Oral Acetyl-L-Carnitine Therapy Reduces Fatigue In Hepatic Encephalopathy
Primary Purpose
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 trial for Hepatic Encephalopathy
Eligibility Criteria
Inclusion Criteria:
- 1) Chronic hepatitis with spontaneous manifest HE (mental state grade 1 or 2 according to the West Haven criteria) and an NCT-A performance time >30 seconds;
- 2) Hyperammonemia (venous ammonia concentration >50 mmol/L);
- 3) Cooperative, hospitalised, adult patients with liver cirrhosis diagnosed by clinical, histological and ultrasonographic findings (reduced dimensions of the liver as well as splenomegaly) and oesophageal varices at stage II and III observed by endoscopy.
Exclusion Criteria:
- 1) Major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis;
- 2) Acute superimposed liver injury;
- 3) Patient with other neurological disease and metabolic disorders, diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease;
- 4) Alcoholic -toxic cirrhosis because toxic brain damage may interfere with the assessment of HE;
- 5) Severe HE;
- 6) Administration of anti-HE medications such as neomycin, branched-chain amino acids;
- 7) Any additional precipitating factors such as high protein intake (additional high-protein meals), constipation or intake of psycho stimulants, sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil), beta-adrenergic blockers, neuromuscular blocking agents, certain antibiotics;
- 8) Patients with fever, sepsis or shock were also excluded to avoid variations caused by body temperature;
- 9) Illiteracy.
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
NCT01223742
First Posted
October 18, 2010
Last Updated
October 18, 2010
Sponsor
University of Catania
1. Study Identification
Unique Protocol Identification Number
NCT01223742
Brief Title
Oral Acetyl-L-Carnitine Therapy Reduces Fatigue In Hepatic Encephalopathy
Official Title
ORAL ACETYL-L-CARNITINE THERAPY REDUCES FATIGUE IN HEPATIC ENCEPHALOPATHY
Study Type
Interventional
2. Study Status
Record Verification Date
December 2000
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Catania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to evaluate the effect of exogenous ALC on the both physical and mental fatigue in mild and moderate encephalopatic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
ACETYL-L-CARNITINE
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
ACETYL-L-CARNITINE
Intervention Description
2 g acetylcarnitine taken orally twice a day.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo twice per day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
1) Chronic hepatitis with spontaneous manifest HE (mental state grade 1 or 2 according to the West Haven criteria) and an NCT-A performance time >30 seconds;
2) Hyperammonemia (venous ammonia concentration >50 mmol/L);
3) Cooperative, hospitalised, adult patients with liver cirrhosis diagnosed by clinical, histological and ultrasonographic findings (reduced dimensions of the liver as well as splenomegaly) and oesophageal varices at stage II and III observed by endoscopy.
Exclusion Criteria:
1) Major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis;
2) Acute superimposed liver injury;
3) Patient with other neurological disease and metabolic disorders, diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease;
4) Alcoholic -toxic cirrhosis because toxic brain damage may interfere with the assessment of HE;
5) Severe HE;
6) Administration of anti-HE medications such as neomycin, branched-chain amino acids;
7) Any additional precipitating factors such as high protein intake (additional high-protein meals), constipation or intake of psycho stimulants, sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil), beta-adrenergic blockers, neuromuscular blocking agents, certain antibiotics;
8) Patients with fever, sepsis or shock were also excluded to avoid variations caused by body temperature;
9) Illiteracy.
Facility Information:
Facility Name
Cannizzaro Hospital
City
Catania
ZIP/Postal Code
95126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21310833
Citation
Malaguarnera M, Vacante M, Giordano M, Pennisi G, Bella R, Rampello L, Malaguarnera M, Li Volti G, Galvano F. Oral acetyl-L-carnitine therapy reduces fatigue in overt hepatic encephalopathy: a randomized, double-blind, placebo-controlled study. Am J Clin Nutr. 2011 Apr;93(4):799-808. doi: 10.3945/ajcn.110.007393. Epub 2011 Feb 10.
Results Reference
derived
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Oral Acetyl-L-Carnitine Therapy Reduces Fatigue In Hepatic Encephalopathy
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