Details

Autor(en) / Beteiligte

• 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

Titel

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

Ist Teil von

• American journal of transplantation, 2023-03, Vol.23 (3), p.366-376

Ort / Verlag

Elsevier Inc

Erscheinungsjahr

2023

Quelle

EZB-FREE-00999 freely available EZB journals

Beschreibungen/Notizen

• 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).