UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036051 |
|---|---|
| Receipt number | R000041067 |
| Scientific Title | Epidemiological survey on childhood development and allergic diseases |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2020/12/22 13:25:45 |
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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
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
yosuken@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041067
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
