L-carnitine supplementation in patients with HIV/AIDS and fatigue: a
double-blind, placebo-controlled pilot study.
Author(s): Cruciani RA(1), Revuelta M(2), Dvorkin E(3), Homel P(4), Lesage P(5),
Esteban-Cruciani N(6).
Affiliation(s): Author information:
(1)Center for Comprehensive Pain Management and Palliative Care, Capital
Institute for Neurosciences, Capital Health Medical Center, Pennington, NJ, USA.
(2)Lee Memorial Hospital, Fort Myers, FL, USA. (3)Institutional Review Board, New
York University, New York, NY, USA. (4)Department of Pain Medicine and Palliative
Care, Beth Israel Medical Center, New York, NY, USA. (5)Maimonides Medical
Center, Brooklyn, NY, USA. (6)Children's Hospital at Montefiore, Albert Einstein
College of Medicine, Bronx, NY, USA.
Publication date & source: 2015, HIV AIDS (Auckl). , 7:65-73
BACKGROUND: The purpose of this study was to determine the effect of L-carnitine
supplementation on fatigue in patients with terminal human immunodeficiency
virus/acquired immune deficiency syndrome (HIV/AIDS).
METHODS: In this randomized, double-blind, placebo-controlled, parallel-group
study, patients who had end-stage HIV/AIDS with carnitine deficiency and fatigue
received 3 g of oral L-carnitine or placebo for 2 weeks, followed by a 2-week,
open-label phase with the same amount of L-carnitine for all patients. The
primary outcome was the degree of fatigue according to the Brief Fatigue
Inventory. Secondary outcomes included serum carnitine and lactate levels,
physical, emotional, social, and functional well-being, performance status, mood,
and CD4 count.
RESULTS: Eighteen patients in the treatment arm and 17 in the placebo arm
completed the trial. At the end of the double-blind phase, total and free
carnitine levels in the treatment arm rose from 28±9 to 48±17 nM/L (P<0.001) and
from 24±8 to 40±13 nM/L (P<0.001) respectively, with no changes in the placebo
arm. The primary outcome, ie, fatigue measured at the end of the blinded phase,
did not improve. Secondary outcomes of function, quality of life, and mood did
not show improvement either. The secondary outcome of serum lactate decreased
from baseline in the treatment group (1.45±0.76 to 1.28±0.52 mmol/L) and
increased in the placebo group (1.38±0.62 to 1.84±0.74 mmol/L; P<0.005).
CONCLUSION: Our study suggests that 3 g of oral L-carnitine supplementation for 2
weeks in terminally ill HIV/AIDS patients does not improve fatigue. This study
might help to determine the dose and duration of treatment used in future
clinical trials, as higher doses and/or longer periods of supplementation might
be needed in order to detect an improvement. The reduction in serum lactate
levels suggests a potential role for L-carnitine supplementation in patients
undergoing certain types of antiretroviral therapy. This study contributes
evidence-based data to the field of alternative and complementary medicine, a
multibillion dollar industry in which controlled studies are not the norm.
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