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| Sponsored by: |
National Institute of Nursing Research (NINR) |
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00079599 |
Purpose
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.
| Condition | Intervention | Phase |
|
HIV Infections AIDS |
Drug: L-carnitine |
Phase II |
| MedlinePlus related topics: | AIDS |
| ChemIDplus related topics: | Carnitine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Phase II Developmental Study on Fatigue in AIDS Patients |
| Estimated Enrollment: | 44 |
| Study Start Date: | November 2002 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |||||
| Department of Pain Medicine and Palliative Care; Beth Israel Medical Center; First Avenue at 16th Street | Recruiting | ||||
| New York, New York, United States, 10003 | |||||
| Contact: Ricardo Cruciani, MD; PhD 212-420-4748 rcrucian@bethisraelny.org | |||||
| Principal Investigator: | Ricardo Cruciani, MD, PhD | Beth Israel Medical Center |
More Information
| Study ID Numbers: | 1 R21 NR08295-01 |
| First Received: | March 9, 2004 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00079599 |
| Health Authority: | United States: Federal Government |
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