UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034864 |
|---|---|
| Receipt number | R000037789 |
| Scientific Title | Prevention of allergic march by vitamin D supplementation during infancy |
| Date of disclosure of the study information | 2018/11/12 |
| Last modified on | 2023/06/26 19:37:49 |
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Basic information
Public title
Prevention of allergic march by vitamin D supplementation during infancy
Acronym
Vitamin D mediated Prevention of Allergic march in Chiba (D-PAC)
Scientific Title
Prevention of allergic march by vitamin D supplementation during infancy
Scientific Title:Acronym
Vitamin D mediated Prevention of Allergic march in Chiba (D-PAC)
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To check the efficiency of vitamin D on prevention of allergic disease during infancy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive ratio of egg white specific IgE at 6 months of age
Key secondary outcomes
Vitamin D blood concentration at 6 months and 1 year of age
Positive ratio of egg white specific IgE at 1 year of age
Food allergy, atopic dermatitis, wheezing episodes at 1 year old of age
Amount of regulatory T cell at 6 months and 1 year of age
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Vitamin D 10ug/day
6 months
Interventions/Control_2
pracebo
6 months
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
| 5 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
term infant
Key exclusion criteria
1) premature baby
2) Baby who has surgical disease (such as esophageal atresia, diaphragmatic hernia etc.) which need tube feeding or who can not take vitamin D
3) Babies judged to be ineligible by research facility director or research doctor.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Shimojo |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Pediatrics
Zip code
2608670
Address
1-8-1 Inohana , Chuo-ku, Chiba city, Chiba, Japan
TEL
043-226-2144
shimojo@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Taiji |
| Middle name | |
| Last name | Nakano |
Organization
Chiba University Hospital
Division name
Department of Pediatrics
Zip code
2608670
Address
1-8-1 Inohana , Chuo-ku, Chiba city, Chiba, Japan
TEL
043-226-2144
Homepage URL
t-nakano@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Other
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
Graduate School of Medicine, Chiba university
Address
1-8-1 Inohana , Chuo-ku, Chiba city, Chiba, Japan
Tel
043-222-7171
igaku-rinri@office.chiba-u.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
医療法人社団 誠馨会 千葉メディカルセンター（千葉県）、千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 12 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 12 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037789
| 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 |
