L-carnitine supplementation in patients with HIV/AIDS and fatigue: a double-blind, placebo-controlled pilot study

Figures & data

Table 1 Demographic and laboratory characteristics in the placebo and L-carnitine supplementation arms

Characteristics	Placebo (n=17)	L-carnitine (n=18)	P-value*
Age, years	45.5±5.4	48.9±8.8	0.21
Female	3 (18%)	1 (6%)	0.26
Race
Black	2 (12%)	3 (17%)	0.31
Hispanic	5 (29%)	9 (50%)
White	10 (59%)	6 (33%)
KPS score	75.0±6.3	71.9±6.6	0.17
Lactate (mmol/L)	1.3±0.6	1.5±0.8	0.41
Hemoglobin (mmol/L)	14.6±1.4	13.5±1.8	0.05
BUN (mmol/L)	13.6±3.4	16.3±5.0	0.07
Creatinine (mmol/L)	0.9±0.2	1.0±0.2	0.15
CD4	370 (62,871)d	299 (95,1000)d	0.32

Notes: The data are shown as the mean ± standard deviation

* P-value comparing the placebo and L-carnitine supplementation arms at baseline.

d =range.

Abbreviations: BUN, blood urea nitrogen; KPS, Karnofsky Performance Status.

Figure 1 Patient disposition. Patients were screen for inclusion and exclusion criteria and randomized into two arms, ie, sham and L-carnitine supplementation. Patients were stratified by hemoglobin level.

Abbreviation: ITT, intent-to-treat.

Table 2 Comparison of carnitine levels, lactate levels, and primary and secondary outcomes between baseline and the end of the placebo-controlled phase: results of mixed model regression based on intent-to-treat

Outcome	Placebo		L-Carnitine		P-value*
	Baseline	Randomized	Baseline	Randomized
Total carnitine	28.4±5.0	29.4±6.1	28.2±9.1	47.9±17.1	<0.001
Free carnitine	24.4±4	24.2±5.0	24.3±7.6	40.58±13.7	<0.001
Acyl-carnitine ratio	0.16±5	0.21±6	0.16±8	0.18±15	0.44
Lactate	1.38±0.62	1.84±0.74	1.45±0.76	1.28±0.52	<0.005
Worst fatigue	6.6±2.4	5.9±2.7	7.1±2.0	7.2±1.7	0.22
Fatigue now	6.1±1.5	4.8±2.2	6.3±1.6	5.6±1.6	0.31
Usual fatigue	5.8±2.0	5.1±1.8	6.3±1.7	6.3±1.9	0.35
Total BFI	6.3±1.6	5.0±2.4	6.9±1.7	6.1±1.5	0.33
LASA energy	37.1±15.7	50.5±22.0	32.6±16.1	47.0±20.1	0.97
LASA daily	42.6±14.9	50.7±19.4	40.4±22.1	54.6±20.1	0.69
LASA QoL	46.6±15.5	54.9±20.2	43.0±23.6	54.1±20.9	0.84
MSAS Phys	1.3±0.5	1.2±0.7	1.8±0.7	1.3±0.5	0.08
MSAS Psych	1.8±1.0	1.9±1.0	2.3±0.6	1.8±0.7	0.05
MSAS GDI	2.0±0.7	1.7±0.9	2.2±0.5	1.7±0.6	0.47
CES-D	23.2±12.1	21.1±13.01	24.8±9.8	16.4±6.9	0.16
FACT total	68.7±11.4	62.6±11.4	66.8±9.7	64.8±10.2	0.06
FACT PWB	14.7±5.6	11.0±6.8	16.5±6.1	12.3±5.4	0.46
FACT EWB	12.6±6.4	10.4±7.2	13.2±7.2	10.6±7.3	0.78
FACT FWB	16.3±6.5	15.4±6.6	13.9±4.4	15.4±2.5	0.10
FACT SWB	18.1±7.6	19.4±7.7	17.7±7.6	20.1±6.6	0.64
FACT CF	7.2±2.2	6.3±2.6	6.0±3.1	6.5±2.6	0.07
MMSE	29.6±1.1	29.7±0.8	29.0±1.3	29.6±0.8	0.25

Notes: The data are shown as the mean ± standard deviation

* P-value comparing the placebo and L-carnitine supplementation arms at baseline and at the end of the closed-label phase.

