At the time of type 1 diabetes diagnosis, although the majority of beta-cells have been destroyed, some still produce insulin. A treatment that could protect beta-cell function or decrease autoimmune destruction would provide important progress in type 1 diabetes therapy. Vitamin D has been known as an immunomodulator in this disease, which blockades beta-cells destruction. In children with type 1 diabetes, vitamin D treatment produces moderate protective effects on residual beta-cell function. However, limited doses can be used because of its hypercalcemic effect. This study investigated whether treatment with a vitamin D analog (1-α-hydroxivitamin D3) or alfacalcidol, can improve glycemic control and beta-cell preservation, as well as improvements in immune responses.
In this single-blind and placebo-controlled clinical trial, 60 patients (aged 8-18 years) with recent-onset type 1 diabetes will be randomized to alfacalcidol (2 * 0.25 microgram/day) or placebo, and will follow up for 6 months. All patients will receive conventional insulin therapy, and insulin dosage will be adjusted every two weeks. Insulin requirement, as well as serum 25(OH)D, fasting C-peptide (FCP), hemoglobin A1C (HbA1C), interleukin-1β (IL-1β), interleukin-2 (IL-2), transforming growth factor β1 (TGF-β1), interferon-gamma (IFN-γ), and glutamic acid decarboxylase (GAD65) autoantibody will be assessed at baseline, and again 3 months and 6 months after the intervention. The alfacalcidol and placebo groups will be compared across time points during 6 months of intervention.