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

NCT02962102 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-29

Study results available
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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.

Conditions

Interventions

DRUG

Calcifediol

Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4

DRUG

Calcitriol

Calcitriol 4mcg orally daily x 5

DRUG

Placebos

Placebo (medium chain triglyceride oil) orally daily x 5

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • David Leaf

    lead OTHER

Principal Investigators

  • David E Leaf, MD, MMSc · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2020-07-16
Completion
2020-08-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02962102 on ClinicalTrials.gov