The effect of cholecalciferol supplementation on allograft function in incident kidney transplant recipients: A randomized controlled study.
Doi, Y., et al.American Journal of Transplantation 2021 [record in progress].
Aims
This study aimed to investigate the effects of cholecalciferol supplements on kidney function among recipients of kidney transplant who are at high risk of vitamin D deficiency.
Interventions
Patients were randomised to either the cholecalciferol group or the placebo group.
Participants
193 adult kidney transplant recipients between 20 to 80 years.
Outcomes
The primary outcome was change in estimated glomerular filtration rate (eGFR). The secondary outcomes were interstitial fibrosis and tubular atrophy (IFTA) on transplanted kidney, changes in urinary biomarkers, and the incidence of hypercalcemia and infections requiring hospitalisations.
Follow-up
12 months
CET Conclusions
The randomised, double-blinded trial aimed to investigate the effect of nutritional vitamin D supplementation on estimated glomerular filtration rate (eGFR) in living kidney transplant recipients. Participants were randomly allocated to cholecalciferol or a matching placebo according to a computer-generated randomisation sequence. A sample size calculation was based on previous study data and showed that 95 patients per arm were needed to provide 85% power. 193 patients were randomised and 180 patients completed the study. The modified intention to treat analysis included all patients who received at least one dose of the study drug and did not show a difference in eGFR at 12 months between groups. Kidney biopsies that were assessed by blinded assessors showed no differences between in severity of interstitial fibrosis and tubular atrophy (IFTA). The authors conclude that cholecalciferol supplementation does not improve kidney function in living kidney transplant recipients.
Data analysis
Per protocol analysis
Trial registration
UMIN Clinical Trials Registry - UMIN000020597