Immunointervention With Calcitriol in New-Onset Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960635
• Other study ID #: 336/00
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2009
• Last updated: August 17, 2009
• Start date: June 2001
• Est. completion date: August 2008

Study information

• Verified date: August 2009
• Source: Institut fur Diabetesforschung, Munich, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

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

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• 1,25-dihydroxy-vitamin D3 (calcitriol)

• placebo
pill without agent

Locations

Country	Name	City	State
Germany	Institut fuer Diabetesforschung	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Institut fur Diabetesforschung, Munich, Germany

Country where clinical trial is conducted

Germany,