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

NCT ID: NCT02889081

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

487 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-04-30

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.

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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infants from birth cohort with AD

maternal biological folate level and maternal biological vitamin D level and offspring's incidence of suffering from atopic dermatitis

maternal biological folate level

Intervention Type OTHER

supplementation status and serum level

maternal biological Vitamin D level

Intervention Type OTHER

supplementation status and serum level

infants from birth cohort without AD

maternal biological folate level and maternal biological vitamin D level and offspring's incidence of not suffering from atopic dermatitis

maternal biological folate level

Intervention Type OTHER

supplementation status and serum level

maternal biological Vitamin D level

Intervention Type OTHER

supplementation status and serum level

Interventions

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maternal biological folate level

supplementation status and serum level

Intervention Type OTHER

maternal biological Vitamin D level

supplementation status and serum level

Intervention Type OTHER

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minhang Maternal and Children Health Care Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guoying Huang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

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Children Hospital of Fudan University

Shanghai, , China

Site Status

Countries

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China

References

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Wegienka G, Havstad S, Zoratti EM, Kim H, Ownby DR, Johnson CC. Association between vitamin D levels and allergy-related outcomes vary by race and other factors. J Allergy Clin Immunol. 2015 Nov;136(5):1309-14.e1-4. doi: 10.1016/j.jaci.2015.04.017. Epub 2015 Jun 12.

Reference Type RESULT
PMID: 26078105 (View on PubMed)

Kiefte-de Jong JC, Timmermans S, Jaddoe VW, Hofman A, Tiemeier H, Steegers EA, de Jongste JC, Moll HA. High circulating folate and vitamin B-12 concentrations in women during pregnancy are associated with increased prevalence of atopic dermatitis in their offspring. J Nutr. 2012 Apr;142(4):731-8. doi: 10.3945/jn.111.154948. Epub 2012 Mar 7.

Reference Type RESULT
PMID: 22399526 (View on PubMed)

Kelleher M, Dunn-Galvin A, Hourihane JO, Murray D, Campbell LE, McLean WHI, Irvine AD. Skin barrier dysfunction measured by transepidermal water loss at 2 days and 2 months predates and predicts atopic dermatitis at 1 year. J Allergy Clin Immunol. 2015 Apr;135(4):930-935.e1. doi: 10.1016/j.jaci.2014.12.013. Epub 2015 Jan 22.

Reference Type RESULT
PMID: 25618747 (View on PubMed)

Other Identifiers

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AD2016-2018

Identifier Type: -

Identifier Source: org_study_id

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