Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

University of Minnesota (UMN)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Prenatal Alcohol Exposure

Alcohol Related Neurodevelopmental Disorder

Fetal Alcohol Spectrum Disorders

Partial Fetal Alcohol Syndrome

Fetal Alcohol Syndrome

Treatments

Dietary Supplement: Placebo for choline bitartrate

Drug: Choline bitartrate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01149538

0910M73517

R21AA019580 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

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