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

Primary Purpose

Fetal Alcohol Spectrum Disorders

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Choline Bitartrate

About this trial

This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders

Eligibility Criteria

30 Months - 72 Months (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

3 months choline bitartrate

6 months choline bitartrate

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Stanford-Binet Intelligence Test (SB-5)

Stanford Binet Intelligence Test - 5th Edition

Minnesota Executive Function Scale (MEFS)

Minnesota Executive Function Scale - Early Childhood Version

NIH Toolbox Flanker Test

NIH Toolbox Flanker Inhibitory and Control Test

NIH Toolbox Picture Sequence Memory Test

Secondary Outcome Measures

Child Behavior Checklist (CBCL)

Child Behavior Checklist - Parent Report Version

Full Information

NCT ID

NCT05108974

First Posted

October 26, 2021

Last Updated

December 13, 2022

Sponsor

Jeff Wozniak

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT05108974

Brief Title

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

Acronym

CHOLINE4

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 22, 2021 (Actual)

Primary Completion Date

August 31, 2026 (Anticipated)

Study Completion Date

August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jeff Wozniak

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fetal Alcohol Spectrum Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

3 months choline bitartrate

Arm Type

Experimental

Arm Description

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

Arm Title

6 months choline bitartrate

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Choline Bitartrate

Other Intervention Name(s)

choline bitartrate formulated in drink mix specifically for this study

Intervention Description

Powdered drink mix for daily consumption

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Change from baseline to 9 months

Title

Stanford-Binet Intelligence Test (SB-5)

Description

Stanford Binet Intelligence Test - 5th Edition

Time Frame

Change from baseline to 9 months

Title

Minnesota Executive Function Scale (MEFS)

Description

Minnesota Executive Function Scale - Early Childhood Version

Time Frame

Change from baseline to 9 months

Title

NIH Toolbox Flanker Test

Description

NIH Toolbox Flanker Inhibitory and Control Test

Time Frame

Change from baseline to 9 months

Title

NIH Toolbox Picture Sequence Memory Test

Description

NIH Toolbox Picture Sequence Memory Test

Time Frame

Change from baseline to 9 months

Secondary Outcome Measure Information:

Title

Child Behavior Checklist (CBCL)

Description

Child Behavior Checklist - Parent Report Version

Time Frame

Change from baseline to 9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Months

Maximum Age & Unit of Time

72 Months

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeffrey R Wozniak, Ph.D.

Phone

612-598-0041

jwozniak@umn.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Michael K Georgieff, M.D.

Phone

712-626-2971

georg001@umn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey R Wozniak, Ph.D.

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55454

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeffrey R Wozniak, Ph.D.

Phone

612-273-9741

jwozniak@umn.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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