Immunointervention With Calcitriol in New-Onset Type 1 Diabetes

Institut fur Diabetesforschung, Munich, Germany

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes

Treatments: Drug: 1,25-dihydroxy-vitamin D3 (calcitriol); Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00960635

336/00

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups, including a placebo group

calcitriol

Active Comparator group

Treatment:

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

pill without agent

Placebo Comparator group

Treatment:

Drug: placebo