NCT03974555

Brief Summary

Objective

  1. 1.To investigate the status of food allergy among children aged 3 to 6 in Wenzhou and Taizhou urban areas.
  2. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

June 5, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

May 30, 2019

Last Update Submit

May 30, 2019

Conditions

Food Hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • the prevalence of food allergy

    3 years

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huan Dai

Wenzhou, Zhejiang, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32410652DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Huan Dai

CONTACT

0577-880021356221696@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2019

First Posted

June 5, 2019

Study Start

September 1, 2018

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

June 5, 2019

Record last verified: 2019-05

Locations

CN(1)