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

NCT01223742 | Completed DMC

• 1 other identifier: 8-12-00 B
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy

Study Arms (2)

ACETYL-L-CARNITINE

EXPERIMENTAL

Dietary Supplement: ACETYL-L-CARNITINE

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

ACETYL-L-CARNITINE DIETARY_SUPPLEMENT

2 g acetylcarnitine taken orally twice a day.

ACETYL-L-CARNITINE

placebo DRUG

placebo twice per day

placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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;
• \) Hyperammonemia (venous ammonia concentration \>50 mmol/L);
• \) 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.

You may not qualify if:

• \) Major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis;
• \) Acute superimposed liver injury;
• \) Patient with other neurological disease and metabolic disorders, diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease;
• \) Alcoholic -toxic cirrhosis because toxic brain damage may interfere with the assessment of HE;
• \) Severe HE;
• \) Administration of anti-HE medications such as neomycin, branched-chain amino acids;
• \) 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;
• \) Patients with fever, sepsis or shock were also excluded to avoid variations caused by body temperature;
• \) Illiteracy.

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

Cannizzaro Hospital

Catania, 95126, Italy

Location

Related Publications (1)

• 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.

  PMID: 21310833 DERIVED

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Acetylcarnitine

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 19, 2010
• Study Start: June 1, 2002
• Study Completion: December 1, 2006
• Last Updated: October 19, 2010

Record last verified: 2000-12

Locations

IT (1)