No Protective Effect of Calcitriol on β-Cell Function in Recent-Onset Type 1 Diabetes: The IMDIAB XIII trial

OBJECTIVE: We investigated whether supplementation of the active form of vitamin D (calcitriol) in recent-onset type 1 diabetes can protect β-cell function evaluated by C-peptide and improve glycemic control assessed by A1C and insulin requirement. RESEARCH DESIGN AND METHODS: Thirty-four subjects (...

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Published inDiabetes care Vol. 33; no. 9; pp. 1962 - 1963
Main Authors Bizzarri, Carla, Pitocco, Dario, Napoli, Nicola, Di Stasio, Enrico, Maggi, Daria, Manfrini, Silvia, Suraci, Concetta, Cavallo, Maria Gisella, Cappa, Marco, Ghirlanda, Giovanni, Pozzilli, Paolo
Format Journal Article
LanguageEnglish
Published United States American Diabetes Association 01.09.2010
Subjects
Adolescent
Adult
c-peptide
C-Peptide - metabolism
calcitriol
Calcitriol - pharmacology
Calcitriol - therapeutic use
Child
children
Diabetes Mellitus, Type 1 - drug therapy
Diabetes Mellitus, Type 1 - metabolism
Female
Glycated Hemoglobin A - metabolism
glycemic control
Humans
Hypoglycemic Agents - pharmacology
Hypoglycemic Agents - therapeutic use
Insulin - therapeutic use
insulin-dependent diabetes mellitus
Insulin-Secreting Cells - drug effects
Insulin-Secreting Cells - metabolism
Male
Original Research
protective effect
Young Adult
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Summary:OBJECTIVE: We investigated whether supplementation of the active form of vitamin D (calcitriol) in recent-onset type 1 diabetes can protect β-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 μg/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 β-cell function in subjects (including children) with recent-onset type 1 diabetes and high C-peptide at diagnosis.
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A complete list of the members of the IMDIAB Group can be found in the appendix.
ISSN:0149-5992
1935-5548
1935-5548
DOI:10.2337/dc10-0814