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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01120119
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : May 10, 2010
Information provided by:
Campus Bio-Medico University

Brief Summary:

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

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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)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Calcitriol

Arm Intervention/treatment
Experimental: Calcitriol Drug: Calcitriol
Placebo Comparator: placebo Drug: Calcitriol

Primary Outcome Measures :
  1. C peptide
    evaluation of baseline and stimulated C peptide

Secondary Outcome Measures :
  1. Glycometabolic control
    To measure insulin requirement and HbA1c

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01120119

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University Campus Bio Medico
Rome, Italy, 00128
Bambino Gesù Children's Hospital
Rome, Italy
Catholic University,
Rome, Italy
Sandro Pertini Hospital
Rome, Italy
University Sapienza
Rome, Italy
Sponsors and Collaborators
Campus Bio-Medico University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Paolo Pozzilli/Principal Investigator, University Campus Bio Medico Identifier: NCT01120119     History of Changes
Other Study ID Numbers: CLF-1 2005-000751-15
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: May 10, 2010
Last Verified: March 2005
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents