Brain DevelopmentPhase 2NCT07699393
Pilot Study of Prenatal Choline Supplementation
A Phase 2 study testing Choline bitartrate in people with Brain Development and Choline Nutrition, run by Wayne State University at 1 site in South Africa.
Trial summary
A double-blind, randomized, placebo-controlled trial (RCT; NCT04395196) of prenatal choline supplementation is ongoing (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of PAE on three primary outcomes: infant recognition memory and postnatal growth restriction… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Development, Choline Nutrition
- What is being tested?
- Choline bitartrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Africa
- Study dates
- 8 Jul 2026to 15 May 2028
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥18 yr
- ≤20 wk gestation
- Singleton pregnancy
- Abstinence from alcohol since conception (by report)
- Current choline dietary intake <1 g/day
- Language fluency in English or Afrikaans
Who cannot join
- Use of methamphetamine or other illicit drugs other than marijuana during the past year
- HIV positive
- Pharmacologic treatment for a serious pre-existing medical condition (e.g., diabetes, hypertension, epilepsy, or cardiac problems)
- Having another child enrolled in the trial from a previous pregnancy
- Plans for mother or child to move away from the area prior to study completion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
University of Cape Town
Cape Town
Anthea Van Wyk, +27665643491, uctmoms@gmail.com
Ernesta M Meinjtes, PhD, ernesta.meintjes@gmail.com
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled Clinical Trial of Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure on Growth and Cognitive Development: Pilot Arm for Non-Drinking Women
A double-blind, randomized, placebo-controlled trial (RCT; NCT04395196) of prenatal choline supplementation is ongoing (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of PAE on three primary outcomes: infant recognition memory and postnatal growth restriction (weight and head circumference); (2) to assess the efficacy of this supplementation for mitigating alcohol effects on the following secondary outcomes: infant eyeblink conditioning, postnatal length, and information processing speed. The study design was based on a pilot feasibility study in 70 heavy-drinking pregnant women. Infants in the choline-treated arm were more likely to meet criterion for eyeblink conditioning than those in the placebo arm. Infants born to both the choline- and placebo-treated mothers were small at birth, but those in the choline arm showed considerable catch-up growth in weight and head circumference by 6.5 months, which persisted through 12 months. At 12 months, infants in the choline arm showed markedly better recognition memory compared to placebo-treated on the Fagan Test of Infant Intelligence, which is known to have predictive validity for school-age IQ. Of note, infants with heavy prenatal alcohol exposure whose mothers were in the active choline treatment arm performed better on FTII novelty preference neurobehavioral testing than infants in an observational study that was running in parallel who had no prenatal alcohol exposure. These pilot findings indicate that any beneficial effects of prenatal choline supplementation seen may be due in part or entirely due to general beneficial effects on fetal brain development rather than mechanisms that are specific to the teratogenic effects of alcohol. Thus, the aim of this pilot study is to enroll and randomize 50 alcohol-abstaining pregnant women to participate in an identical study protocol (same study procedures and primary and secondary outcomes) to NCT04395196, which includes only alcohol-consuming pregnant women. Effect sizes between this pilot, non-drinking group and the larger study of alcohol-consuming women will be compared to explore the degree to which prenatal choline supplementation benefits growth and neurobehavior in infants without prenatal alcohol exposure and to explore the degree to which beneficial treatment effects of choline are specific to prenatal alcohol exposure.
Read the detailed description
The study protocol will be identical to NCT04395196 except for sample size (goal = 50 pregnant women and their infants) and that instead of including heavy-drinking pregnant women, inclusion criteria require that women have fully abstained from alcohol during pregnancy at the time of randomization. All other inclusion/exclusion criteria and study procedures are identical.
- Conditions
- Brain Development, Choline Nutrition
- Being tested
- Placebo, Choline bitartrate
- Keywords
- Choline, Prenatal nutrition, dietary supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Provided in beverage form
Choline bitartrateDietary supplement
Provided in beverage form.
| Study group | Role | What they receive |
|---|---|---|
| High-dose choline supplementation | Experimental | 2 g choline cation per day Receives: Dietary Supplement: Choline bitartrate |
| Placebo | Placebo comparator | Placebo identical to active treatment in appearance, taste, and smell. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant recognition memory
Novelty preference from the Fagan Test of Infant Intelligence
Measured: 12 months
Postnatal infant weight gain
Measured: 6.5 months
Postnatal growth in infant head circumference
Measured: 6.5 months
Secondary outcomes (2)
Infant information processing speed
Processing speed on the Fagan Test of Infant Intelligence
Measured: 12 months
Postnatal growth in infant length
Measured: 6.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start8 Jul 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DevelopmentStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, University of Cape Town
- Responsible party
- Principal investigator, Sandra W. Jacobson, Ph.D, Wayne State University
- Investigators
- R. Colin Carter, MD, MMSc, Principal investigator, Columbia UniversitySandra W Jacobson, PhD, Principal investigator, Wayne State UniversityJoseph L Jacobson, PhD, Principal investigator, Wayne State UniversityErnesta M Meinjtes, PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699393
- Sponsor's protocol ID
- UCTCHOLINERCTPHASEB
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share deidentified data with researchers and regulatory bodies who request the data for verification of findings, for collaboration, and/or for research purposes deemed ethical and scientifically justified by the PIs.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled Clinical Trial of Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure on Growth and Cognitive Development: Pilot Arm for Non-Drinking Women
- ClinicalTrials.gov ID
- NCT07699393
- Acronym / sponsor ID
- UCTCHOLINERCTPHASEB
- Conditions
- Brain Development, Choline Nutrition
- Keywords
- Choline, Prenatal nutrition, dietary supplementation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Columbia University, University of Cape Town
- Study start
- 8 Jul 2026 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 13 Jul 2026 (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.
