Randomized controlled trial comparing zinc-BCAA combination therapy with BCAA monotherapy in liver cirrhosis patients with hypoalbuminemia

Not Applicable

• Conditions: iver cirrhosis with hypoalbuminemia

• Registration Number: JPRN-UMIN000048321
• Lead Sponsor: Keio University, School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-11
• Last Update Posted: 17 October 2023
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

1)Beyond Child-Pugh score 8. 2)Severe hypoalbuminemia (Serum albumin less than 2.8g/dL) 3)Past history of hepatic encephalopathy 4)Doubtful case of Wilson disease 5)Symptomatic hypozincemia 6)Severe renal dysfunction (serum creatinine more than 2.0 mg/dl) 7)Malabsorption due to digestive diseases 8)Poor oral intake due to alcohol use disorder and anorexia nervosa 9)Severe dementia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of serum albumin

Secondary Outcome Measures

Name	Time	Method
1)Achievement rate of serum albumin>3.5g/dL, value of serum albumin 2)Changes of child pugh score, ALBI score 3)Changes of Skeletal muscle index(BIA), grip strength, SARC-F 4)Cumulative incidence rate of HCC 5)Cumulative incidence rate of acute decompensation and ACLF 6)Overall survival 7)Achievement rate of serum zinc>80mcg/dl value, changes of serum zinc 8)Changes of NH3, BTR 9)Changes of liver fibrosis marker(type4 collagen 7s, autotaxine and M2BPGi) and scoring system(FIB4 index, APRI)