Minimal Hepatic EncephalopathyNCT02520817
Antioxidants and Zinc Improving Minimal Hepatic Encephalopathy In Truck Drivers; a Pilot Study
An observational study of Minimal Hepatic Encephalopathy, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Minimal Hepatic Encephalopathy
- What is being tested?
- 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 and Lactulose
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2013to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Truck drivers with liver cirrhosis and minimal hepatic encephalopathy.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- 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
- Keywords
- Antioxidants, Zinc, Truck drivers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
LactuloseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant supplementation and zinc plus Lactulose(Group A) | Patients With MHE were assigned to receive zinc and antioxidant plus lactulose (group A) Receives: 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) Receives: Dietary Supplement: Lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychometric tests including number connection test-part A, digit symbol test and block-design test.
Measured: 3 months
Serum ammonia levels
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasser Mousa, Mansoura University
- Investigators
- Tropical Medicine Tropical Medicine, Principal investigator, Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520817
- Sponsor's protocol ID
- Nasser hamed ahmed Mousa
- Status last verified
- Aug 2015
- First submitted
- 23 Jul 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professor of Tropical Medicine
- ClinicalTrials.gov ID
- NCT02520817
- Acronym / sponsor ID
- Nasser hamed ahmed Mousa
- Conditions
- Minimal Hepatic Encephalopathy
- Keywords
- Antioxidants, Zinc, Truck drivers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidant supplementation and zinc 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 monthsPatients With MHE were assigned to receive zinc and antioxidant plus lactulose (group A) |
| Lactulose only (Group B) | – | Dietary Supplement: LactulosePatients with MHE were assigned to receive lactulose oly (group B) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- Truck drivers with liver cirrhosis and minimal hepatic encephalopathy.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Antioxidant supplementation and zinc plus Lactulose(Group A) |
| Lactulose | Dietary supplement | Lactulose only (Group B) |
Primary outcome
Neuropsychometric tests including number connection test-part A, digit symbol test and block-design test.
Time frame: 3 months
Serum ammonia levels
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tropical Medicine Tropical Medicine principal investigator
Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimal Hepatic Encephalopathy, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychometric tests including number connection test-part A, digit symbol test and block-design test. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.