UMIN-CTR Clinical Trial

Basic information
Public title	A randomized pilot trial of oral branched-chain amino acids in early liver cirrhosis
Acronym	Branched-chain amino acids in early cirrhosis
Scientific Title	A randomized pilot trial of oral branched-chain amino acids in early liver cirrhosis
Scientific Title:Acronym	Branched-chain amino acids in early cirrhosis
Region	Japan

Condition
Condition	compensated liver cirrhosis(Child A cirrhosis)
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study tested the hypothesis whether that early interventional oral branched-chain amino acids (BCAA) would: 1. inhibit the occurrence of major complications related to cirrhosis, and 2. preserve outcome markers such as the Model for End-Stage Liver Disease (MELD) score, Child-Turcott-Pugh (CTP) score, and the asialoscintigraphic clearance index (CI).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Eligible patients received the assigned treatment for at least 1 year. The primary endpoint of the study was the incidence of complications related to cirrhosis after enrollment. Major cirrhotic complications were defined as the first confirmation of hepatocellular carcinoma (HCC), ascites, esophagogastric varices, or hepatic encephalopathy.
Key secondary outcomes	Secondary endpoints were defined as the receipt of any of the following treatments, which can influence quantitative hepatic reserve markers such as MELD score, CTP score, and CI: (i) albumin infusions for ascites; (ii) endoscopic sclerotherapy/ligation for varices; (iii) open surgery, interventional radiology, or percutaneous therapy for HCC; and (iv) parenteral BCAA for encephalopathy.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients in the BCAA group received a cirrhotic diet supplemented with a Japanese nutritional preparation (LIVACT granules; AJINOMOTO Co., Inc., Tokyo, Japan; 4.15 g BCAA granules per sachet containing 952 mg L-isoleucine, 1904 mg L-leucine, and 1144 mg L-valine) given three times daily. The daily cirrhotic diet consisted of a total calorie intake of 25 to 35 kcal/kg and 1.0 to 1.2 g/kg protein (including 12.45 g/day BCAA in the BCAA group), adjusted to standard body weight (height (m)^2*22) according to the guidelines of the European Society of Parenteral and Enteral Nutrition (ESPEN). All patients received the same dietary instructions throughout the study. All patients completed questionnaires on their diet at 6-month intervals after enrollment.
Interventions/Control_2	Patients in the control group received the same dietary instructions without BCAA. All patients completed questionnaires on their diet at 6-month intervals after enrollment.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients had to have (i) an age of 20 to 75 years, (ii) Child class A cirrhosis, and (iii) hepatitis C virus, hepatitis B virus, or alcohol-related cirrhosis.
Key exclusion criteria	Patients were also excluded if they had (i) been receiving albumin infusions at least once per week for 1 month or longer, (ii) a history of oral BCAA supplementation/dietary protein restriction for 6 months or longer, (iii) major cirrhotic complications such as HCC, ascites, esophagogastric varices, or hepatic encephalopathy, or (iv) other non-hepatic major diseases.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Middle name Last name Susumu Shiomi
Organization	Graduate School of Medicine, Osaka City University
Division name	Departments of Nuclear Medicine
Zip code
Address	1-4-3 Asahimachi, Abenoku, Osaka 545-8585, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Etsushi Kawamura
Organization	Graduate School of Medicine, Osaka City University
Division name	Departments of Nuclear Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute	Graduate School of Medicine, Osaka City University
Institute
Department

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2009 Year 01 Month 01 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
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	1998 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	1999 Year 01 Month 01 Day
Last follow-up date	2005 Year 12 Month 01 Day
Date of closure to data entry	2008 Year 08 Month 01 Day
Date trial data considered complete	2008 Year 08 Month 01 Day
Date analysis concluded	2008 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date	2008 Year 09 Month 08 Day
Last modified on	2009 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001658

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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