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CHOLINE4: Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study

Sponsor
Jeff Wozniak (Other)
Overall Status
Recruiting
CT.gov ID
NCT05108974
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
60
Enrollment
1
Location
2
Arms
58.3
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, double-blind controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline. The primary outcome measures are cognitive measures.

Condition or Disease Intervention/Treatment Phase
  • Drug: Choline Bitartrate
 Phase 2

Detailed Description

This project is the fourth in a series of randomized, double-blind controlled trials of choline bitartrate in children ages 2-5 (under 6) years with prenatal alcohol exposure. 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 in two dosing regimens (3 months choline vs. 6 months choline). Outcome measures include an elicited imitation memory paradigm, IQ measures, and measures of memory and executive functioning, and behavior.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 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 Study
Actual Study Start Date :
Oct 22, 2021
Anticipated Primary Completion Date :
Aug 31, 2026
Anticipated Study Completion Date :
Aug 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 3 months choline bitartrate

Over the 9-month study, participants will receive a total of 3 months of choline bitartrate (19 mg/kg) and a total of 6 months of placebo

Drug: Choline Bitartrate
Powdered drink mix for daily consumption
Other Names:
  • choline bitartrate formulated in drink mix specifically for this study

    		•
    Experimental: 6 months choline bitartrate

    Over the 9-month study, participants will receive a total of 6 months of choline bitartrate (19 mg/kg) and a total of 3 months of placebo

    Drug: Choline Bitartrate
    Powdered drink mix for daily consumption
    Other Names:
  • choline bitartrate formulated in drink mix specifically for this study

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm) [Change from baseline to 9 months]

      Elicited Imitation short-delay memory measure (percent correct for recall)

    2. Stanford-Binet Intelligence Test (SB-5) [Change from baseline to 9 months]

      Stanford Binet Intelligence Test - 5th Edition

    3. Minnesota Executive Function Scale (MEFS) [Change from baseline to 9 months]

      Minnesota Executive Function Scale - Early Childhood Version

    4. NIH Toolbox Flanker Test [Change from baseline to 9 months]

      NIH Toolbox Flanker Inhibitory and Control Test

    5. NIH Toolbox Picture Sequence Memory Test [Change from baseline to 9 months]

      NIH Toolbox Picture Sequence Memory Test

    Secondary Outcome Measures

    1. Child Behavior Checklist (CBCL) [Change from baseline to 9 months]

      Child Behavior Checklist - Parent Report Version

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Months to 72 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Ages 2.5 years to 5 years old (<6 years of age) at enrollment

    • Prenatal alcohol exposure

    • Available parent or legal guardian capable of giving informed consent for participation.

    Exclusion Criteria:

    • History of a neurological condition (ex. epilepsy, traumatic brain injury)

    • History of a medical condition known to affect brain function

    • Other neurodevelopmental disorder (ex. autism, Down syndrome)

    • History of very low birthweight (<1500 grams)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55454

    Sponsors and Collaborators

    • Jeff Wozniak
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    Investigators

    • Principal Investigator: Jeffrey R Wozniak, Ph.D., University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeff Wozniak, Professor, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT05108974
    Other Study ID Numbers:
    • UMN-1506M74642
    • R01AA024123
    First Posted:
    Nov 5, 2021
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fetal Alcohol Spectrum Disorders
    Choline

    Study Results

    No Results Posted as of Nov 30, 2021