VITA-D: cholecalciferol substitution in vitamin D deficient kidney transplant recipients: a randomized, placebo-controlled study to evaluate the post-transplant outcome.

What Was Tested

This randomized controlled trial looks at Vitamin D, K2, Magnesium and Zinc.

The VITA-D study, a randomized, placebo-controlled, double-blind study with two parallel groups including a total of 200 kidney transplant recipients, is designed to investigate the immunomodulatory and renoprotective effects of cholecalciferol (vitamin D3) within the transplant setting.

The objective is to evaluate the influence of vitamin D3 substitution in vitamin D deficient kidney transplant recipients on the post-transplant outcome.

Why It Was Studied

Vitamin D does not only regulate calcium homeostasis but also plays an important role as an immune modulator.

It influences the immune system through the induction of immune shifts and regulatory cells resulting in immunologic tolerance.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and parallel-group study.

The participants were allocated by chance, so the Vitamin D, K2, Magnesium and Zinc group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.

Some participants received a placebo instead of Vitamin D, K2, Magnesium and Zinc, giving a reference point.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a primary endpoint glomerular filtration rate calculated with the MDRD formula (modification of diet in renal disease) one year after kidney transplantation will be evaluated.

Incidence of acute rejection episodes, and the number and severity of infections (analyzed by means of C-reactive protein) within the first year after transplantation will be monitored as well.

As a secondary endpoint the influence of vitamin D3 on bone mineral density within the first year post-transplant will be assessed.

Three DXA analyses will be performed, one within the first four weeks post-transplant, one five months and one twelve months after kidney transplantation.

What Was Measured

Topics PubMed links to this paper include Cholecalciferol, Glomerular Filtration Rate, Graft Rejection, Graft Survival, Immunologic Factors, Kidney Transplantation and Risk Assessment.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc.

The publication is from 2009 (Trials), a journal based in England.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.