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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Arkansas Children's Hospital Research Institute; University of California, Davis
• Treatments: Vitamin B 12

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