VITamine D Supplementation in RenAL Transplant Recipients - VITALE

• Status: Completed
• Trial end date: 2016-02-02
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Laboratoire Crinex
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Renal transplant recipients between 12 and 48 months after transplantation with a stable renal function during the past 3 months.

• Vitamine D insufficiency defined as a concentration of 25OHD lower than 30 ng/ml.

• Patient between 18 and 75 years old

• Patient capable of understanding the advantages and the risks of the study.

• Affiliated with social security health insurance

• Written informed consent

Exclusion Criteria:

• Calcaemia > 2,7 mmol/l

• Phosphataemia > 1,5 mmol/l

• Serum creatinine > 250 µmol/l

• Treatment by an active form of the vitamin D not being able to be interrupted

• Transplant of an organ other than the kidney

• Type I or type II diabetes mellitus

• Past medical history of granulomatosis or active granulomatosis

• Primary hyperoxaluria

• Malabsorption proved by the liposoluble vitamins

• Simultaneous participation in another therapeutic essay

• Patients presenting a drug addiction or a psychiatric disorder

• Pregnant or breast-feeding women

• Vitamin D hyper sensibility