Child DevelopmentPhase 1NCT03028857
Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal
A Phase 1 study testing Choline in people with Child Development and Prenatal Stress, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women improves early brain development with improved brain-related development during the first four years of life. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Development, Prenatal Stress
- What is being tested?
- Choline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jun 2017to 22 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- General Health: Other than pregnancy related illnesses, physically healthy expectant mothers
- ages 18-45 years
- prepregnancy BMI>18 and <45
Who cannot join
- Prior history of fetal death
- Current personal history of chronic infections, including HIV
- Current personal or family history out to first degree relatives of
- Trimethylaminuria
- Homocystinuria
- Primary language other than English or Spanish
- Evidence of noncompliance
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCHealth
Aurora, Colorado, 80045
Saint Joseph Hospital
Denver, Colorado, 80218
About this study
Official title: Double-blind Trial of Phosphatidylcholine Supplementation During Pregnancy: Impact on Attention and Social Withdrawal at 4 Years of Age
The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women improves early brain development with improved brain-related development during the first four years of life. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcome is the child's behavior at four years of age as reported by the primary caregiver. Secondary outcomes include motor development, socio-emotional development, language development, and cognitive development. Potential contributors beyond the supplement, including maternal stress and placental function will also be assessed.
Read the detailed description
Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and other meats. It is important for the composition and repair of normal cellular membranes, normal brain function, and normal cardiovascular function. Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development. Additionally, adequate prenatal choline levels may have long-lasting positive effects on cognitive function, including memory. However, sufficient research has not been done on the effects of choline on pregnant women and their unborn babies. This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether taking choline during pregnancy will have an effect on infant development.
Participants in this double-blind study will be randomly assigned to receive either placebo or 1250 mg of choline daily throughout pregnancy, until delivery. Vital signs will be taken, potential side effects will be assessed, and study medication will be given at each visit. Blood samples will be taken at enrollment and approximately at weeks 20, 28, 32. Children will be followed and assessed until 4 years of age.
- Conditions
- Child Development, Prenatal Stress
- Being tested
- Choline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholineDrug
Also called Phosphatidylcholine
Mothers are instructed to take the capsules twice a day, five 450 mg phosphatidylcholine capsules at breakfast and five phosphatidylcholine 450 mg capsules at dinner. Increased awareness into the benefits of choline by obstetricians and pregnant women, as well as our recently published results from an observational study showing a wide distribution of serum choline concentrations in pregnant women, suggest that serum choline concentration is a more apt independent variable for analyses.
PlaceboDrug
Also called Corn oil every day in place of choline
Mothers are instructed to take the capsules twice a day, five placebo corn oil capsules at breakfast and five placebo corn oil capsules at dinner. Increased awareness into the benefits of choline by obstetricians and pregnant women, as well as our recently published results from an observational study showing a wide distribution of serum choline concentrations in pregnant women, suggest that serum choline concentration is a more apt independent variable for analyses.
| Study group | Role | What they receive |
|---|---|---|
| Participants will take placebo | Placebo comparator | Participants will take placebo. Corn oil every day in place of choline Receives: Drug: Placebo |
| Drug: Choline | Active comparator | Participants will take 4500 mg of phosphatidylcholine twice per day, the equivalent of approximately 1250 mg of choline per day until delivery Receives: Drug: Choline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior rated on the Child Behavior Checklist.
Our primary behavioral outcome is behavior as measured by the Child Behavior Checklist at 4 years of age.
Measured: 4 Years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start12 Jun 2017
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille Hoffman, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028857
- Sponsor's protocol ID
- 16-1510
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2017
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A copy of the locked database with all outcome, safety, and demographic measures will be provided as a supplement to the primary publication.
Publications
Ross RG, Hunter SK, Hoffman MC, McCarthy L, Chambers BM, Law AJ, Leonard S, Zerbe GO, Freedman R. Perinatal Phosphatidylcholine Supplementation and Early Childhood Behavior Problems: Evidence for CHRNA7 Moderation. Am J Psychiatry. 2016 May 1;173(5):509-16. doi: 10.1176/appi.ajp.2015.15091188. Epub 2015 Dec 7.
