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NCT03974555

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

Status unknown Last updated 5 June 2019
What this trial tests

trial in Food Hypersensitivity in 8,000 participants. Status unknown.

Timeline
1 September 2018
Primary endpoint
31 August 2021
31 August 2021

Quick facts

Lead sponsorSecond Affiliated Hospital of Wenzhou Medical University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment8,000
Start date1 September 2018
Primary completion31 August 2021
Estimated completion31 August 2021
Sites1 location across China

Conditions studied

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Who can join

Adults 3 to 6, any sex, with Food Hypersensitivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. An epidemiological investigation of food allergy among children aged 3 to 6 in an urban area of Wenzhou, China.
    Dai H, Wang F, Wang L, Wan J, et al · · 2020 · cited 15× · PMID 32410652 · DOI 10.1186/s12887-020-02115-8

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Other recruiting trials for Food Hypersensitivity

Currently open trials in the same condition.

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