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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: maternal biological folate level
* Other: maternal biological Vitamin D level


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| infants from birth cohort with AD<br>maternal biological folate level and maternal biological vitamin D level and offspring's incidence of suffering from atopic dermatitis | Other: maternal biological folate level<br>* supplementation status and serum level<br>Other: maternal biological Vitamin D level<br>* supplementation status and serum level<br>|
| infants from birth cohort without AD<br>maternal biological folate level and maternal biological vitamin D level and offspring's incidence of not suffering from atopic dermatitis | Other: maternal biological folate level<br>* supplementation status and serum level<br>Other: maternal biological Vitamin D level<br>* supplementation status and serum level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant atopic dermatitis | Disease diagnosis according to the criteria of Williams | incident of AD during 6 months after birth, diagnosis confirmed based on disease history till 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal RBC folate level | Whole blood sample collected will be used for evaluation | 12-14 gestational weeks | 
| Maternal serum vitamin D level | Serum sample collected at different trimesters will be used for evaluation | 12-14 gestational weeks | 
| Maternal serum vitamin D level | Serum sample collected at different trimesters will be used for evaluation | 22-26 gestational weeks | 
| Maternal serum vitamin D level | Serum sample collected at different trimesters will be used for evaluation | 34-36 gestational weeks | 
| Maternal serum folate level | Serum sample collected at different trimesters will be used for evaluation | 12-14 gestational weeks | 
| Maternal serum folate level | Serum sample collected at different trimesters will be used for evaluation | 22-26 gestational weeks | 
| Maternal serum folate level | Serum sample collected at different trimesters will be used for evaluation | 34-36 gestational weeks | 
| Maternal folic acid supplement intake | Questionnaire survey will be used to obtain the data of maternal supplement intake | 12-14 gestational weeks | 
| Maternal vitamin D supplement intake | Questionnaire survey will be used to obtain the data of maternal supplement intake | 12-14 gestational weeks | 
| Infant skin barrier function (Transepidermal Water Loss, TEWL） | TEWL will be evaluated by the device of Multi Probe Adapter 4. | infant 24-48 hours | 
| Infant skin barrier function (Transepidermal Water Loss, TEWL） | TEWL will be evaluated by the device of Multi Probe Adapter 4. | infant 42 days old | 
| Infant skin barrier function (Transepidermal Water Loss, TEWL） | TEWL will be evaluated by the device of Multi Probe Adapter 4. | infant 6 months old | 
| Infant atopic dermatitis incidence by 1year old | Disease diagnosis according to the criteria of Williams | from birth , to 12months old | 
| Infant skin barrier function (Stratum corneum hydration, SCH) | SCH will be evaluated by the device of Multi Probe Adapter 4. | infant 24-48 hours | 
| Infant skin barrier function (Stratum corneum hydration, SCH) | SCH will be evaluated by the device of Multi Probe Adapter 4. | infant 42 days old | 
| Infant skin barrier function (Stratum corneum hydration, SCH) | SCH will be evaluated by the device of Multi Probe Adapter 4. | infant 6 months old | 
| Infant skin barrier function (skin surface pH) | Skin pH will be evaluated by the device of Multi Probe Adapter 4. | infant 24-48 hours | 
| Infant skin barrier function (skin surface pH) | Skin pH will be evaluated by the device of Multi Probe Adapter 4. | infant 42 days old | 
| Infant skin barrier function (skin surface pH) | Skin pH will be evaluated by the device of Multi Probe Adapter 4. | infant 6 months old | 
| Infant skin barrier function (sebum content) | Sebum content will be evaluated by the device of Multi Probe Adapter 4. | infant 24-48 hours | 
| Infant skin barrier function (sebum content) | Sebum content will be evaluated by the device of Multi Probe Adapter 4. | infant 42 days old | 
| Infant skin barrier function (sebum content) | Sebum content will be evaluated by the device of Multi Probe Adapter 4. | infant 6 months old | 
| Maternal serum Vitamin E level | Serum sample collected at different trimesters will be used for evaluation | 12-14 gestational weeks | 
| Maternal serum Vitamin A level | Serum sample collected at different trimesters will be used for evaluation | 12-14 gestational weeks | 
| Child atopic dermatitis from 1 year old to 2 years old | Disease diagnosis according to the criteria of Williams | from 1 year old to 2 years old | 
| Child atopic dermatitis from 2 years old to 5 years old | Disease diagnosis according to the criteria of Williams | from 2 years old to 5 years old | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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birth cohort, prenatal, skin barrier, atopic dermatitis, key nutritional factors