UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026369 |
|---|---|
| Receipt number | 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 | 2024/03/07 13:32:51 |
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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
| 1 | days-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 | Masaki |
| Middle name | |
| Last name | Futamura |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Division of Pediatrics
Zip code
4600001
Address
Sannomaru 4-1-1, Naka-ku, Nagoya
TEL
052-951-1111
masakifutamura@gmail.com
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Futamura |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Division of Pediatrics
Zip code
4600001
Address
Sannomaru 4-1-1, Naka-ku, Nagoya
TEL
052-951-1111
Homepage URL
safety.nho@gmail.com
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
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
National Hospital Organization
Address
2-5-23 Higashioka, Meguro-ku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.jp
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
1006
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Under analysis
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
| 2016 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 09 | 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
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030251
| Research Plan | |
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| 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 |
