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Completed

NCT Number: NCT01120119

Efficacy of Calcitriol in Recent Onset Type 1 Diabetes

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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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

11 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bambino Gesù Children's Hospital, Rome, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • cardiovascular disease;
  • renal disease;
  • liver disease;
  • neurological disorders;
  • allergic diathesis;
  • hyperparathyroidism;
  • neoplasia.

Treatment and study plan

calcitriol

Drug

Primary outcomes

  1. C peptide

    evaluation of baseline and stimulated C peptide

Secondary outcomes

  1. Glycometabolic control

    To measure insulin requirement and HbA1c

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

Clinical Study to Evaluate the Efficacy of 1,25(OH)2D3 (Calcitriol) Versus Placebo in Recent Onset Type 1 Diabetes(IMDIAB XIII)

Acronym: IMDIABXIII

Important dates

First posted
May 10, 2010
Registry last updated
May 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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