Immunointervention With Calcitriol in New-Onset Type 1 Diabetes

• Sponsor: Institut fur Diabetesforschung, Munich, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT00960635
• Collaborator: (none)
• Location: 1
• Arms: 2
• Duration (Months): 86

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Drug: 1,25-dihydroxy-vitamin D3 (calcitriol); Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Primary Purpose: Prevention
• Official Title: Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes
• Study Start Date: Jun 1, 2001
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: calcitriol	Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)
Placebo Comparator: pill without agent	Drug: placebo; pill without agent

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut fuer Diabetesforschung	Munich		Germany	80804

Sponsors and Collaborators

• Institut fur Diabetesforschung, Munich, Germany

Investigators

• Principal Investigator: Anette G Ziegler, MD, Institut fuer Diabetesforschung

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00960635
• Other Study ID Numbers: 336/00
• First Posted: Aug 18, 2009
• Last Update Posted: Aug 18, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: new-onset
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Vitamin D; Cholecalciferol; Calcitriol; Dihydroxycholecalciferols

Study Results

No Results Posted as of Aug 18, 2009