NCT02520817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

9 months

First QC Date

July 23, 2015

Last Update Submit

August 9, 2015

Conditions

Minimal Hepatic Encephalopathy

Keywords

AntioxidantsZincTruck drivers

Outcome Measures

Primary Outcomes (2)

  • Neuropsychometric tests including number connection test-part A, digit symbol test and block-design test.

    3 months

  • Serum ammonia levels

    3 months

Study Arms (2)

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

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 monthsDIETARY_SUPPLEMENT
Antioxidant supplementation and zinc plus Lactulose(Group A)
LactuloseDIETARY_SUPPLEMENT
Lactulose only (Group B)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Truck drivers with liver cirrhosis and minimal hepatic encephalopathy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

gluconic acidVitamin AAscorbic AcidLactulose

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydratesDisaccharidesOligosaccharidesPolysaccharidesSugars

Study Officials

  • Tropical Medicine Tropical Medicine

    Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Tropical Medicine

Study Record Dates

First Submitted

July 23, 2015

First Posted

August 13, 2015

Study Start

January 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

EG(1)