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

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 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


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

Value
https://center6.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