Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Overview
- Phase
- Phase 2
- Intervention
- Choline bitartrate
- Conditions
- Fetal Alcohol Spectrum Disorders
- Sponsor
- University of Minnesota
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
Choline bitartrate
Powdered drink mix containing choline bitartrate 19 mg. per kg.
Intervention: Choline bitartrate
Placebo
Powdered drink mix containing matching placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months
Time Frame: Change from baseline to 6 months in percentage correct
Elicited Imitation memory paradigm - short delay memory measure at 6 months; scores are in percentage correct.
Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months
Time Frame: Change from baseline to 9 months
Elicited Imitation memory paradigm - short delay memory measure at 9 months
Secondary Outcomes
- Minnesota Executive Function Scale: 6 Months(Change from baseline to 6 months)
- Stanford-Binet Intelligence Scales: 9 Months(Change from baseline to 9 months in IQ points)
- Minnesota Executive Function Scale: 9 Months(Change from baseline to 9 months in t-score points)
- NIH Toolbox Flanker Task: 9 Months(Change from baseline to 9 months in fully-corrected t-score points)
- NIH Toolbox Flanker Task: 6 Months(Change from baseline to 6 months)
- Child Behavior Checklist: 6 Months(Change from baseline to 6 months)
- Child Behavior Checklist: 9 Months(Change from baseline to 9 months in t-score points)