The Relationship Between VDR Gene Polymorphism and Children's Physical and Intellectual Development

Development, Child Clinical Trial

— RVDRGPCPID  

Official title:

Multi-Center Clinical Study on the Relationship Between Vitamin D Receptor Gene Polymorphism and Children's Physical and Intellectual Development

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03742310
• Other study ID #: HX201856
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: July 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Hui Li, PHD,MD
• Phone: +8618991232133
• Email: huili[@]mail.xjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was used to determine the relationship between vitamin D receptor gene polymorphism and children's physical and intellectual development, further adjust the doses of vitamin D supplementation after birth, and provide individualized vitamin D and calcium supplements.

Description:

High risk children aged 0-3 years old who visited the pediatrics clinic and ward of the first affiliated hospital of Xi'an Jiaotong university and other cooperative hospitals from 2018 to 2020 were randomly selected. Personal information of the children and parents who were enrollment was collected by questionnaire survey and a follow-up file was established. 500 to 1,000 people are planned to participate in the study, were randomly divided into research group and the control group. Then collect the sample(saliva) of children to examine Vitamin D Receptor(VDR) genotype, according to results, divide the research group into high, medium and low risk, given individual vitamin D and calcium supplement. Monitor the children's weight, body length, head circumference, the Neonatal Behavioral Assessment Scale(NBAS), bailey rating scale respectively, up to 3 years old. All sample analyses were performed by the Gene Medical Laboratory. Laboratory personnel were blinded to mother and infant outcomes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: March 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Years

Eligibility

Inclusion Criteria:

• infant age from 0 to 3 years old

• enjoy good health, there is no history of specific diseases

Exclusion Criteria:

• this time or always exists serious lung infection, or with nervous system disease, kidney disease, malignant tumor, etc

• has bone metabolic diseases or other genetic metabolic disease

• taking affect bone metabolism of drugs for a long time

Related Conditions & MeSH terms

• Development, Child

Intervention

Drug:
• Vitamin D
Vitamin D is essential for healthy bones, and to control the amount of calcium in our blood.It is important at every stage of life, but especially for rapidly growing infants and teenagers and for pregnant and breastfeeding women.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (3)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	The First Affiliated Hospital of Zhengzhou University, Xian Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight	We will use the baby scale to measure infant body weight	From date of randomization until the date of three year-old
Primary	body height	We will use the baby scale to measure infant body height	From date of randomization until the date of three year-old
Primary	head circumference	We will use the tape to measure infant head circumference	From date of randomization until the date of three year-old