Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients

Phase 3

• Conditions: Kidney Transplantation; Vitamin D Deficiency; Renal Osteodystrophy
• Interventions: Drug: Placebo; Drug: Cholecalciferol

• Registration Number: NCT00752401
• Lead Sponsor: Medical University of Vienna

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 acute rejection episodes, number of infections and C-reactive protein levels within the first year after transplantation) in vitamin D deficient kidney transplant recipients.

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, especially in kidney transplant recipients considering the fact that approximately 40% of all kidney transplant recipients are vitamin D deficient.

Therefore, the objective is to conduct a randomized, double-blind, placebo-controlled study focusing on the impact of Cholecalciferol substitution in vitamin D deficient kidney transplant recipients on graft function (glomerular filtration rate as well as serum creatinine levels), incidence of acute rejection episodes, frequency and severity (CRP levels) of posttransplant infections within the first year after kidney transplantation.

Moreover, the impact of Vitamin D3 on renal osteodystrophy will be analyzed by means of bone mineral density. DXA measurements will be performed during the first four weeks after kidney transplantation, after 5, and after 12 months posttransplant.

Kidney transplant recipients found to have vitamin D deficiency (defined as 25-hydroxyvitamin D \< 50 nmol/l) will be included and will be randomized to receive either oral Vitamin D3 therapy or placebo. Vitamin D3 will be administered at a daily dose of 6800IU over a time period of one year.

All in all, 200 subjects will be included in the VITA-D study.

Study Timeline

• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-15
• Study Start: 2009-05
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Oral placebo solution daily for one year
1	Cholecalciferol	6800 IU/day of Cholecalciferol (Vitamin D3) orally for one year

Primary Outcome Measures

Name	Time	Method
CRP levels	one year after kidney transplantation
Courses of calcium levels	within the first year after kidney transplantation
The immunologic effects of Vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of: Glomerular filtration rate	one year after kidney transplantation
Number of acute rejection episodes	one year after kidney transplantation
Number of infections	one year after kidney transplantation

Secondary Outcome Measures

Name	Time	Method
The impact of Vitamin D3 substitution on renal osteopathy will be analyzed by means of absolute bone mineral density (g/cm2)	within the first year after kidney transplantation

Trial Locations

Locations (1)

Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis; 🇦🇹 Vienna, Austria