Back to resultsImmunointervention With Calcitriol in New-Onset Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
1,25-dihydroxy-vitamin D3 (calcitriol)
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Type 1 Diabetes focused on measuring new-onset
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
Sites / Locations
- Institut fuer Diabetesforschung
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
calcitriol
pill without agent
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00960635
First Posted
August 17, 2009
Last Updated
August 17, 2009
Sponsor
Institut fur Diabetesforschung, Munich, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00960635
Brief Title
Immunointervention With Calcitriol in New-Onset Type 1 Diabetes
Official Title
Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institut fur Diabetesforschung, Munich, Germany
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
new-onset
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Arm Title
calcitriol
Arm Type
Active Comparator
Arm Title
pill without agent
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
1,25-dihydroxy-vitamin D3 (calcitriol)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
pill without agent
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anette G Ziegler, MD
Organizational Affiliation
Institut fuer Diabetesforschung
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut fuer Diabetesforschung
City
Munich
ZIP/Postal Code
80804
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20357369
Citation
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.
Results Reference
derived
Learn more about this trial
Immunointervention With Calcitriol in New-Onset Type 1 Diabetes
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