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临床试验/NCT02889081
NCT02889081已完成不适用

Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 487 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
487
试验地点
1
主要终点
Infant atopic dermatitis

研究概览

简要总结

The study is a prospective birth cohort study and the purpose is to describe the status of maternal key nutrients(eg. folate and vitamin D) supplementation among pregnancies at early gestation in Shanghai, to find out the association between the level of serum key nutrients and atopic dermatitis (AD) in offsprings during 6 months.

详细描述

This study based on Shanghai pregnancy population is a prospective birth cohort. The investigators obtain the data of participants' folic acid and vitamin D supplement intake through the questionnaire at 12-14 gestational weeks. And the investigators collect participants' blood samples during gestation to directly detect the biological exposure levels of folate and vitamin D. In the follow-up, skin barrier function is evaluated at time of infant 24-48 hours, 42 days and 6 months. During 6 months from birth, the incidence of AD is investigated on offsprings. This cohort study is aimed to (1) clarify the association between prenatal key nutrients with offspring AD; (2) assess the role of maternal key nutrients in the skin barrier of offsprings. It will be a good evidence for the AD prevention and a meaningful protocol to reduce the incidence of AD by its unique design.Univariate and multivariate association analyses will be performed to identify risk factors to AD by using multivariate logistic regression model.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Mother plans to proceed prenatal care and delivery in Minhang Maternal and Children Health Care Hospital
  • Offspring plans to stay in Shanghai until 6 months and proceed follow-up in Children's Hospital of Fudan University

排除标准

  • 未提供

结局指标

主要结局

Infant atopic dermatitis

时间窗: incident of AD during 6 months after birth, diagnosis confirmed based on disease history till 12 months

Disease diagnosis according to the criteria of Williams

次要结局

  • Maternal RBC folate level(12-14 gestational weeks)
  • Maternal folic acid supplement intake(12-14 gestational weeks)
  • Infant skin barrier function (Stratum corneum hydration, SCH)(infant 6 months old)
  • Maternal vitamin D supplement intake(12-14 gestational weeks)
  • Infant atopic dermatitis incidence by 1year old(from birth , to 12months old)
  • Infant skin barrier function (sebum content)(infant 6 months old)
  • Maternal serum Vitamin E level(12-14 gestational weeks)
  • Maternal serum folate level(34-36 gestational weeks)
  • Infant skin barrier function (Transepidermal Water Loss, TEWL)(infant 6 months old)
  • Maternal serum Vitamin A level(12-14 gestational weeks)
  • Child atopic dermatitis from 2 years old to 5 years old(from 2 years old to 5 years old)
  • Maternal serum vitamin D level(34-36 gestational weeks)
  • Infant skin barrier function (skin surface pH)(infant 6 months old)
  • Child atopic dermatitis from 1 year old to 2 years old(from 1 year old to 2 years old)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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