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

Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02889081
Acronym
MKNFOAD
Enrollment
487
Registered
2016-09-05
Start date
2016-06-01
Completion date
2018-04-30
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

birth cohort, prenatal, skin barrier, atopic dermatitis, key nutritional factors

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.

Interventions

OTHERmaternal biological folate level

supplementation status and serum level

OTHERmaternal biological Vitamin D level

supplementation status and serum level

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER
Minhang Maternal and Children Health Care Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Infant atopic dermatitisincident of AD during 6 months after birth, diagnosis confirmed based on disease history till 12 monthsDisease diagnosis according to the criteria of Williams

Secondary

MeasureTime frameDescription
Maternal RBC folate level12-14 gestational weeksWhole blood sample collected will be used for evaluation
Maternal serum vitamin D level12-14 gestational weeksSerum sample collected at different trimesters will be used for evaluation
Maternal serum folate level12-14 gestational weeksSerum sample collected at different trimesters will be used for evaluation
Maternal folic acid supplement intake12-14 gestational weeksQuestionnaire survey will be used to obtain the data of maternal supplement intake
Maternal vitamin D supplement intake12-14 gestational weeksQuestionnaire survey will be used to obtain the data of maternal supplement intake
Infant skin barrier function (Transepidermal Water Loss, TEWL)infant 24-48 hoursTEWL will be evaluated by the device of Multi Probe Adapter 4.
Infant atopic dermatitis incidence by 1year oldfrom birth , to 12months oldDisease diagnosis according to the criteria of Williams
Infant skin barrier function (Stratum corneum hydration, SCH)infant 24-48 hoursSCH will be evaluated by the device of Multi Probe Adapter 4.
Infant skin barrier function (skin surface pH)infant 24-48 hoursSkin pH will be evaluated by the device of Multi Probe Adapter 4.
Infant skin barrier function (sebum content)infant 24-48 hoursSebum content will be evaluated by the device of Multi Probe Adapter 4.
Maternal serum Vitamin E level12-14 gestational weeksSerum sample collected at different trimesters will be used for evaluation
Maternal serum Vitamin A level12-14 gestational weeksSerum sample collected at different trimesters will be used for evaluation
Child atopic dermatitis from 1 year old to 2 years oldfrom 1 year old to 2 years oldDisease diagnosis according to the criteria of Williams
Child atopic dermatitis from 2 years old to 5 years oldfrom 2 years old to 5 years oldDisease diagnosis according to the criteria of Williams
Maternal serum fatty acid level12-14 gestational weeksSerum sample collected at different trimesters will be used for evaluation
Child atopic dermatitis from 5 years old to 8 years oldfrom 5 years old to 8 years oldDisease diagnosis according to the criteria of Williams

Countries

China

Contacts

PRINCIPAL_INVESTIGATORGuoying Huang, MD,PhD

Children's Hospital of Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026