	2021-09-01
Language	English
Handle URL	https://hdl.handle.net/11094/92482
PISSN	16006135
eISSN	16006143
NCID	AA11615749
Relation.isIdenticalTo	DOI (Publisher Version) https://doi.org/10.1111/ajt.16530
Access Rights	open access
CopyRight	This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
CopyRight	© 2021 Doi Y.,et al. American Journal of Transplantation published by Wiley Periodicals LLC on behalf of The American Society of Transplantation and the American Society of Transplant Surgeons.
oaire:version	Version of Record
Category	学術雑誌論文 Journal Article

Resource Type	journal article
Local Type	Journal Article
DCMI Type	Text
DCTERMS.bibliographicCitation	American Journal of Transplantation. 2021, 21(9), p. 3043-3054
DC.title	The effect of cholecalciferol supplementation on allograft function in incident kidney transplant recipients: A randomized controlled study
DC.creator	Doi, Yohei
	Tsujita, Makoto
	Hamano, Takayuki
	Obi, Yoshitsugu
	Namba-Hamano, Tomoko
	Tomosugi, Toshihide
	Futamura, Kenta
	Okada, Manabu
	Hiramitsu, Takahisa
	Goto, Norihiko
	Nishiyama, Akira
	Takeda, Asami
	Narumi, Shunji
	Watarai, Yoshihiko
	Isaka, Yoshitaka
DC.publisher	John Wiley and Sons Inc
DC.language' scheme='DCTERMS.RFC1766	English
DC.type' scheme='DCTERMS.DCMIType	Text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2021-09-01
DC.identifier	https://doi.org/10.1111/ajt.16530
DC.subject	clinical research/practice
	clinical trial
	kidney (allograft) function/dysfunction
	kidney transplantation/nephrology
DC.description	Doi Y., Tsujita M., Hamano T., et al. The effect of cholecalciferol supplementation on allograft function in incident kidney transplant recipients: A randomized controlled study. American Journal of Transplantation 21, 3043 (2021); https://doi.org/10.1111/ajt.16530.
DCTERMS.abstract	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 <45 mL/min/1.73 m2 (Pinteraction <0.05, between-group difference; −4.3 mL/min/1.73 m2 [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.
DC.rights	This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
DC.rights	© 2021 Doi Y.,et al. American Journal of Transplantation published by Wiley Periodicals LLC on behalf of The American Society of Transplantation and the American Society of Transplant Surgeons.
DC.format	92482
citation_title	The effect of cholecalciferol supplementation on allograft function in incident kidney transplant recipients: A randomized controlled study
citation_author	Doi, Yohei
	Tsujita, Makoto
	Hamano, Takayuki
	Obi, Yoshitsugu
	Namba-Hamano, Tomoko
	Tomosugi, Toshihide
	Futamura, Kenta
	Okada, Manabu
	Hiramitsu, Takahisa
	Goto, Norihiko
	Nishiyama, Akira
	Takeda, Asami
	Narumi, Shunji
	Watarai, Yoshihiko
	Isaka, Yoshitaka
citation_publisher	John Wiley and Sons Inc
citation_language	English
citation_date	2021-09-01
citation_journal_title	American Journal of Transplantation
citation_volume	21
citation_issue	9
citation_firstpage	3043
citation_lastpage	3054
citation_doi	https://doi.org/10.1111/ajt.16530
citation_public_url	https://hdl.handle.net/11094/92482

The effect of cholecalciferol supplementation on allograft function in incident kidney transplant recipients: A randomized controlled study

Link to primary information

Item Information

Show details