PubMed 26651393
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Trial of Phosphatidylcholine Supplementation During Pregnancy: Impact on Attention and Social Withdrawal at 4 Years of Age
- ClinicalTrials.gov ID
- NCT03028857
- Acronym / sponsor ID
- 16-1510
- Conditions
- Child Development, Prenatal Stress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 23 Jan 2017 (estimated)
- 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.
The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women improves early brain development with improved brain-related development during the first four years of life. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcome is the child's behavior at four years of age as reported by the primary caregiver. Secondary outcomes include motor development, socio-emotional development, language development, and cognitive development. Potential contributors beyond the supplement, including maternal stress and placental function will also be assessed.
Detailed description
Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and other meats. It is important for the composition and repair of normal cellular membranes, normal brain function, and normal cardiovascular function. Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development. Additionally, adequate prenatal choline levels may have long-lasting positive effects on cognitive function, including memory. However, sufficient research has not been done on the effects of choline on pregnant women and their unborn babies. This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether taking choline during pregnancy will have an effect on infant development.
Participants in this double-blind study will be randomly assigned to receive either placebo or 1250 mg of choline daily throughout pregnancy, until delivery. Vital signs will be taken, potential side effects will be assessed, and study medication will be given at each visit. Blood samples will be taken at enrollment and approximately at weeks 20, 28, 32. Children will be followed and assessed until 4 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants will take placebo | Placebo comparator | Drug: PlaceboParticipants will take placebo. Corn oil every day in place of choline |
| Drug: Choline | Active comparator | Drug: CholineParticipants will take 4500 mg of phosphatidylcholine twice per day, the equivalent of approximately 1250 mg of choline per day until delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- General Health: Other than pregnancy related illnesses, physically healthy expectant mothers
- ages 18-45 years
- prepregnancy BMI>18 and <45
Key exclusion criteria (7 listed)
- Prior history of fetal death
- Current personal history of chronic infections, including HIV
- Current personal or family history out to first degree relatives of
- Primary language other than English or Spanish
- Evidence of noncompliance
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 |
|---|---|---|
| CholineAlso: PhosphatidylcholineMothers are instructed to take the capsules twice a day, five 450 mg phosphatidylcholine capsules at breakfast and five phosphatidylcholine 450 mg capsules at dinner. Increased awareness into the benefits of choline by obstetricians and pregnant women, as well as our recently published results from an observational study showing a wide distribution of serum choline concentrations in pregnant women, suggest that serum choline concentration is a more apt independent variable for analyses. | Drug | Drug: Choline |
| PlaceboAlso: Corn oil every day in place of cholineMothers are instructed to take the capsules twice a day, five placebo corn oil capsules at breakfast and five placebo corn oil capsules at dinner. Increased awareness into the benefits of choline by obstetricians and pregnant women, as well as our recently published results from an observational study showing a wide distribution of serum choline concentrations in pregnant women, suggest that serum choline concentration is a more apt independent variable for analyses. | Drug | Participants will take placebo |
Primary outcome
Behavior rated on the Child Behavior Checklist.
Time frame: 4 Years of age
Our primary behavioral outcome is behavior as measured by the Child Behavior Checklist at 4 years of age.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 26651393Ross RG, Hunter SK, Hoffman MC, McCarthy L, Chambers BM, Law AJ, Leonard S, Zerbe GO, Freedman R. Perinatal Phosphatidylcholine Supplementation and Early Childhood Behavior Problems: Evidence for CHRNA7 Moderation. Am J Psychiatry. 2016 May 1;173(5):509-16. doi: 10.1176/appi.ajp.2015.15091188. Epub 2015 Dec 7.
- Individual participant dataSharing planned: Yes. A copy of the locked database with all outcome, safety, and demographic measures will be provided as a supplement to the primary publication.
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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.
Camille Hoffman, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Choline in people with Child Development and Prenatal Stress, run by University of Colorado, Denver at 2 sites 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 7 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Behavior rated on the Child Behavior Checklist. (time frame: 4 Years of age). 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 NCT03028857, which also lists 1 linked publication.
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 7 Jan 2026.