Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

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.

Study Overview

• Status: Completed
• Conditions: Fetal Alcohol Spectrum Disorders
• Intervention / Treatment: Drug: Placebo; Drug: Choline bitartrate

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Jeffrey R Wozniak, Ph.D., University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): September 10, 2021
• Study Completion (Actual): September 10, 2021

Study Registration Dates

• First Submitted: April 2, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 2, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Fetal Diseases; Pregnancy Complications; Alcohol-Induced Disorders; Fetal Alcohol Spectrum Disorders; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: PSYCH-2016-23989; R01AA024123 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No