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

Child Development Clinical Trial

Official title:

Clinical and Genetic Markers of Bone Metabolism in Children Under One Year of Age in the Kazakh Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375331
• Other study ID #: 777.04.12.2020
• Status: Recruiting
• Start date: December 31, 2020
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2023
• Source: West Kazakhstan Medical University
• Contact: Irina Kim
• Phone: +7015281354
• Email: irina.kim.90[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 245
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Gender: All
• Age group: 1 Day to 1 Year

Eligibility

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.

Related Conditions & MeSH terms

• Bone Remodeling Disorder
• Child Development
• Genetic Change

Locations

Country	Name	City	State
Kazakhstan	Irina Kim	Aktobe

Sponsors (1)

Lead Sponsor	Collaborator
West Kazakhstan Medical University

Country where clinical trial is conducted

Kazakhstan, 

References & Publications (4)

Antonucci R, Locci C, Clemente MG, Chicconi E, Antonucci L. Vitamin D deficiency in childhood: old lessons and current challenges. J Pediatr Endocrinol Metab. 2018 Mar 28;31(3):247-260. doi: 10.1515/jpem-2017-0391. — View Citation

Bao L, Chen M, Lei Y, Zhou Z, Shen H, Le F. Association between vitamin D receptor BsmI polymorphism and bone mineral density in pediatric patients: A meta-analysis and systematic review of observational studies. Medicine (Baltimore). 2017 Apr;96(17):e671 — View Citation

Basit S. Vitamin D in health and disease: a literature review. Br J Biomed Sci. 2013;70(4):161-72. doi: 10.1080/09674845.2013.11669951. — View Citation

Bizzaro G, Antico A, Fortunato A, Bizzaro N. Vitamin D and Autoimmune Diseases: Is Vitamin D Receptor (VDR) Polymorphism the Culprit? Isr Med Assoc J. 2017 Jul;19(7):438-443. — View Citation

Outcome

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