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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name