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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00672360
Eligibility Criteria:
Inclusion Criteria:
1. Child participant has a confirmed diagnosis of AD by Autism Diagnostic Observation Schedule and Autism Diagnostic Interview--Revised criteria
2. Child participant is in stable condition with relatively good control of seizures and no other significant medical problems, including liver, kidney, or heart problems, at the time of entrance to the study. If the child participant is taking medication for a seizure disorder, the investigators will assess his/her eligibility with particular regard to type of seizure medication and other health-related information gleaned during the medical examination
3. Child participant and parents are willing to comply with the proposed treatments
4. Child participant is able to take oral medication
5. Family is fluent in the English language
6. Parent/caregiver agrees to provide behavioral data on participating children at the requested time points
7. Family agrees to be contacted weekly by study personnel during the treatment phases
Exclusion Criteria:
1. Child participant has co-morbid medical and/or genetic disorders, including celiac disease
2. Child participant has a history of liver or renal disease
3. Child participant is currently being treated for a serious acute illness
4. Child participant has a known allergy to any of the proposed supplements
5. Child participant has uncontrolled seizures
6. Child participant meets criteria for Asperger's syndrome, PDD-NOS, or does not meet strict criteria for AD
7. Family is not proficient in the English language
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00672360
Study Brief:
Protocol Section:
NCT00672360