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

March 17, 2026 updated by: Children's Hospital of Fudan University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
487

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Infant atopic dermatitis
Time Frame: incident of AD during 6 months after birth, diagnosis confirmed based on disease history till 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal RBC folate level
Time Frame: 12-14 gestational weeks
Whole blood sample collected will be used for evaluation
12-14 gestational weeks
Maternal serum vitamin D level
Time Frame: 12-14 gestational weeks
Serum sample collected at different trimesters will be used for evaluation
12-14 gestational weeks
Maternal serum vitamin D level
Time Frame: 22-26 gestational weeks
Serum sample collected at different trimesters will be used for evaluation
22-26 gestational weeks
Maternal serum vitamin D level
Time Frame: 34-36 gestational weeks
Serum sample collected at different trimesters will be used for evaluation
34-36 gestational weeks
Maternal serum folate level
Time Frame: 12-14 gestational weeks
Serum sample collected at different trimesters will be used for evaluation
12-14 gestational weeks
Maternal serum folate level
Time Frame: 22-26 gestational weeks
Serum sample collected at different trimesters will be used for evaluation
22-26 gestational weeks
Maternal serum folate level
Time Frame: 34-36 gestational weeks
Serum sample collected at different trimesters will be used for evaluation
34-36 gestational weeks
Maternal folic acid supplement intake
Time Frame: 12-14 gestational weeks
Questionnaire survey will be used to obtain the data of maternal supplement intake
12-14 gestational weeks
Maternal vitamin D supplement intake
Time Frame: 12-14 gestational weeks
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）
Time Frame: infant 24-48 hours
TEWL will be evaluated by the device of Multi Probe Adapter 4.
infant 24-48 hours
Infant skin barrier function (Transepidermal Water Loss, TEWL）
Time Frame: infant 42 days old
TEWL will be evaluated by the device of Multi Probe Adapter 4.
infant 42 days old
Infant skin barrier function (Transepidermal Water Loss, TEWL）
Time Frame: infant 6 months old
TEWL will be evaluated by the device of Multi Probe Adapter 4.
infant 6 months old
Infant atopic dermatitis incidence by 1year old
Time Frame: from birth , to 12months old
Disease diagnosis according to the criteria of Williams
from birth , to 12months old
Infant skin barrier function (Stratum corneum hydration, SCH)
Time Frame: infant 24-48 hours
SCH will be evaluated by the device of Multi Probe Adapter 4.
infant 24-48 hours
Infant skin barrier function (Stratum corneum hydration, SCH)
Time Frame: infant 42 days old
SCH will be evaluated by the device of Multi Probe Adapter 4.
infant 42 days old
Infant skin barrier function (Stratum corneum hydration, SCH)
Time Frame: infant 6 months old
SCH will be evaluated by the device of Multi Probe Adapter 4.
infant 6 months old
Infant skin barrier function (skin surface pH)
Time Frame: infant 24-48 hours
Skin pH will be evaluated by the device of Multi Probe Adapter 4.
infant 24-48 hours
Infant skin barrier function (skin surface pH)
Time Frame: infant 42 days old
Skin pH will be evaluated by the device of Multi Probe Adapter 4.
infant 42 days old
Infant skin barrier function (skin surface pH)
Time Frame: infant 6 months old
Skin pH will be evaluated by the device of Multi Probe Adapter 4.
infant 6 months old
Infant skin barrier function (sebum content)
Time Frame: infant 24-48 hours
Sebum content will be evaluated by the device of Multi Probe Adapter 4.
infant 24-48 hours
Infant skin barrier function (sebum content)
Time Frame: infant 42 days old
Sebum content will be evaluated by the device of Multi Probe Adapter 4.
infant 42 days old
Infant skin barrier function (sebum content)
Time Frame: infant 6 months old
Sebum content will be evaluated by the device of Multi Probe Adapter 4.
infant 6 months old
Maternal serum Vitamin E level
Time Frame: 12-14 gestational weeks
Serum sample collected at different trimesters will be used for evaluation
12-14 gestational weeks
Maternal serum Vitamin A level
Time Frame: 12-14 gestational weeks
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
Time Frame: 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
Time Frame: from 2 years old to 5 years old
Disease diagnosis according to the criteria of Williams
from 2 years old to 5 years old
Maternal serum fatty acid level
Time Frame: 12-14 gestational weeks
Serum sample collected at different trimesters will be used for evaluation
12-14 gestational weeks
Child atopic dermatitis from 5 years old to 8 years old
Time Frame: from 5 years old to 8 years old
Disease diagnosis according to the criteria of Williams
from 5 years old to 8 years old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Minhang Maternal and Children Health Care Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guoying Huang, MD,PhD, Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AD2016-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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