Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury

Phase 2 Completed 150 enrolled David Leaf National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of acute kidney injury (AKI) in critically ill patients.

Timeline

Start: 2017-04-03
Primary completion: 2020-07-16
Completion: 2020-08-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Calcifediol vs Placebo; p = 0.52; Fisher Exact NCT02962102 ↗

registry analysis (superiority test); Calcitriol vs Placebo; p = 0.58; Fisher Exact NCT02962102 ↗

paper The global rank score for the primary endpoint was similar among calcifediol- (n = 51) versus placebo- (n = 49) treated patients (P = 0.85) PMID 40924491 ↗

paper and for calcitriol (n = 50) versus placebo-treated patients (P = 0.58). PMID 40924491 ↗

Publications

Results Leaf DE, Shenoy T, Zinchuk K, Gupta S, Dias JA, Sanchez-Almanzar D, Ginde AA, Athar H, Cheng C, Tamura T, Kim EY, Waikar SS. Randomized trial of activated vitamin D for acute kidney injury prevention in critically ill patients. JCI Insight. 2025 Sep 9;10(20):e193523. doi: 10.1172/jci.insight.193523. eCollection 2025 Oct 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Calcifediol	Unknown	200 ug	Oral
Subject	Calcitriol	Small molecule	4 ug	Oral