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Immunointervention With Calcitriol in New-Onset Type 1 Diabetes

This study has been completed.
Information provided by:
Institut fur Diabetesforschung, Munich, Germany Identifier:
First received: August 17, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
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 Intervention Phase
Type 1 Diabetes Drug: 1,25-dihydroxy-vitamin D3 (calcitriol) Drug: placebo Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes

Resource links provided by NLM:

Further study details as provided by Institut fur Diabetesforschung, Munich, Germany:

Study Start Date: June 2001
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: calcitriol Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)
Placebo Comparator: pill without agent Drug: placebo
pill without agent


Ages Eligible for Study:   18 Years to 39 Years   (Adult)
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
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Please refer to this study by its identifier: NCT00960635

Institut fuer Diabetesforschung
Munich, Germany, 80804
Sponsors and Collaborators
Institut fur Diabetesforschung, Munich, Germany
Principal Investigator: Anette G Ziegler, MD Institut fuer Diabetesforschung
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anette Ziegler, MD, Institut fuer Diabetesforschung Identifier: NCT00960635     History of Changes
Other Study ID Numbers: 336/00
Study First Received: August 17, 2009
Last Updated: August 17, 2009

Keywords provided by Institut fur Diabetesforschung, Munich, Germany:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents processed this record on August 21, 2017