Treating Oxidative Stress in Children With Autism

This study has been completed.
Sponsor:
Information provided by:
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00692315
First received: June 4, 2008
Last updated: April 13, 2016
Last verified: April 2016
  Purpose

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 Intervention
Autistic Disorder
Drug: Methylcobalamin (methylB12)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • Glutathione redox status (GSH/GSSG) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    HPLC analysis


Secondary Outcome Measures:
  • Vineland Adaptive Behavior Scales [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Behavior measure


Enrollment: 40
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: June 4, 2008
Last Updated: April 13, 2016
Health Authority: United States: Food and Drug Administration

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
Mental Disorders
Neurodevelopmental Disorders
Folic Acid
Levoleucovorin
Vitamin B 12
Antidotes
Growth Substances
Hematinics
Micronutrients
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on May 26, 2016