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Immunointervention With Calcitriol in New-Onset Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Institut fur Diabetesforschung, Munich, Germany
ClinicalTrials.gov Identifier:
NCT00960635
First received: August 17, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted

August 17, 2009
August 17, 2009
June 2001
August 2008   (final data collection date for primary outcome measure)
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Not Provided
No Changes Posted
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Immunointervention With Calcitriol in New-Onset Type 1 Diabetes
Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes

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.
Not Provided
Interventional
Phase 2
Primary Purpose: Prevention
Type 1 Diabetes
  • Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)
  • Drug: placebo
    pill without agent
  • Active Comparator: calcitriol
    Intervention: Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)
  • Placebo Comparator: pill without agent
    Intervention: Drug: placebo
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. Epub 2010 Mar 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 39 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00960635
336/00
No
Anette Ziegler, MD, Institut fuer Diabetesforschung
Institut fur Diabetesforschung, Munich, Germany
Not Provided
Principal Investigator: Anette G Ziegler, MD Institut fuer Diabetesforschung
Institut fur Diabetesforschung, Munich, Germany
August 2009

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