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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025402
Receipt No. R000029128
Scientific Title Randomized controlled trial of strategy for prevention of cow's milk allergy by early introduction of cow's milk formula
Date of disclosure of the study information 2017/01/01
Last modified on 2019/03/06

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Basic information
Public title Randomized controlled trial of strategy for prevention of cow's milk allergy by early introduction of cow's milk formula
Acronym Strategy for prevention of cow's milk allergy (SPCMA)
Scientific Title Randomized controlled trial of strategy for prevention of cow's milk allergy by early introduction of cow's milk formula
Scientific Title:Acronym Strategy for prevention of cow's milk allergy (SPCMA)
Region
Japan

Condition
Condition Cow's milk allergy
Classification by specialty
Clinical immunology Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the early introduction of cow's milk formula prevents cow's milk allergy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of cow's milk allergy at 6 months of age
Key secondary outcomes The incidence of cow's milk sesitization and measurement of cow's milk specific IgE and IgG4 titer at 6 months of age

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Infants of ingesting cow's milk formula group intake cow's milk formula at least 10mL daily between 1 month of age to 3 months of age. They ingest cow's milk formula spontaneously from 4 months of age. They will be performed oral food challenge test at 6 months of age to assess the development of cow's milk allergy.
Interventions/Control_2 Infants of eliminating cow's milk formula group remove cow's milk formula between 1 month of age to 3 months of age. They ingest cow's milk formula spontaneously from 4 months of age. They will be performed oral food challenge test at 6 months of age to assess the development of cow's milk allergy.
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
7 days-old >=
Gender Male and Female
Key inclusion criteria gestationa age>=35 weeks and birth weight>=2000g
Key exclusion criteria (1)complication of any severe underlying disease
(2)may not continue breast feeding
Target sample size 764

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuhiro Sakihara
Organization Social medical corporation KARIYUSHIKAI Heartlife Hospital
Division name Pediatrics
Zip code
Address 208 Iju, Nakagusuku-son, Nakagami-gun, OKINAWA 901-2492, Japan
TEL 098-895-3255
Email odekorin2000@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuhiro Sakihara
Organization Social medical corporation KARIYUSHIKAI Heartlife Hospital
Division name Pediatrics
Zip code
Address 208 Iju, Nakagusuku-son, Nakagami-gun, OKINAWA 901-2492, Japan
TEL 098-895-3255
Homepage URL
Email odekorin2000@yahoo.co.jp

Sponsor
Institute Social medical corporation KARIYUSHIKAI Heartlife Hospital
Institute
Department

Funding Source
Organization Social medical corporation KARIYUSHIKAI Heartlife Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Okinawa Kyodo Hospital
Naha City Hospital
Department of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus
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 社会医療法人かりゆし会ハートライフ病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 01 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 02 Month 28 Day
Date analysis concluded
2020 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 26 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029128

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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