UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003509
Receipt number R000004253
Scientific Title The seaweed intervention study for preschool children
Date of disclosure of the study information 2010/04/21
Last modified on 2019/06/19 11:37:28

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Basic information

Public title

The seaweed intervention study for preschool children

Acronym

The seaweed intervention study

Scientific Title

The seaweed intervention study for preschool children

Scientific Title:Acronym

The seaweed intervention study

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess effects of seaweed for health among preschool children

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Blood pressure level

Key secondary outcomes

urinary sex steroids etc.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Seaweed 1.76g/d

Interventions/Control_2

Control

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

4 years-old <=

Age-upper limit

5 years-old >=

Gender

Male and Female

Key inclusion criteria

100 children who go to a kindergarten in Aichi prefecture

Key exclusion criteria

Children who have any thyroid diseases

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Keiko
Middle name
Last name Wada

Organization

Gifu University,Graduate School of Medicine

Division name

Epidemiology and Preventive Medicine

Zip code

501-1194

Address

1-1 Yanagido Gifu 501-1194, Japan.

TEL

058-230-6412

Email

dr_keiko@gifu-u.ac.jp


Public contact

Name of contact person

1st name Keiko
Middle name
Last name Wada

Organization

Gifu University,Graduate School of Medicine

Division name

Epidemiology and Preventive Medicine

Zip code

501-1194

Address

1-1 Yanagido Gifu 501-1194, Japan.

TEL

058-230-6412

Homepage URL


Email

dr_keiko@gifu-u.ac.jp


Sponsor or person

Institute

Department of Epidemiology and Preventive Medicine, Gifu University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The grants from the Ministry of Education, Culture, Sports, Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

he ethical board of Gifu University Graduate School of Medicine, Gifu, Japan

Address

1-1 Yanagido Gifu 501-1194, Japan.

Tel

058-230-6059

Email

gjme00004@jim.gifu-u.ac.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

愛知文教女子短期大学付属第一幼稚園(愛知県)


Other administrative information

Date of disclosure of the study information

2010 Year 04 Month 21 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


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

No longer recruiting

Date of protocol fixation

2010 Year 04 Month 09 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 04 Month 20 Day

Last modified on

2019 Year 06 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004253


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name