Overview
Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury
Status:
Completed
Completed
Trial end date:
2020-08-06
2020-08-06
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
David LeafCollaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Treatments:
Calcifediol
Calcitriol
Vitamin D
Criteria
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