Skip to main content
OpenTrials
Completed

NCT Number: NCT00692315

Treating Oxidative Stress 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylcobalamin (methylB12)

Drug

75 ug/Kg methylB12 every 3 days by subcutaneous injection

Other names: Vitamin B12

Primary outcomes

  1. Glutathione redox status (GSH/GSSG)

    Time frame: 3 months

    HPLC analysis

Secondary outcomes

  1. Vineland Adaptive Behavior Scales

    Time frame: 3 months

    Behavior measure

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 6, 2008
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.