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Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis (MKNFOAD)

Completed
Conditions
Atopic Dermatitis
Interventions
Other: maternal biological folate level
Other: maternal biological Vitamin D level
Registration Number
NCT02889081
Lead Sponsor
Children's Hospital of Fudan University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
487
Inclusion Criteria
  • 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
Exclusion Criteria
  • none

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
infants from birth cohort with ADmaternal biological Vitamin D levelmaternal biological folate level and maternal biological vitamin D level and offspring's incidence of suffering from atopic dermatitis
infants from birth cohort without ADmaternal biological Vitamin D levelmaternal biological folate level and maternal biological vitamin D level and offspring's incidence of not suffering from atopic dermatitis
infants from birth cohort with ADmaternal biological folate levelmaternal biological folate level and maternal biological vitamin D level and offspring's incidence of suffering from atopic dermatitis
infants from birth cohort without ADmaternal biological folate levelmaternal biological folate level and maternal biological vitamin D level and offspring's incidence of not suffering from atopic dermatitis
Primary Outcome Measures
NameTimeMethod
Infant atopic dermatitisincident of AD during 6 months after birth, diagnosis confirmed based on disease history till 12 months

Disease diagnosis according to the criteria of Williams

Secondary Outcome Measures
NameTimeMethod
Maternal folic acid supplement intake12-14 gestational weeks

Questionnaire survey will be used to obtain the data of maternal supplement intake

Infant skin barrier function (Stratum corneum hydration, SCH)infant 6 months old

SCH will be evaluated by the device of Multi Probe Adapter 4.

Maternal serum folate level34-36 gestational weeks

Serum sample collected at different trimesters will be used for evaluation

Infant skin barrier function (Transepidermal Water Loss, TEWL)infant 6 months old

TEWL will be evaluated by the device of Multi Probe Adapter 4.

Maternal serum Vitamin A level12-14 gestational weeks

Serum sample collected at different trimesters will be used for evaluation

Child atopic dermatitis from 2 years old to 5 years oldfrom 2 years old to 5 years old

Disease diagnosis according to the criteria of Williams

Maternal RBC folate level12-14 gestational weeks

Whole blood sample collected will be used for evaluation

Maternal vitamin D supplement intake12-14 gestational weeks

Questionnaire survey will be used to obtain the data of maternal supplement intake

Infant atopic dermatitis incidence by 1year oldfrom birth , to 12months old

Disease diagnosis according to the criteria of Williams

Infant skin barrier function (sebum content)infant 6 months old

Sebum content will be evaluated by the device of Multi Probe Adapter 4.

Maternal serum Vitamin E level12-14 gestational weeks

Serum sample collected at different trimesters will be used for evaluation

Maternal serum vitamin D level34-36 gestational weeks

Serum sample collected at different trimesters will be used for evaluation

Infant skin barrier function (skin surface pH)infant 6 months old

Skin pH will be evaluated by the device of Multi Probe Adapter 4.

Child atopic dermatitis from 1 year old to 2 years oldfrom 1 year old to 2 years old

Disease diagnosis according to the criteria of Williams

Trial Locations

Locations (1)

Children Hospital of Fudan University

🇨🇳

Shanghai, China

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