MedPath

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

Not Applicable
Conditions
Development, Child
Interventions
Registration Number
NCT03742310
Lead Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Brief 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.

Detailed 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 & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
500
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
identical supplement groupVitamin DTake vitamin D supplements according to genotype. If the genotype result is "high risk", we will give vitamin d 800 international unit(IU)/d, when the result is "middle risk", we will give 600 international unit(IU)/d, when the result is "low risk", we will give 400 international unit(IU)/d.
Primary Outcome Measures
NameTimeMethod
body weightFrom date of randomization until the date of three year-old

We will use the baby scale to measure infant body weight

body heightFrom date of randomization until the date of three year-old

We will use the baby scale to measure infant body height

head circumferenceFrom date of randomization until the date of three year-old

We will use the tape to measure infant head circumference

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University

🇨🇳

Xi'an, Shaanxi, China

© Copyright 2025. All Rights Reserved by MedPath