Comprehensive assessment of the pharmacokinetic properties of a single bolus dose of colecalciferol in terms of efficacy and safety

Abstract

Background: The lack of a unified approach to the treatment of deficiency and vitamin D deficiency stimulated a detailed study of the dynamics of indicators of phosphorus-calcium metabolism, parathyroid hormone, 25(OH)D (calcidiol).
 Aim: To evaluate the pharmacokinetic properties of colecalciferol at a dosage of 150 000 IU, from the standpoint of its efficacy and safety in clinical practice.
 Materials and methods: Observational, single-center, prospective, selective, uncontrolled study of a comprehensive assessment of the pharmacokinetic properties of a single saturating dose of 150 000 IU of colecalciferol. To assess the pharmacokinetic properties of colecalciferol at a dosage of 150 000 IU, we set efficacy and safety criteria. The criterion for the effectiveness of treatment was to achieve an adequate level of vitamin D (more than 30 ng / ml at the initial insufficient level and more than 20 ng / ml for patients with vitamin D deficiency). The safety criteria for the correction of vitamin D deficiency or deficiency were the absence of patient complaints, adverse events and / or serious adverse events, as well as the preservation of the main laboratory parameters of phosphorus-calcium metabolism within the reference values.
 Results: When studying the efficacy of a dose of 150 000 IU in patients with vitamin D deficiency and insufficiency, it was found that the level of calcidiol was significantly higher in the group after treatment with colecalciferol compared with the group before treatment (p 0.05). The peak of the maximum value for patients with deficiency was established on the 14 day from the moment of administration of colecalciferol and was 37.1 6.28 ng / ml, and for patients with initial vitamin D deficiency 40.1 3.71 ng / ml. In the study of the safety of colecalciferol in a bolus dose of 150 000 IU, there were no statistically significant differences in the laboratory parameters of calcium-phosphorus metabolism, both in the group before treatment and after correction of deficiency and vitamin D insufficiency in both groups.
 Conclusion: Colecalciferol in the form of a single bolus dose of 150 000 IU demonstrated its efficacy and safety in real clinical practice.