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Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy

NCT ID: NCT01223729

Last Updated: 2010-10-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2005-11-30

Brief Summary

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Minimal hepatic encephalopathy represents a common complication present in well-compensated cirrhotic patients that impairs patients daily functioning and health-related quality of life. Acetyl-L-carnitine has been shown to be useful in improving blood ammonia and cognitive functions in cirrhotic patients with minimal hepatic encephalopathy. This study evaluated the effects of acetyl-L-carnitine treatment on health related quality of life and on depression in patients with minimal hepatic encephalopathy.

Detailed Description

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Conditions

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Minimal Hepatic Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Acetyl-L-Carnitine

Group Type EXPERIMENTAL

Acetyl-L-Carnitine

Intervention Type DRUG

2 g acetyl-L carnitine twice a day

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo twice per day

Interventions

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Acetyl-L-Carnitine

2 g acetyl-L carnitine twice a day

Intervention Type DRUG

placebo

placebo twice per day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients diagnosed as having cirrhosis at the outpatient Internal Medicine of the Department of Senescence of Cannizzaro Hospital (Catania) were candidates for enrolment. The diagnosis of cirrhosis was based on clinical, biochemical and ultrasonographic or liver histological data.
Minimum Eligible Age

34 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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University of Catania

Locations

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Cannizzaro Hospital

Catania, , Italy

Site Status

Countries

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Italy

References

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Malaguarnera M, Gargante MP, Cristaldi E, Vacante M, Risino C, Cammalleri L, Pennisi G, Rampello L. Acetyl-L-carnitine treatment in minimal hepatic encephalopathy. Dig Dis Sci. 2008 Nov;53(11):3018-25. doi: 10.1007/s10620-008-0238-6. Epub 2008 Mar 21.

Reference Type BACKGROUND
PMID: 18357530 (View on PubMed)

Other Identifiers

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8-12-00 A

Identifier Type: -

Identifier Source: org_study_id