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Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02735473
Recruitment Status : Completed
First Posted : April 12, 2016
Results First Posted : November 1, 2022
Last Update Posted : November 1, 2022
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fetal Alcohol Spectrum Disorders Drug: Choline bitartrate Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Actual Study Start Date : June 2016
Actual Primary Completion Date : September 10, 2021
Actual Study Completion Date : September 10, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Stanford-Binet Intelligence Scales: 9 Months [ Time Frame: 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)

  2. Minnesota Executive Function Scale: 6 Months [ Time Frame: Change from baseline to 6 months ]
    Minnesota Executive Function Scale - Early Childhood Version at 6 months

  3. Minnesota Executive Function Scale: 9 Months [ Time Frame: 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)

  4. NIH Toolbox Flanker Task: 9 Months [ Time Frame: 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)

  5. NIH Toolbox Flanker Task: 6 Months [ Time Frame: Change from baseline to 6 months ]
    NIH Toolbox Flanker Inhibitory and Control Task at 6 months

  6. Child Behavior Checklist: 6 Months [ Time Frame: Change from baseline to 6 months ]
    Child Behavior Checklist - parent report instrument at 6 months

  7. Child Behavior Checklist: 9 Months [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735473


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Jeffrey R Wozniak, Ph.D. University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Study Protocol and Statistical Analysis Plan  [PDF] January 8, 2020
Informed Consent Form  [PDF] January 10, 2020

More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02735473    
Other Study ID Numbers: PSYCH-2016-23989
R01AA024123 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2016    Key Record Dates
Results First Posted: November 1, 2022
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Fetal Diseases
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
 Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents