Hepatic EncephalopathyNCT01223742
Oral Acetyl-L-Carnitine Therapy Reduces Fatigue In Hepatic Encephalopathy
A study testing ACETYL-L-CARNITINE in people with Hepatic Encephalopathy, run by University of Catania at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- ACETYL-L-CARNITINE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Jun 2002to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ORAL ACETYL-L-CARNITINE THERAPY REDUCES FATIGUE IN HEPATIC ENCEPHALOPATHY
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
- Being tested
- ACETYL-L-CARNITINE, placebo
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACETYL-L-CARNITINEDietary supplement
2 g acetylcarnitine taken orally twice a day.
placeboDrug
placebo twice per day
| Study group | Role | What they receive |
|---|---|---|
| ACETYL-L-CARNITINE | Experimental | Not described Receives: Dietary Supplement: ACETYL-L-CARNITINE |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startJun 2002
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223742
- Sponsor's protocol ID
- 8-12-00 B
- Status last verified
- Dec 2000
- First submitted
- 18 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21310833
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORAL ACETYL-L-CARNITINE THERAPY REDUCES FATIGUE IN HEPATIC ENCEPHALOPATHY
- ClinicalTrials.gov ID
- NCT01223742
- Acronym / sponsor ID
- 8-12-00 B
- Conditions
- Hepatic Encephalopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- Jun 2002
- Study completion
- Dec 2006
- First posted
- 19 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACETYL-L-CARNITINE | Experimental | Dietary Supplement: ACETYL-L-CARNITINE |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACETYL-L-CARNITINE2 g acetylcarnitine taken orally twice a day. | Dietary supplement | ACETYL-L-CARNITINE |
| placeboplacebo twice per day | Drug | placebo |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
- Derived from this study: PubMed 21310833Malaguarnera 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.
Related trials for Hepatic Encephalopathy
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
Not yet recruitingPhase 4
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
Liver Cirrhosis, Sleep Disturbance
Not yet recruiting
Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
Liver Cirrhosis, Hepatic Encephalopathy (HE)
Recruiting
4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis
Cirrhosis, Portal Hypertension
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACETYL-L-CARNITINE in people with Hepatic Encephalopathy, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01223742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2010.