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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

Trial profile of L-carnitine.
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f2-medscimonit-17-6-pi15: Trial profile of L-carnitine.

Mentions: This was a randomized, double-blind, placebo-controlled study. The study was conducted between 2008 and 2010. The study subjects were recruited through community contacts. The study protocol called for 20 subjects to receive L-carnitine and 10 study subjects to receive placebo. Figure 2 summarizes the overall design of the present study. A total of 34 subjects were recruited for the present study. Four subjects withdrew prior to randomization into L-carnitine or placebo groups. A total of 30 subjects were randomly assigned to receive L-carnitine or placebo, and of these a total of 7 subjects (4 in the L-carnitine group and 3 in the placebo group) withdrew prior to successful completion of 3-months of therapy. Among the 7 subjects withdrawing from the study prior to successful completion of 3-months of therapy, 4 subjects withdrew because of adverse reactions (1 in the L-carnitine group and 3 in the placebo group), 2 subjects did not comply with the study protocol, and 1 was lost to follow-up with no known adverse reaction. Further, among the 4 subjects that withdrew because of adverse reactions, these patients were assessed using CARS and CGI scoring at the time of their withdrawal from the study.


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)

Trial profile of L-carnitine.
© Copyright Policy
Related In: Results  -  Collection

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

f2-medscimonit-17-6-pi15: Trial profile of L-carnitine.
Mentions: This was a randomized, double-blind, placebo-controlled study. The study was conducted between 2008 and 2010. The study subjects were recruited through community contacts. The study protocol called for 20 subjects to receive L-carnitine and 10 study subjects to receive placebo. Figure 2 summarizes the overall design of the present study. A total of 34 subjects were recruited for the present study. Four subjects withdrew prior to randomization into L-carnitine or placebo groups. A total of 30 subjects were randomly assigned to receive L-carnitine or placebo, and of these a total of 7 subjects (4 in the L-carnitine group and 3 in the placebo group) withdrew prior to successful completion of 3-months of therapy. Among the 7 subjects withdrawing from the study prior to successful completion of 3-months of therapy, 4 subjects withdrew because of adverse reactions (1 in the L-carnitine group and 3 in the placebo group), 2 subjects did not comply with the study protocol, and 1 was lost to follow-up with no known adverse reaction. Further, among the 4 subjects that withdrew because of adverse reactions, these patients were assessed using CARS and CGI scoring at the time of their withdrawal from the study.

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