Phase 3 N=57 Randomized Triple-blind Treatment

Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism

Autistic Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01039792 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Clinical Global Impression-Improvement (CGI-I) — 3.1; 2.4 CGI- Improvement

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Methyl B12 (Drug); Placebo (Dietary_supplement)
Age: Pediatric · 3+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Global Impression-Improvement (CGI-I)	3.1; 2.4	—

Summary

The purpose of this study is to determine whether the supplement Methyl B12 is effective in treating some of the symptoms of Autism.

Eligibility Criteria

Inclusion Criteria

Diagnosis of DSM IV defined autism and meets cut off on Autism Diagnostic Inventory-Revised (ADI-R) and/or the Autism Diagnostic Observation Scale (ADOS)
Age 3 through 7 years
IQ of 50 or above
Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 8 week intervention
Willingness to have blood drawn, without the use of a sedative prescription from the study doctor

Exclusion Criteria

Bleeding disorder
Cancer
Seizure disorder
Fragile X or other known genetic cause of autism
Perinatal brain injury (i.e.: cerebral palsy)
Other serious medical illnesses
Current use of any B12 supplement

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01039792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.