Clinical Trial: L-Carnitine to Treat Fatigue in AIDS Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Developmental Study on Fatigue in AIDS Patients

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: National Institute of Nursing Research (NINR)

Current Primary Outcome: 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) ]

Original Primary Outcome:

Current Secondary Outcome:

  • 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) ]
  • 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) ]


Original Secondary Outcome:

Information By: National Institute of Nursing Research (NINR)

Dates:
Date Received: March 9, 2004
Date Started: November 2002
Date Completion:
Last Updated: September 2, 2008
Last Verified: September 2008