Minimal Hepatic EncephalopathyNCT01223729
Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy
A study testing Acetyl-L-Carnitine in people with Minimal Hepatic Encephalopathy, run by University of Catania at 1 site in Italy.
Trial summary
Minimal hepatic encephalopathy represents a common complication present in well-compensated cirrhotic patients that impairs patients daily functioning and health-related quality of life. Read more about this study
- Who is it for?
- Ages 34 to 67 years
- Conditions the study is for
- Minimal Hepatic Encephalopathy
- What is being tested?
- Acetyl-L-Carnitine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2002to Nov 2005
- Phase
- Interventional
- 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 34 to 67 years
- All sexes
- Adult, Older adult
Who may be able to join
- All patients diagnosed as having cirrhosis at the outpatient Internal Medicine of the Department of Senescence of Cannizzaro Hospital (Catania) were candidates for enrolment. The diagnosis of cirrhosis was based on clinical, biochemical and ultrasonographic or liver histological data.
Who cannot join
- Exclusion criteria were overt hepatic encephalopathy or a history of overt HE; history of recent alcohol intake; infection; recent antibiotic use or gastrointestinal bleeding; history of recent use of drugs affecting psychometric performances like benzodiazepines, antiepileptics or psychotropic drugs; a history of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension; electrolyte imbalance; renal impairment; hepatocellular carcinoma; severe medical problems such as congestive heart failure, pulmonary disease or neurological or psychiatric disorder that could influence quality of life measurement; inability to perform neuropsycological tests.
Trial locations and contacts
1 site in 1 country.
About this study
Minimal hepatic encephalopathy represents a common complication present in well-compensated cirrhotic patients that impairs patients daily functioning and health-related quality of life. Acetyl-L-carnitine has been shown to be useful in improving blood ammonia and cognitive functions in cirrhotic patients with minimal hepatic encephalopathy. This study evaluated the effects of acetyl-L-carnitine treatment on health related quality of life and on depression in patients with minimal hepatic encephalopathy.
- Conditions
- Minimal Hepatic Encephalopathy
- Being tested
- Acetyl-L-Carnitine, placebo
- Keywords
- Acetyl-L-carnitine;, Minimal hepatic encephalopathy;, Quality of life;, Depression.
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl-L-CarnitineDrug
2 g acetyl-L carnitine twice a day
placeboOther
placebo twice per day
| Study group | Role | What they receive |
|---|---|---|
| Acetyl-L-Carnitine | Experimental | Not described Receives: Drug: Acetyl-L-Carnitine |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startApr 2002
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Minimal Hepatic EncephalopathyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 67 participants
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223729
- Sponsor's protocol ID
- 8-12-00 A
- Status last verified
- Dec 2000
- First submitted
- 18 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Malaguarnera M, Gargante MP, Cristaldi E, Vacante M, Risino C, Cammalleri L, Pennisi G, Rampello L. Acetyl-L-carnitine treatment in minimal hepatic encephalopathy. Dig Dis Sci. 2008 Nov;53(11):3018-25. doi: 10.1007/s10620-008-0238-6. Epub 2008 Mar 21.
PubMed 18357530
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT01223729
- Acronym / sponsor ID
- 8-12-00 A
- Conditions
- Minimal Hepatic Encephalopathy
- Keywords
- Acetyl-L-carnitine;, Minimal hepatic encephalopathy;, Quality of life;, Depression.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- Apr 2002
- Study completion
- Nov 2005
- First posted
- 19 Oct 2010 (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 represents a common complication present in well-compensated cirrhotic patients that impairs patients daily functioning and health-related quality of life. Acetyl-L-carnitine has been shown to be useful in improving blood ammonia and cognitive functions in cirrhotic patients with minimal hepatic encephalopathy. This study evaluated the effects of acetyl-L-carnitine treatment on health related quality of life and on depression in patients with minimal hepatic encephalopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetyl-L-Carnitine | Experimental | Drug: Acetyl-L-Carnitine |
| placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 34 to 67 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients diagnosed as having cirrhosis at the outpatient Internal Medicine of the Department of Senescence of Cannizzaro Hospital (Catania) were candidates for enrolment. The diagnosis of cirrhosis was based on clinical, biochemical and ultrasonographic or liver histological data.
Key exclusion criteria (1 listed)
- Exclusion criteria were overt hepatic encephalopathy or a history of overt HE; history of recent alcohol intake; infection; recent antibiotic use or gastrointestinal bleeding; history of recent use of drugs affecting psychometric performances like benzodiazepines, antiepileptics or psychotropic drugs; a history of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension; electrolyte imbalance; renal impairment; hepatocellular carcinoma; severe medical problems such as congestive heart failure, pulmonary disease or neurological or psychiatric disorder that could influence quality of life measurement; inability to perform neuropsycological tests.
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 |
|---|---|---|
| Acetyl-L-Carnitine2 g acetyl-L carnitine twice a day | Drug | Acetyl-L-Carnitine |
| placeboplacebo twice per day | Other | placebo |
Primary outcome
Not reported in the source record.
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 19 Oct 2010.
- Background: PubMed 18357530Malaguarnera M, Gargante MP, Cristaldi E, Vacante M, Risino C, Cammalleri L, Pennisi G, Rampello L. Acetyl-L-carnitine treatment in minimal hepatic encephalopathy. Dig Dis Sci. 2008 Nov;53(11):3018-25. doi: 10.1007/s10620-008-0238-6. Epub 2008 Mar 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetyl-L-Carnitine in people with Minimal Hepatic Encephalopathy, run by University of Catania at 1 site in Italy.
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 1 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 19 Oct 2010. 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 Italy. 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. Some participants in this study may receive a placebo. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01223729, which also lists 1 linked publication.
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 19 Oct 2010.