L-Carnitine to Treat 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase II Developmental Study on Fatigue in AIDS Patients|
- Level of fatigue, measured by the fatigue sub-scale of the FAHI [ Time Frame: Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination) ] [ Designated as safety issue: No ]
- Changes in fatigue in the treatment and control groups [ Time Frame: Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination) ] [ Designated as safety issue: No ]
- Changes in cognative status, mood, activity, and HGB levels mesured by BFI, LASA, KPS, and MSAS-SF [ Time Frame: Baseline; 2 weeks since starting L-carnitine or Placebo supplementation; 4 weeks (study termination) ] [ Designated as safety issue: No ]
|Study Start Date:||November 2002|
|Study Completion Date:||March 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
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 Comparator: 2||
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.
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.
|United States, New York|
|Department of Pain Medicine and Palliative Care; Beth Israel Medical Center; First Avenue at 16th Street|
|New York, New York, United States, 10003|
|Principal Investigator:||Ricardo Cruciani, MD, PhD||Beth Israel Medical Center|