A double-blind, randomized, placebo-controlled trial (RCT; NCT04395196) of prenatal choline supplementation is ongoing (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of PAE on three primary outcomes: infant recognition memory and postnatal growth restriction (weight and head circumference); (2) to assess the efficacy of this supplementation for mitigating alcohol effects on the following secondary outcomes: infant eyeblink conditioning, postnatal length, and information processing speed. The study design was based on a pilot feasibility study in 70 heavy-drinking pregnant women. Infants in the choline-treated arm were more likely to meet criterion for eyeblink conditioning than those in the placebo arm. Infants born to both the choline- and placebo-treated mothers were small at birth, but those in the choline arm showed considerable catch-up growth in weight and head circumference by 6.5 months, which persisted through 12 months. At 12 months, infants in the choline arm showed markedly better recognition memory compared to placebo-treated on the Fagan Test of Infant Intelligence, which is known to have predictive validity for school-age IQ. Of note, infants with heavy prenatal alcohol exposure whose mothers were in the active choline treatment arm performed better on FTII novelty preference neurobehavioral testing than infants in an observational study that was running in parallel who had no prenatal alcohol exposure. These pilot findings indicate that any beneficial effects of prenatal choline supplementation seen may be due in part or entirely due to general beneficial effects on fetal brain development rather than mechanisms that are specific to the teratogenic effects of alcohol. Thus, the aim of this pilot study is to enroll and randomize 50 alcohol-abstaining pregnant women to participate in an identical study protocol (same study procedures and primary and secondary outcomes) to NCT04395196, which includes only alcohol-consuming pregnant women. Effect sizes between this pilot, non-drinking group and the larger study of alcohol-consuming women will be compared to explore the degree to which prenatal choline supplementation benefits growth and neurobehavior in infants without prenatal alcohol exposure and to explore the degree to which beneficial treatment effects of choline are specific to prenatal alcohol exposure.
Detailed description
The study protocol will be identical to NCT04395196 except for sample size (goal = 50 pregnant women and their infants) and that instead of including heavy-drinking pregnant women, inclusion criteria require that women have fully abstained from alcohol during pregnancy at the time of randomization. All other inclusion/exclusion criteria and study procedures are identical.
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 |
|---|---|---|
| High-dose choline supplementation | Experimental | Dietary Supplement: Choline bitartrate2 g choline cation per day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo identical to active treatment in appearance, taste, and smell. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ≥18 yr
- ≤20 wk gestation
- Singleton pregnancy
- Abstinence from alcohol since conception (by report)
- Current choline dietary intake <1 g/day
Key exclusion criteria (5 listed)
- Use of methamphetamine or other illicit drugs other than marijuana during the past year
- HIV positive
- Pharmacologic treatment for a serious pre-existing medical condition (e.g., diabetes, hypertension, epilepsy, or cardiac problems)
- Having another child enrolled in the trial from a previous pregnancy
- Plans for mother or child to move away from the area prior to study completion
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 |
|---|---|---|
| PlaceboProvided in beverage form | Dietary supplement | Placebo |
| Choline bitartrateProvided in beverage form. | Dietary supplement | High-dose choline supplementation |
Primary outcome
Infant recognition memory
Time frame: 12 months
Novelty preference from the Fagan Test of Infant Intelligence
Postnatal infant weight gain
Time frame: 6.5 months
Postnatal growth in infant head circumference
Time frame: 6.5 months
2 secondary outcomes
Infant information processing speed
Time frame: 12 months
Postnatal growth in infant length
Time frame: 6.5 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 14 Jul 2026.
- Individual participant dataSharing planned: Yes. We will share deidentified data with researchers and regulatory bodies who request the data for verification of findings, for collaboration, and/or for research purposes deemed ethical and scientifically justified by the PIs.
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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.
R. Colin Carter, MD, MMSc principal investigator
Columbia University
Sandra W Jacobson, PhD principal investigator
Wayne State University
Joseph L Jacobson, PhD principal investigator
Wayne State University
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 Brain Development and Choline Nutrition, run by Wayne State University at 1 site in South Africa.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 14 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 South Africa. 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?
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?
Contact R. Colin Carter, MD, MMSc (+12123052995, rcc2142@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant recognition memory (time frame: 12 months). The study lists 3 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 14 Jul 2026.