Efficacy Study of Subcutaneous Methyl-B12 in Children With Autism

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

We will be testing a specific dietary supplement, methylcobalamin (vitamin B12). Follow-up assessments with our clinical team will take place over the 12-week study period so that we can record any changes in development. The main goal of this study is to determine if subcutaneous injections of vitamin B12 given every three days can positively affect behavior and development in children with autism.

Hypothesis: Methylcobalamin injections will improve measures of executive function, speech, and socialization in children with autism, and will be associated with metabolic improvement.

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

Details

• Lead Sponsor: University of California, Davis; University of California, San Francisco
• Treatments: Vitamin B 12; Vitamins

Criteria

Inclusion Criteria:

• Diagnosis of DSM IV defined autism and meets cut off on Autism Diagnostic Inventory-Revised (ADI-R) and the Autism Diagnostic Observation Scale (ADOS).

• Age 3 to 8 years

• IQ of 50 or above

• Willingness of parents to administer subcutaneous methyl B12.

• Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 12 week intervention or wait list.

Exclusion Criteria:

• Clinical evidence of seizure disorder

• Cancer

• Recent surgery

• Active infection with fever

• Fragile X or other known genetic cause of autism

• Bleeding disorder

• Perinatal brain injury (e.g. cerebral palsy)

• Current use of any methyl B12 product

• Evidence for malnutrition seen in abnormal albumin level