NCT02889081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
487

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

August 31, 2016

Last Update Submit

March 17, 2026

Conditions

Atopic Dermatitis

Keywords

birth cohortprenatalskin barrieratopic dermatitiskey nutritional factors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (28)

  • Maternal RBC folate level

    12-14 gestational weeks

  • Maternal serum vitamin D level

    12-14 gestational weeks

  • Maternal serum vitamin D level

    22-26 gestational weeks

  • Maternal serum vitamin D level

    34-36 gestational weeks

  • Maternal serum folate level

    12-14 gestational weeks

  • +23 more secondary outcomes

Study Arms (2)

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 levelOther: maternal biological Vitamin D 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 levelOther: maternal biological Vitamin D level

Interventions

maternal biological folate levelOTHER

supplementation status and serum level

infants from birth cohort with ADinfants from birth cohort without AD
maternal biological Vitamin D levelOTHER

supplementation status and serum level

infants from birth cohort with ADinfants from birth cohort without AD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital of Fudan University

Shanghai, 201102, China

Location

Related Publications (3)

  • 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.

    PMID: 26078105RESULT

  • 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.

    PMID: 22399526RESULT

  • 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.

    PMID: 25618747RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Maternal venous blood and offspring's cord blood

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Guoying Huang, MD,PhD

    Children's Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 5, 2016

Study Start

June 1, 2016

Primary Completion

October 31, 2017

Study Completion

April 30, 2018

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

CN(1)