Epidemiological Investigation and Cohort Study on Food Al... | NCT03974555

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

NCT03974555

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Status

Unknown status

Last Update Posted

Jun 5, 2019Actual

Enrollment

8,000Estimated

Phase

Not provided

Conditions

Food Hypersensitivity

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Aug 31, 2021Estimated

Completion Date

Aug 31, 2021Estimated

First Submitted Date

May 30, 2019

First Submission Date that Met QC Criteria

May 30, 2019

First Posted Date

Jun 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2019

Last Update Posted Date

Jun 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective

To investigate the status of food allergy among children aged 3 to 6 in Wenzhou and Taizhou urban areas.
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.
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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8,000Estimated

Measure	Description	Time Frame
the prevalence of food allergy		3 years

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Preschool children aged 3 to 6 years in Lucheng District, Ouhai District of Wenzhou and Jiaojiang District and Huangyan District of Taizhou

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Huan Dai	Contact	0577-88002135		6221696@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huan Dai	Recruiting	Wenzhou	Zhejiang		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32410652	Derived	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.

ID	Term
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases