To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites.
Branched-chain amino acid (BCAA) is known to reduce the relapse rate of liver cancer as it is associated with insulin resistance and has been reported to improve the progression of liver fibrosis when used in combination with an angiotensin-converting enzyme. With regard to the effect of liver function improvement, in a research conducted in South Korea, approximately 41.2% of the patients showed recovery of the normal albumin level when BCAA was administered to them for about 10 weeks during radiation therapy for liver cancer. Additionally, in other overseas researches, the changes in the values of total protein and albumin were significantly smaller in the patients who underwent transarterial chemoembolization (TACE) to whom BCAA was administered than in those to whom BCAA was not administered. The hypothesis of this study is that the serum albumin value will be increased significantly in the cirrhotic patients with ascites to whom BCAA is administered than the patients to whom placebo is administered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
188
BCAA (livact) will be administered 3 times a day during 24 weeks
Placebo will be administered in the same way
Stanford University School of Medicine
Palo Alto, California, United States
NOT_YET_RECRUITINGWonju severance christian hospital
Wŏnju, Gangwon-do, South Korea
RECRUITINGSoon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Change in serum albumin level
Time frame: 24 week
Change in serum albumin level
Time frame: 12 week
Rates of albumin normalization
Time frame: 12, 24 week
Change in dose of diuretics
Time frame: 12, 24 week
Improvement in terms of severity of ascites (International Ascites Club grade)
Time frame: 24 week
Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc)
Time frame: 24 week
Improvement in Child-Pugh score, class
Time frame: 24 week
Change in MELD, MELD-Na
Time frame: 24 week
Improvement in sarcopenia
Time frame: 24 week
Change in muscle mass
Time frame: 24 week
Change in muscle strength
Time frame: 24 week
Improvement in SF-36(short form-36)
Time frame: 24 week
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Kyunghee university hospital
Seoul, South Korea
RECRUITINGKorea university anam hospital
Seoul, South Korea
RECRUITINGSeverance hospital
Seoul, South Korea
RECRUITINGSoonchunhyang university seoul hospital
Seoul, South Korea
RECRUITINGHanyang university hospital
Seoul, South Korea
RECRUITINGChange in HOMA-IR(homeostatic model assessment-insulin resistance)
Time frame: 24 week