Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients

• Status: Unknown status
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the effects of Cholecalciferol (Vitamin D3) substitution on the posttransplant outcome (glomerular filtration rate as well as serum creatinine levels, number of acute rejection episodes, number of infections and C-reactive protein levels within the first year after transplantation) in vitamin D deficient kidney transplant recipients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• age > 18

• deceased donor kidney transplant recipients

• only kidney transplant recipients

• vitamin D deficiency defined as 25 (OH)D < 50nmol/l

Exclusion Criteria:

• re-transplantation for the second time if the patient is highly immunized and therefore included in the aphaeresis program

• re-transplantation for the third or further time

• significant impaired intestinal resorption: malabsorption due to celiac sprue, systemic scleroderma; maldigestion due to chronic pancreatitis, pancreatic insufficiency, pancreas resection, mucoviscidosis, Zollinger-Ellison-syndrome

• history of inflammatory bowel disease: Crohn's disease, ulcerative colitis

• previous gastrectomy, small bowel or large bowel resection, intestinal bypass surgery

• severe liver disease: cirrhosis

• HIV positive