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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Powdered drink mix for daily consumption
University of Minnesota
Minneapolis, Minnesota, United States
Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)
Elicited Imitation short-delay memory measure (percent correct for recall)
Time frame: Change from baseline to 9 months
Stanford-Binet Intelligence Test (SB-5)
Stanford Binet Intelligence Test - 5th Edition
Time frame: Change from baseline to 9 months
Minnesota Executive Function Scale (MEFS)
Minnesota Executive Function Scale - Early Childhood Version
Time frame: Change from baseline to 9 months
NIH Toolbox Flanker Test
NIH Toolbox Flanker Inhibitory and Control Test
Time frame: Change from baseline to 9 months
NIH Toolbox Picture Sequence Memory Test
NIH Toolbox Picture Sequence Memory Test
Time frame: Change from baseline to 9 months
Child Behavior Checklist (CBCL)
Child Behavior Checklist - Parent Report Version
Time frame: Change from baseline to 9 months
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