Effectiveness of zinc supplement in minimal hepatic encephalophathy: A prospective, randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210423001

Enrollment

Registered

2021-04-23

Start date

2020-03-02

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Minimal hepatic encephalopathy in cirrhosis patients Minimal hepatic encephalopathy

Interventions

Zinc supplement present as zinc amino acid (bisglycinate) chelate tablet 75 mg per tablet that consists of elemental zinc 15 mg per tablet, supplement 45 mg of elemental zinc per day (3 tablets/day),Z

Active Comparator Drug,Placebo Comparator No treatment

Zinc supplement,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Minimal hepatic encephalopathy 2. cirrhosis

Exclusion criteria

Exclusion criteria: 1.history of overt HE 2.gastrointestinal bleeding and spontaneous bacterial peritonitis in past 6 weeks 3.neurological diseases causes of impaired cognitive function eg. Parkinson disease, Alzheimer disease 4.recent alcohol consumption within 6 weeks 5.on medication affecting psychometric performances like benzodiazepines, antiepileptics or psychotropic drugs 6.concurrent with hepatocellular carcinoma or active other malignancy 7.pregnancy 8.blindness 9.cannot read and write

Design outcomes

Primary

Measure	Time frame
absolute mean change of NP tests from baseline and after 12-week zinc supplement compared with placebo at end of treatment (3 month) Neuropsychometric test	—

Secondary

Measure	Time frame
mean change in health-related quality of life from baseline and after 12-week zinc supplement compared with placebo at end of treatment (3 month) SF-36 questionnaires,serum zinc and ammonia level from baseline and after 12-week zinc supplement compared with placebo at end of treatment (3 month) serum zinc and ammonia level,safety of zinc was monitored in term of adverse events at end of treatment (3 month) Common Terminology Criteria for Adverse Events ,In zinc group,subgroup to baseline zinc deficiency was level lower than 60 mcg/dL and normal zinc level, compare mean change of NP tests and SF-36 test between group from baseline and end of treatment at end of treatment (3 month) Neuropsychometric test, SF-36 questionnaires	—

Measure

Time frame

mean change in health-related quality of life from baseline and after 12-week zinc supplement compared with placebo at end of treatment (3 month) SF-36 questionnaires,serum zinc and ammonia level from baseline and after 12-week zinc supplement compared with placebo at end of treatment (3 month) serum zinc and ammonia level,safety of zinc was monitored in term of adverse events at end of treatment (3 month) Common Terminology Criteria for Adverse Events ,In zinc group,subgroup to baseline zinc deficiency was level lower than 60 mcg/dL and normal zinc level, compare mean change of NP tests and SF-36 test between group from baseline and end of treatment at end of treatment (3 month) Neuropsychometric test, SF-36 questionnaires

—

Countries

Thailand

Contacts

Public ContactRattaya Janyajirawong

Navamindradhiraj University

yokiapple1@gmail.com66816327212

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026