Fetal Alcohol Spectrum DisordersPhase 2NCT02735473
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
A Phase 2 study testing Choline bitartrate in people with Fetal Alcohol Spectrum Disorders, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- Choline bitartrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 10 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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)
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, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures.
Read the detailed description
This project is the third in a series of randomized, double-blind placebo-controlled trials of choline bitartrate in children ages 2-5 who have been diagnosed with Fetal Alcohol Spectrum Disorders (FASD). 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 vs. placebo for 9 months. Outcome measures include an elicited imitation memory paradigm, global cognitive functioning, and aspects of executive functioning. The study will also continue to collect safety and tolerability data.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- Choline bitartrate, Placebo
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Choline bitartrate | Experimental | Powdered drink mix containing choline bitartrate 19 mg. per kg. Receives: Drug: Choline bitartrate |
| Placebo | Placebo comparator | Powdered drink mix containing matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Change from baseline to 9 months
Secondary outcomes (7)
Stanford-Binet Intelligence Scales: 9 Months
Stanford-Binet Intelligence Scales at 9 months; scores are standardized scores (mean 100 points, standard deviation of 15 points)
Measured: Change from baseline to 9 months in IQ points
Minnesota Executive Function Scale: 6 Months
Minnesota Executive Function Scale - Early Childhood Version at 6 months
Measured: Change from baseline to 6 months
Minnesota Executive Function Scale: 9 Months
Minnesota Executive Function Scale - Early Childhood Version at 9 months; scores are in t-scores (mean=50, standard deviation=10)
Measured: Change from baseline to 9 months in t-score points
NIH Toolbox Flanker Task: 9 Months
NIH Toolbox Flanker Inhibitory and Control Task at 9 months; scores are fully-corrected t-scores (mean=40, standard deviation=10)
Measured: Change from baseline to 9 months in fully-corrected t-score points
NIH Toolbox Flanker Task: 6 Months
NIH Toolbox Flanker Inhibitory and Control Task at 6 months
Measured: Change from baseline to 6 months
Child Behavior Checklist: 6 Months
Child Behavior Checklist - parent report instrument at 6 months
Measured: Change from baseline to 6 months
Child Behavior Checklist: 9 Months
Child Behavior Checklist - parent report instrument at 9 months; scores are t-scores (mean=50, standard deviation=10)
Measured: Change from baseline to 9 months in t-score points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startJun 2016
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Jeffrey R Wozniak, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735473
- Sponsor's protocol ID
- PSYCH-2016-23989
- Other IDs
- R01AA024123
- Status last verified
- Oct 2022
- First submitted
- 2 Apr 2016
- Last updated
- 1 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tran PV, Maxim ZL, Eckerle JK, Zeisel SH, Georgieff MK, Wozniak JR. Plasma and Brain-Derived Extracellular Vesicle Biomarkers Following a Randomized Controlled Trial of Choline for Neurodevelopment in Fetal Alcohol Spectrum Disorder: A Pilot Analysis. Nutrients. 2026 Sep 16;18(18):3022. doi: 10.3390/nu18183022.
PubMed 42797005Wozniak 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.
PubMed 39956364
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. 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
- ClinicalTrials.gov ID
- NCT02735473
- Acronym / sponsor ID
- PSYCH-2016-23989
- Conditions
- Fetal Alcohol Spectrum Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jun 2016 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 1 Nov 2022
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, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures.
Detailed description
This project is the third in a series of randomized, double-blind placebo-controlled trials of choline bitartrate in children ages 2-5 who have been diagnosed with Fetal Alcohol Spectrum Disorders (FASD). 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 vs. placebo for 9 months. Outcome measures include an elicited imitation memory paradigm, global cognitive functioning, and aspects of executive functioning. The study will also continue to collect safety and tolerability data.
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 |
|---|---|---|
| Choline bitartrate | Experimental | Drug: Choline bitartratePowdered drink mix containing choline bitartrate 19 mg. per kg. |
| Placebo | Placebo comparator | Drug: PlaceboPowdered drink mix containing matching placebo |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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)
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 bitartrate | Drug | Choline bitartrate |
| Placebo | Drug | Placebo |
Primary outcome
Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months
Time frame: Change from baseline to 6 months in percentage correct
Elicited Imitation memory paradigm - short delay memory measure at 6 months; scores are in percentage correct.
Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months
Time frame: Change from baseline to 9 months
Elicited Imitation memory paradigm - short delay memory measure at 9 months
7 secondary outcomes
Stanford-Binet Intelligence Scales: 9 Months
Time frame: Change from baseline to 9 months in IQ points
Minnesota Executive Function Scale: 6 Months
Time frame: Change from baseline to 6 months
Minnesota Executive Function Scale: 9 Months
Time frame: Change from baseline to 9 months in t-score points
NIH Toolbox Flanker Task: 9 Months
Time frame: Change from baseline to 9 months in fully-corrected t-score points
NIH Toolbox Flanker Task: 6 Months
Time frame: Change from baseline to 6 months
Child Behavior Checklist: 6 Months
Time frame: Change from baseline to 6 months
Child Behavior Checklist: 9 Months
Time frame: Change from baseline to 9 months in t-score points
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42797005Tran PV, Maxim ZL, Eckerle JK, Zeisel SH, Georgieff MK, Wozniak JR. Plasma and Brain-Derived Extracellular Vesicle Biomarkers Following a Randomized Controlled Trial of Choline for Neurodevelopment in Fetal Alcohol Spectrum Disorder: A Pilot Analysis. Nutrients. 2026 Sep 16;18(18):3022. doi: 10.3390/nu18183022.
- Derived from this study: PubMed 39956364Wozniak 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.
- Individual participant dataSharing planned: No
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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 University of Minnesota 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 4 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: finished, as of the sponsor's last update on 1 Nov 2022. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 - Short Delay Memory Measure: 6 Months (time frame: Change from baseline to 6 months in percentage correct). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02735473, which also lists 2 linked publications.
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 1 Nov 2022.