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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT01039792
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
7 Years
Study:
NCT01039792
Study Brief:
Protocol Section:
NCT01039792