UMIN-CTR Clinical Trial

Basic information
Public title	Epidemiological survey on childhood development and allergic diseases
Acronym	Epidemiological survey of allergic diseases in children
Scientific Title	Epidemiological survey on childhood development and allergic diseases
Scientific Title:Acronym	Epidemiological survey of allergic diseases in children
Region	Japan

Condition
Condition	General children
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Questionnaire and blood tests for general children, to investigate the relationship between childhood growth and allergic diseases
Basic objectives2	Others
Basic objectives -Others	To investigate the relationship between allergic disease and periostin
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence of allergic disease
Key secondary outcomes	serum periostin

Base
Study type	Others,meta-analysis etc

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	9 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	1) The subjects were male and female from elementary school fourth to sixth graders (9 to 12 years old) and junior high school first to third graders (12 to 15 years old) 2) consent of the substitute
Key exclusion criteria	1) subjects with infectious diseases 2) subjects who have judged that research researcher and research cooperator are inappropriate as research subjects
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Hiromi Middle name Last name Takeuchi
Organization	Faculty of Medicine, Tottori University
Division name	Division of Otolaryngology, Head and Neck Surgery, Department of Medicine of Sensory and Motor Organs
Zip code	683-8504
Address	36-1, Nishi-cho, Yonago
TEL	0859-38-6627
Email	yosuken@tottori-u.ac.jp

Public contact
Name of contact person	1st name Yosuke Middle name Last name Nakamura
Organization	Faculty of Medicine, Tottori University
Division name	Division of Otolaryngology, Head and Neck Surgery, Department of Medicine of Sensory and Motor Organ
Zip code	683-8504
Address	36-1, Nishi-cho, Yonago
TEL	0859-38-6627
Homepage URL
Email	yosuken@med.tottori-u.ac.jp

Sponsor
Institute	Tottori University
Institute
Department

Funding Source
Organization	Tottori University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	NPO Japan Promotion Supporting Network
Name of secondary funder(s)	Hitachi Chemical

IRB Contact (For public release)
Organization	Faculity of Medicine,Tottori university
Address	36-1, Nishi-cho, Yonago
Tel	0859-38-7108
Email	me-kenkyu@ml.adm.tottori-u.ac.jp

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	2019 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	100
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	Completed
Date of protocol fixation	2016 Year 10 Month 04 Day
Date of IRB	2016 Year 11 Month 30 Day
Anticipated trial start date	2016 Year 11 Month 30 Day
Last follow-up date	2020 Year 07 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Subjects of elementary and junior high school students were recruited by advertisement as a general health survey.

Management information
Registered date	2019 Year 03 Month 01 Day
Last modified on	2020 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041067