Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury (NCT02962102) | Clinical Trial Compass
CompletedPhase 2
Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury
United States150 participantsStarted 2017-04-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Death Within 7 Days
Timeframe: 7 days
2
Number of Participants Who Received Renal Replacement Therapy Within 7 Days
Timeframe: 7 days
3
Relative Average Change in Serum Creatinine From Day 0 to Days 1-7