Status:
UNKNOWN
Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients
Lead Sponsor:
Medical University of Vienna
Conditions:
Kidney Transplantation
Vitamin D Deficiency
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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...
Detailed Description
Apart from its classical actions in calcium homeostasis, vitamin D acts as a potent immunomodulatory agent. As such, vitamin D is thought to have beneficial effects in the transplant setting, especial...
Eligibility Criteria
Inclusion
- age \> 18
- deceased donor kidney transplant recipients
- only kidney transplant recipients
- vitamin D deficiency defined as 25 (OH)D \< 50nmol/l
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00752401
Start Date
May 1 2009
End Date
July 1 2014
Last Update
January 22 2014
Active Locations (1)
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1
Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
Vienna, Austria