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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
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 1
 Drug: Calcitriol
 Phase 2

Study Type: Interventional
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 NLM:

Drug Information available for: Calcitriol
U.S. FDA Resources

Further study details as provided by Campus Bio-Medico University:

Primary Outcome Measures:
  • C peptide
    evaluation of baseline and stimulated C peptide


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


Arms Assigned Interventions
Experimental: Calcitriol Drug: Calcitriol
Placebo Comparator: placebo Drug: Calcitriol

  Eligibility

Ages Eligible for Study:   11 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120119

Locations
Italy
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paolo Pozzilli/Principal Investigator, University Campus Bio Medico
ClinicalTrials.gov Identifier: NCT01120119     History of Changes
Other Study ID Numbers: CLF-1 2005-000751-15
Study First Received: May 6, 2010
Last Updated: May 7, 2010
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Calcitriol
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013