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VITamin D supplementation in renAL transplant recipients (VITALE): a prospective, multicentre, double-blind, randomized trial of vitamin D estimating the benefit and safety of vitamin D3 treatment at a dose of 100,000 UI compared with a dose of 12,000 UI in renal transplant recipients: study protocol for a double-blind, randomized, controlled trial.
Trials 2014; 15:430T

Abstract

BACKGROUND

In addition to their effects on bone health, high doses of cholecalciferol may have beneficial non-classic effects including the reduction of incidence of type 2 diabetes mellitus, cardiovascular disease, and cancer. These pleiotropic effects have been documented in observational and experimental studies or in small intervention trials. Vitamin D insufficiency is a frequent finding in renal transplant recipients (RTRs), and this population is at risk of the previously cited complications.

METHODS/DESIGN

The VITALE study is a prospective, multicentre, double-blind, randomized, controlled trial with two parallel groups that will include a total of 640 RTRs. RTRs with vitamin D insufficiency, defined as circulating 25-hydroxyvitamin D levels of less than 30 ng/ml (or 75 nmol/l), will be randomized between 12 and 48 months after transplantation to blinded groups to receive vitamin D3 (cholecalciferol) either at high or low dose (respectively, 100,000 UI or 12,000 UI every 2 weeks for 2 months then monthly for 22 months) with a follow-up of 2 years. The primary objective of the study is to evaluate the benefit/risk ratio of high-dose versus low-dose cholecalciferol on a composite endpoint consisting of de novo diabetes mellitus; major cardiovascular events; de novo cancer; and patient death. Secondary endpoints will include blood pressure (BP) control; echocardiography findings; the incidences of infection and acute rejection episodes; renal allograft function using estimated glomerular filtration rate; proteinuria; graft survival; bone mineral density; the incidence of fractures; and biological relevant parameters of mineral metabolism.

DISCUSSION

We previously reported that the intensive cholecalciferol treatment (100 000 IU every 2 weeks for 2 months) was safe in RTR. Using a pharmacokinetic approach, we showed that cholecalciferol 100,000 IU monthly should maintain serum 25-hydroxyvitamin D at above 30 ng/ml but below 80 ng/ml after renal transplantation. Taken together, these results are reassuring regarding the safety of the cholecalciferol doses that will be used in the VITALE study. Analysis of data collected during the VITALE study will demonstrate whether high or low-dose cholecalciferol is beneficial in RTRs with vitamin D insufficiency.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01431430.

Authors+Show Affiliations

Department of Physiology, Assistance Publique-hôpitaux de Paris, Hôpital Européen Georges Pompidou, F-75015 Paris, France. marie.courbebaisse@egp.aphp.fr.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25376735

