UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The beneficial effect of branched-chain amino acids for patients with HCV related chronic liver disease
Title of the study (Brief title)	The beneficial effect of branched-chain amino acids for patients with HCV related chronic liver disease
Region	Japan

Condition
Condition	HCV related chronic liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the efficancy of branched-chain amino acid for HCV related chronic liver disease patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Improvement of insulin resistance 2) Reduction of oxidative stress
Key secondary outcomes	1) Change of HCV-RNA 2) Improvement of loss of zinc 3) Improvement of BTR 4) Incidence of HCC 5) Occurrence of side effect

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Patients who obtained the consent, administer the BCAA enriched supplement for 12 weeks in addition to the original treatment. containing
Interventions/Control_2
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) Age, over 20 years old 2) Male and female 3) Patients who has inslin resistance 4) Patients who has no HCC 5) Patients who obtained the consent
Key exclusion criteria	1) Cirrotic patients with BCAA formulation while taking 2) Patients during interferon therapy in chronic hepatitis C, cirrhosis 3) Patients receiving medication for diabetes 4) Patients in the intake of dietary supplements containing the BCAA and zinc 5) Patients for branched-chain amino acids and zinc formulation, with a history of hypersensitivity 6) Pregnant woman and women who may possibly be pregnant, women in nursing
Target sample size	100

Research contact person
Name of lead principal investigator	Isao Hidaka
Organization	Yamaguchi Univercity Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	1-1-1 Minamikogushi, Uba, Yamaguchi
TEL	0836-22-2241
Email	isao-h@yamaguchi-u.ac.jp

Public contact
Name of contact person	Isao Hidaka
Organization	Yamaguchi Univercity Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	1-1-1 Minamikogushi, Uba, Yamaguchi
TEL	0836-22-2241
Homepage URL
Email	isao-h@yamaguchi-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine
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	山口大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 10 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 09 Day
Last modified on	2018 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019439