Status:
COMPLETED
Folate Rechallenge
Lead Sponsor:
Baylor College of Medicine
Conditions:
Autism
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
New evidence suggests that autistic disorder (AD) may be associated with abnormalities in folate metabolism, which is a process that affects genetic expression by facilitating the formation of methyl ...
Detailed Description
There are limited data on the use of folic acid as a treatment for children with autistic disorder (AD). Most experimentation thus far has focused on the effects of folic acid supplementation in small...
Eligibility Criteria
Inclusion
- Child participant has a confirmed diagnosis of AD by Autism Diagnostic Observation Schedule and Autism Diagnostic Interview--Revised criteria
- 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
- Child participant and parents are willing to comply with the proposed treatments
- Child participant is able to take oral medication
- Family is fluent in the English language
- Parent/caregiver agrees to provide behavioral data on participating children at the requested time points
- Family agrees to be contacted weekly by study personnel during the treatment phases
Exclusion
- Child participant has co-morbid medical and/or genetic disorders, including celiac disease
- Child participant has a history of liver or renal disease
- Child participant is currently being treated for a serious acute illness
- Child participant has a known allergy to any of the proposed supplements
- Child participant has uncontrolled seizures
- Child participant meets criteria for Asperger's syndrome, PDD-NOS, or does not meet strict criteria for AD
- Family is not proficient in the English language
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00672360
Start Date
May 1 2007
End Date
February 1 2015
Last Update
October 19 2020
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030