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

NCT ID: NCT05375331

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-31

Study Completion Date

2024-03-01

Brief Summary

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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

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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.

Conditions

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Bone Remodeling Disorder Child Development Genetic Change

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West Kazakhstan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Irina Kim

Principal investigator of Department of Children's diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Irina Kim

Aktobe, , Kazakhstan

Site Status RECRUITING

Countries

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Kazakhstan

Central Contacts

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Irina Kim

Role: CONTACT

+7015281354

Mairamkul Zharlykasinova

Role: CONTACT

+77086454298

Facility Contacts

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Irina Kim

Role: primary

+77015281354

References

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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.

Reference Type RESULT
PMID: 28786260 (View on PubMed)

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):e6718. doi: 10.1097/MD.0000000000006718.

Reference Type RESULT
PMID: 28445285 (View on PubMed)

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.

Reference Type RESULT
PMID: 24400428 (View on PubMed)

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.

Reference Type RESULT
PMID: 29397388 (View on PubMed)

Other Identifiers

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777.04.12.2020

Identifier Type: -

Identifier Source: org_study_id

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