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A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders.
Med Sci Monit. 2011 Jun; 17(6):PI15-23.MS

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.

Authors+Show Affiliations

The Institute of Chronic Illnesses, Inc., Silver Spring, MD, USA. mgeier@comcast.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21629200

Citation

Geier, David A., et al. "A Prospective Double-blind, Randomized Clinical Trial of Levocarnitine to Treat Autism Spectrum Disorders." Medical Science Monitor : International Medical Journal of Experimental and Clinical Research, vol. 17, no. 6, 2011, pp. PI15-23.
Geier DA, Kern JK, Davis G, et al. A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders. Med Sci Monit. 2011;17(6):PI15-23.
Geier, D. A., Kern, J. K., Davis, G., King, P. G., Adams, J. B., Young, J. L., & Geier, M. R. (2011). A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders. Medical Science Monitor : International Medical Journal of Experimental and Clinical Research, 17(6), PI15-23.
Geier DA, et al. A Prospective Double-blind, Randomized Clinical Trial of Levocarnitine to Treat Autism Spectrum Disorders. Med Sci Monit. 2011;17(6):PI15-23. PubMed PMID: 21629200.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders. AU - Geier,David A, AU - Kern,Janet K, AU - Davis,Georgia, AU - King,Paul G, AU - Adams,James B, AU - Young,John L, AU - Geier,Mark R, PY - 2011/6/2/entrez PY - 2011/6/2/pubmed PY - 2011/9/23/medline SP - PI15 EP - 23 JF - Medical science monitor : international medical journal of experimental and clinical research JO - Med Sci Monit VL - 17 IS - 6 N2 - 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. SN - 1643-3750 UR - https://www.unboundmedicine.com/medline/citation/21629200/A_prospective_double_blind_randomized_clinical_trial_of_levocarnitine_to_treat_autism_spectrum_disorders_ L2 - https://www.medscimonit.com/download/index/idArt/881792 DB - PRIME DP - Unbound Medicine ER -