An interventional study of Methylcobalamin (methylB12) in Autistic Disorder, sponsored by Arkansas Children's Hospital Research Institute. Completed at 1 site in United States. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2016-04-15.
Sponsored by Arkansas Children's Hospital Research Institute · Not applicable, Interventional, and Treatment
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Arkansas Children's Hospital Research Institute is the lead sponsor of 118 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subcutaneous injection of 75 micrograms/Kg
Drug: Methylcobalamin (methylB12)
400 micrograms orally twice a day
Drug: Methylcobalamin (methylB12)
75 ug/Kg methylB12 every 3 days by subcutaneous injection
Also known as: Vitamin B12
Glutathione redox status (GSH/GSSG)
HPLC analysis
Time frame: 3 months
Vineland Adaptive Behavior Scales
Behavior measure
Time frame: 3 months
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Arkansas Children's Hospital Research Institute