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

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 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

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

Value
https://center6.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