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

NCT ID: NCT02520817

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-10-31

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).

Conditions

Minimal Hepatic Encephalopathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Antioxidant supplementation and zinc plus Lactulose(Group A)

Patients With MHE were assigned to receive zinc and antioxidant 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

Intervention Type: DIETARY_SUPPLEMENT

Lactulose only (Group B)

Patients with MHE were assigned to receive lactulose oly (group B)

Lactulose

Intervention Type: DIETARY_SUPPLEMENT

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Lactulose

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Nasser Mousa

Professor of Tropical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tropical Medicine Tropical Medicine

Role: PRINCIPAL_INVESTIGATOR

Tropical Medicine

Locations

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

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

Nasser hamed ahmed Mousa

Identifier Type: -

Identifier Source: org_study_id