Status:
COMPLETED
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Fetal Alcohol Spectrum Disorders
Fetal Alcohol Syndrome
Eligibility:
All Genders
2-5 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and ...
Eligibility Criteria
Inclusion
- Available parent or legal guardian capable of participating in informed consent process
- Documented history of heavy prenatal alcohol exposure (self-report, social service records, or adoption records) or presence of facial dysmorphology characteristic of FASD or both
- Evidence of cognitive deficit in at least one neurocognitive domain
Exclusion
- History of neurological condition (ex. epilepsy, cerebral palsy, traumatic brain injury)
- History of medical condition known to affect brain function
- History of other neurodevelopmental disorder (ex. autism, down syndrome)
- History of very low birthweight (\<1500 grams)
- History of prenatal exposure to drugs other than alcohol, nicotine, and caffeine
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01149538
Start Date
July 1 2010
End Date
September 1 2014
Last Update
December 19 2016
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55454