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

Completed

• Conditions: Minimal Hepatic Encephalopathy
• Interventions: 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

• Registration Number: NCT02520817
• Lead Sponsor: Mansoura University

Brief Summary

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.

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 Timeline

• Study Start: 2013-01
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2015-07-23
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-09
• Last Update Submitted: 2015-08-09
• Study First Posted: 2015-08-13
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antioxidant supplementation and zinc plus Lactulose(Group A)	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	Patients With MHE were assigned to receive zinc and antioxidant plus lactulose (group A)
Lactulose only (Group B)	Lactulose	Patients with MHE were assigned to receive lactulose oly (group B)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nasser H Mousa,MD,mousa_medic@yahoo.com. +201227029213; 🇪🇬 Mansoura, Egypt