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

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ClinicalTrials.gov Identifier: NCT05108974
Recruitment Status : Recruiting
First Posted : November 5, 2021
Last Update Posted : December 15, 2022
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jeff Wozniak, University of Minnesota

Study Description
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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
Fetal Alcohol Spectrum Disorders 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 22, 2021
Estimated Primary Completion Date : August 31, 2026
Estimated Study Completion Date : August 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: choline bitartrate formulated in drink mix specifically for this study


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Child Behavior Checklist (CBCL) [ Time Frame: Change from baseline to 9 months ]
    Child Behavior Checklist - Parent Report Version


Eligibility Criteria
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Ages Eligible for Study:   30 Months to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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): NCT05108974


Contacts
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Contact: Jeffrey R Wozniak, Ph.D. 612-598-0041 jwozniak@umn.edu
Contact: Michael K Georgieff, M.D. 712-626-2971 georg001@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Jeffrey R Wozniak, Ph.D.    612-273-9741    jwozniak@umn.edu   
Sponsors and Collaborators
Jeff Wozniak
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Jeffrey R Wozniak, Ph.D. University of Minnesota
More Information
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Responsible Party: Jeff Wozniak, Professor, University of Minnesota
ClinicalTrials.gov Identifier: NCT05108974    
Other Study ID Numbers: UMN-1506M74642
R01AA024123 ( U.S. NIH Grant/Contract )
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: December 15, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Fetal Diseases
Pregnancy Complications
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