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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Development, Child

Intervention / Treatment
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* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: identical supplement group<br>Take 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. | Drug: Vitamin D<br>* 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.<br>* Other names: calcitriol;|
| No Intervention: control group<br>General dose. Whatever the result is, we all give 400 international unit(IU)/d. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | We will use the baby scale to measure infant body weight | From date of randomization until the date of three year-old | 
| body height | We will use the baby scale to measure infant body height | From date of randomization until the date of three year-old | 
| head circumference | We will use the tape to measure infant head circumference | From date of randomization until the date of three year-old | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D Receptor gene, physical development, intelligent development