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

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ClinicalTrials.gov Identifier: NCT02889081
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Minhang Maternal and Children Health Care Hospital
Information provided by (Responsible Party):
Weili Yan, Children's Hospital of Fudan University

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.

Condition or disease Intervention/treatment
Atopic Dermatitis 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 [Patient Registry]
Actual Enrollment : 487 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Maternal Key Nutritional Factors and Offspring's Atopic Dermatitis
Actual Study Start Date : June 2016
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Vitamin D

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Maternal RBC folate level [ Time Frame: 12-14 gestational weeks ]
    Whole blood sample collected will be used for evaluation

  2. Maternal serum vitamin D level [ Time Frame: 12-14 gestational weeks ]
    Serum sample collected at different trimesters will be used for evaluation

  3. Maternal serum vitamin D level [ Time Frame: 22-26 gestational weeks ]
    Serum sample collected at different trimesters will be used for evaluation

  4. Maternal serum vitamin D level [ Time Frame: 34-36 gestational weeks ]
    Serum sample collected at different trimesters will be used for evaluation

  5. Maternal serum folate level [ Time Frame: 12-14 gestational weeks ]
    Serum sample collected at different trimesters will be used for evaluation

  6. Maternal serum folate level [ Time Frame: 22-26 gestational weeks ]
    Serum sample collected at different trimesters will be used for evaluation

  7. Maternal serum folate level [ Time Frame: 34-36 gestational weeks ]
    Serum sample collected at different trimesters will be used for evaluation

  8. Maternal folic acid supplement intake [ Time Frame: 12-14 gestational weeks ]
    Questionnaire survey will be used to obtain the data of maternal supplement intake

  9. Maternal vitamin D supplement intake [ Time Frame: 12-14 gestational weeks ]
    Questionnaire survey will be used to obtain the data of maternal supplement intake

  10. 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.

  11. 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.

  12. 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.

  13. Infant atopic dermatitis incidence by 1year old [ Time Frame: from birth , to 12months old ]
    Disease diagnosis according to the criteria of Williams


Biospecimen Retention:   Samples With DNA
Maternal venous blood and offspring's cord blood


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889081


Locations
China
Children Hospital of Fudan University
Shanghai, China, 201102
Sponsors and Collaborators
Children's Hospital of Fudan University
Minhang Maternal and Children Health Care Hospital
Investigators
Principal Investigator: Guoying Huang, MD,PhD Children's Hospital of Fudan University

Publications of Results:
Responsible Party: Weili Yan, Professer and Director of Department of Clinical Epidemiology, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT02889081     History of Changes
Other Study ID Numbers: AD2016-2018
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Weili Yan, Children's Hospital of Fudan University:
birth cohort
prenatal
skin barrier
atopic dermatitis
key nutritional factors

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Folic Acid
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hematinics