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

December 22, 2023 updated by: Jeff Wozniak
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jeffrey R Wozniak, Ph.D.
  • Phone Number: 612-598-0041
  • Email: jwozniak@umn.edu

Study Contact Backup

  • Name: Michael K Georgieff, M.D.
  • Phone Number: 712-626-2971
  • Email: georg001@umn.edu

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 4 years (Child)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline to 9 months
Stanford-Binet Intelligence Test (SB-5)
Time Frame: Change from baseline to 9 months
Stanford Binet Intelligence Test - 5th Edition
Change from baseline to 9 months
Minnesota Executive Function Scale (MEFS)
Time Frame: Change from baseline to 9 months
Minnesota Executive Function Scale - Early Childhood Version
Change from baseline to 9 months
NIH Toolbox Flanker Test
Time Frame: Change from baseline to 9 months
NIH Toolbox Flanker Inhibitory and Control Test
Change from baseline to 9 months
NIH Toolbox Picture Sequence Memory Test
Time Frame: Change from baseline to 9 months
NIH Toolbox Picture Sequence Memory Test
Change from baseline to 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Behavior Checklist (CBCL)
Time Frame: Change from baseline to 9 months
Child Behavior Checklist - Parent Report Version
Change from baseline to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeff Wozniak

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2021

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMN-1506M74642
  • R01AA024123 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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