Atopic DermatitisMKNFOADNCT02889081
Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis (MKNFOAD)
An observational study of Atopic Dermatitis, run by Children's Hospital of Fudan University at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- maternal biological folate level and maternal biological Vitamin D level
- How many people
- 487 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to 30 Apr 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregancies at early gestation and offspring from Minhang Maternal and Children Health Care Hospital in Shanghai from June 2016
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- maternal biological folate level, maternal biological Vitamin D level
- Keywords
- birth cohort, prenatal, skin barrier, atopic dermatitis, key nutritional factors
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maternal biological folate levelOther
supplementation status and serum level
maternal biological Vitamin D levelOther
supplementation status and serum level
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: maternal biological folate level; Other: 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 Receives: Other: maternal biological folate level; Other: maternal biological Vitamin D level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant atopic dermatitis
Disease diagnosis according to the criteria of Williams
Measured: incident of AD during 6 months after birth, diagnosis confirmed based on disease history till 12 months
Secondary outcomes (28)
Maternal RBC folate level
Whole blood sample collected will be used for evaluation
Measured: 12-14 gestational weeks
Maternal serum vitamin D level
Serum sample collected at different trimesters will be used for evaluation
Measured: 12-14 gestational weeks
Maternal serum vitamin D level
Serum sample collected at different trimesters will be used for evaluation
Measured: 22-26 gestational weeks
Maternal serum vitamin D level
Serum sample collected at different trimesters will be used for evaluation
Measured: 34-36 gestational weeks
Maternal serum folate level
Serum sample collected at different trimesters will be used for evaluation
Measured: 12-14 gestational weeks
Maternal serum folate level
Serum sample collected at different trimesters will be used for evaluation
Measured: 22-26 gestational weeks
Maternal serum folate level
Serum sample collected at different trimesters will be used for evaluation
Measured: 34-36 gestational weeks
Maternal folic acid supplement intake
Questionnaire survey will be used to obtain the data of maternal supplement intake
Measured: 12-14 gestational weeks
Maternal vitamin D supplement intake
Questionnaire survey will be used to obtain the data of maternal supplement intake
Measured: 12-14 gestational weeks
Infant skin barrier function (Transepidermal Water Loss, TEWL）
TEWL will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 24-48 hours
Infant skin barrier function (Transepidermal Water Loss, TEWL）
TEWL will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 42 days old
Infant skin barrier function (Transepidermal Water Loss, TEWL）
TEWL will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 6 months old
Infant atopic dermatitis incidence by 1year old
Disease diagnosis according to the criteria of Williams
Measured: 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.
Measured: infant 24-48 hours
Infant skin barrier function (Stratum corneum hydration, SCH)
SCH will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 42 days old
Infant skin barrier function (Stratum corneum hydration, SCH)
SCH will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 6 months old
Infant skin barrier function (skin surface pH)
Skin pH will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 24-48 hours
Infant skin barrier function (skin surface pH)
Skin pH will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 42 days old
Infant skin barrier function (skin surface pH)
Skin pH will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 6 months old
Infant skin barrier function (sebum content)
Sebum content will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 24-48 hours
Infant skin barrier function (sebum content)
Sebum content will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 42 days old
Infant skin barrier function (sebum content)
Sebum content will be evaluated by the device of Multi Probe Adapter 4.
Measured: infant 6 months old
Maternal serum Vitamin E level
Serum sample collected at different trimesters will be used for evaluation
Measured: 12-14 gestational weeks
Maternal serum Vitamin A level
Serum sample collected at different trimesters will be used for evaluation
Measured: 12-14 gestational weeks
Child atopic dermatitis from 1 year old to 2 years old
Disease diagnosis according to the criteria of Williams
Measured: 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
Measured: from 2 years old to 5 years old
Maternal serum fatty acid level
Serum sample collected at different trimesters will be used for evaluation
Measured: 12-14 gestational weeks
Child atopic dermatitis from 5 years old to 8 years old
Disease diagnosis according to the criteria of Williams
Measured: from 5 years old to 8 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startJun 2016
- Primary completion31 Oct 2017
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 487 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Minhang Maternal and Children Health Care Hospital
- Responsible party
- Sponsor
- Investigators
- Guoying Huang, MD,PhD, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889081
- Sponsor's protocol ID
- AD2016-2018
- Acronym
- MKNFOAD
- Status last verified
- Mar 2026
- First submitted
- 31 Aug 2016
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 26078105Kiefte-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.
