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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2020-08-06

Brief Summary

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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.

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Detailed Description

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Decreased circulating levels of active vitamin D metabolites, including 25-hydroxyvitamin D (25D) and 1,25-dihydroxyvitamin D (1,25D), are common in critically ill patients, and lower levels are independently associated with a higher risk of acute kidney injury (AKI). Further, administration of 25D and 1,25D attenuates AKI in animal models. The purpose of this study is to assess if administration of 25D and 1,25D decreases the incidence and severity of AKI in critically ill patients.

Conditions

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Critically Ill Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Calcifediol

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

Group Type EXPERIMENTAL

Calcifediol

Intervention Type DRUG

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

Calcitriol

Calcitriol 4mcg orally daily x 5 days

Group Type EXPERIMENTAL

Calcitriol

Intervention Type DRUG

Calcitriol 4mcg orally daily x 5

Placebo

Equal volume of medium chain triglyceride (MCT) oil orally daily x 5 days

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo (medium chain triglyceride oil) orally daily x 5

Interventions

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Calcifediol

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

Intervention Type DRUG

Calcitriol

Calcitriol 4mcg orally daily x 5

Intervention Type DRUG

Placebos

Placebo (medium chain triglyceride oil) orally daily x 5

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18
* Admitted to the ICU within 48h prior to enrollment
* Likely to remain in the ICU (alive) for ≥72h
* Naso/orogastric tube or ability to swallow
* High risk of severe AKI

Exclusion Criteria

* Serum total calcium \> 9.0 mg/dl or phosphate \> 6.0 mg/dL within previous 48h
* Currently receiving oral calcium supplementation
* Ingestion of vitamin D3 \>1,000 IU/day or any 25-hydroxyvitamin D or 1,25-dihydroxyvitamin D during the previous 7 days
* AKI stage 2 or 3 (based on KDIGO serum creatinine and/or urine output criteria)
* History of transplantation or receiving chronic (\>7days) of immunosuppressive medications (not including glucocorticoid steroids at a dose less than or equivalent to prednisone 20 mg/day)
* Neutropenia in the previous 48h
* Active primary parathyroid disease, active granulomatous disease, or symptomatic nephrolithiasis in the previous 3 months
* Receiving cytochrome P450 inhibitors
* Chronic Kidney Disease stage V or End Stage Renal Disease
* Hemoglobin \< 7 g/dL
* GI malabsorption
* Prisoner
* Pregnancy or breast feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No