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 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- Government
- Japan Society for the Promotion of Science
- Grants
- Japan Society for the Promotion of Science (19K23997)
Based on 1 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2021-02-11 · Am J Transplant · vol. 21 · issue 9 · pp. 3043–3054
- Publisher
- Elsevier BV
- Cited
- 11 citations · more than 79% of similar papers · 1.3× the field average
- References
- 31 works
- Access
- Open access (hybrid journal) · CC-BY-NC
- Research areas
- Pregnancy and Medication Impact · Pancreatitis Pathology and Treatment · Pneumocystis jirovecii pneumonia detection and treatment
- Keywords
- 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 authors
From JP, US
- Yohei DoiThe University of Osaka
- Makoto TsujitaNagoya Memorial Hospital; Japanese Red Cross Nagoya Daini Hospital
- Takayuki Hamano · correspondingNagoya City University; The University of Osaka
- Yoshitsugu ObiUniversity of Tennessee Health Science Center
- Tomoko Namba‐HamanoThe University of Osaka
- Toshihide TomosugiJapanese Red Cross Nagoya Daini Hospital
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 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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC).
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