Treating Oxidative Stress in Children With Autism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-12-31

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.

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Detailed Description

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Conditions

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Autistic Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methyl B12

Subcutaneous injection of 75 micrograms/Kg

Group Type EXPERIMENTAL

Methylcobalamin (methylB12)

Intervention Type DRUG

75 ug/Kg methylB12 every 3 days by subcutaneous injection

Folinic Acid

400 micrograms orally twice a day

Group Type EXPERIMENTAL

Methylcobalamin (methylB12)

Intervention Type DRUG

75 ug/Kg methylB12 every 3 days by subcutaneous injection

Interventions

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Methylcobalamin (methylB12)

75 ug/Kg methylB12 every 3 days by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Vitamin B12

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No