Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

• Status: Completed
• Trial end date: 2021-09-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Choline

Criteria

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)