NCT02735473

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 1, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

5.3 years

First QC Date

April 2, 2016

Results QC Date

September 1, 2022

Last Update Submit

October 2, 2022

Conditions

Fetal Alcohol Spectrum Disorders

Outcome Measures

Primary Outcomes (2)

  • Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months

    Elicited Imitation memory paradigm - short delay memory measure at 6 months; scores are in percentage correct.

    Change from baseline to 6 months in percentage correct

  • Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months

    Elicited Imitation memory paradigm - short delay memory measure at 9 months

    Change from baseline to 9 months

Secondary Outcomes (7)

  • Stanford-Binet Intelligence Scales: 9 Months

    Change from baseline to 9 months in IQ points

  • Minnesota Executive Function Scale: 6 Months

    Change from baseline to 6 months

  • Minnesota Executive Function Scale: 9 Months

    Change from baseline to 9 months in t-score points

  • NIH Toolbox Flanker Task: 9 Months

    Change from baseline to 9 months in fully-corrected t-score points

  • NIH Toolbox Flanker Task: 6 Months

    Change from baseline to 6 months

  • +2 more secondary outcomes

Study Arms (2)

Choline bitartrate

EXPERIMENTAL

Powdered drink mix containing choline bitartrate 19 mg. per kg.

Drug: Choline bitartrate

Placebo

PLACEBO COMPARATOR

Powdered drink mix containing matching placebo

Drug: Placebo

Interventions

Choline bitartrateDRUG
Choline bitartrate
PlaceboDRUG
Placebo

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

  • Wozniak JR, Eckerle JK, Gimbel BA, Ernst AM, Anthony ME, Tuominen KA, de Water E, Zeisel SH, Georgieff MK. Choline enhances elicited imitation memory performance in preschool children with prenatal alcohol exposure: a cumulative report of 3 randomized controlled trials. Am J Clin Nutr. 2025 Apr;121(4):921-931. doi: 10.1016/j.ajcnut.2025.02.009. Epub 2025 Feb 14.

    PMID: 39956364DERIVED

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Choline

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsOnium Compounds

Results Point of Contact

Title
Jeffrey R Wozniak
Organization
University of Minnesota
jwozniak@umn.edu
612-273-9741

Study Officials

  • Jeffrey R Wozniak, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2016

First Posted

April 12, 2016

Study Start

June 1, 2016

Primary Completion

September 10, 2021

Study Completion

September 10, 2021

Last Updated

November 1, 2022

Results First Posted

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)