NCT01223729

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
Last Updated

October 19, 2010

Status Verified

December 1, 2000

First QC Date

October 18, 2010

Last Update Submit

October 18, 2010

Conditions

Minimal Hepatic Encephalopathy

Keywords

Acetyl-L-carnitine;Minimal hepatic encephalopathy;Quality of life;Depression.

Study Arms (2)

Acetyl-L-Carnitine

EXPERIMENTAL
Drug: Acetyl-L-Carnitine

placebo

PLACEBO COMPARATOR
Other: placebo

Interventions

Acetyl-L-CarnitineDRUG

2 g acetyl-L carnitine twice a day

Acetyl-L-Carnitine
placeboOTHER

placebo twice per day

placebo

Eligibility Criteria

Age34 Years - 67 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cannizzaro Hospital

Catania, 95126, Italy

Location

Related Publications (1)

  • 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.

    PMID: 18357530BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Acetylcarnitine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CarnitineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 19, 2010

Study Start

April 1, 2002

Study Completion

November 1, 2005

Last Updated

October 19, 2010

Record last verified: 2000-12

Locations

IT(1)