Oral Acetyl-L-Carnitine Therapy Reduces Fatigue In Hepatic Encephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01223742
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : October 19, 2010
Information provided by:
University of Catania

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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Dietary Supplement: ACETYL-L-CARNITINE Drug: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Study Start Date : June 2002
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ACETYL-L-CARNITINE Dietary Supplement: ACETYL-L-CARNITINE
2 g acetylcarnitine taken orally twice a day.
Placebo Comparator: placebo Drug: placebo
placebo twice per day

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01223742

Cannizzaro Hospital
Catania, Italy, 95126
Sponsors and Collaborators
University of Catania

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01223742     History of Changes
Other Study ID Numbers: 8-12-00 B
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: October 19, 2010
Last Verified: December 2000

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Nootropic Agents