Efficacy of Calcitriol in Recent Onset Type 1 Diabetes (IMDIABXIII)

Campus Bio-Medico University of Rome

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Calcitriol

Study type: Interventional

Funder types: Other

Identifiers

NCT01120119

CLF-1 2005-000751-15

Details and patient eligibility

About

Reduction in vitamin D levels has been reported in subjects with recent onset type 1 diabetes. Several studies suggest that vitamin D supplementation in early childhood decreases the risk of developing type 1 diabetes, therefore vitamin D deficiency might play a role in the disease pathogenesis. We investigated whether the supplementation of the active form of vitamin D (calcitriol) in subjects with recent-onset type 1 diabetes can protect residual beta cell function evaluated by C peptide and improve glycaemic control as evaluated by HbA1c and insulin requirement.

Thirty-four subjects (age range 11-35 years, median 18 years) with recent-onset type 1 diabetes (<12 weeks duration) and high basal C-peptide >0.25 nmol/l were randomized in a double-blind trial to calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3 [1,25-(OH)2D3] ) at the dose of 0.25 ug/day or placebo, and followed up for 2 years.

Sex: All

Ages: 11 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. diagnosis of type 1 diabetes according to the American Diabetes Association (ADA) guidelines;
2. age at presentation between 11 and 35 years;
3. duration of clinical disease (since the beginning of insulin therapy) <12 weeks;
4. baseline C-peptide >0.25 nmol/l;
5. no medical contra-indications or any other major chronic disease;
6. willingness and capability to participate in a regular follow-up.

Exclusion criteria

1. cardiovascular disease;
2. renal disease;
3. liver disease;
4. neurological disorders;
5. allergic diathesis;
6. hyperparathyroidism;
7. neoplasia.

Trial design

0 participants in 2 patient groups, including a placebo group

Calcitriol

Experimental group

Treatment:

Drug: Calcitriol

placebo

Placebo Comparator group

Treatment:

Drug: Calcitriol