UMIN-CTR Clinical Trial

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 milk Allergy by Daily ingestion of infant formula in Early infancy (SPADE) study
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 milk Allergy by Daily ingestion of infant formula in Early infancy (SPADE) study
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 Tetsuhiro Middle name Last name Sakihara
Organization	Social medical corporation KARIYUSHIKAI Heartlife Hospital
Division name	Pediatrics
Zip code	9012492
Address	208 Iju, Nakagusuku-son, Nakagami-gun, OKINAWA, Japan
TEL	098-895-3255
Email	odekorin2000@yahoo.co.jp

Public contact
Name of contact person	1st name Tetsuhiro Middle name Last name Sakihara
Organization	Social medical corporation KARIYUSHIKAI Heartlife Hospital
Division name	Pediatrics
Zip code	9012492
Address	208 Iju, Nakagusuku-son, Nakagami-gun, OKINAWA, 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	Social medical corporation KARIYUSHIKAI Heartlife Hospital Institutional Review Board
Address	208 Iju, Nakagusuku-son, Nakagami-gun, OKINAWA 901-2492, Japan
Tel	0988953255
Email	n.ikuno@heartlife.or.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	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	518
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	Completed
Date of protocol fixation	2016 Year 09 Month 25 Day
Date of IRB	2016 Year 11 Month 15 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2019 Year 12 Month 30 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 04 Month 06 Day

Other
Other related information

Management information
Registered date	2016 Year 12 Month 26 Day
Last modified on	2020 Year 04 Month 13 Day

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