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Study of effects of Nobelzin capsules (zinc acetate) on hyperammonemia in patients with liver cirrhosis; A randomized, double-blind, placebo-controlled study in patients with liver cirrhosis

Study of effects of Nobelzin capsules (zinc acetate) on hyperammonemia in patients with liver cirrhosis; A randomized, double-blind, placebo-controlled study in patients with liver cirrhosis - Effects of Zinc supplementation on Hyperammonemia in patients with Liver Cirrhosis (EZ trial)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002402
Enrollment
50
Registered
2009-09-15
Start date
2009-09-01
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

Interventions

Patietns will receive 3 capsules of Nobelzin (zinc acetate, 1 capsule includes 50mg zinc) per day for 12 weeks Patietns will receive 3 capsules of placebo per day for 12 weeks

Sponsors

Ministry of Health, Labour and Welfare
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Liver Cirrhosis 2.Hyperammonemia >= ULN (more than 2 times within the past 2 months) 3.Hepatic coma grade <= 2 4.Serum levels of zinc <= 65 microgram/dl 5.Ages 20 or older 6.Out-clinic patients

Exclusion criteria

Exclusion criteria: 1.Hepatic coma grade >= 3 2.Fulminant hepatitis 3.Patients with malignant diseases who need to be treated during the period of this trial 4.Patients with cardiac, renal or pancreatic diseases who need admission for the therapy 5.Patients who are associated with heavy hematological disorders or cerebrovascular diseases 6.Known or suspected history of allergy to zinc 7.Inegible patients at a physician's discretion

Design outcomes

Primary

MeasureTime frame
Serum levels of ammonia (0-week and 12-week) Adverse effects(during trial, 0-12 week)

Secondary

MeasureTime frame
Serum levels of BTR, psychometric testing, hepatic coma grade (0-week and 12-week)

Countries

Japan

Contacts

Public ContactRyujin Endo

Iwate Medical University, School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine

ryuendo@iwate-med.ac.jp019-651-5111

Outcome results

None listed

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