Fetal Alcohol Spectrum Disorders
Conditions
Brief summary
This is a randomized, double-blind controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline. The primary outcome measures are cognitive measures.
Detailed description
This project is the fourth in a series of randomized, double-blind controlled trials of choline bitartrate in children ages 2-5 (under 6) years with prenatal alcohol exposure. Pre-clinical data suggests that choline may attenuate the cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). This study will evaluate the effects of daily choline supplementation in two dosing regimens (3 months choline vs. 6 months choline). Outcome measures include an elicited imitation memory paradigm, IQ measures, and measures of memory and executive functioning, and behavior.
Interventions
Powdered drink mix for daily consumption
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Jeff Wozniak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Months to 72 Months
Healthy volunteers
No
Inclusion criteria
* Ages 2.5 years to 5 years old (\<6 years of age) at enrollment * Prenatal alcohol exposure * Available parent or legal guardian capable of giving informed consent for participation.
Exclusion criteria
* History of a neurological condition (ex. epilepsy, traumatic brain injury) * History of a medical condition known to affect brain function * Other neurodevelopmental disorder (ex. autism, Down syndrome) * History of very low birthweight (\<1500 grams)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm) | Change from baseline to 9 months | Elicited Imitation short-delay memory measure (percent correct for recall) |
| Stanford-Binet Intelligence Test (SB-5) | Change from baseline to 9 months | Stanford Binet Intelligence Test - 5th Edition |
| Minnesota Executive Function Scale (MEFS) | Change from baseline to 9 months | Minnesota Executive Function Scale - Early Childhood Version |
| NIH Toolbox Flanker Test | Change from baseline to 9 months | NIH Toolbox Flanker Inhibitory and Control Test |
| NIH Toolbox Picture Sequence Memory Test | Change from baseline to 9 months | NIH Toolbox Picture Sequence Memory Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Behavior Checklist (CBCL) | Change from baseline to 9 months | Child Behavior Checklist - Parent Report Version |
Countries
United States
Outcome results
None listed