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

ORAL ACETYL-L-CARNITINE THERAPY REDUCES FATIGUE IN HEPATIC ENCEPHALOPATHY

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Encephalopathy
• Intervention / Treatment: Dietary supplement: ACETYL-L-CARNITINE; Drug: placebo

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95126
    • Cannizzaro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: placebo; placebo twice per day
EXPERIMENTAL: ACETYL-L-CARNITINE	Dietary supplement: ACETYL-L-CARNITINE; 2 g acetylcarnitine taken orally twice a day.

Collaborators and Investigators

• Sponsor: University of Catania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Study Completion: December 1, 2006

Study Registration Dates

• First Submitted: October 18, 2010
• First Submitted That Met QC Criteria: October 18, 2010
• First Posted (ESTIMATE): October 19, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 19, 2010
• Last Update Submitted That Met QC Criteria: October 18, 2010
• Last Verified: December 1, 2000

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Hepatic Encephalopathy; Brain Diseases; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Nootropic Agents; Acetylcarnitine
• Other Study ID Numbers: 8-12-00 B