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

Xi'an Jiaotong University

Status: Unknown

Conditions: Development, Child

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT03742310

HX201856

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 1 day to 3 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

identical supplement group

Experimental group

Description:

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.

Treatment:

Drug: Vitamin D

control group

No Intervention group

Description:

General dose. Whatever the result is, we all give 400 international unit(IU)/d.