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

Food Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03974555
• Other study ID #: SAHoWMU-CR2018-06-214
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: May 2019
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Huan Dai
• Phone: 0577-88002135
• Email: 6221696[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity

Locations

Country	Name	City	State
China	Huan Dai	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the prevalence of food allergy		3 years