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

• Status: Completed
• Trial end date: 2020-08-06
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Leaf
• Collaborator: 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