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

NCT03742310 | Unknown

• 1 other identifier: HX201856
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Development, Child

Keywords

Vitamin D Receptor gene; physical development; intelligent development

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

identical supplement group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

Vitamin D 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.

Also known as: calcitriol

identical supplement group

Eligibility Criteria

• Age: 1 Day - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• infant age from 0 to 3 years old
• enjoy good health, there is no history of specific diseases

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Xian Children's Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Interventions

Vitamin D; Calcitriol

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Hui Li, PHD,MD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Hui Li, PHD,MD

CONTACT

+8618991232133; huili@mail.xjtu.edu.cn

Zhongliang Zhu, PHD

CONTACT

+8613991289992; zlzhu@mail.xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 15, 2018

Record last verified: 2018-07

Locations

CN (1)