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

This study has been completed.
Sponsor:
Information provided by:
Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT01120119
First received: May 6, 2010
Last updated: May 7, 2010
Last verified: March 2005

May 6, 2010
May 7, 2010
Not Provided
Not Provided
C peptide
evaluation of baseline and stimulated C peptide
Same as current
Complete list of historical versions of study NCT01120119 on ClinicalTrials.gov Archive Site
Glycometabolic control
To measure insulin requirement and HbA1c
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
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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.
Both
11 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01120119
CLF-1 2005-000751-15
No
Paolo Pozzilli/Principal Investigator, University Campus Bio Medico
Campus Bio-Medico University
Not Provided
Not Provided
Campus Bio-Medico University
March 2005

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