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Treating Oxidative Stress in Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00692315
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : April 15, 2016
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: Methylcobalamin (methylB12) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Methylcobalamin and Folinic Acid Treatment on Glutathione Redox Status and Core Behavior in Children With Autism
Study Start Date : September 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Methyl B12
Subcutaneous injection of 75 micrograms/Kg
Drug: Methylcobalamin (methylB12)
75 ug/Kg methylB12 every 3 days by subcutaneous injection
Other Name: Vitamin B12

Experimental: Folinic Acid
400 micrograms orally twice a day
Drug: Methylcobalamin (methylB12)
75 ug/Kg methylB12 every 3 days by subcutaneous injection
Other Name: Vitamin B12

Primary Outcome Measures :
  1. Glutathione redox status (GSH/GSSG) [ Time Frame: 3 months ]
    HPLC analysis

Secondary Outcome Measures :
  1. Vineland Adaptive Behavior Scales [ Time Frame: 3 months ]
    Behavior measure

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00692315

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United States, Arkansas
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
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Principal Investigator: S. Jill James, PhD University of Arkansas
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: S. Jill James, Arkansas Children's Hospital Research Institute Identifier: NCT00692315    
Other Study ID Numbers: 28839
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Keywords provided by Arkansas Children's Hospital Research Institute:
folinic acid
oxidative stress
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Vitamin B 12
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex