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Completed

NCT Number: NCT02735473

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.

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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

2 year–5 year

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 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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

choline bitartrate

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2016
Registry last updated
Nov 1, 2022

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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