Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study

Study Overview
=================
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.

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

Conditions
-----------------
Fetal Alcohol Spectrum Disorders

Intervention / Treatment
-----------------
* Drug: Choline Bitartrate


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 30 Months
Maximum Age: 72 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 months choline bitartrate<br>Over the 9-month study, participants will receive a total of 3 months of choline bitartrate (19 mg/kg) and a total of 6 months of placebo | Drug: Choline Bitartrate<br>* Powdered drink mix for daily consumption<br>* Other names: choline bitartrate formulated in drink mix specifically for this study;|
| Experimental: 6 months choline bitartrate<br>Over the 9-month study, participants will receive a total of 6 months of choline bitartrate (19 mg/kg) and a total of 3 months of placebo | Drug: Choline Bitartrate<br>* Powdered drink mix for daily consumption<br>* Other names: choline bitartrate formulated in drink mix specifically for this study;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm) | Elicited Imitation short-delay memory measure (percent correct for recall) | Change from baseline to 9 months | 
| Stanford-Binet Intelligence Test (SB-5) | Stanford Binet Intelligence Test - 5th Edition | Change from baseline to 9 months | 
| Minnesota Executive Function Scale (MEFS) | Minnesota Executive Function Scale - Early Childhood Version | Change from baseline to 9 months | 
| NIH Toolbox Flanker Test | NIH Toolbox Flanker Inhibitory and Control Test | Change from baseline to 9 months | 
| NIH Toolbox Picture Sequence Memory Test | NIH Toolbox Picture Sequence Memory Test | Change from baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Behavior Checklist (CBCL) | Child Behavior Checklist - Parent Report Version | Change from baseline to 9 months |