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NCT00692315 · ClinicalTrials.gov registry record · NA
Treating Oxidative Stress in Children With Autism
A NA study, sponsored by Arkansas Children's Hospital Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT00692315 is a NA study that has completed, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 40 participants.
The verdict
NCT00692315, a NA study, has completed, sponsored by Arkansas Children's Hospital Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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.
Interventions
- DRUG Methylcobalamin (methylB12)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2006-09 |
| Est. Completion | 2007-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00692315
The ClinicalTrials.gov registry entry for NCT00692315 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arkansas Children's Hospital Research Institute, which has 97 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Methylcobalamin (methylB12) is the first listed.
NCT00692315 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00692315 about?
NCT00692315 is a clinical study titled "Treating Oxidative Stress in Children With Autism". 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 invol...
What is the current status of trial NCT00692315?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2006-09. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00692315?
The interventions under investigation include: Methylcobalamin (methylB12) (DRUG).
Who is sponsoring clinical trial NCT00692315?
This trial is sponsored by Arkansas Children's Hospital Research Institute, which has 97 total clinical trials registered on ClinicalTrials.gov.
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