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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034864
Receipt No. 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 2018/11/12

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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
Middle name
Last name Naoki Shimojo
Organization Graduate School of Medicine, Chiba University
Division name Department of Pediatrics
Zip code
Address 1-8-1 Inohana , Chuo-ku, Chiba city, Chiba, Japan
TEL 043-226-2144
Email shimojo@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taiji Nakano
Organization Chiba University Hospital
Division name Department of Pediatrics
Zip code
Address 1-8-1 Inohana , Chuo-ku, Chiba city, Chiba, Japan
TEL 043-226-2144
Homepage URL
Email t-nakano@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 12 Day
Last modified on
2018 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037789

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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