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Immunointervention With Calcitriol in New-Onset Type 1 Diabetes

NCT00960635 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2009-08-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

1,25-dihydroxy-vitamin D3 (calcitriol)

DRUG

placebo

pill without agent

Sponsors & Collaborators

  • Institut fur Diabetesforschung, Munich, Germany

    lead OTHER

Principal Investigators

  • Anette G Ziegler, MD · Institut fuer Diabetesforschung

Study Design

Purpose
PREVENTION

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00960635 on ClinicalTrials.gov