Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

Phase 2

Completed

• Conditions: Fetal Alcohol Spectrum Disorders
• Interventions: Drug: Choline bitartrate; Drug: Placebo

• Registration Number: NCT02735473
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2016-04-02
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Study Start: 2016-06
• Primary Completion: 2021-09-10
• Study Completion: 2021-09-10
• Results First Submitted: 2022-09-01
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-02
• Last Update Submitted: 2022-10-02
• Results First Posted: 2022-11-01
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Ages 2 years to 5 years of age
2. Available parent or legal guardian capable of giving informed consent for participation.
3. Documented prenatal alcohol exposure (self-report, social service records, or adoption records).
4. 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).

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Exclusion Criteria

1. Known history of a neurological condition (ex. epilepsy, traumatic brain injury)
2. Known history of a medical condition known to affect brain function.
3. Known history of other neurodevelopmental disorder (ex. autism, Down syndrome)
4. Known history of very low birthweight (<1500 grams)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Choline bitartrate	Choline bitartrate	Powdered drink mix containing choline bitartrate 19 mg. per kg.
Placebo	Placebo	Powdered drink mix containing matching placebo

Primary Outcome Measures

Name	Time	Method
Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months	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	Change from baseline to 9 months	Elicited Imitation memory paradigm - short delay memory measure at 9 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States