Treating Oxidative Stress in Children With Autism

• Sponsor: Arkansas Children's Hospital Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00692315
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autistic Disorder	Drug: Methylcobalamin (methylB12)	N/A

Study Design

• Study Type: Interventional
• 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: Sep 1, 2006
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

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 Names: 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 Names: Vitamin B12

Outcome Measures

Primary Outcome Measures

1. Glutathione redox status (GSH/GSSG) [3 months]

   HPLC analysis

Secondary Outcome Measures

1. Vineland Adaptive Behavior Scales [3 months]

   Behavior measure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 7 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00692315
• Other Study ID Numbers: 28839
• First Posted: Jun 6, 2008
• Last Update Posted: Apr 15, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by , ,: glutathione; methionine; folinic acid; redox; oxidative stress; behavior
• Additional relevant MeSH terms: Autistic Disorder; Vitamin B 12

Study Results

No Results Posted as of Apr 15, 2016