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

Atopic Dermatitis Clinical Trial

— MKNFOAD  

Official title:

Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889081
• Other study ID #: AD2016-2018
• Status: Completed
• Start date: June 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: March 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: April 30, 2018
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• maternal biological folate level
supplementation status and serum level
• maternal biological Vitamin D level
supplementation status and serum level

Locations

Country	Name	City	State
China	Children Hospital of Fudan University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Minhang Maternal and Children Health Care Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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 Ap — View Citation

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 — View Citation

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 2 — View Citation

Outcome

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