UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022305 |
|---|---|
| Receipt number | 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 14:48:20 |
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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
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
m04067th@jichi.ac.jp
Sponsor or person
Institute
Takayama Medical Association
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025640
