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

Phase 2

Completed

• Conditions: Minimal hepatic encephalopathy in cirrhosis patients; Minimal hepatic encephalopathy

• Registration Number: TCTR20210423001
• Lead Sponsor: avamindradhiraj University Research Fund

Brief Summary

Significant improvement of NP tests was established in zinc supplement group when compared with placebo (NCT-A p 0.029, NCT-B, p 0.008, SDT, p 0.002 , DST, p below 0.001). Significant improvement of HRQOL assessed by SF-36 score was seen only in the zinc group, p below 0.001. In the zinc supplement group, not only the improvement of psychomotor performance but quality of life were achieved irrespective of baseline zinc level.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-12-09
• Study Start: 2021-04-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

1. Minimal hepatic encephalopathy
2. cirrhosis

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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