Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol Related Neurodevelopmental Disorder, Prenatal Alcohol Exposure

In brief

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 cognitive functioning.

Key facts

Study ID

NCT01149538

Run by

University of Minnesota

People needed

60

Starts

2010-07-01

Expected to finish

2014-09-01

Last updated by the study team

2016-12-19

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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