Expired Study
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Little Rock, Arkansas 72202


Purpose:

An open label trial was undertaken in 40 autistic children to determine whether treatment with metabolic precursors methylcobalamin and folinic acid would improve plasma biomarkers of oxidative stress and measures of core behavior using the Vineland Adaptive Behavior Scales (VABS). Metabolites involved in methionine and glutathione synthesis and VABS behavior scores were measured before and after a three month intervention period. The results indicated that pre-treatment metabolites in autistic children were significantly different from values in age-matched control children. The three month intervention resulted in significant increases in cysteine, cysteinylglycine, and glutathione (GSH, p < 0.001). The oxidized disulfide form of glutathione (GSSG) was decreased (p < 0.008) and the glutathione redox ratio (GSH/GSSG) was increased after treatment (p < 0.001). Although significantly improved, these metabolites remained below control levels after intervention (p > 0.01). Similarly, increases in VABS composite score and sub-scores for Socialization, Communication, and Daily Living Skills increased after treatment (p < 0.007) but also remained below standard scores.


Criteria:

Inclusion Criteria: - Clinical diagnosis of Autistic Disorder by DSM-IV 299.0 or CARS score >30 Exclusion Criteria: - Primary genetic disease with co-morbid autism - frequent seizures - recent surgery - active infection with fever - high dose vitamin/mineral supplements - severe gastrointestinal symptoms


NCT ID:

NCT00692315


Primary Contact:

Principal Investigator
S. Jill James, PhD
University of Arkansas


Backup Contact:

N/A


Location Contact:

Little Rock, Arkansas 72202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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