Title :

Nonskeletal and skeletal effects of high doses versus low doses of vitamin D ₃ in renal transplant recipients: Results of the VITALE (VITamin D supplementation in renAL transplant recipients) study, a randomized clinical trial.

Author(s) :

Courbebaisse, Marie [Auteur]
Hôpital Européen Georges Pompidou [APHP] [HEGP]
Bourmaud, Aurélie [Auteur]
AP-HP Hôpital universitaire Robert-Debré [Paris]
Souberbielle, Jean-Claude [Auteur]
Hôpital Necker - Enfants Malades [AP-HP]
Sberro-Soussan, Rebecca [Auteur]
Hôpital Necker - Enfants Malades [AP-HP]
Moal, Valérie [Auteur]
Hôpital de la Conception [CHU - APHM] [LA CONCEPTION]
Le Meur, Yannick [Auteur]
Centre Hospitalier Régional Universitaire de Brest [CHRU Brest]
Kamar, Nassim [Auteur]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Albano, Laetitia [Auteur]
Centre Hospitalier Universitaire de Nice [CHU Nice]
Thierry, Antoine [Auteur]
Fédération Hospitalo-Universitaire « SUrvival oPtimization in ORgan Transplantation » [FHU SUPORT]
Dantal, Jacques [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Danthu, Clément [Auteur]
CHU Limoges
Moreau, Karine [Auteur]
Centre Hospitalier Universitaire de Bordeaux [CHU Bordeaux]
Morelon, Emmanuel [Auteur]
Hospices Civils de Lyon [HCL]
Heng, Anne-Elisabeth [Auteur]
CHU Clermont-Ferrand
Bertrand, Dominique [Auteur]
CHU Rouen
Arzouk, Nadia [Auteur]
CHU Pitié-Salpêtrière [AP-HP]
Perrin, Peggy [Auteur]
Centre Hospitalier Universitaire [Strasbourg] [CHU Strasbourg]
Morin, Marie-Pascale [Auteur]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Rieu, Philippe [Auteur]
Hôpital universitaire Robert Debré [Reims] [CHU Reims]
Presne, Claire [Auteur]
CHU Amiens-Picardie
Grimbert, Philippe [Auteur]
CHU Henri Mondor [Créteil]
Ducloux, Didier [Auteur]
Centre Hospitalier Régional Universitaire de Besançon [CHRU Besançon]
Büchler, Matthias [Auteur]
CHU Trousseau [Tours]
Le Quintrec, Moglie [Auteur]
Hôpital Foch [Suresnes]
Ouali, Nacéra [Auteur]
CHU Tenon [AP-HP]
Pernin, Vincent [Auteur]
Centre Hospitalier Régional Universitaire [Montpellier] [CHRU Montpellier]
Bouvier, Nicolas [Auteur]
CHU Caen
Durrbach, Antoine [Auteur]
Institut Gustave Roussy [IGR]
Alamartine, Eric [Auteur]
Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] [CHU ST-E]
Randoux, Christine [Auteur]
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
Besson, Virginie [Auteur]
Centre Hospitalier Universitaire d'Angers [CHU Angers]
Hazzan, Marc [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Pages, Justine [Auteur]
Centre d'Investigation Clinique 1426 [CIC 1426]
Colas, Sandra [Auteur]
Hôpital Necker - Enfants Malades [AP-HP]
Piketty, Marie-Liesse [Auteur]
Hôpital Necker - Enfants Malades [AP-HP]
Friedlander, Gérard [Auteur]
Prié, Dominique [Auteur]
Institut Necker Enfants-Malades [INEM - UM 111 (UMR 8253 / U1151)]
Alberti, Corinne [Auteur]
Hôpital Robert Debré
Thervet, Eric [Auteur]
Hôpital Robert Debré

Journal title :

American Journal of Transplantation

Abbreviated title :

Am J Transplant

Publication date :

2023-01-29

ISSN :

1600-6143

English keyword(s) :

clinical research/practice
kidney transplantation/nephrology
kidney disease: metabolic
hyperparathyroidism
complication: medical/metabolic
complication: malignant
clinical trial

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

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 ...
Show more >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).Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-01-11T23:29:14Z
2024-03-21T15:06:31Z