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

May 7, 2010 updated by: Campus Bio-Medico University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00128
        • University Campus Bio Medico
      • Rome, Italy
        • Bambino Gesu Children's Hospital
      • Rome, Italy
        • Catholic University,
      • Rome, Italy
        • Sandro Pertini Hospital
      • Rome, Italy
        • University Sapienza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Drug: Calcitriol
EXPERIMENTAL: Calcitriol
Drug: Calcitriol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
C peptide
evaluation of baseline and stimulated C peptide

Secondary Outcome Measures

Outcome Measure
Measure Description
Glycometabolic control
To measure insulin requirement and HbA1c

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (ESTIMATE)

May 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 10, 2010

Last Update Submitted That Met QC Criteria

May 7, 2010

Last Verified

March 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLF-1 2005-000751-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on Calcitriol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe