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Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study

Recruiting

This is a double-blind randomized placebo-controlled clinical trial examining choline supplementation in 2-5 year old children with Fetal Alcohol Spectrum Disorders. Outcome measures are neurocognitive tests of memory, attention, and behavior.

I'm interested

All
2 Years to 5 Years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Ages 2 years to 5 years of age
• Available parent or legal guardian capable of giving informed consent for participation.
• Documented prenatal alcohol exposure (self-report, social service records, or adoption records).
• 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:

• Known history of a neurological condition (ex. epilepsy, traumatic brain injury)
• Known history of a medical condition known to affect brain function.
• Known history of other neurodevelopmental disorder (ex. autism, Down syndrome)
• Known history of very low birthweight (<1500 grams)

Drug: Choline bitartrate, Drug: Placebo

Fetal Alcohol Spectrum Disorders

Mary Anthony - antho248@umn.edu
Jeffrey Wozniak
Phase 2
1506M74642
NCT02735473
See this study on ClinicalTrials.gov

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