Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study
CHOLINE4
2 other identifiers
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2021
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2021
CompletedFirst Submitted
Initial submission to the registry
October 26, 2021
CompletedFirst Posted
Study publicly available on registry
November 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
July 31, 2025
July 1, 2025
4.8 years
October 26, 2021
July 28, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)
Elicited Imitation short-delay memory measure (percent correct for recall)
Change from baseline to 9 months
Stanford-Binet Intelligence Test (SB-5)
Stanford Binet Intelligence Test - 5th Edition
Change from baseline to 9 months
Minnesota Executive Function Scale (MEFS)
Minnesota Executive Function Scale - Early Childhood Version
Change from baseline to 9 months
NIH Toolbox Flanker Test
NIH Toolbox Flanker Inhibitory and Control Test
Change from baseline to 9 months
NIH Toolbox Picture Sequence Memory Test
NIH Toolbox Picture Sequence Memory Test
Change from baseline to 9 months
Secondary Outcomes (1)
Child Behavior Checklist (CBCL)
Change from baseline to 9 months
Study Arms (2)
3 months choline bitartrate
EXPERIMENTALOver 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
6 months choline bitartrate
EXPERIMENTALOver 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
Interventions
Powdered drink mix for daily consumption
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55454, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey R Wozniak, Ph.D.
University of Minnesota
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 INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 26, 2021
First Posted
November 5, 2021
Study Start
October 22, 2021
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
July 31, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share