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Treating Oxidative Stress in Children With Autism

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ClinicalTrials.gov Identifier: NCT00692315
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : April 15, 2016
Sponsor:
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

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

MedlinePlus related topics: Folic Acid
U.S. FDA Resources

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



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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00692315


Locations
United States, Arkansas
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: S. Jill James, PhD University of Arkansas

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: S. Jill James, Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00692315     History of Changes
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:
glutathione
methionine
folinic acid
redox
oxidative stress
behavior

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Leucovorin
Levoleucovorin
Folic Acid
Vitamin B 12
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Hematinics