Efficacy of Calcitriol in Recent Onset Type 1 Diabetes (IMDIABXIII)
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|ClinicalTrials.gov Identifier: NCT01120119|
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : May 10, 2010
Reduction in vitamin D levels has been reported in subjects with recent onset type 1 diabetes. Several studies suggest that vitamin D supplementation in early childhood decreases the risk of developing type 1 diabetes, therefore vitamin D deficiency might play a role in the disease pathogenesis. We investigated whether the supplementation of the active form of vitamin D (calcitriol) in subjects with recent-onset type 1 diabetes can protect residual beta cell function evaluated by C peptide and improve glycaemic control as evaluated by HbA1c and insulin requirement.
Thirty-four subjects (age range 11-35 years, median 18 years) with recent-onset type 1 diabetes (<12 weeks duration) and high basal C-peptide >0.25 nmol/l were randomized in a double-blind trial to calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3 [1,25-(OH)2D3] ) at the dose of 0.25 ug/day or placebo, and followed up for 2 years.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: Calcitriol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Clinical Study to Evaluate the Efficacy of 1,25(OH)2D3 (Calcitriol) Versus Placebo in Recent Onset Type 1 Diabetes(IMDIAB XIII)|
|Placebo Comparator: placebo||
- C peptideevaluation of baseline and stimulated C peptide
- Glycometabolic controlTo measure insulin requirement and HbA1c
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120119
|University Campus Bio Medico|
|Rome, Italy, 00128|
|Bambino Gesù Children's Hospital|
|Sandro Pertini Hospital|