No protective effect of calcitriol on beta-cell function in recent-onset type 1 diabetes: the IMDIAB XIII trial
Carla Bizzarri, Dario Pitocco, Nicola Napoli, Enrico Di Stasio, Daria Maggi, Silvia Manfrini, Concetta Suraci, Maria Gisella Cavallo, Marco Cappa, Giovanni Ghirlanda, Paolo Pozzilli, IMDIAB Group, M Altomare, E Astorri, I Barchetta, D Benevento, G Beretta Anguissola, C Bizzarri, R Buzzetti, M Capizzi, M Cappa, M R Cassone Faldetta, M G Cavallo, L Cipolloni, E Cipponeri, F Costantino, A Crinò, E Di Stasio, E Fioriti, G Ghirlanda, C Guglielmi, A Lauria, D Maggi, S Manfrini, A R Maurizi, C Moretti, L Morbiducci, N Napoli, A Palermo, P Patera, D Pitocco, R Portuesi, P Pozzilli, R Scrocca, S Spera, R Strollo, C Suraci, C Tubili, D Tuccinardi, L Valente, N Visalli, Carla Bizzarri, Dario Pitocco, Nicola Napoli, Enrico Di Stasio, Daria Maggi, Silvia Manfrini, Concetta Suraci, Maria Gisella Cavallo, Marco Cappa, Giovanni Ghirlanda, Paolo Pozzilli, IMDIAB Group, M Altomare, E Astorri, I Barchetta, D Benevento, G Beretta Anguissola, C Bizzarri, R Buzzetti, M Capizzi, M Cappa, M R Cassone Faldetta, M G Cavallo, L Cipolloni, E Cipponeri, F Costantino, A Crinò, E Di Stasio, E Fioriti, G Ghirlanda, C Guglielmi, A Lauria, D Maggi, S Manfrini, A R Maurizi, C Moretti, L Morbiducci, N Napoli, A Palermo, P Patera, D Pitocco, R Portuesi, P Pozzilli, R Scrocca, S Spera, R Strollo, C Suraci, C Tubili, D Tuccinardi, L Valente, N Visalli
Abstract
Objective: We investigated whether supplementation of the active form of vitamin D (calcitriol) in recent-onset type 1 diabetes can protect beta-cell function evaluated by C-peptide and improve glycemic control assessed by A1C and insulin requirement.
Research design and methods: Thirty-four subjects (aged 11-35 years, median 18 years) with recent-onset type 1 diabetes and high basal C-peptide >0.25 nmol/l were randomized in a double-blind trial to 0.25 microg/day calcitriol or placebo and followed-up for 2 years.
Results: At 6, 12, and 24 months follow-up, A1C and insulin requirement in the calcitriol group did not differ from the placebo group. C-peptide dropped significantly (P < 0.001) but similarly in both groups, with no significant differences at each time point.
Conclusions: At the doses used, calcitriol is ineffective in protecting beta-cell function in subjects (including children) with recent-onset type 1 diabetes and high C-peptide at diagnosis.
Trial registration: ClinicalTrials.gov NCT01120119.
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Source: PubMed