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
PHASE2
44 participants
INTERVENTIONAL
2002-11-30
2007-03-31
Brief Summary
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Detailed Description
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Levocarnitine (L-carnitine) is a micronutrient found in meat and dairy products that plays a major role in energy metabolism. Preliminary research has shown that patients with end stage AIDS experienced decreased levels of fatigue after L-carnitine supplementation. This study will evaluate the effectiveness of L-carnitine to treat patients with carnitine deficiency, fatigue, and AIDS.
Participants in this study will be randomly assigned to receive either L-carnitine or placebo for 2 weeks. To reduce the possibility of side effects, the doses of L-carnitine and placebo will be titrated over 6 days to the desired study dose. After 2 weeks, participants receiving placebo will be switched over to receive L-carnitine. All participants will continue on L-carnitine for an additional 2 weeks.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
L-carnitine
A study drug, L-carnitine, titrating the doses from 0.5 g to 3 g to reduce the possibility of side effects, lasting for two weeeks followed by an extension phase where all patients recieved L-carnitine for an additional two weeks.
2
Placebo
A placebo, where patients underwent the dose titration identical to the study patients, lasting for two weeeks followed by an extension phase where all patients recieved L-carnitine for an additional two weeks.
Interventions
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L-carnitine
A study drug, L-carnitine, titrating the doses from 0.5 g to 3 g to reduce the possibility of side effects, lasting for two weeeks followed by an extension phase where all patients recieved L-carnitine for an additional two weeks.
Placebo
A placebo, where patients underwent the dose titration identical to the study patients, lasting for two weeeks followed by an extension phase where all patients recieved L-carnitine for an additional two weeks.
Eligibility Criteria
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Inclusion Criteria
* Karnofsky Performance Score \> 50
* Clinically significant, persistent fatigue
* If undergoing pre-existing treatment for fatigue, must have been on a stable regimen for at least 4 weeks prior to study entry
* Concurrent use of epoetin alfa (PROCRIT®) will be allowed if the patient has been on a stable dose of epoetin alfa for at least 60 days prior to study entry
Exclusion Criteria
* Hemodialysis
* Treatment or replacement therapy with any form of carnitine within 12 months prior to study entry
* Known sensitivity to carnitine
* Acute illness within 30 days of study entry that in the opinion of the study investigator would interfere with participation
* Active drug or alcohol use or dependence
* History of any central nervous system disease involving the brain that may put the patient at risk for seizure (e.g., primary or metastatic brain tumor, stroke) or history of seizure
* History of dementia, aphasia, or other deficits of cognition or speech/language function
18 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Responsible Party
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Beth Israel Medical Center
Principal Investigators
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Ricardo Cruciani, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Medical Center
Locations
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Department of Pain Medicine and Palliative Care; Beth Israel Medical Center; First Avenue at 16th Street
New York, New York, United States
Countries
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Other Identifiers
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