UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012886
Receipt number R000015060
Scientific Title Effect of omega-3 fatty acid on NADH/NAFLD
Date of disclosure of the study information 2014/01/17
Last modified on 2017/07/21 14:48:21

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Basic information

Public title

Effect of omega-3 fatty acid on NADH/NAFLD

Acronym

Effect of EPA/DHA on NADH/NAFLD

Scientific Title

Effect of omega-3 fatty acid on NADH/NAFLD

Scientific Title:Acronym

Effect of EPA/DHA on NADH/NAFLD

Region

Japan


Condition

Condition

NASH/NAFLD

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of EPA/DHA on ALT levels ih the patients with NASH/NAFLD

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Improvement rate of ALT levels

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

EPA/DHA 4 g per day

Interventions/Control_2

EPA/DHA 2 g per day

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1 Hyperlipidemia
2 NASH/NAFLD
3 ALT > or = 31 IU/L

Key exclusion criteria

Allergy for EPA/DHA
High risk of hemorrhage

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Arai

Organization

Chiba University Hospital

Division name

Gastroenterology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba City

TEL

043-226-2083

Email

araim-cib@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Arai

Organization

Chiba Univeristy Hospital

Division name

Gastroenterology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba City, JAPAN

TEL

043-226-2083

Homepage URL


Email

araim-cib@umin.ac.jp


Sponsor or person

Institute

Chiba Univeristy

Institute

Department

Personal name



Funding Source

Organization

Chiba Univeristy

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

千葉大学病院(千葉県)


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 17 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

Completed

Date of protocol fixation

2013 Year 12 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 17 Day

Last modified on

2017 Year 07 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015060


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name