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
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960635

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

No publications provided by Institut fur Diabetesforschung, Munich, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anette Ziegler, MD, Institut fuer Diabetesforschung
ClinicalTrials.gov Identifier: NCT00960635     History of Changes
Other Study ID Numbers: 336/00
Study First Received: August 17, 2009
Last Updated: August 17, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institut fur Diabetesforschung, Munich, Germany:
new-onset

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
Vitamins
Cholecalciferol
Calcitriol
Dihydroxycholecalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014