Autistic Disorder Clinical Trial
Official title:
Efficacy of Methylcobalamin and Folinic Acid Treatment on Glutathione Redox Status and Core Behavior in Children With Autism
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 7 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Arkansas Children's Hospital Research Institute | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Arkansas Children's Hospital Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glutathione redox status (GSH/GSSG) | HPLC analysis | 3 months | No |
Secondary | Vineland Adaptive Behavior Scales | Behavior measure | 3 months | No |
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