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

Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: maternal biological folate level; Other: maternal biological Vitamin D level

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.

• Study Type: Observational
• Enrollment (Actual): 487

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201102
    • Children Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pregancies at early gestation and offspring from Minhang Maternal and Children Health Care Hospital in Shanghai from June 2016

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: maternal biological folate level; supplementation status and serum level; Other: maternal biological Vitamin D level; 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	Other: maternal biological folate level; supplementation status and serum level; Other: maternal biological Vitamin D level; supplementation status and serum level

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Minhang Maternal and Children Health Care Hospital
• Investigators: Principal Investigator: Guoying Huang, MD,PhD, Children's Hospital of Fudan University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: atopic dermatitis; prenatal; birth cohort; skin barrier; key nutritional factors
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: AD2016-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED