Antioxidants and Zinc Improving Minimal Hepatic Encephalopathy In Truck Drivers; a Pilot Study

Professor of Tropical Medicine

Minimal hepatic encephalopathy (MHE) can have a far-reaching impact on quality and ability to function in daily life and may progress to overt Hepatic Encephalopathy. Patients with MHE were missed in clinical follow up and are more exposure to work accident. The aim of the present study was to assess the effects of oral supplementation of antioxidant and zinc gluconate Versus Lactulose inTruck driver cirrhotic patients with MHE.

Study Overview

• Status: Completed
• Conditions: Minimal Hepatic Encephalopathy
• Intervention / Treatment: Dietary supplement: 175 mg zinc gluconate, 50000 IU vitamin A, 500 mg vitamin C and 100 mg vitamin E once daily plus lactulose; dose 30-60 ml/day for 3 months; Dietary supplement: Lactulose

Detailed Description

The aim of the present study was to assess the effects of oral supplementation of antioxidant and zinc gluconate in patients with MHE. Zinc, may be considered as a cofactor of urea cycle enzymes, that deficient in cirrhotic patients; especially if associated, with malnutrition or encephalopathy . Zinc is essential for the synthesis of coenzymes that mediate biogenic amine synthesis and metabolism. Data from studies sustain that, there is a synergistic combined effect between systemic oxidative stress, and ammonia that is implicated in the pathogenesis of hepatic encephalopathy, so that the present study was designed to assess the effects of oral supplementation of antioxidant and zinc gluconate in cirrhotic Truck drivers patients with MHE.

A prospective randomized controlled study comparing the effect of zinc and antioxidant supplementation plus lactulose on MHE versus lactulose alone. Patients who were diagnosed as having MHE were randomly assigned either to receive zinc and antioxidant plus lactulose (group A) or lactulose alone (group B, the control). Patients in group A received 175 mg zinc gluconate, 50000 iu vitamin A, 500 mg vitamin C and 100 mg vitamin E once daily plus lactulose (30-60 ml in 2 or 3 divided doses), while patients in group B received 30-60 ml lactulose in 2 or 3 divided doses so that the patient passed 2-3 semi soft stools per day. The therapy was taken daily for 3 months or until the patients discontinued the study drugs for any reason (e.g. non compliance). All patients were followed up every month for treatment compliance and for development of any complications. The compliance with the therapy was assured primarily by ensuring increased stool frequency and a change to a softer consistency and by counting the number of bottles of lactulose consumed. None of the study, patients were specifically treated by other therapy for MHE within the study period (e.g. rifaximin).

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Nasser H Mousa,MD,mousa_medic@yahoo.com. +201227029213

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients (truck drivers) with liver cirrhosis were screened for MHE. The patients attended the Tropical and Neurology Outpatient clinics in Mansoura university Hospital, Mansoura

Description

Inclusion Criteria:

• Truck drivers with liver cirrhosis and minimal hepatic encephalopathy.

Exclusion criteria:

• Overt hepatic encephalopathy.
• Sensory or motor deficits; neurological causes of impaired cognition
• Electrolyte imbalances (serum sodium level <125 mmol/L; serum calcium level >10 mg per /DL and potassium level <2.5 mmol/L)
• Ongoing systemic illnesses, intercurrent infection or active spontaneous bacterial peritonitis.
• Recent history (< 6 weeks) of alcohol intake.
• Patients on drugs affecting psychometric performances.
• Recent (<6 weeks) intake of antibiotics for gastrointestinal bleeding, history of shunt operation or trans jugular intrahepatic portosystemic shunt for portal hypertension.
• Chronic renal impairment (creatinine level >2.0 mg per/ DL.
• Patients with color blindness, mature cataract and diabetic retinopathy,
• Hepatocellular carcinoma, or other comorbidities such as congestive heart failure and pulmonary disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Antioxidant supplementation and zinc plus Lactulose(Group A); Patients With MHE were assigned to receive zinc and antioxidant plus lactulose (group A)	Dietary supplement: 175 mg zinc gluconate, 50000 IU vitamin A, 500 mg vitamin C and 100 mg vitamin E once daily plus lactulose; dose 30-60 ml/day for 3 months
Lactulose only (Group B); Patients with MHE were assigned to receive lactulose oly (group B)	Dietary supplement: Lactulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neuropsychometric tests including number connection test-part A, digit symbol test and block-design test.	3 months
Serum ammonia levels	3 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Tropical Medicine Tropical Medicine, Tropical Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: August 9, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 9, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Antioxidants; Zinc; Truck drivers
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Hepatic Encephalopathy; Brain Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Protective Agents; Micronutrients; Antioxidants; Lactulose; Vitamin E; Vitamins; Ascorbic Acid; Vitamin A
• Other Study ID Numbers: Nasser hamed ahmed Mousa