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Immunointervention With Calcitriol in New-Onset Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT00960635
Recruitment Status : Completed
First Posted : August 18, 2009
Last Update Posted : August 18, 2009
Sponsor:
Information provided by:
Institut fur Diabetesforschung, Munich, Germany

Tracking Information
First Submitted Date  ICMJE August 17, 2009
First Posted Date  ICMJE August 18, 2009
Last Update Posted Date August 18, 2009
Study Start Date  ICMJE June 2001
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunointervention With Calcitriol in New-Onset Type 1 Diabetes
Official Title  ICMJE Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Prevention
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)
  • Drug: placebo
    pill without agent
Study Arms  ICMJE
  • Active Comparator: calcitriol
    Intervention: Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)
  • Placebo Comparator: pill without agent
    Intervention: Drug: placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00960635
Other Study ID Numbers  ICMJE 336/00
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anette Ziegler, MD, Institut fuer Diabetesforschung
Study Sponsor  ICMJE Institut fur Diabetesforschung, Munich, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anette G Ziegler, MD Institut fuer Diabetesforschung
PRS Account Institut fur Diabetesforschung, Munich, Germany
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP