UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018560 |
|---|---|
| Receipt number | R000021478 |
| Scientific Title | Comparison of infantile allergic disease prevalence by 12 year interval cohort studies |
| Date of disclosure of the study information | 2016/08/06 |
| Last modified on | 2023/02/14 10:30:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of infantile allergic disease prevalence by 12 year interval cohort studies
Acronym
Sagamihara infant cohort study
(Sagamihara cohort)
Scientific Title
Comparison of infantile allergic disease prevalence by 12 year interval cohort studies
Scientific Title:Acronym
Sagamihara infant cohort study
(Sagamihara cohort)
Region
| Japan |
Condition
Condition
food allergy
atopic dermatitis
bronchial asthma
allergic rhinitis
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We had followed up a birth cohort in Sagamihara-City to clarify profiles of allergic diseases during the first 7 years of life from 2002. We began to follow the same cohort again from 2014 with a 12 year interval. The purpose of the current survey is to clarify changes in prevalence of infantile allergic diseases and environmental factors, compared with data from 2002.
Basic objectives2
Others
Basic objectives -Others
Prevalence of infantile allergic diseases at 4 months, 8 months, 1 year, 3 years, 5 years, 7 years.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of infantile allergic diseases at 4 months, 8 months, 1 year, 3 years, 5 years, 7 years.
Key secondary outcomes
Association of prevalence of infantile allergic diseases with following factors.
# Method of feeding
# Indirect cigarette exposure
# Environmental antigen exposure
# Family history of allergic disease
# Birth order
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
| 4 | months-old | <= |
Age-upper limit
| 84 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who received the mass medical examination at the age of 4 months, and whose parents agreed to participate in the study
Key exclusion criteria
None
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Ebisawa |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
TEL
042-742-8311
mebisawa@foodallergy.jp
Public contact
Name of contact person
| 1st name | Chizuko |
| Middle name | |
| Last name | Sugizaki |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
TEL
042-742-8311
Homepage URL
sugizaki@foodallergy.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Research grant by the Ministry of Health, Labour and Welfare of Japan
The Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Ethics Committee of National Hospital Organization Sagamihara National Hospital
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
Tel
042-742-8311
yamagishi.hideki.ws@mail.hosp.go.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
国立病院機構相模原病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 06 | 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
| 2013 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 30 | Day |
Other
Other related information
Using the mass medical examination system at the age of 4 months, we obtained basic profile information on subjects from Jan 1st, 2014 to Dec 31st, 2014. We also follow up the subjects whose parents agreed to participate in this study at the ages of 8 months, 1/3/5/7 years.
Management information
Registered date
| 2015 | Year | 08 | Month | 06 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021478
