Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
Overview
- Phase
- Phase 1
- Intervention
- Choline bitartrate
- Conditions
- Fetal Alcohol Spectrum Disorders
- Sponsor
- University of Minnesota
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Side Effects of Choline Bitartrate
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
Choline Bitartrate
Choline Bitartrate supplementation
Intervention: Choline bitartrate
Placebo
Placebo for choline bitartrate supplementation
Intervention: Placebo for choline bitartrate
Outcomes
Primary Outcomes
Side Effects of Choline Bitartrate
Time Frame: Baseline, 6 months, & 9 months
Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.
Mullen Scales of Early Learning - Early Learning Composite
Time Frame: Baseline and 9 months
The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details.
Secondary Outcomes
- Elicited Imitation Task Memory(Baseline, 6 months, and 9 months)
- Evoked Response Potentials Microvolts(Baseline, 6 months, and 9 months)
- Evoked Response Potential - Negative Component Latency(Baseline, 6 months, and 9 months)