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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026369
Receipt No. R000030251
Scientific Title Sensitization to Allergic Food with Eczema and Timing of food introduction in a Year
Date of disclosure of the study information 2017/03/09
Last modified on 2019/03/04

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Basic information
Public title Sensitization to Allergic Food with Eczema and Timing of food introduction in a Year
Acronym Sensitization to Allergic Food with Eczema and Timing of food introduction in a Year (SAFETY study)
Scientific Title Sensitization to Allergic Food with Eczema and Timing of food introduction in a Year
Scientific Title:Acronym Sensitization to Allergic Food with Eczema and Timing of food introduction in a Year (SAFETY study)
Region
Japan

Condition
Condition Healthy infants
Classification by specialty
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To survey the mutual influence of two factors, namely nutrition intakes and infantile eczema, to allergic sensitization to food antigens.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Positive rate of specific IgE to egg white at the age of 12 and 36 months
Key secondary outcomes At the age of 12 months:
-positive rate of specific IgE to ovomucoid, cow's milk and casein
-value of specific IgE to egg white, ovomucoid, cow's milk and casein
-value of specific IgG4 to egg white, ovomucoid and casein
-value of non-specific IgE
-prevalence rate of eczema with medical determination
In 12 months of life:
-incidence rate of immediate food allergy reaction
At the age of 36 months:
-positive rate of specific IgE to ovomucoid, cow's milk, casein, Japanese cedar and mite
-value of specific IgE to egg white, ovomucoid, cow's milk, casein, Japanese cedar and mite
-value of specific IgG4 to egg white, ovomucoid and casein
-value of non-specific IgE
-prevalence rate of asthma, allergic rhino-conjunctivitis and atopic dermatitis
In 36 months of life:
-incidence rate of immediate food allergy reaction

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
2 months-old >
Gender Male and Female
Key inclusion criteria Infants fulfilling all of the following criteria:
1) Whose gestational age was 37 weeks or older.
2) Whose birth weight was 2300g or more.
3) Who are under 2 months of age at time of recruitment.
Key exclusion criteria Infants fulfilling or suspected to fulfill any of the following criteria:
1) With immune deficiency.
2) With a severe congenital disorder.
3) With a disorder which affects the introduction timing of complementary feeding, like a neuromuscular disease.
4) With skin abnormality which affects determination of infantile eczema.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Futamura
Organization National Hospital Organization, Nagoya Medical Center
Division name Division of Pediatrics
Zip code
Address Sannomaru 4-1-1, Naka-ku, Nagoya
TEL 052-951-1111
Email masakifutamura@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Futamura
Organization National Hospital Organization, Nagoya Medical Center
Division name Division of Pediatrics
Zip code
Address Sannomaru 4-1-1, Naka-ku, Nagoya
TEL 052-951-1111
Homepage URL
Email safety.nho@gmail.com

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 H28-NHO(Seiiku)-01
Org. issuing International ID_1 National Hospital Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 高崎医療総合センター(群馬県)、埼玉病院(埼玉県)、横浜医療センター(神奈川県)、相模原病院(神奈川県)、三重中央医療センター(三重県)、小倉医療センター(福岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 09 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
2016 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 09 Day
Last follow-up date
2022 Year 03 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Birth information, parental histories of allergy and smoking, nutrition intakes and presence of eczema in every month, and a skin examination and an allergic test at the age of 12 months

Management information
Registered date
2017 Year 03 Month 02 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030251

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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