NCT01120119

Efficacy of Calcitriol in Recent Onset Type 1 Diabetes

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Campus Bio-Medico University · Academic / Other
• Sex: All
• Age: 11 Years – 40 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Calcitriol

Timeline

• First posted: 2010-05-10
• Last updated: 2010-05-10

Locations

5 sites across 1 country: Italy