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Active, Not Recruiting

NCT Number: NCT05108974

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Fetal Alcohol Spectrum Disorders Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Pregnancy Complications Substance-Related Disorders Urogenital Diseases

Age range

30 month–72 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

choline bitartrate

Drug

Powdered drink mix for daily consumption

Other names: choline bitartrate formulated in drink mix specifically for this study

Primary outcomes

  1. Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)

    Time frame: Change from baseline to 9 months

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

  2. Stanford-Binet Intelligence Test (SB-5)

    Time frame: Change from baseline to 9 months

    Stanford Binet Intelligence Test - 5th Edition

  3. Minnesota Executive Function Scale (MEFS)

    Time frame: Change from baseline to 9 months

    Minnesota Executive Function Scale - Early Childhood Version

  4. NIH Toolbox Flanker Test

    Time frame: Change from baseline to 9 months

    NIH Toolbox Flanker Inhibitory and Control Test

  5. NIH Toolbox Picture Sequence Memory Test

    Time frame: Change from baseline to 9 months

    NIH Toolbox Picture Sequence Memory Test

Secondary outcomes

  1. Child Behavior Checklist (CBCL)

    Time frame: Change from baseline to 9 months

    Child Behavior Checklist - Parent Report Version

Sponsors and collaborators

Lead sponsor

Jeff Wozniak

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: CHOLINE4

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2021
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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