Clinical and Genetic Markers of Bone Metabolism in Children Under One Year

Recruiting

• Conditions: Genetic Change; Bone Remodeling Disorder; Child Development

• Registration Number: NCT05375331
• Lead Sponsor: West Kazakhstan Medical University

Brief Summary

The study of children under one year of age for molecular genetic testing-VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759) with the study of the frequency distribution of alleles and genotypes by polymorphisms, analysis of the relationship of molecular genetic markers with indicators of bone metabolism.

Detailed Description

Children under the age of one year of Kazakh nationality born in Aktobe will be examined.

Each child included in the study will have an individual registration card, where information about the health status of the child and the health status of the mother during pregnancy will be filled in.

A biochemical analysis will be determined for the level of calcium, phosphorus, calcitonin, parathyroid hormone, osteocalcin, vitamin D in blood serum and deoxypyridinoline in urine.

Blood will be taken to determine the genetic polymorphism of VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759).

The state of bone tissue remodeling (osteocalcin, vitamin D, Ca, P, calcitonin, deoxypyridinoline) will be revealed The frequencies of allelic variants of the VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759) genes in children under the age of one year in the population of Kazakhstan were determined.

Study Timeline

• Study Start: 2020-12-31
• Study First Submitted: 2022-04-24
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

-Children 0 -12 months old

Exclusion Criteria

• Musculoskeletal system diseases;
• Severe chronic somatic diseases;
• Supplementation of vitamin D in a therapeutic dose;
• Lack of consent of the parents or legal representatives to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Optimization of the method for diagnosing bone metabolism disorders in children under one year old in the Kazakh population	2 years	The state of bone metabolism was assessed using the quantitative content of calcium, phosphorus, vitamin D, osteocalcin, and parathyroid hormone.

Trial Locations

Locations (1)

Irina Kim; 🇰🇿 Aktobe, Kazakhstan