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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000048321

Enrollment

Registered

2022-07-11

Start date

2022-07-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cirrhosis with hypoalbuminemia

Interventions

Zinc + BCAA(12g/day). Starting dose of zinc is 50mg/day for &lt

60kg, 75mg/day for 60kg-80kg, 100mg/day for &gt

80kg. For cases with the serum zinc level is less than 80 mcg/dl at 4 and 8 weeks of administration, the amount of zinc is increased by 25mg/day. Total administration period is 12 weeks. BCAA(12g/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with hypozincemia and hypoalbuminemia due to liver cirrhosis, specifically patients who meet all the following conditions 1) Hypozincemia (<70mcg/dl) 2) hypoalbuminemia (<3.5g/dL)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Changes of serum albumin	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactRyosuke Kasuga

Keio University, School of Medicine Division of Gastroenterology and Hepatology

rk-keio2020@keio.jp+81-3-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026