UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006394
Receipt number R000007426
Scientific Title Improved efficacy of seasonal influenza vaccination in the elderly orally receiving Mekabu fucoidan from edible seaweed: a randomised placebo controlled trial
Date of disclosure of the study information 2011/09/22
Last modified on 2011/09/22 16:54:51

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Basic information

Public title

Improved efficacy of seasonal influenza vaccination in the elderly orally receiving Mekabu fucoidan from edible seaweed: a randomised placebo controlled trial

Acronym

Investigation of edible seaweed Mekabu fucoidan intake on the preventive effect of influenza in the elderly

Scientific Title

Improved efficacy of seasonal influenza vaccination in the elderly orally receiving Mekabu fucoidan from edible seaweed: a randomised placebo controlled trial

Scientific Title:Acronym

Investigation of edible seaweed Mekabu fucoidan intake on the preventive effect of influenza in the elderly

Region

Japan


Condition

Condition

influenza

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test improved antibody production and immunopotentiating effect of Mekabu fucoidan in the elderly receiving influenza vaccination

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Influenza vaccination titer

Key secondary outcomes

NK-cell activity, IgA, IgG


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 not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Test products:
Mekabu fucoidan 300mg
Indigestible dextrin 300mg
Pullulan 6.6mg
one pack of granular powders per day 24-week intervention period

Interventions/Control_2

Placebo products:
Indigestible dextrin 600mg
Pullulan 3mg
Food dye 3.9mg
one pack of granular powders per day 24-week intervention period

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Males and females in Toyonaka Aiwakai Special Home for the Elderly
2.Those who themselves or whose family member signed the informed consent for participation in the study

Key exclusion criteria

1.Those who were taking any drugs or supplements affecting immunological response.
2.Those who suffered from severe forms of rheumatoid arthritis
3.Those who had allergy against seaweeds and other dietary components.
4.These who were judged not to be appropriate for the study by a responsible doctor.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukio Yamori

Organization

Mukogawa Women's University

Division name

Institute for World Health Development

Zip code


Address

4-16 Edagawa-cho, Nishinomiya-City, Hyogo 663-8143, JAPAN

TEL

+81-798-45-9980

Email



Public contact

Name of contact person

1st name
Middle name
Last name Mari Mori

Organization

Mukogawa Women's University

Division name

Institute for World Health Development

Zip code


Address

4-16 Edagawa-cho, Nishinomiya-City, Hyogo 663-8143, JAPAN

TEL

+81-798-45-9980

Homepage URL


Email

project@mukogawa-u.ac.jp


Sponsor or person

Institute

Institute for World Health Development, Mukogawa Women's University

Institute

Department

Personal name



Funding Source

Organization

Riken Vitamin Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Aijinkai Healthcare Corporation

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

社会福祉法人 豊中愛和会(大阪府)


Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 22 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Efficacy of influenza vaccines was improved by the administration of Mekabu fucoidan (MF). Particularly in response to B type influenza virus, the efficacy of vaccination was proved only in MF group, but not in placebo group. The efficacy was marked in the individuals whose antibody titer was lower (< 1:10).
The efficacy improvement by MF was proven against all types of influenza vaccination.
14th International Congress Immunology Aug, 26, 2010

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

2009 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2010 Year 03 Month 01 Day

Date of closure to data entry

2010 Year 06 Month 01 Day

Date trial data considered complete

2010 Year 06 Month 01 Day

Date analysis concluded

2010 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 09 Month 22 Day

Last modified on

2011 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007426


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name