Diabetes Mellitus, Type 1
Conditions
Brief summary
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.
Interventions
DRUGCalcitriol
Sponsors
Campus Bio-Medico University
Eligibility
Sex/Gender
ALL
Age
11 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C peptide | — | evaluation of baseline and stimulated C peptide |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycometabolic control | — | To measure insulin requirement and HbA1c |
Countries
Italy
Outcome results
None listed