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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:

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: 1,25-dihydroxy-vitamin D3 (calcitriol) Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Official Title: Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes
Study Start Date : June 2001
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Calcitriol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: calcitriol Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)
Placebo Comparator: pill without agent Drug: placebo
pill without agent


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009

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
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcitriol
Dihydroxycholecalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents