UMIN-CTR Clinical Trial

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

compensated liver cirrhosis(Child A cirrhosis)

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Graduate School of Medicine, Osaka City University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2008

Year

09

Month

08

Day

Last modified on

2009

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001658