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NCT Number: NCT02889081

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Hospital of Fudan University

Shanghai, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

maternal biological folate level

Other

supplementation status and serum level

maternal biological Vitamin D level

Other

supplementation status and serum level

Primary outcomes

  1. Infant atopic dermatitis

    Time frame: 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

Secondary outcomes

  1. Maternal RBC folate level

    Time frame: 12-14 gestational weeks

    Whole blood sample collected will be used for evaluation

  2. Maternal serum vitamin D level

    Time frame: 12-14 gestational weeks

    Serum sample collected at different trimesters will be used for evaluation

  3. Maternal serum vitamin D level

    Time frame: 22-26 gestational weeks

    Serum sample collected at different trimesters will be used for evaluation

  4. Maternal serum vitamin D level

    Time frame: 34-36 gestational weeks

    Serum sample collected at different trimesters will be used for evaluation

  5. Maternal serum folate level

    Time frame: 12-14 gestational weeks

    Serum sample collected at different trimesters will be used for evaluation

  6. Maternal serum folate level

    Time frame: 22-26 gestational weeks

    Serum sample collected at different trimesters will be used for evaluation

  7. Maternal serum folate level

    Time frame: 34-36 gestational weeks

    Serum sample collected at different trimesters will be used for evaluation

  8. Maternal folic acid supplement intake

    Time frame: 12-14 gestational weeks

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

  9. Maternal vitamin D supplement intake

    Time frame: 12-14 gestational weeks

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

  10. Infant skin barrier function (Transepidermal Water Loss, TEWL）

    Time frame: infant 24-48 hours

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

  11. Infant skin barrier function (Transepidermal Water Loss, TEWL）

    Time frame: infant 42 days old

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

  12. Infant skin barrier function (Transepidermal Water Loss, TEWL）

    Time frame: infant 6 months old

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

  13. Infant atopic dermatitis incidence by 1year old

    Time frame: from birth , to 12months old

    Disease diagnosis according to the criteria of Williams

  14. Infant skin barrier function (Stratum corneum hydration, SCH)

    Time frame: infant 24-48 hours

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

  15. Infant skin barrier function (Stratum corneum hydration, SCH)

    Time frame: infant 42 days old

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

  16. Infant skin barrier function (Stratum corneum hydration, SCH)

    Time frame: infant 6 months old

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

  17. Infant skin barrier function (skin surface pH)

    Time frame: infant 24-48 hours

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

  18. Infant skin barrier function (skin surface pH)

    Time frame: infant 42 days old

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

  19. Infant skin barrier function (skin surface pH)

    Time frame: infant 6 months old

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

  20. Infant skin barrier function (sebum content)

    Time frame: infant 24-48 hours

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

  21. Infant skin barrier function (sebum content)

    Time frame: infant 42 days old

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

  22. Infant skin barrier function (sebum content)

    Time frame: infant 6 months old

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

  23. Maternal serum Vitamin E level

    Time frame: 12-14 gestational weeks

    Serum sample collected at different trimesters will be used for evaluation

  24. Maternal serum Vitamin A level

    Time frame: 12-14 gestational weeks

    Serum sample collected at different trimesters will be used for evaluation

  25. Child atopic dermatitis from 1 year old to 2 years old

    Time frame: from 1 year old to 2 years old

    Disease diagnosis according to the criteria of Williams

  26. Child atopic dermatitis from 2 years old to 5 years old

    Time frame: from 2 years old to 5 years old

    Disease diagnosis according to the criteria of Williams

  27. Maternal serum fatty acid level

    Time frame: 12-14 gestational weeks

    Serum sample collected at different trimesters will be used for evaluation

  28. Child atopic dermatitis from 5 years old to 8 years old

    Time frame: from 5 years old to 8 years old

    Disease diagnosis according to the criteria of Williams

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Minhang Maternal and Children Health Care Hospital

Registry information

Official study title

Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis

Acronym: MKNFOAD

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 5, 2016
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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