Multi-Center Clinical Study on the Relationship Between Vitamin D Receptor Gene Polymorphism and Children's Physical and Intellectual Development
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infant age from 0 to 3 years old
- •enjoy good health, there is no history of specific diseases
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Vitamin D (Drug)
结局指标
主要结局
body weight
时间窗: From date of randomization until the date of three year-old
We will use the baby scale to measure infant body weight
body height
时间窗: From date of randomization until the date of three year-old
We will use the baby scale to measure infant body height
head circumference
时间窗: From date of randomization until the date of three year-old
We will use the tape to measure infant head circumference
次要结局
未报告次要终点