Treating Oxidative Stress in Children With Autism

NCT00692315 | Completed DMC

• 1 other identifier: 28839
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autistic Disorder

Keywords

glutathione; methionine; folinic acid; redox; oxidative stress; behavior

Outcome Measures

Primary Outcomes (1)

• Glutathione redox status (GSH/GSSG)

  HPLC analysis

  3 months

Secondary Outcomes (1)

• Vineland Adaptive Behavior Scales

  3 months

Study Arms (2)

Methyl B12

EXPERIMENTAL

Subcutaneous injection of 75 micrograms/Kg

Drug: Methylcobalamin (methylB12)

Folinic Acid

EXPERIMENTAL

400 micrograms orally twice a day

Drug: Methylcobalamin (methylB12)

Interventions

Methylcobalamin (methylB12) DRUG

75 ug/Kg methylB12 every 3 days by subcutaneous injection

Also known as: Vitamin B12

Folinic Acid; Methyl B12

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of Autistic Disorder by DSM-IV 299.0 or CARS score \>30

You may not qualify if:

• Primary genetic disease with co-morbid autism
• frequent seizures
• recent surgery
• active infection with fever
• high dose vitamin/mineral supplements
• severe gastrointestinal symptoms

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

Related Publications (1)

• 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.

  PMID: 19056591 DERIVED

MeSH Terms

Conditions

Autistic Disorder; Behavior

Interventions

mecobalamin; Vitamin B 12

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• S. Jill James, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: September 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

US (1)