UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026979 |
|---|---|
| Receipt number | R000022170 |
| Scientific Title | Epidemiological studies about effects of environmental and genetic factors for the development of allergic diseases in general population |
| Date of disclosure of the study information | 2017/04/13 |
| Last modified on | 2018/08/12 11:19:44 |
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Basic information
Public title
Epidemiological studies about effects of environmental and genetic factors for the development of allergic diseases in general population
Acronym
Effects of environmental and genetic factors for the development of allergic diseases in general population
Scientific Title
Epidemiological studies about effects of environmental and genetic factors for the development of allergic diseases in general population
Scientific Title:Acronym
Effects of environmental and genetic factors for the development of allergic diseases in general population
Region
| Japan |
Condition
Condition
Allergic diseases
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal effects of feto-maternal or infant-maternal interactions among prenatal environmental factors, such as diet, infections and earth conditions, and genetic factors on the development of allergic diseases in a general population by using epidemiological methods.
Basic objectives2
Others
Basic objectives -Others
To apply the results from the studies to strategy for prevention and treatment of allergic diseases.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
development of allergic diseases
Key secondary outcomes
Timing of development of allergic diseases
Cure or tolerance of allergic diseases
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
| 0 | months-old | <= |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Kochi Baby Examination has been held annually in spring since the end of the 2nd World War, and is a large baby health medical examination for around 2500 newborn babies in a general population in Kochi, Japan.
The Kochi Baby Examination has been supposed by the Kochi Shinbun-Broadcasting in Kochi, Japan.
Objectives:
* Parents-baby pairs in a general population who participated to the Kochi Baby Examination.
* Parents-baby pairs with written informed consent.
Key exclusion criteria
Parents-baby pairs without written informed consent.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miwa Shinohara |
Organization
Ehime University Hospital
Division name
Department of Pediatrics
Zip code
Address
454 Shitsukawa, Toon-City Ehime, 791-0295, JAPAN
TEL
089-960-5320
shinohara.miwa.vv@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miwa Shinohara |
Organization
Ehime University Hospital
Division name
Department of Pediatrics
Zip code
Address
454 Shitsukawa, Toon-City Ehime, 791-0295, JAPAN
TEL
089-960-5320
Homepage URL
shinohara.miwa.vv@ehime-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Ehime University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ehime University Hospital
Department of Pediatrics
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Allergy and Immunology, National Center for Child Health and Development
Name of secondary funder(s)
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
愛媛大学医学部附属病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 13 | 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
Results
Our results suggest the presence of possible epigenetic mechanisms regulating the onset of AR in humans presumably through increased organ-specific hypersensitivity.
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
Main results already published
Date of protocol fixation
| 1999 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1999 | Year | 01 | 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
Allergol Int. 2007 Dec;56(4):411-7. Epub 2007 Sep 1.
Symptoms of allergic rhinitis in women during early pregnancy are associated with higher prevalence of allergic rhinitis in their offspring.
Shinohara M1, Wakiguchi H, Saito H, Matsumoto K.
https://www.ncbi.nlm.nih.gov/pubmed/17713362
Management information
Registered date
| 2017 | Year | 04 | Month | 13 | Day |
Last modified on
| 2018 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022170
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
