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Efficacy of Calcitriol in Recent Onset Type 1 Diabetes (IMDIABXIII)

This study has been completed.
Information provided by:
Campus Bio-Medico University Identifier:
First received: May 6, 2010
Last updated: May 7, 2010
Last verified: March 2005

May 6, 2010
May 7, 2010
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C peptide
evaluation of baseline and stimulated C peptide
Same as current
Complete list of historical versions of study NCT01120119 on Archive Site
Glycometabolic control
To measure insulin requirement and HbA1c
Same as current
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Efficacy of Calcitriol in Recent Onset Type 1 Diabetes
Clinical Study to Evaluate the Efficacy of 1,25(OH)2D3 (Calcitriol) Versus Placebo in Recent Onset Type 1 Diabetes(IMDIAB XIII)

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.

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Phase 2
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Diabetes Mellitus, Type 1
Drug: Calcitriol
  • Experimental: Calcitriol
    Intervention: Drug: Calcitriol
  • Placebo Comparator: placebo
    Intervention: Drug: Calcitriol

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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Inclusion Criteria:

  1. diagnosis of type 1 diabetes according to the American Diabetes Association (ADA) guidelines;
  2. age at presentation between 11 and 35 years;
  3. duration of clinical disease (since the beginning of insulin therapy) <12 weeks;
  4. baseline C-peptide >0.25 nmol/l;
  5. no medical contra-indications or any other major chronic disease;
  6. willingness and capability to participate in a regular follow-up.

Exclusion Criteria:

  1. cardiovascular disease;
  2. renal disease;
  3. liver disease;
  4. neurological disorders;
  5. allergic diathesis;
  6. hyperparathyroidism;
  7. neoplasia.
11 Years to 40 Years
Contact information is only displayed when the study is recruiting subjects
CLF-1 2005-000751-15
Paolo Pozzilli/Principal Investigator, University Campus Bio Medico
Campus Bio-Medico University
Not Provided
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Campus Bio-Medico University
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP