Vitamin D Deficiency Clinical Trial
Official title:
VITA-D: Cholecalciferol Substitution in Vitamin D Deficient Kidney Transplant Recipients: A Randomized, Placebo-controlled Study to Evaluate the Posttransplant Outcome
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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