Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079599
Status:
COMPLETED
Last Update Posted:
2008-09-04
First Post:
2004-03-09
Brief Title:
L-Carnitine to Treat Fatigue in AIDS Patients
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institute of Nursing Research NINR
Study Overview
Official Title:
Phase II Developmental Study on Fatigue in AIDS Patients
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None