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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001360
Receipt No. R000001658
Scientific Title A randomized pilot trial of oral branched-chain amino acids in early liver cirrhosis
Date of disclosure of the study information 2009/01/01
Last modified on 2009/12/26

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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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