Status:
COMPLETED
Efficacy Study of Subcutaneous Methyl-B12 in Children With Autism
Lead Sponsor:
University of California, San Francisco
Conditions:
Autistic Disorder
Eligibility:
All Genders
3-8 years
Phase:
PHASE2
PHASE3
Brief 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 ch...
Detailed Description
Autism is a complex neurodevelopmental disorder that is thought to involve an interaction between multiple and variable susceptibility genes (Keller \& Persico, 2003), epigenetic effects (Beaudet, 200...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00273650
Start Date
July 1 2005
End Date
August 1 2009
Last Update
October 9 2019
Active Locations (1)
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1
UC Davis MIND Institute
Sacramento, California, United States, 95817