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document
A prospective double-blind , randomized clinical trial of levocarnitine to treat autism spectrum disorders . 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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Intervention_Pharmacological
levocarnitine
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Intervention_Pharmacological
L-carnitine
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Intervention_Pharmacological
standardized regimen ( 50 mg L-carnitine/kg bodyweight/day ) of liquid L-carnitine ( n=19 )
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Intervention_Control
placebo ( n=11 ) for 3-months
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Outcome_Mental
Childhood Autism Rating Scale ( CARS )
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Outcome_Mental
modified clinical global impression ( CGI ) forms
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Outcome_Mental
parent completed Autism Treatment Evaluation Checklist ( ATEC )
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Outcome_Mental
treatment adherence measurement ( TAM )
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Outcome_Adverse-effects
frequency and intensity of side effect rating ( FISER ) /global rating of side effect burden ( GRSEB ) /patient report of incidence of side effects ( PRISE ) forms
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Outcome_Mental
CARS
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Outcome_Mental
CGI
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Outcome_Mental
ATEC scores
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Outcome_Physical
hand muscle strength
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Outcome_Mental
cognitive scores
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Outcome_Mental
CARS scores
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Participant_Condition
autism spectrum disorders .
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Participant_Condition
patients diagnosed with an autism spectrum disorder
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Participant_Condition
Thirty subjects diagnosed with an ASD