Immunointervention With Calcitriol in New-Onset Type 1 Diabetes

NCT ID: NCT00960635

Last Updated: 2009-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2008-08-31

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.

Conditions

Type 1 Diabetes

Study Design

• Primary Study Purpose: PREVENTION

Study Groups

calcitriol

Group Type: ACTIVE_COMPARATOR

1,25-dihydroxy-vitamin D3 (calcitriol)

Intervention Type: DRUG

pill without agent

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

pill without agent

Interventions

1,25-dihydroxy-vitamin D3 (calcitriol)

Intervention Type: DRUG

placebo

pill without agent

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut fur Diabetesforschung, Munich, Germany

OTHER

Sponsor Role: lead

Responsible Party

Institut fuer Diabetesforschung

Principal Investigators

Anette G Ziegler, MD

Role: PRINCIPAL_INVESTIGATOR

Institut fuer Diabetesforschung

Locations

Institut fuer Diabetesforschung

Munich, , Germany

Countries

Germany

References

Walter M, Kaupper T, Adler K, Foersch J, Bonifacio E, Ziegler AG. No effect of the 1alpha,25-dihydroxyvitamin D3 on beta-cell residual function and insulin requirement in adults with new-onset type 1 diabetes. Diabetes Care. 2010 Jul;33(7):1443-8. doi: 10.2337/dc09-2297. Epub 2010 Mar 31.

Reference Type: DERIVED

PMID: 20357369 (View on PubMed)

Other Identifiers

336/00

Identifier Type: -

Identifier Source: org_study_id