Fracture 4X less likely following kidney transplant if high-dose Vitamin D (100,000 every 2 weeks) – RCT

Created January 2023

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 Jan 9;S1600-6135(22)29286-7. doi: 10.1016/j.ajt.2022.12.007

Marie Courbebaisse 1, Aurelie Bourmaud 2, Jean-Claude Souberbielle 3, Rebecca Sberro-Soussan 4, Valérie Moal 5, Yannick Le Meur 6, Nassim Kamar 7, Laetitia Albano 8, Antoine Thierry 9, Jacques Dantal 10, Clément Danthu 11, Karine Moreau 12, Emmanuel Morelon 13, Anne-Elisabeth Heng 14, Dominique Bertrand 15, Nadia Arzouk 16, Peggy Perrin 17, Marie-Pascale Morin 18, Philippe Rieu 19, Claire Presne 20, Philippe Grimbert 21, Didier Ducloux 22, Matthias Büchler 23, Moglie Le Quintrec 24, Nacéra Ouali 25, Vincent Pernin 26, Nicolas Bouvier 27, Antoine Durrbach 28, Eric Alamartine 29, Christine Randoux 30, Virginie Besson 31, Marc Hazzan 32, Justine Pages 33, Sandra Colas 34, Marie-Liesse Piketty 3, Gérard Friedlander 35, Dominique Prié 36, Corinne Alberti 2, Eric Thervet 37

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).

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