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Effects of supplementation for liver disease on compensated cirrhotic patients: a randomized, double-blind, placebo-controlled trial

Effects of supplementation for liver disease on compensated cirrhotic patients: a randomized, double-blind, placebo-controlled trial - Effects of BCAA and zinc-enriched supplement on cirrhotic patients: a randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012815
Enrollment
60
Registered
2014-01-14
Start date
2012-01-20
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

HCV-related liver disease

Interventions

In the supplement group, the patients were given two sachets of the BCAA and zinc-enriched supplement containing 6400 mg/day BCAA and 10 mg/day zinc (Aminofeel, Seikatsu Bunkasya Co. Inc, Chiba, Japan

Sponsors

Kurume University School of Medicine
Lead Sponsor
1. Department of Gastroenterology and Rheumatology, Fukushima Medical University, Fukushima, Japan. 2. Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University, Chiba, Japan. 3. Department of Gastroenterology, Faculty of Medicine, Oita University, Yuhu, Japan. 4. Narao Medical Center, Shinkamigoto, Japan. 5. Department of Medical Oncology and Hematology, Sapporo Medical University, School of Medicine, Sapporo, Japan. 6. Biostatistics Center, Kurume Univer
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. > 65 years-old 2. HCV infection 3. Serum albumin level is more than 3.5 g/dL and less than 4.0 g/dL 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Subjects who had taken the supplement 2. Subjects who were treated with BCAA-containing agents 3. Subjects who were treated with antidiabetic agents 4. Subjects who were treated with zinc-containing agent or supplement 5. Subjects with obstruction of gut 6. Subjects with hepatic encepharlopathy 7. Subjects with severe hepato-renal diseases 8. Subjects with hepatocellular carcinoma 9. Subjects with risky esophageal varices 10. Subjects with other liver diseases including hepatitis B-related liver disease, alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, haemochromatosis, Wilson disease 11. HCV-infected subjects who are or will be treated with interferon thrapy 12. Subject with any type of severe extra-hepatic diseases

Design outcomes

Primary

MeasureTime frame
The primary outcomes were the following known prognostic factors for patients with chronic liver disease: 1) platelet count, 2) serum albumin level, 3) serum AFP level, 4) HOMA-IR value, 5) serum BTR, and 6) serum zinc level.—

Countries

Japan

Contacts

Public ContactTakumi Kawaguchi

Kurume University School of Medicine Division of Gastroenterology, Department of Medicine

takumi@med.kurume-u.ac.jp0942-35-3311

Outcome results

None listed

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