Clinical trial NCT02520817: Antioxidants and Zinc Improving Minimal Hepatic Encephalopathy In Truck Drivers; a Pilot Study
Official title: Professor of Tropical Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minimal Hepatic Encephalopathy
Keywords: Antioxidants
Zinc
Truck drivers
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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).

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.

Primary outcomes:
measure: Neuropsychometric tests including number connection test-part A, digit symbol test and block-design test.
timeFrame: 3 months
measure: Serum ammonia levels
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Nasser H Mousa,MD,mousa_medic@yahoo.com. +201227029213
Study officials:
affiliation: Tropical Medicine
name: Tropical Medicine Tropical Medicine
role: PRINCIPAL_INVESTIGATOR
References: