Treating Oxidative Stress in Children With Autism

Not Applicable

Completed

• Conditions: Autistic Disorder
• Interventions: Drug: Methylcobalamin (methylB12)

• Registration Number: NCT00692315
• Lead Sponsor: Arkansas Children's Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-06
• Study Completion: 2007-12
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Folinic Acid	Methylcobalamin (methylB12)	400 micrograms orally twice a day
Methyl B12	Methylcobalamin (methylB12)	Subcutaneous injection of 75 micrograms/Kg

Primary Outcome Measures

Name	Time	Method
Glutathione redox status (GSH/GSSG)	3 months	HPLC analysis

Secondary Outcome Measures

Name	Time	Method
Vineland Adaptive Behavior Scales	3 months	Behavior measure

Trial Locations

Locations (1)

Arkansas Children's Hospital Research Institute; 🇺🇸 Little Rock, Arkansas, United States