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

アクセス数:2,030件（2025-09-12 08:47 集計）

固定URL: https://hdl.handle.net/11094/92482

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タイトル	The effect of cholecalciferol supplementation on allograft function in incident kidney transplant recipients: A randomized controlled study
著者	NRID 1000030846382 1000030846382 ORCID 0000-0002-5165-291X 0000-0002-5165-291X researchmap permalink DOI-YOHEI DOI-YOHEI 著者名 Doi, Yohei
	著者名 Tsujita, Makoto
	著者名 Hamano, Takayuki
	著者名 Obi, Yoshitsugu
	NRID 1000030734420 1000030734420 researchmap permalink namba-handai3857 namba-handai3857 Scopus Author ID 8577526800 8577526800 著者名 Namba-Hamano, Tomoko
	著者名 Tomosugi, Toshihide
	著者名 Futamura, Kenta
	著者名 Okada, Manabu
	著者名 Hiramitsu, Takahisa
	著者名 Goto, Norihiko
	NRID 1000010325334 1000010325334 著者名 Nishiyama, Akira
	著者名 Takeda, Asami
	著者名 Narumi, Shunji
	著者名 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 著者名 Isaka, Yoshitaka
キーワード等	clinical research/practice
	clinical trial
	kidney (allograft) function/dysfunction
	kidney transplantation/nephrology
内容	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.
抄録	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.
出版者	John Wiley and Sons Inc
収録物名	American Journal of Transplantation
巻(号)	21(9)
ページ	3043-3054
刊行年月	2021-09-01
言語	英語
ハンドルURL	https://hdl.handle.net/11094/92482
PISSN	16006135
eISSN	16006143
NCID	AA11615749
関連情報 (isIdenticalTo)	DOI (出版社版) https://doi.org/10.1111/ajt.16530
アクセス権	open access
権利情報	This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
権利情報	© 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.
出版タイプ	Version of Record
カテゴリ	学術雑誌論文 Journal Article

資源タイプ	学術雑誌論文
ローカル資源タイプ	学術雑誌論文
DCMI資源タイプ	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	英語
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	英語
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

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