Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT00273650
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
8 Years
Study:
NCT00273650
Study Brief:
Protocol Section:
NCT00273650