Immunointervention With Calcitriol in New-Onset Type 1 Diabetes
Immunointervention With Calcitriol in New-Onset Type 1 Diabetes
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.
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