Clinical trial NCT03974555: Epidemiological Investigation and Cohort Study on Food Allergy in Children Aged 3 to 6 Years in Wenzhou and Taizhou Urban Areas
Official title: Epidemiological Investigation and Cohort Study on Food Allergy in Children Aged 3 to 6 Years in Wenzhou and Taizhou Urban Areas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Food Hypersensitivity
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 8000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preschool children aged 3 to 6 years in Lucheng District, Ouhai District of Wenzhou and Jiaojiang District and Huangyan District of Taizhou

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: the prevalence of food allergy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Huan Dai
state: Zhejiang
Study officials:
References:
citation: 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.