Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

This project is the third in a series of randomized, double-blind placebo-controlled trials
of choline bitartrate in children ages 2-5 who have been diagnosed with Fetal Alcohol
Spectrum Disorders (FASD). Pre-clinical data suggests that choline may attenuate the
cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). This
study will evaluate the effects of daily choline supplementation vs. placebo for 9 months.
Outcome measures include an elicited imitation memory paradigm, global cognitive functioning,
and aspects of executive functioning. The study will also continue to collect safety and
tolerability data.

Inclusion Criteria:

1. Ages 2 years to 5 years of age

2. Available parent or legal guardian capable of giving informed consent for
participation.

3. Documented prenatal alcohol exposure (self-report, social service records, or adoption
records).

4. Modified Institute of Medicine (IOM) criteria for Fetal Alcohol Syndrome (FAS),
Partial Fetal Alcohol Syndrome (PFAS), or Alcohol-Related Neurodevelopmental Disorder
(ARND) (Hoyme, May, et al., 2005).

Exclusion Criteria:

1. Known history of a neurological condition (ex. epilepsy, traumatic brain injury)

2. Known history of a medical condition known to affect brain function.

3. Known history of other neurodevelopmental disorder (ex. autism, Down syndrome)

4. Known history of very low birthweight (<1500 grams)