Oral Acetyl-L-Carnitine Therapy Reduces Fatigue In Hepatic Encephalopathy
NCT ID: NCT01223742
Last Updated: 2010-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
2002-06-30
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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ACETYL-L-CARNITINE
ACETYL-L-CARNITINE
2 g acetylcarnitine taken orally twice a day.
placebo
placebo
placebo twice per day
Interventions
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ACETYL-L-CARNITINE
2 g acetylcarnitine taken orally twice a day.
placebo
placebo twice per day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
65 Years
ALL
No
Sponsors
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University of Catania
OTHER
Locations
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Cannizzaro Hospital
Catania, , Italy
Countries
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References
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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.
Other Identifiers
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8-12-00 B
Identifier Type: -
Identifier Source: org_study_id