Treating Oxidative Stress in Children With Autism

Study Overview
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Brief Summary
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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.

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

Conditions
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Autistic Disorder

Intervention / Treatment
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* Drug: Methylcobalamin (methylB12)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methyl B12<br>Subcutaneous injection of 75 micrograms/Kg | Drug: Methylcobalamin (methylB12)<br>* 75 ug/Kg methylB12 every 3 days by subcutaneous injection<br>* Other names: Vitamin B12;|
| Experimental: Folinic Acid<br>400 micrograms orally twice a day | Drug: Methylcobalamin (methylB12)<br>* 75 ug/Kg methylB12 every 3 days by subcutaneous injection<br>* Other names: Vitamin B12;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glutathione redox status (GSH/GSSG) | HPLC analysis | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vineland Adaptive Behavior Scales | Behavior measure | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glutathione, methionine, folinic acid, redox, oxidative stress, behavior