Epidemiological Investigation and Cohort Study on Food Allergy in Children Aged 3 to 6 Years in Wenzhou and Taizhou Urban Areas

NCT ID: NCT03974555

Last Updated: 2019-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

8000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-08-31

Brief Summary

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Objective

1. To investigate the status of food allergy among children aged 3 to 6 in Wenzhou and Taizhou urban areas.
2. To obtain the self-reported rate of parents or guardians of food allergy among children aged 3 to 6 in Wenzhou and Taizhou urban areas.
3. To obtain the prevalence of food allergy among children aged 3 to 6 in Wenzhou and Taizhou urban areas by conducting skin prick test (SPT), blood eosinophil (EOS) count, total immunoglobulin E (tIgE) measurement and serum specific IgE (sIgE) determination in children who self-reported food allergy, and conducting the open food challenge (OFC) if it is needed for further diagnosis.

Methods The preschool children aged 3 to 6 from kindergartens in Wenzhou and Taizhou urban areas were selected by cluster sampling and random sampling to conduct a preliminary screening questionnaire. Then telephone interviewe the children who had diseases or problems caused by certain food or certain types of food. Make them finish further food allergy questionnaires, SPT, EOS, tIgE detection, sIgE detection. SPT has 17 kinds of food allergens including milk, egg white, egg yolk, shrimp, crab, wheat, mackerel, perch, cod, peanut, cashew nut, soybean, peach, pineapple, mango, orange and kiwifruit. sIgE has 10 kinds of food allergens including milk, egg white, shrimp, crab, soybean, peanut, wheat, nut mixed group and food mixed group. Children whose results of SPT and/or sIgE didn't meet the diagnostic criteria and children whose results of SPT and sIgE were negative but its history strongly supported food allergy need to conduct OFC. Descriptive analysis and risk factor analysis were carried out on the results, and SPSS 18.0 statistical software was used in statistics analyzation.

Detailed Description

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Conditions

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Food Hypersensitivity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* The date of birth is in the range of 2011.9.1-2015.8.31

Exclusion Criteria

* The date of birth is not in the range of 2011.9.1-2015.8.31 or the children who's parents cannot cooperate
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Huan Dai

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huan Dai

Role: CONTACT

0577-88002135

Facility Contacts

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Huan Dai

Role: primary

057788002135 ext. 057788002135

References

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Dai H, Wang F, Wang L, Wan J, Xiang Q, Zhang H, Zhao W, Zhang W. An epidemiological investigation of food allergy among children aged 3 to 6 in an urban area of Wenzhou, China. BMC Pediatr. 2020 May 14;20(1):220. doi: 10.1186/s12887-020-02115-8.

Reference Type DERIVED
PMID: 32410652 (View on PubMed)

Other Identifiers

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SAHoWMU-CR2018-06-214

Identifier Type: -

Identifier Source: org_study_id

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