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

This study has been completed.
Sponsor:
Information provided by:
University of Catania
ClinicalTrials.gov Identifier:
NCT01223742
First received: October 18, 2010
Last updated: NA
Last verified: December 2000
History: No changes posted
  Purpose

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 Intervention
Hepatic Encephalopathy
Dietary Supplement: ACETYL-L-CARNITINE
Drug: placebo

Study Type: Interventional
Official Title: ORAL ACETYL-L-CARNITINE THERAPY REDUCES FATIGUE IN HEPATIC ENCEPHALOPATHY

Resource links provided by NLM:


Further study details as provided by University of Catania:

Study Start Date: June 2002
Estimated Study Completion Date: December 2006
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223742

Locations
Italy
Cannizzaro Hospital
Catania, Italy, 95126
Sponsors and Collaborators
University of Catania
  More Information

No publications provided by University of Catania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01223742     History of Changes
Other Study ID Numbers: 8-12-00 B
Study First Received: October 18, 2010
Last Updated: October 18, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Carnitine
Acetylcarnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014