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A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders.

Geier DA, Kern JK, Davis G, King PG, Adams JB, Young JL, Geier MR - Med. Sci. Monit. (2011)

Bottom Line: Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047).Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given.L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended.

View Article: PubMed Central - PubMed

Affiliation: The Institute of Chronic Illnesses, Inc., Silver Spring, MD, USA. mgeier@comcast.net

ABSTRACT

Background: L-carnitine was proposed as a potential treatment for patients diagnosed with an autism spectrum disorder to improve mitochondrial dysfunction, but no prior randomized controlled trials have been conducted.

Material/methods: Thirty subjects diagnosed with an ASD were randomly assigned to receive a standardized regimen (50 mg L-carnitine/kg bodyweight/day) of liquid L-carnitine (n=19) or placebo (n=11) for 3-months. Measures included changes in professionally completed Childhood Autism Rating Scale (CARS), hand muscle testing, and modified clinical global impression (CGI) forms; parent completed Autism Treatment Evaluation Checklist (ATEC), treatment adherence measurement (TAM), frequency and intensity of side effect rating (FISER)/global rating of side effect burden (GRSEB)/patient report of incidence of side effects (PRISE) forms; and lab testing.

Results: Significant improvements were observed in CARS (-2.03, 95% CI=-3.7 to -0.31), CGI (-0.69, 95% CI=-1.1 to -0.06), and ATEC scores. Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047). Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given.

Conclusions: L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended.

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Related in: MedlinePlus

The chemical structure of Levocarnitine. Empirical Formula: C7H15NO3; Molecular Weight: 161.20.
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f1-medscimonit-17-6-pi15: The chemical structure of Levocarnitine. Empirical Formula: C7H15NO3; Molecular Weight: 161.20.

Mentions: As a result of the aforementioned observations in patients diagnosed with an ASD, one suggested approach to treating patients diagnosed with an ASD entails the administration of mitochondrial respiratory chain co-factors to enhance mitochondrial function. Such a strategy would employ stimulation of enzyme activity by supplying precursors or co-enzyme and alternative substrates. Levocarnitine (L-carnitine) was among the suggested options for treatment [3,8]. L-carnitine is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane. The chemical name of L-carnitine is 3-carboxy-2(R)-hydroxy-N,N,N-trimethyl-1-propanaminium, inner salt. L-carnitine is a white crystalline, hygroscopic powder. It is readily soluble in water, hot alcohol, and insoluble in acetone. Its chemical structure is shown in Figure 1. L-carnitine is a naturally occurring substance required in mammalian energy metabolism. The highest concentrations of carnitine are found in red meat and dairy products. In skeletal and cardiac muscle, where fatty acids are the main substrate for energy production, it has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production.


A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders.

Geier DA, Kern JK, Davis G, King PG, Adams JB, Young JL, Geier MR - Med. Sci. Monit. (2011)

The chemical structure of Levocarnitine. Empirical Formula: C7H15NO3; Molecular Weight: 161.20.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3539542&req=5

f1-medscimonit-17-6-pi15: The chemical structure of Levocarnitine. Empirical Formula: C7H15NO3; Molecular Weight: 161.20.
Mentions: As a result of the aforementioned observations in patients diagnosed with an ASD, one suggested approach to treating patients diagnosed with an ASD entails the administration of mitochondrial respiratory chain co-factors to enhance mitochondrial function. Such a strategy would employ stimulation of enzyme activity by supplying precursors or co-enzyme and alternative substrates. Levocarnitine (L-carnitine) was among the suggested options for treatment [3,8]. L-carnitine is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane. The chemical name of L-carnitine is 3-carboxy-2(R)-hydroxy-N,N,N-trimethyl-1-propanaminium, inner salt. L-carnitine is a white crystalline, hygroscopic powder. It is readily soluble in water, hot alcohol, and insoluble in acetone. Its chemical structure is shown in Figure 1. L-carnitine is a naturally occurring substance required in mammalian energy metabolism. The highest concentrations of carnitine are found in red meat and dairy products. In skeletal and cardiac muscle, where fatty acids are the main substrate for energy production, it has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production.

Bottom Line: Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047).Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given.L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended.

View Article: PubMed Central - PubMed

Affiliation: The Institute of Chronic Illnesses, Inc., Silver Spring, MD, USA. mgeier@comcast.net

ABSTRACT

Background: L-carnitine was proposed as a potential treatment for patients diagnosed with an autism spectrum disorder to improve mitochondrial dysfunction, but no prior randomized controlled trials have been conducted.

Material/methods: Thirty subjects diagnosed with an ASD were randomly assigned to receive a standardized regimen (50 mg L-carnitine/kg bodyweight/day) of liquid L-carnitine (n=19) or placebo (n=11) for 3-months. Measures included changes in professionally completed Childhood Autism Rating Scale (CARS), hand muscle testing, and modified clinical global impression (CGI) forms; parent completed Autism Treatment Evaluation Checklist (ATEC), treatment adherence measurement (TAM), frequency and intensity of side effect rating (FISER)/global rating of side effect burden (GRSEB)/patient report of incidence of side effects (PRISE) forms; and lab testing.

Results: Significant improvements were observed in CARS (-2.03, 95% CI=-3.7 to -0.31), CGI (-0.69, 95% CI=-1.1 to -0.06), and ATEC scores. Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047). Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given.

Conclusions: L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended.

Show MeSH
Related in: MedlinePlus