NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Patients with Chronic Liver Diseases Complicated by Zinc Deficiency or Latent Zinc Deficiency
Date of first enrollment	03/12/2025
Target sample size	100
Countries of recruitment
Study type	Observational
Intervention(s)	none

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.