Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures.

Detailed Description
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This project is the third in a series of randomized, double-blind placebo-controlled trials of choline bitartrate in children ages 2-5 who have been diagnosed with Fetal Alcohol Spectrum Disorders (FASD). 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 vs. placebo for 9 months. Outcome measures include an elicited imitation memory paradigm, global cognitive functioning, and aspects of executive functioning. The study will also continue to collect safety and tolerability data.

Official Title
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Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

Conditions
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Fetal Alcohol Spectrum Disorders

Intervention / Treatment
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* Drug: Choline bitartrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 2 years to 5 years of age Available parent or legal guardian capable of giving informed consent for participation. Documented prenatal alcohol exposure (self-report, social service records, or adoption records). Modified Institute of Medicine (IOM) criteria for Fetal Alcohol Syndrome (FAS), Partial Fetal Alcohol Syndrome (PFAS), or Alcohol-Related Neurodevelopmental Disorder (ARND) (Hoyme, May, et al., 2005). Exclusion Criteria: Known history of a neurological condition (ex. epilepsy, traumatic brain injury) Known history of a medical condition known to affect brain function. Known history of other neurodevelopmental disorder (ex. autism, Down syndrome) Known history of very low birthweight (<1500 grams)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Choline bitartrate<br>Powdered drink mix containing choline bitartrate 19 mg. per kg. | Drug: Choline bitartrate<br> <br> |
| Placebo Comparator: Placebo<br>Powdered drink mix containing matching placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months | Elicited Imitation memory paradigm - short delay memory measure at 6 months; scores are in percentage correct. | Change from baseline to 6 months in percentage correct | 
| Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months | Elicited Imitation memory paradigm - short delay memory measure at 9 months | Change from baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stanford-Binet Intelligence Scales: 9 Months | Stanford-Binet Intelligence Scales at 9 months; scores are standardized scores (mean 100 points, standard deviation of 15 points) | Change from baseline to 9 months in IQ points | 
| Minnesota Executive Function Scale: 6 Months | Minnesota Executive Function Scale - Early Childhood Version at 6 months | Change from baseline to 6 months | 
| Minnesota Executive Function Scale: 9 Months | Minnesota Executive Function Scale - Early Childhood Version at 9 months; scores are in t-scores (mean=50, standard deviation=10) | Change from baseline to 9 months in t-score points | 
| NIH Toolbox Flanker Task: 9 Months | NIH Toolbox Flanker Inhibitory and Control Task at 9 months; scores are fully-corrected t-scores (mean=40, standard deviation=10) | Change from baseline to 9 months in fully-corrected t-score points | 
| NIH Toolbox Flanker Task: 6 Months | NIH Toolbox Flanker Inhibitory and Control Task at 6 months | Change from baseline to 6 months | 
| Child Behavior Checklist: 6 Months | Child Behavior Checklist - parent report instrument at 6 months | Change from baseline to 6 months | 
| Child Behavior Checklist: 9 Months | Child Behavior Checklist - parent report instrument at 9 months; scores are t-scores (mean=50, standard deviation=10) | Change from baseline to 9 months in t-score points |