Efficacy and Safety of Long-term Administration of Zinc Histidine Hydrate

Efficacy and Safety of Long-term Administration of Zinc Histidine Hydrate in Patients with Chronic Liver Diseases Complicated by Zinc Deficiency or Latent Zinc Deficiency

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031250502

Enrollment

100

Registered

2025-12-03

Start date

2025-12-03

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

Patients with Chronic Liver Diseases Complicated by Zinc Deficiency or Latent Zinc Deficiency liver disease

Interventions

none

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosed as having chronic liver disease. 2) Aged 18 years or older. 3) Documented history of fasting serum zinc level < 80 micro g/dL and judged as eligible for zinc histidine hydrate administration. 4) Provided informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1) Patients with a known allergy to zinc preparations. 2) Pregnant or lactating women. 3) Patients with uncontrolled malignant tumors. 4) Patients undergoing maintenance dialysis. 5) Patients deemed unsuitable for participation in the study at the discretion of the attending physician.

Design outcomes

Primary

Measure	Time frame
Changes in serum ammonia levels and blood zinc concentrations during the 12 months following initiation of zinc histidine hydrate treatment.	—

Secondary

Measure	Time frame
Incidence of overt hepatic encephalopathy (West Haven grade II or higher) within 12 months after initiation of zinc histidine hydrate therapy Incidence of covert hepatic encephalopathy within 12 months after initiation of zinc histidine hydrate therapy Frequency of adverse events within 12 months after initiation of zinc histidine hydrate therapy Changes in CNAQ-J and FAACT A/CS scores during the 12 months following initiation of zinc histidine hydrate therapy Changes in liver function-related laboratory parameters during the 12 months following initiation of zinc histidine hydrate therapy	—

Measure

Time frame

Incidence of overt hepatic encephalopathy (West Haven grade II or higher) within 12 months after initiation of zinc histidine hydrate therapy Incidence of covert hepatic encephalopathy within 12 months after initiation of zinc histidine hydrate therapy Frequency of adverse events within 12 months after initiation of zinc histidine hydrate therapy Changes in CNAQ-J and FAACT A/CS scores during the 12 months following initiation of zinc histidine hydrate therapy Changes in liver function-related laboratory parameters during the 12 months following initiation of zinc histidine hydrate therapy

—

Contacts

Public ContactYoshihito Uchida

Saitama Medical University

uchida.yoshihito@1972.saitama-med.ac.jp+81-49-276-1198

Outcome results

None listed

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