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Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

Primary Purpose

Fetal Alcohol Spectrum Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Choline bitartrate
Placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Choline bitartrate

Placebo

Arm Description

Powdered drink mix containing choline bitartrate 19 mg. per kg.

Powdered drink mix containing matching placebo

Outcomes

Primary Outcome Measures

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.
Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months
Elicited Imitation memory paradigm - short delay memory measure at 9 months

Secondary Outcome Measures

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)
Minnesota Executive Function Scale: 6 Months
Minnesota Executive Function Scale - Early Childhood Version at 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)
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)
NIH Toolbox Flanker Task: 6 Months
NIH Toolbox Flanker Inhibitory and Control Task at 6 months
Child Behavior Checklist: 6 Months
Child Behavior Checklist - parent report instrument at 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)

Full Information

First Posted
April 2, 2016
Last Updated
October 2, 2022
Sponsor
University of Minnesota
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02735473
Brief Title
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Official Title
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Choline bitartrate
Arm Type
Experimental
Arm Description
Powdered drink mix containing choline bitartrate 19 mg. per kg.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Powdered drink mix containing matching placebo
Intervention Type
Drug
Intervention Name(s)
Choline bitartrate
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months
Description
Elicited Imitation memory paradigm - short delay memory measure at 6 months; scores are in percentage correct.
Time Frame
Change from baseline to 6 months in percentage correct
Title
Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months
Description
Elicited Imitation memory paradigm - short delay memory measure at 9 months
Time Frame
Change from baseline to 9 months
Secondary Outcome Measure Information:
Title
Stanford-Binet Intelligence Scales: 9 Months
Description
Stanford-Binet Intelligence Scales at 9 months; scores are standardized scores (mean 100 points, standard deviation of 15 points)
Time Frame
Change from baseline to 9 months in IQ points
Title
Minnesota Executive Function Scale: 6 Months
Description
Minnesota Executive Function Scale - Early Childhood Version at 6 months
Time Frame
Change from baseline to 6 months
Title
Minnesota Executive Function Scale: 9 Months
Description
Minnesota Executive Function Scale - Early Childhood Version at 9 months; scores are in t-scores (mean=50, standard deviation=10)
Time Frame
Change from baseline to 9 months in t-score points
Title
NIH Toolbox Flanker Task: 9 Months
Description
NIH Toolbox Flanker Inhibitory and Control Task at 9 months; scores are fully-corrected t-scores (mean=40, standard deviation=10)
Time Frame
Change from baseline to 9 months in fully-corrected t-score points
Title
NIH Toolbox Flanker Task: 6 Months
Description
NIH Toolbox Flanker Inhibitory and Control Task at 6 months
Time Frame
Change from baseline to 6 months
Title
Child Behavior Checklist: 6 Months
Description
Child Behavior Checklist - parent report instrument at 6 months
Time Frame
Change from baseline to 6 months
Title
Child Behavior Checklist: 9 Months
Description
Child Behavior Checklist - parent report instrument at 9 months; scores are t-scores (mean=50, standard deviation=10)
Time Frame
Change from baseline to 9 months in t-score points

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey R Wozniak, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

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