UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025402 |
|---|---|
| Receipt number | 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 | 2020/04/13 13:36:00 |
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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 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
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
odekorin2000@yahoo.co.jp
Sponsor or person
Institute
Social medical corporation KARIYUSHIKAI Heartlife Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029128
