Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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 cognitive functioning.

• Phase: Phase 1/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; Ethanol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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