UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010826 |
|---|---|
| Receipt number | R000012655 |
| Scientific Title | The quantitative evaluation of desert-dust (Asian dust)'s effects to respiratory/allergic diseases, taking into account the time spent outside |
| Date of disclosure of the study information | 2013/05/29 |
| Last modified on | 2015/05/31 20:53:32 |
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Basic information
Public title
The quantitative evaluation of desert-dust (Asian dust)'s effects to respiratory/allergic diseases, taking into account the time spent outside
Acronym
Asian dust and Children's health
Scientific Title
The quantitative evaluation of desert-dust (Asian dust)'s effects to respiratory/allergic diseases, taking into account the time spent outside
Scientific Title:Acronym
Asian dust and Children's health
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the risk of Asian dust/PM2.5 exposure to respiratory/allergy symptom of pregnant women and asthmatic/non-asthmatic infants and to allergic diseases incidence of infants
Basic objectives2
Others
Basic objectives -Others
Incidence
To assess the risk of components of particulates to respiratory/allergy symptom of pregnant women and asthmatic/non-asthmatic infants
To assess the risk of vitamin D deficiency during pregnancy to disease incidence in children
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Respiratory/allergy symptom of pregnant women and asthmatic/non-asthmatic infants
Incidence of asthma/asthmatic bronchitis/wheeze in infants
Key secondary outcomes
Allergic rhinoconjunctivitis in infants
Pollinosis in infants
Food allergy in infants
Respiratory symptom in infants
Possible factors affecting Asian-dust's sensitivity such as vitamin D, antibody to fungus, and cytokines
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pregnant women and their future children who participate EcoChil study in Kyoto, Toyama, or Tottori unit center.
Agreed with this study.
Using email function of mobile phone, smartphone, or PC.
Key exclusion criteria
N.A.
Target sample size
9000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeo Nakayama |
Organization
Kyoto University Graduate School of Medicine
Division name
School of Public Health, Health Informatics
Zip code
Address
Yoshida Konoe-cho, Sakyo, Kyoto
TEL
075-753-4488
nakayama.takeo.4a@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumiko T Kanatani |
Organization
Kyoto University Graduate School of Medicine
Division name
School of Public Health, Health Informatics
Zip code
Address
Yoshida Konoe-cho, Sakyo, Kyoto
TEL
075-761-1065
Homepage URL
http://kosa.kyotolog.net
kanatani.kumiko.2r@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine, Health Informatics
Institute
Department
Personal name
Funding Source
Organization
The Environment Research and Technology Development Fund
Environmental Restoration and Conservation Agency
Grants-in-Aid for Scientific Research by JSPS
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
京都府京都市左京区・北区
滋賀県長浜市
京都府木津川市
鳥取県
富山県
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pubmed/24958210
Publication of results
Partially published
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
| 2011 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Observational study acquiring new data
Management information
Registered date
| 2013 | Year | 05 | Month | 29 | Day |
Last modified on
| 2015 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012655
| 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 |
