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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Autistic Disorder

In brief

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

Key facts

Study ID

NCT01039792

Run by

University of California, San Francisco

People needed

57

Starts

2010-01-01

Expected to finish

2013-11-01

Last updated by the study team

2017-02-24

Who can join

Age: 3 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF — San Francisco, California, United States

Full record on ClinicalTrials.gov

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