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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | compensated liver cirrhosis(Child A cirrhosis) | |
Classification by specialty |
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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 |
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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. | |
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Eligibility | ||||
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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 |
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Organization | Graduate School of Medicine, Osaka City University | ||||||
Division name | Departments of Nuclear Medicine | ||||||
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Address | 1-4-3 Asahimachi, Abenoku, Osaka 545-8585, Japan | ||||||
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Organization | Graduate School of Medicine, Osaka City University | ||||||
Division name | Departments of Nuclear Medicine | ||||||
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Institute | Graduate School of Medicine, Osaka City University |
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Organization | None |
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Category of Funding Organization | Self funding |
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Secondary IDs | NO |
Study ID_1 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
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Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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Research case data | |
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