PubMed 22399526Kelleher 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.
PubMed 25618747
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02889081
- Acronym / sponsor ID
- MKNFOAD / AD2016-2018
- Conditions
- Atopic Dermatitis
- Keywords
- birth cohort, prenatal, skin barrier, atopic dermatitis, key nutritional factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Minhang Maternal and Children Health Care Hospital
- Study start
- Jun 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infants from birth cohort with AD | – | Other: maternal biological folate level, Other: maternal biological Vitamin D levelmaternal biological folate level and maternal biological vitamin D level and offspring's incidence of suffering from atopic dermatitis |
| infants from birth cohort without AD | – | Other: maternal biological folate level, Other: maternal biological Vitamin D levelmaternal biological folate level and maternal biological vitamin D level and offspring's incidence of not suffering from atopic dermatitis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregancies at early gestation and offspring from Minhang Maternal and Children Health Care Hospital in Shanghai from June 2016
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maternal biological folate levelsupplementation status and serum level | Other | infants from birth cohort with AD, infants from birth cohort without AD |
| maternal biological Vitamin D levelsupplementation status and serum level | Other | infants from birth cohort with AD, infants from birth cohort without AD |
Primary outcome
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
28 secondary outcomes
Maternal RBC folate level
Time frame: 12-14 gestational weeks
Maternal serum vitamin D level
Time frame: 12-14 gestational weeks
Maternal serum vitamin D level
Time frame: 22-26 gestational weeks
Maternal serum vitamin D level
Time frame: 34-36 gestational weeks
Maternal serum folate level
Time frame: 12-14 gestational weeks
Maternal serum folate level
Time frame: 22-26 gestational weeks
Maternal serum folate level
Time frame: 34-36 gestational weeks
Maternal folic acid supplement intake
Time frame: 12-14 gestational weeks
Maternal vitamin D supplement intake
Time frame: 12-14 gestational weeks
Infant skin barrier function (Transepidermal Water Loss, TEWL）
Time frame: infant 24-48 hours
Infant skin barrier function (Transepidermal Water Loss, TEWL）
Time frame: infant 42 days old
Infant skin barrier function (Transepidermal Water Loss, TEWL）
Time frame: infant 6 months old
Infant atopic dermatitis incidence by 1year old
Time frame: from birth , to 12months old
Infant skin barrier function (Stratum corneum hydration, SCH)
Time frame: infant 24-48 hours
Infant skin barrier function (Stratum corneum hydration, SCH)
Time frame: infant 42 days old
Infant skin barrier function (Stratum corneum hydration, SCH)
Time frame: infant 6 months old
Infant skin barrier function (skin surface pH)
Time frame: infant 24-48 hours
Infant skin barrier function (skin surface pH)
Time frame: infant 42 days old
Infant skin barrier function (skin surface pH)
Time frame: infant 6 months old
Infant skin barrier function (sebum content)
Time frame: infant 24-48 hours
Infant skin barrier function (sebum content)
Time frame: infant 42 days old
Infant skin barrier function (sebum content)
Time frame: infant 6 months old
Maternal serum Vitamin E level
Time frame: 12-14 gestational weeks
Maternal serum Vitamin A level
Time frame: 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
Child atopic dermatitis from 2 years old to 5 years old
Time frame: from 2 years old to 5 years old
Maternal serum fatty acid level
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Results publication: PubMed 26078105Wegienka 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.
- Results publication: PubMed 22399526Kiefte-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.
- Results publication: PubMed 25618747Kelleher 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoying Huang, MD,PhD principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant atopic dermatitis (time frame: incident of AD during 6 months after birth, diagnosis confirmed based on disease history till 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02889081, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.