Clinical trial NCT02889081: Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis (MKNFOAD)
Official title: Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: birth cohort
prenatal
skin barrier
atopic dermatitis
key nutritional factors
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Minhang Maternal and Children Health Care Hospital
First posted: 2016-09-05
Enrollment: 487
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant atopic dermatitis
timeFrame: incident of AD during 6 months after birth, diagnosis confirmed based on disease history till 12 months
Secondary outcomes:
measure: Maternal RBC folate level
timeFrame: 12-14 gestational weeks
measure: Maternal serum vitamin D level
timeFrame: 12-14 gestational weeks
measure: Maternal serum vitamin D level
timeFrame: 22-26 gestational weeks
measure: Maternal serum vitamin D level
timeFrame: 34-36 gestational weeks
measure: Maternal serum folate level
timeFrame: 12-14 gestational weeks
measure: Maternal serum folate level
timeFrame: 22-26 gestational weeks
measure: Maternal serum folate level
timeFrame: 34-36 gestational weeks
measure: Maternal folic acid supplement intake
timeFrame: 12-14 gestational weeks
measure: Maternal vitamin D supplement intake
timeFrame: 12-14 gestational weeks
measure: Infant skin barrier function (Transepidermal Water Loss, TEWL）
timeFrame: infant 24-48 hours
measure: Infant skin barrier function (Transepidermal Water Loss, TEWL）
timeFrame: infant 42 days old
measure: Infant skin barrier function (Transepidermal Water Loss, TEWL）
timeFrame: infant 6 months old
measure: Infant atopic dermatitis incidence by 1year old
timeFrame: from birth , to 12months old
measure: Infant skin barrier function (Stratum corneum hydration, SCH)
timeFrame: infant 24-48 hours
measure: Infant skin barrier function (Stratum corneum hydration, SCH)
timeFrame: infant 42 days old
measure: Infant skin barrier function (Stratum corneum hydration, SCH)
timeFrame: infant 6 months old
measure: Infant skin barrier function (skin surface pH)
timeFrame: infant 24-48 hours
measure: Infant skin barrier function (skin surface pH)
timeFrame: infant 42 days old
measure: Infant skin barrier function (skin surface pH)
timeFrame: infant 6 months old
measure: Infant skin barrier function (sebum content)
timeFrame: infant 24-48 hours
measure: Infant skin barrier function (sebum content)
timeFrame: infant 42 days old
measure: Infant skin barrier function (sebum content)
timeFrame: infant 6 months old
measure: Maternal serum Vitamin E level
timeFrame: 12-14 gestational weeks
measure: Maternal serum Vitamin A level
timeFrame: 12-14 gestational weeks
measure: Child atopic dermatitis from 1 year old to 2 years old
timeFrame: from 1 year old to 2 years old
measure: Child atopic dermatitis from 2 years old to 5 years old
timeFrame: from 2 years old to 5 years old
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
Study officials:
affiliation: Children's Hospital of Fudan University
name: Guoying Huang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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 2015 Jun 12.
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 offspring. J Nutr. 2012 Apr;142(4):731-8. doi: 10.3945/jn.111.154948. Epub 2012 Mar 7.
citation: 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.