Immunointervention With Calcitriol in New-Onset Type 1 Diabetes

Phase 2

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: 1,25-dihydroxy-vitamin D3 (calcitriol); Drug: placebo

• Registration Number: NCT00960635
• Lead Sponsor: Institut fur Diabetesforschung, Munich, Germany

Brief Summary

This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the daily intake of 1,25-dihydroxy-vitamin D3 \[1,25(OH)2D3\], improves beta cell function in patients with recently diagnosed type 1 diabetes. The treatment consists of the daily oral administration of 0.25 µg 1,25(OH)2D3 or placebo for 9 months and an equal follow-up time without supplementation. Fasting, peak and AUC C-peptide concentrations during a 2-hour mixed meal tolerance test are measured at the beginning of the study, as well as at the end of the treatment and the follow-up period in month 9 and 18. The null hypothesis is that there is no difference between 1,25(OH)2D3 treated subjects and the placebo group in the AUC C-peptide at month 18.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-08
• Study First Submitted: 2009-08-17
• Study First Submitted QC: 2009-08-17
• Last Update Submitted: 2009-08-17
• Study First Posted: 2009-08-18
• Last Update Posted: 2009-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• New onset Typ 1 diabetes (< 6 weeks insulin therapy)
• Age 18-39 years
• GADA and/or IA-2A positive

Exclusion Criteria

• Kidney disease
• Pregnancy
• Lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
calcitriol	1,25-dihydroxy-vitamin D3 (calcitriol)	-
pill without agent	placebo	-

Trial Locations

Locations (1)

Institut fuer Diabetesforschung; 🇩🇪 Munich, Germany