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Phase II Developmental Study on Fatigue in AIDS Patients
Patients with AIDS may develop a deficiency of the micronutrient carnitine and such a deficiency may contribute to fatigue in these patients. This study will determine whether carnitine supplementation will improve fatigue and related symptoms in carnitine-deficient patients with AIDS.
Fatigue is a commonly reported symptom in patients with end stage AIDS. Appropriate treatment can relieve suffering and improve quality of life. The role of progression of the disease, depression, anemia, and poor nutritional status in the development of fatigue is well recognized. However, the impact of micronutrient deficiencies has been minimally explored. AIDS patients are at risk for micronutrient deficiencies because of decreased caloric intake, increased metabolic requirements, and treatment with medications that can interfere with absorption, synthesis, and excretion. Patients with AIDS are particularly likely to be carnitine deficient. 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Department of Pain Medicine and Palliative Care; Beth Israel Medical Center; First Avenue at 16th Street
New York, New York, United States
Start Date
November 1, 2002
Primary Completion Date
March 1, 2007
Completion Date
March 1, 2007
Last Updated
September 4, 2008
44
ACTUAL participants
L-carnitine
DRUG
Placebo
OTHER
Lead Sponsor
National Institute of Nursing Research (NINR)
NCT04929028
NCT06694805
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04142047