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

NCT ID: NCT03742310

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-03-01

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.

Conditions

Development, Child

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

identical supplement group

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.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

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.

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

calcitriol

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xian Children's Hospital

OTHER_GOV

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Li, PHD,MD

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Hui Li, PHD,MD

Role: CONTACT

huili@mail.xjtu.edu.cn

+8618991232133

Zhongliang Zhu, PHD

Role: CONTACT

zlzhu@mail.xjtu.edu.cn

+8613991289992

Facility Contacts

Hui A Li, PhD, MD

Role: primary

huili@mail.xjtu.edu.cn

+8618991232133

Other Identifiers

HX201856

Identifier Type: -

Identifier Source: org_study_id