Abbreviations: BFI, Brief Fatigue inventory; LASA, Linear Analog Scale-Anemia; MSAS, Memorial Symptom Assessment Scale; GDI, Global Distress Index; Psych, psychological distress; Phys, physical distress; CES-D, Clinical Evaluation Scale of Depression; FACT, Functional Assessment Cancer Therapy; CF, cognitive functioning; PWB, physical well-being; SWB, social well-being; EWB, emotional well-being; FWB, functional well-being; MMSE, Mini Mental Status Examination; QoL, quality of life.

Table 3 Comparison of carnitine levels and primary and secondary outcomes between the end of the placebo phase and the end of the open-label phase

Outcome	Placebo first	L-carnitine first	P-value*
Total L-carnitine	43.1±11.3	47.9±16.0	0.32
Free L-carnitine	36.0±.9.7	40.2±14.0	0.31
Total BFI	3.5±2.4	3.5±2.2	0.15
Fatigue now	3.2±2.2	3.5±2.1	0.50
Worst fatigue	4.1±2.4	4.1±2.4	0.19
Usual fatigue	3.7±2.6	3.0±1.8	0.05
LASA energy	63.6±22.9	61.1±14.5	0.87
LASA daily	66.0±21.1	66.4±16.4	0.61
LASA QoL	64.1±21.1	70.3±19.3	0.24
MSAS Phys	1.1± 0.6	1.3±0.8	0.39
MSAS Psych	1.7±1.0	1.8±0.8	0.54
MSAS GDI	1.5±0.9	1.6±0.7	0.74
CES-D	18.2±13.0	16.3±11.8	0.43
FACT total	63.6±9.2	61.8±7.2	0.23
FACT PWB	8.7±6.9	9.4±5.9	0.45
FACT EWB	10.0±7.4	9.1±6.4	0.51
FACT FWB	16.9±5.8	16.8±4.2	0.91
FACT SWB	20.3±6.8	19.4±6.9	0.94
FACT CF	7.7±2.4	7.2.±3.0	0.23
MMSE	29.7±0.6	29.4±1.0	0.27

Notes: Data are shown as the mean ± standard deviation

* P-value comparing the end of closed-label phase with the end of the open-label phase.

Abbreviations: BFI, Brief Fatigue inventory; LASA, Linear Analog Scale-Anemia; MSAS, Memorial Symptom Assessment Scale; GDI, Global Distress Index; Psych, psychological distress; Phys, physical distress; CES-D, Clinical Evaluation Scale of Depression; FACT, Functional Assessment Cancer Therapy; CF, cognitive functioning; PWB, physical well-being; SWB, social well-being; EWB, emotional well-being; FWB, functional well-being; MMSE, Mini Mental Status Examination; QoL, quality of life.

Table 4 Comparison of side effects between placebo and L-carnitine supplementation arm by the end of the placebo-controlled phase (P>0.05)

Adverse events	Placebo (n=17)	L-carnitine (n=18)
Cold symptoms	1 (6%)	2 (11%)
Diarrhea	2 (12%)	2 (11%)
Dizziness	2 (12%)	0 (0%)
Headache	3 (18%)	1 (6%)
Hoarseness	1 (6%)	1 (6%)
Nervousness	2 (12%)	0 (0%)
Sore throat	1 (6%)	1 (6%)
Stomach discomfort	1 (6%)	2 (11%)
Other adverse events*	10	12

Note:

* Sum of all events, not independent count.