Overview

This trial is active, not recruiting.

Conditions kidney transplantation, vitamin d deficiency, renal osteodystrophy
Treatments cholecalciferol, placebo
Phase phase 3
Sponsor Medical University of Vienna
Start date May 2009
End date July 2014
Trial size 200 participants
Trial identifier NCT00752401, EudraCT Number 2008-002807-21, VitaD-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
6800 IU/day of Cholecalciferol (Vitamin D3) orally for one year
cholecalciferol Vitamin D3
6800 IU of Cholecalciferol will be administered in the form of Oleovit® D3-drops once a day for one year. Treatment starts on day 5 after kidney transplantation. At serum calcium levels >2,65 mmol/l vitamin D3 administration will be reduced to 3600 IU per day. If calcium levels persist above 2,85 mmol/l over a period of four weeks vitamin D3 administration will be discontinued and restarted when serum calcium levels declined to ≤ 2,65 mmol/l with only 3600 International Units per day.
(Placebo Comparator)
Oral placebo solution daily for one year
placebo
An oral placebo solution matching Cholecalciferol in terms of appearance, smell and taste will be administered once a day for one year. Treatment starts on day 5 after kidney transplantation.

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title VITA-D: Cholecalciferol Substitution in Vitamin D Deficient Kidney Transplant Recipients: A Randomized, Placebo-controlled Study to Evaluate the Posttransplant Outcome
Principal investigator Kyra Borchhardt, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Medical University of Vienna.