Abstract:The paper presents the results of a multicenter study assessing efficacy and safety of a course-based regimen for hypovitaminosis D management in children under the age of three years. A dose of cholecalciferol was prescribed to children differentially, based on the baseline 25(OH)D levels. The dependence of the baseline vitamin D levels on the pre-test administration of cholecalciferol has been demonstrated. A high efficacy of the proposed management regimen in children, starting from the first 6 months of life, allows to widely recommend it in outpatient clinical practice. The level of calcidiol in children following one-month administration of 1000 to 4000 IU/day increased from 23.7 ng/ml to 45.5 ng/ml (P < 0.001), and the frequency of normal levels increased from 33.3% to 74.5 % (P < 0.001). The median increase in calcidiol levels following the one-month course of 1000 IU/day, 2000 IU/day, 3000 IU/day, and 4000 IU/day was 2.9 ng/ml, 22.3 ng/ml, 22.6 ng/ml, and 32.0 ng/ml, respectively. An increase in 25(OH)D levels closely correlates with the daily dose of cholecalciferol (r = 0.504, P < 0.001). The regimen proposed by the authors demonstrated, along with the efficacy, a high safety profile, the threshold limit of 100 ng/ml being exceeded only in 3.9% of children.