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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: Completed NA study, sponsored by Arkansas Children's Hospital Research Institute.
NCT00692315 is a NA study that has completed, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
HPLC analysis
Interventions
- DRUG Methylcobalamin (methylB12)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2006-09 |
| Est. Completion | 2007-12 |
| Phase | NA |
What the finished NCT00692315 record still lists
NCT00692315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Methylcobalamin (methylB12) is the first listed.
NCT00692315 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00692315's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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