VITA-D RCT: Vitamin D, improving kidney transplant outcome?

Vitamin D as an immunomodulatory agent in transplantation is a novel approach and has not been investigated so far. We hypothesize that correction of vitamin D deficiency in kidney transplant recipients would contribute to better allograft tolerance and thus improve the outcome after transplantation. Within our currently ongoing VITA- D study, a multidisciplinary, randomized, placebo-controlled study, we evaluate the impact of vitamin D 3 therapy on the outcome within the first year after kidney transplantation. Design of the VITA-D study: The study population consists of 200 deceased-donor kidney transplant recipients with vitamin D deficiency at the time of transplantation, i.e. 25-hydroxyvitamin D < 50 nmol/l. The active treatment consists of oral vitamin D3 at a dose of 6.800 International Units per day. Treatment starts on the 5th day after transplantation and is given for one year. The primary aim is to evaluate the impact of vitamin D 3 therapy on graft function after one year of treatment, the incidence of acute rejection episodes as well as the number and severity of infections within the first year after kidney transplantation. The secondary aim is to evaluate whether vitamin D3 therapy prevents the usual decline in bone mineral density after transplantation by analyzing the course of absolute bone mineral density within the first post-transplant year. Preliminary data: We screened 367 kidney transplant recipients and found 75% of them to suffer from vitamin D deficiency. So far, 129 patients have been included in the VITA-D study and a recent analysis demonstrated that the chosen dosage regimen is effective and safe in correcting vitamin D deficiency in these patients. Significance of the results: Our study will clarify whether correction of vitamin D deficiency in kidney transplant recipients improves the outcome with respect to graft function, rejection episodes, and infectious complications. If this is the case, correction of vitamin D deficiency could be a very simple, well-tolerated, and cost-effective approach that directly benefits the patients. Approvals were obtained from the Ethics Committee (213/2008) and the Austrian Competent Authorities. The study was registered to the European Clinical Trial Database (EudraCT 2008-002807-21) and the open access ClinicalTrials.gov registry (NCT00752401).