VITamine D Supplementation in RenAL Transplant Recipients - VITALE
Status:
Completed
Trial end date:
2016-02-02
Target enrollment:
Participant gender:
Summary
It has been proposed that the intake of high dose of cholecalciferol may have beneficial non
classical effects (beside bone health). This could include the reduction of type 2 diabetes
mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. These
pleiotropic effects are mostly documented by observational and experimental studies or small
intervention trials. In renal transplant recipients, vitamin D insufficiency, defined as
circulating 25(OH)vitamin D (25OHD) less than 30 ng/mL, is a frequent finding and this
population is at risk of the previously cited complications.The primary purpose of this study
is to compare the effects of high dose vs. low dose of cholecalciferol on a composite
endpoint consisting in de novo diabetes mellitus, cardiovascular diseases, de novo cancer and
patient death.Renal transplant recipients between 12 and 48 months after transplantation will
be randomized to blindly receive either high or low dose of cholecalciferol with a follow-up
of 2 years.
Phase:
Phase 4
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Laboratoire Crinex
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins