Clinical and Genetic Markers of Bone Metabolism in Children Under One Year
1 other identifier
observational
245
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2020
CompletedFirst Submitted
Initial submission to the registry
April 24, 2022
CompletedFirst Posted
Study publicly available on registry
May 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedApril 25, 2023
April 1, 2023
3.2 years
April 24, 2022
April 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
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
You may qualify if:
- Children 0 -12 months old
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Irina Kim
Aktobe, 040017, Kazakhstan
Related Publications (4)
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.
PMID: 28786260RESULTBao 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.
PMID: 28445285RESULTBasit 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.
PMID: 24400428RESULTAntonucci 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.
PMID: 29397388RESULT
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator of Department of Children's diseases
Study Record Dates
First Submitted
April 24, 2022
First Posted
May 16, 2022
Study Start
December 31, 2020
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
April 25, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share