Treating Oxidative Stress in Children With Autism
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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 |
Dietary Supplement: Methylcobalamin (methylB12) Dietary Supplement: Folinic acid |
| 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 |
- Glutathione redox status (GSH/GSSG) [ Designated as safety issue: No ]
- Vineland Adaptive Behavior Scales [ Designated as safety issue: No ]
| 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) |
-
Dietary Supplement: Methylcobalamin (methylB12)
Eligibility| Ages Eligible for Study: | 3 Years to 7 Years |
| Genders Eligible for Study: | Both |
| 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| United States, Arkansas | |
| Arkansas Children's Hospital Research Institute | |
| Little Rock, Arkansas, United States, 72202 | |
| Principal Investigator: | S. Jill James, PhD | University of Arkansas |
More Information
No publications provided by Arkansas Children's Hospital Research Institute
Additional 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: | June 5, 2008 |
| 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 Diagnosed in Childhood Mental Disorders Vitamin B 12 Leucovorin Folic Acid Levoleucovorin Vitamin B Complex Vitamins |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013