Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

Study Overview
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Brief Summary
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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.

Official Title
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Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

Conditions
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Partial Fetal Alcohol Syndrome, Alcohol Related Neurodevelopmental Disorder, Prenatal Alcohol Exposure, Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome

Intervention / Treatment
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* Drug: Choline bitartrate
* Dietary Supplement: Placebo for choline bitartrate


Participation Criteria
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Eligibility Criteria
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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

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>Choline Bitartrate supplementation | Drug: Choline bitartrate<br>* Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.<br>|
| Placebo Comparator: Placebo<br>Placebo for choline bitartrate supplementation | Dietary Supplement: Placebo for choline bitartrate<br>* Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effects of Choline Bitartrate | Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact. | Baseline, 6 months, & 9 months | 
| Mullen Scales of Early Learning - Early Learning Composite | 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. | Baseline and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elicited Imitation Task Memory | The Elicited Imitation (EI) paradigm (P.J. Bauer, 1989, Dev. Psychology) was used to measure memory in the participants at baseline, 6 months, and 9 months. The measures were items recalled after a delay (delayed items) and pairs of items recalled after a delay (delayed pairs). The sample was split by age in the analysis (young vs. old) as reflected in the outcome data. Outcome data measures included here are the slopes of the regression lines reflecting change over the three timepoints, controlling for immediate memory performance on the EI task.The slopes are given, as opposed to the raw scores, because these were the values used in the growth curve analyses. Details of these analyses are included in Wozniak et al. (2015) AJCN, doi:10.3945/ajcn.114.099168. NOTE that the means presented below represent the simple slopes that estimate the change in task performance (% of items correct) per 6-month unit of time. To estimate change in task performance over 9 months, multiply by 1.5. | Baseline, 6 months, and 9 months | 
| Evoked Response Potentials Microvolts | Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included. | Baseline, 6 months, and 9 months | 
| Evoked Response Potential - Negative Component Latency | Evoked Response Potential - negative component latency data are included. | Baseline, 6 months, and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FASD, FAS, Alcohol, Prenatal Alcohol