Citation

Courbebaisse, Marie, et al. "VITamin D Supplementation in renAL Transplant Recipients (VITALE): a Prospective, Multicentre, Double-blind, Randomized Trial of Vitamin D Estimating the Benefit and Safety of Vitamin D3 Treatment at a Dose of 100,000 UI Compared With a Dose of 12,000 UI in Renal Transplant Recipients: Study Protocol for a Double-blind, Randomized, Controlled Trial." Trials, vol. 15, 2014, p. 430.
Courbebaisse M, Alberti C, Colas S, et al. VITamin D supplementation in renAL transplant recipients (VITALE): a prospective, multicentre, double-blind, randomized trial of vitamin D estimating the benefit and safety of vitamin D3 treatment at a dose of 100,000 UI compared with a dose of 12,000 UI in renal transplant recipients: study protocol for a double-blind, randomized, controlled trial. Trials. 2014;15:430.
Courbebaisse, M., Alberti, C., Colas, S., Prié, D., Souberbielle, J. C., Treluyer, J. M., & Thervet, E. (2014). VITamin D supplementation in renAL transplant recipients (VITALE): a prospective, multicentre, double-blind, randomized trial of vitamin D estimating the benefit and safety of vitamin D3 treatment at a dose of 100,000 UI compared with a dose of 12,000 UI in renal transplant recipients: study protocol for a double-blind, randomized, controlled trial. Trials, 15, p. 430. doi:10.1186/1745-6215-15-430.
Courbebaisse M, et al. VITamin D Supplementation in renAL Transplant Recipients (VITALE): a Prospective, Multicentre, Double-blind, Randomized Trial of Vitamin D Estimating the Benefit and Safety of Vitamin D3 Treatment at a Dose of 100,000 UI Compared With a Dose of 12,000 UI in Renal Transplant Recipients: Study Protocol for a Double-blind, Randomized, Controlled Trial. Trials. 2014 Nov 6;15:430. PubMed PMID: 25376735.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - VITamin D supplementation in renAL transplant recipients (VITALE): a prospective, multicentre, double-blind, randomized trial of vitamin D estimating the benefit and safety of vitamin D3 treatment at a dose of 100,000 UI compared with a dose of 12,000 UI in renal transplant recipients: study protocol for a double-blind, randomized, controlled trial. AU - Courbebaisse,Marie, AU - Alberti,Corinne, AU - Colas,Sandra, AU - Prié,Dominique, AU - Souberbielle,Jean-Claude, AU - Treluyer,Jean-Marc, AU - Thervet,Eric, Y1 - 2014/11/06/ PY - 2014/06/03/received PY - 2014/10/15/accepted PY - 2014/11/8/entrez PY - 2014/11/8/pubmed PY - 2015/7/15/medline SP - 430 EP - 430 JF - Trials JO - Trials VL - 15 N2 - BACKGROUND: In addition to their effects on bone health, high doses of cholecalciferol may have beneficial non-classic effects including the reduction of incidence of type 2 diabetes mellitus, cardiovascular disease, and cancer. These pleiotropic effects have been documented in observational and experimental studies or in small intervention trials. Vitamin D insufficiency is a frequent finding in renal transplant recipients (RTRs), and this population is at risk of the previously cited complications. METHODS/DESIGN: The VITALE study is a prospective, multicentre, double-blind, randomized, controlled trial with two parallel groups that will include a total of 640 RTRs. RTRs with vitamin D insufficiency, defined as circulating 25-hydroxyvitamin D levels of less than 30 ng/ml (or 75 nmol/l), will be randomized between 12 and 48 months after transplantation to blinded groups to receive vitamin D3 (cholecalciferol) either at high or low dose (respectively, 100,000 UI or 12,000 UI every 2 weeks for 2 months then monthly for 22 months) with a follow-up of 2 years. The primary objective of the study is to evaluate the benefit/risk ratio of high-dose versus low-dose cholecalciferol on a composite endpoint consisting of de novo diabetes mellitus; major cardiovascular events; de novo cancer; and patient death. Secondary endpoints will include blood pressure (BP) control; echocardiography findings; the incidences of infection and acute rejection episodes; renal allograft function using estimated glomerular filtration rate; proteinuria; graft survival; bone mineral density; the incidence of fractures; and biological relevant parameters of mineral metabolism. DISCUSSION: We previously reported that the intensive cholecalciferol treatment (100 000 IU every 2 weeks for 2 months) was safe in RTR. Using a pharmacokinetic approach, we showed that cholecalciferol 100,000 IU monthly should maintain serum 25-hydroxyvitamin D at above 30 ng/ml but below 80 ng/ml after renal transplantation. Taken together, these results are reassuring regarding the safety of the cholecalciferol doses that will be used in the VITALE study. Analysis of data collected during the VITALE study will demonstrate whether high or low-dose cholecalciferol is beneficial in RTRs with vitamin D insufficiency. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01431430. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/25376735/VITamin_D_supplementation_in_renAL_transplant_recipients__VITALE_:_a_prospective_multicentre_double_blind_randomized_trial_of_vitamin_D_estimating_the_benefit_and_safety_of_vitamin_D3_treatment_at_a_dose_of_100000_UI_compared_with_a_dose_of_12000_UI_in_renal_transplant_recipients:_study_protocol_for_a_double_blind_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-430 DB - PRIME DP - Unbound Medicine ER -