Glycemic control after vitamin D repletion in type 1 diabetes mellitus pediatric population: a clinical trial intervention

Abstract

Background. It has been discovered that 3% of the human genome is regulated directly or indirectly by the vitamin D and that with adequate levels of vitamin D, if the established relations with cancer and others are correct, death rate would drop a 7%. Several studies show a high prevalence of vitamin D deficiency in children and adolescents with type 1 diabetes, ranging between 43 and 91%. Currently, the screening and treatment of vitamin D deficiency is not considered standard of care for T1DM patients.

Justification. Vitamin D is required for and improves the production of insulin, and also improves insulin sensitivity. On this basis, vitamin D repletion should improve glycemic control in T1DM patients.

Purpose. The goal of the present work is to evaluate improvement in glycemic control after vitamin D repletion in T1DM pediatric population with vitamin D levels ranging below normality. Glycemic control will be evaluated on basis of glycated hemoglobin.

Design. This protocol is for a multicenter, prospective, randomized, double blind, placebo controlled 12 months clinical trial in pediatric patients with T1DM.

Participants. T1DM pediatric population with vitamin D levels ranging below sufficiency from Pediatric Endocrinology Unit in Hospital Josep Trueta, Hospital de Palamós, Hospital de Calella, Hospital de Figueres and Hospital de Blanes.

Method. 158 T1DM patients with vitamin D levels below sufficiency (<30 μg/ml) will be randomized into treatment or placebo group (1:1) receiving 25.000 IU of cholecalciferol or placebo respectively. Measurements will be collected at month 0, 6 and 12, coinciding with T1DM follow up visit