VITamine D Supplementation in RenAL Transplant Recipients - VITALE

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.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

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

• RESULTCourbebaisse M, Bourmaud A, Souberbielle JC, Sberro-Soussan R, Moal V, Le Meur Y, Kamar N, Albano L, Thierry A, Dantal J, Danthu C, Moreau K, Morelon E, Heng AE, Bertrand D, Arzouk N, Perrin P, Morin MP, Rieu P, Presne C, Grimbert P, Ducloux D, Buchler M, Le Quintrec M, Ouali N, Pernin V, Bouvier N, Durrbach A, Alamartine E, Randoux C, Besson V, Hazzan M, Pages J, Colas S, Piketty ML, Friedlander G, Prie D, Alberti C, Thervet E. Nonskeletal and skeletal effects of high doses versus low doses of vitamin D3 in renal transplant recipients: Results of the VITALE (VITamin D supplementation in renAL transplant recipients) study, a randomized clinical trial. Am J Transplant. 2023 Mar;23(3):366-376. doi: 10.1016/j.ajt.2022.12.007. Epub 2023 Jan 9. PMID 36695682
• RESULTCourbebaisse M, Alberti C, Colas S, Prie D, Souberbielle JC, Treluyer JM, Thervet E. VITamin D supplementation in renAL transplant recipients (VITALE): a prospective, multicentre, double-blind, randomized trial of vitamin D estimating the benefit and safety of vitamin D3 treatment at a dose of 100,000 UI compared with a dose of 12,000 UI in renal transplant recipients: study protocol for a double-blind, randomized, controlled trial. Trials. 2014 Nov 6;15:430. doi: 10.1186/1745-6215-15-430. PMID 25376735