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

April 24, 2023 updated by: Irina Kim, West Kazakhstan Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mairamkul Zharlykasinova
  • Phone Number: +77086454298
  • Email: kimsab@mail.ru

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

In accordance with the goal and objectives of the project, 245 children under the age of one year from the Kazakh population born in Aktobe will be examined. (N*-13500, p=16% n=204 +20%(41)=245 children).

*N is the total fertility of children; n is how many children should be taken + 20% losses. total for research you need 245

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Kazakhstan Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2020

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

April 24, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 777.04.12.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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