Fetal Alcohol Spectrum DisordersPhase 2CHOLINE4NCT05108974
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study
A Phase 2 study testing Choline Bitartrate in people with Fetal Alcohol Spectrum Disorders, run by Jeff Wozniak at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 72 months
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- Choline Bitartrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2021to 31 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
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.
Read the 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.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- Choline Bitartrate
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choline BitartrateDrug
Also called choline bitartrate formulated in drink mix specifically for this study
Powdered drink mix for daily consumption
| Study group | Role | What they receive |
|---|---|---|
| 3 months choline bitartrate | Experimental | 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 Receives: Drug: Choline Bitartrate |
| 6 months choline bitartrate | Experimental | 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 Receives: Drug: Choline Bitartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)
Elicited Imitation short-delay memory measure (percent correct for recall)
Measured: Change from baseline to 9 months
Stanford-Binet Intelligence Test (SB-5)
Stanford Binet Intelligence Test - 5th Edition
Measured: Change from baseline to 9 months
Minnesota Executive Function Scale (MEFS)
Minnesota Executive Function Scale - Early Childhood Version
Measured: Change from baseline to 9 months
NIH Toolbox Flanker Test
NIH Toolbox Flanker Inhibitory and Control Test
Measured: Change from baseline to 9 months
NIH Toolbox Picture Sequence Memory Test
NIH Toolbox Picture Sequence Memory Test
Measured: Change from baseline to 9 months
Secondary outcomes (1)
Child Behavior Checklist (CBCL)
Child Behavior Checklist - Parent Report Version
Measured: Change from baseline to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start22 Oct 2021
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeff Wozniak
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Jeff Wozniak, University of Minnesota
- Investigators
- Jeffrey R Wozniak, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108974
- Sponsor's protocol ID
- UMN-1506M74642
- Other IDs
- R01AA024123
- Acronym
- CHOLINE4
- Status last verified
- Jul 2026
- First submitted
- 26 Oct 2021
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study
- ClinicalTrials.gov ID
- NCT05108974
- Acronym / sponsor ID
- CHOLINE4 / UMN-1506M74642
- Conditions
- Fetal Alcohol Spectrum Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Jeff WozniakUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 months choline bitartrate | Experimental | Drug: Choline BitartrateOver 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 | Experimental | Drug: Choline BitartrateOver 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 |
Who may qualify
- Ages
- 30 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choline BitartrateAlso: choline bitartrate formulated in drink mix specifically for this studyPowdered drink mix for daily consumption | Drug | 3 months choline bitartrate, 6 months choline bitartrate |
Primary outcome
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)
Stanford-Binet Intelligence Test (SB-5)
Time frame: Change from baseline to 9 months
Stanford Binet Intelligence Test - 5th Edition
Minnesota Executive Function Scale (MEFS)
Time frame: Change from baseline to 9 months
Minnesota Executive Function Scale - Early Childhood Version
NIH Toolbox Flanker Test
Time frame: Change from baseline to 9 months
NIH Toolbox Flanker Inhibitory and Control Test
NIH Toolbox Picture Sequence Memory Test
Time frame: Change from baseline to 9 months
NIH Toolbox Picture Sequence Memory Test
1 secondary outcome
Child Behavior Checklist (CBCL)
Time frame: Change from baseline to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Fetal Alcohol Spectrum Disorders
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FASD Prevention R33
Alcohol and Tobacco/Cannabis Use
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Families Moving Forward (FMF) Connect Pro for Mental Health Providers
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The Synchrony Study: Examining Music Training for Children With FASD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey R Wozniak, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Choline Bitartrate in people with Fetal Alcohol Spectrum Disorders, run by Jeff Wozniak at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm) (time frame: Change from baseline to 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.