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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022305
Receipt No. R000025640
Scientific Title Epidemiological study of the prevalence of children's allergic diseases and risk factors in Takayama city.
Date of disclosure of the study information 2016/06/01
Last modified on 2016/08/18

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Basic information
Public title Epidemiological study of the prevalence of children's allergic diseases and risk factors in Takayama city.
Acronym Epidemiological study of children's allergic diseases.
Scientific Title Epidemiological study of the prevalence of children's allergic diseases and risk factors in Takayama city.
Scientific Title:Acronym Epidemiological study of children's allergic diseases.
Region
Japan

Condition
Condition Allergic diseases in children (bronchial asthma, allergic rhinitis, atopic dermatitis, food allergy)
Classification by specialty
Clinical immunology Pediatrics Dermatology
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the prevalence of allergic diseases (bronchial asthma, allergic rhinitis, atopic dermatitis, food allergy) in Takayama city.
Basic objectives2 Others
Basic objectives -Others Cross-sectional study

To investigate the prevalence of allergic diseases (bronchial asthma, allergic rhinitis, atopic dermatitis, food allergy) by questionnaire.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To clarify the prevalence of childhood allergic symptoms in Takayama city by International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire for bronchial asthma/allergic rhinitis/atopic dermatitis and West Japan Study of Asthma and Allergies in Childhood (WJSAAC) 2012 questionnaire for food allergy.
Key secondary outcomes To evaluate the relation between the prevalence of allergic diseases and items as follows;
1) Sex
2) BMI
3) Region
4) Risk factors in living environment
5) Risk factors in lifestyle

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
3 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who live in Takayama city.

Subjects who agree to participate in the study.
Key exclusion criteria Subjects who did not agree to participate in the study (those who cannot answer or denied to answer the quetionnarie).
Target sample size 9000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Hioki
Organization Takayama Medical Association

Takayama City National Health Insurance Kuguno Clinic
Division name None
Zip code
Address 2-18 Hanaoka-cho, Takayama, Gifu, Japan
TEL 0577-32-0606
Email takayama-j@takayama.gifu.med.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Hioki
Organization Takayama City National Health Insurance Kuguno Clinic
Division name Department of Internal Medicine
Zip code
Address 642-1 Musugo, Kuguno-cho, Takayama, Gifu, Japan
TEL 0577-52-2074
Homepage URL
Email m04067th@jichi.ac.jp

Sponsor
Institute Takayama Medical Association
Institute
Department

Funding Source
Organization Jichi Medical University Graduate School Medical Department Alumni Association
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Takayama Medical Association
Self-funding

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional study

The questionnaire survey will be conducted for children 3 to 15 years and their parents who live in Takayama city at June, 2016.

Management information
Registered date
2016 Year 05 Month 13 Day
Last modified on
2016 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025640

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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