UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011951
Receipt number R000013958
Scientific Title Effect of epigallocatechin supplementation on the immune response to influenza vaccination
Date of disclosure of the study information 2013/10/08
Last modified on 2015/07/08 11:15:28

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Basic information

Public title

Effect of epigallocatechin supplementation on the immune response to influenza vaccination

Acronym

Epigallocatechin and immune response to influenza vaccination

Scientific Title

Effect of epigallocatechin supplementation on the immune response to influenza vaccination

Scientific Title:Acronym

Epigallocatechin and immune response to influenza vaccination

Region

Japan


Condition

Condition

Influenza infection

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether epigallocatechin supplementation augment the immune response to influenza vaccination

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Rate of influenza-infection symptoms and antibody titer to influenza after the influenza vaccination

Key secondary outcomes

The extent of cytokine production by lymphocyte fraction after antigen stimulation by ELISPOT method


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

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

6

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Supplementation of EGC (3.0 mg/dL) for 4 months in subjects <65 years.

Interventions/Control_2

Supplementation of EGC (1.5 mg/dL) for 4 months in subjects <65 years.

Interventions/Control_3

Supplementation of placebo tea for 4 months in subjects <65 years.

Interventions/Control_4

Supplementation of EGC (3.0 mg/dL) for 4 months in subjects &#8805;70 years.

Interventions/Control_5

Supplementation of EGC (1.5 mg/dL) for 4 months in subjects &#8805;70 years.

Interventions/Control_6

Supplementation of placebo tea for 4 months in subjects &#8805;70 years.

Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects who are recruited in the Osaka Medical College (n=90) and subjects in the Aiwa geriatric health services facilities (n=90).

Key exclusion criteria

Subjects who are in the bad health condition, those who cannot safely ingest EGC-containing Tea, and those who are taking corticosteroid or other immuno-suppressive agents will be excluded from the study.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobukazu Ishizaka

Organization

Osaka Medical College

Division name

Internal Medicine3

Zip code


Address

Daigaku-machi2-7 Takatsuki-shi Osaka Japan

TEL

072-683-1221

Email

omc3nai-group@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichi Sohmiya

Organization

Osaka Medical College

Division name

Internal Medicine3

Zip code


Address

Daigaku-machi2-7 Takatsuki-shi Osaka Japan

TEL

072-683-1221

Homepage URL


Email

omc3nai-group@umin.ac.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Agriculture-Medicine cooperation project

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

大阪医科大学附属病院(大阪)、豊中愛和会(大阪)


Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 08 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

This study did not shown that epigallocatechin tea could activate immune function after influenza vaccination.

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

2013 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date

2014 Year 02 Month 28 Day

Date of closure to data entry

2014 Year 03 Month 31 Day

Date trial data considered complete

2014 Year 03 Month 31 Day

Date analysis concluded

2016 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 10 Month 03 Day

Last modified on

2015 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013958


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name