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Efficacy of Calcitriol in Recent Onset Type 1 Diabetes

NCT01120119 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2010-05-10

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Calcitriol

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Eligibility

Min Age
11 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120119 on ClinicalTrials.gov