Treating Oxidative Stress in Children With Autism
Primary Purpose
Autistic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methylcobalamin (methylB12)
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Disorder focused on measuring glutathione, methionine, folinic acid, redox, oxidative stress, behavior
Eligibility 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
Sites / Locations
- Arkansas Children's Hospital Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Methyl B12
Folinic Acid
Arm Description
Subcutaneous injection of 75 micrograms/Kg
400 micrograms orally twice a day
Outcomes
Primary Outcome Measures
Glutathione redox status (GSH/GSSG)
HPLC analysis
Secondary Outcome Measures
Vineland Adaptive Behavior Scales
Behavior measure
Full Information
NCT ID
NCT00692315
First Posted
June 4, 2008
Last Updated
April 13, 2016
Sponsor
Arkansas Children's Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00692315
Brief Title
Treating Oxidative Stress in Children With Autism
Official Title
Efficacy of Methylcobalamin and Folinic Acid Treatment on Glutathione Redox Status and Core Behavior in Children With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Arkansas Children's Hospital Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
glutathione, methionine, folinic acid, redox, oxidative stress, behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methyl B12
Arm Type
Experimental
Arm Description
Subcutaneous injection of 75 micrograms/Kg
Arm Title
Folinic Acid
Arm Type
Experimental
Arm Description
400 micrograms orally twice a day
Intervention Type
Drug
Intervention Name(s)
Methylcobalamin (methylB12)
Other Intervention Name(s)
Vitamin B12
Intervention Description
75 ug/Kg methylB12 every 3 days by subcutaneous injection
Primary Outcome Measure Information:
Title
Glutathione redox status (GSH/GSSG)
Description
HPLC analysis
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Vineland Adaptive Behavior Scales
Description
Behavior measure
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Jill James, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19056591
Citation
James SJ, Melnyk S, Fuchs G, Reid T, Jernigan S, Pavliv O, Hubanks A, Gaylor DW. Efficacy of methylcobalamin and folinic acid treatment on glutathione redox status in children with autism. Am J Clin Nutr. 2009 Jan;89(1):425-30. doi: 10.3945/ajcn.2008.26615. Epub 2008 Dec 3.
Results Reference
derived
Learn more about this trial
Treating Oxidative Stress in Children With Autism
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