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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

2023; Elsevier BV; Volume: 23; Issue: 3 Linguagem: Inglês

10.1016/j.ajt.2022.12.007

1600-6143

Marie Courbebaisse, Aurélie Bourmaud, Jean–Claude Souberbielle, Rébecca Sberro‐Soussan, Valérie Moal, Yannick Le Meur, Nassim Kamar, Laetitia Albano, Antoine Thierry, Jacques Dantal, Clément Danthu, Karine Moreau, Emmanuel Morélon, Anne-Elisabeth Heng, Dominique Bertrand, Nadia Arzouk, Peggy Perrin, Marie-Pascale Morin, Philippe Rieu, Claire Presne, Philippe Grimbert, Didier Ducloux, Matthias Büchler, Moglie Le Quintrec, Nacéra Ouali, Vincent Pernin, Nicolas Bouvier, Antoine Dürrbach, É. Alamartine, Christine Randoux, Virginie Besson, Marc Hazzan, Justine Pages, Sandra Colas, Marie‐Liesse Piketty, Gérard Friedlander, Dominique Prié, Corinne Alberti, Éric Thervet,

Neurological Complications and Syndromes

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).