Trial | NCT00960635  Report issue

Title

Immunointervention With Calcitriol in New-Onset Type 1 Diabetes
Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    calcitriol ...

  • Study Participants

    None
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.
Study Started
Jun 30
2001
Primary Completion
Aug 31
2008
Study Completion
Aug 31
2008
Last Update
Aug 18
2009
Estimate

Drug 1,25-dihydroxy-vitamin D3 (calcitriol)

Drug placebo

pill without agent

calcitriol Active Comparator

pill without agent Placebo Comparator

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
No Results Posted