UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of omega-3 fatty acid on NADH/NAFLD
Title of the study (Brief title)	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	Makoto Arai
Organization	Chiba University Hospital
Division name	Gastroenterology
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	Makoto Arai
Organization	Chiba Univeristy Hospital
Division name	Gastroenterology
Address	1-8-1 Inohana, Chuo-ku, Chiba City, JAPAN
TEL	043-226-2083
Homepage URL
Email	araim-cib@umin.ac.jp

Sponsor
Institute	Chiba Univeristy
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015060