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Treating Oxidative Stress in Children With Autism

Efficacy of Methylcobalamin and Folinic Acid Treatment on Glutathione Redox Status and Core Behavior in Children With Autism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00692315
Enrollment
40
Registered
2008-06-06
Start date
2006-09-30
Completion date
2007-12-31
Last updated
2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autistic Disorder

Keywords

glutathione, methionine, folinic acid, redox, oxidative stress, behavior

Brief summary

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.

Interventions

75 ug/Kg methylB12 every 3 days by subcutaneous injection

Sponsors

Arkansas Children's Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Glutathione redox status (GSH/GSSG)3 monthsHPLC analysis

Secondary

MeasureTime frameDescription
Vineland Adaptive Behavior Scales3 monthsBehavior measure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026