학술논문
Nonskeletal and skeletal effects of high doses versus low doses of vitamin D3in renal transplant recipients: Results of the VITALE (VITamin D supplementation in renAL transplant recipients) study, a randomized clinical trial
Document Type
Article
Author
Courbebaisse, Marie; Bourmaud, Aurelie; Souberbielle, Jean-Claude; Sberro-Soussan, Rebecca; Moal, Valérie; Le Meur, Yannick; Kamar, Nassim; Albano, Laetitia; Thierry, Antoine; Dantal, Jacques; Danthu, Clément; Moreau, Karine; Morelon, Emmanuel; Heng, Anne-Elisabeth; Bertrand, Dominique; Arzouk, Nadia; Perrin, Peggy; Morin, Marie-Pascale; Rieu, Philippe; Presne, Claire; Grimbert, Philippe; Ducloux, Didier; Büchler, Matthias; Le Quintrec, Moglie; Ouali, Nacéra; Pernin, Vincent; Bouvier, Nicolas; Durrbach, Antoine; Alamartine, Eric; Randoux, Christine; Besson, Virginie; Hazzan, Marc; Pages, Justine; Colas, Sandra; Piketty, Marie-Liesse; Friedlander, Gérard; Prié, Dominique; Alberti, Corinne; Thervet, Eric
Source
American journal of transplantation; March 2023, Vol. 23 Issue: 3 p366-376, 11p
Subject
Language
ISSN
16006135; 16006143
Abstract
Vitamin D sufficiency is associated with a reduced risk of fractures, diabetes mellitus, cardiovascular events, and cancers, which are frequent complications after renal transplantation. The VITALE (VITamin D supplementation in renAL transplant recipients) study is a multicenter double-blind randomized trial, including nondiabetic adult renal transplant recipients with serum 25-hydroxy vitamin D (25(OH) vitamin D) levels of <30 ng/mL, which is randomized 12 to 48 months after transplantation to receive high (100 000 IU) or low doses (12 000 IU) of cholecalciferol every 2 weeks for 2 months and then monthly for 22 months. The primary outcome was a composite endpoint, including diabetes mellitus, major cardiovascular events, cancer, and death. Of 536 inclusions (50.8 [13.7] years, 335 men), 269 and 267 inclusions were in the high-dose and low-dose groups, respectively. The serum 25(OH) vitamin D levels increased by 23 versus 6 ng/mL in the high-dose and low-dose groups, respectively (P< .0001). In the intent-to-treat analysis, 15% versus 16% of the patients in the high-dose and low-dose groups, respectively, experienced a first event of the composite endpoint (hazard ratio, 0.94 [0.60-1.48]; P= .78), whereas 1% and 4% of patients in the high-dose and low-dose groups, respectively, experienced an incident symptomatic fracture (odds ratio, 0.24 [0.07-0.86], P= .03). The incidence of adverse events was similar between the groups. After renal transplantation, high doses of cholecalciferol are safe but do not reduce extraskeletal complications (trial registration: ClinicalTrials.gov; identifier: NCT01431430).