Back to resultsAcetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy
Primary Purpose
Minimal Hepatic Encephalopathy
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Acetyl-L-Carnitine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Minimal Hepatic Encephalopathy focused on measuring Acetyl-L-carnitine;, Minimal hepatic encephalopathy;, Quality of life;, Depression.
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Cannizzaro Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acetyl-L-Carnitine
placebo
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01223729
First Posted
October 18, 2010
Last Updated
October 18, 2010
Sponsor
University of Catania
1. Study Identification
Unique Protocol Identification Number
NCT01223729
Brief Title
Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy
Official Title
Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2000
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Catania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimal Hepatic Encephalopathy
Keywords
Acetyl-L-carnitine;, Minimal hepatic encephalopathy;, Quality of life;, Depression.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
67 (false)
8. Arms, Groups, and Interventions
Arm Title
Acetyl-L-Carnitine
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetyl-L-Carnitine
Intervention Description
2 g acetyl-L carnitine twice a day
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo twice per day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
34 Years
Maximum Age & Unit of Time
67 Years
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Cannizzaro Hospital
City
Catania
ZIP/Postal Code
95126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
18357530
Citation
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.
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Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy
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