Child DevelopmentPhase 1NCT06379971
Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development
A Phase 1 study testing Choline in people with Child Development and Cannabis Use, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring\'s brain-related development during the first 3 months. 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, Cannabis Use
- 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
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2024to 30 Apr 2029
- Phase
- Phase 1
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who report cannabis use during current pregnancy
Who cannot join
- Pregnancies complicated by fetal anomaly, including neural tube defect or chromosomal abnormality, or multiple gestations due to increased obstetrical risks
- Women with major preexisting maternal medical morbidities
- Women with a 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 or homocystinuria
- Primary language other than English or Spanish
- Evidence of noncompliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Health
Aurora, Colorado, 80045
Sharon Hunter, PhD, 303-724-6246, sharon.hunter@cuanschutz.edu
About this study
Official title: Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development
The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring\'s brain-related development during the first 3 months. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcomes are the child\'s brain responses to sound at 4 weeks corrected age and infant behaviors at 3 months corrected age as reported by the primary caregiver. Secondary outcomes include motor, socio-emotional, language and cognitive development.
Read the detailed description
Phosphatidylcholine (PC) is a form of choline, a nutrient that is sometimes referred to as Vitamin B4 or Vitamin J. Choline is for normal growth everywhere in the body, including in the brain. PC is a naturally occurring substance and can be found in many different kinds of food including milk, liver, and eggs so most people get enough choline. However, when a woman is pregnant and her baby is growing many new cells, more PC may be needed. Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development and may have long-lasting positive effects on cognitive function. Problems in behavioral and cognitive development into childhood have been reported in children of mothers who used cannabis during gestation. Alternatively, two studies of maternal choline levels during pregnancy have reported beneficial effects of higher levels on childhood behavioral and cognitive development. This study assesses whether a higher dose of choline taken during pregnancy will have positive results on offspring development.
Participants in this double-blind study will be randomly assigned to receive either placebo or 1028 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 16, 22, 28, 34. Children will be followed and assessed until 3 months of age.
- Conditions
- Child Development, Cannabis Use
- Being tested
- Placebo, Choline
- Keywords
- phosphatidylcholine, choline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called rice bran oil and pumpkin seed oil
Pregnant women are instructed to take the capsules twice per day, 4 placebo capsules at breakfast and 4 placebo capsules at dinner. Increased awareness of the benefits of choline by obstetricians and pregnant women, as well as our published results from an observational study showing a wide distribution of plasma choline concentration, is a more apt independent variable for analyses.
CholineDrug
Also called Phosphatidylcholine
Pregnant women are instructed to take the capsules twice per day, 4 900mg phosphatidylcholine capsules at breakfast and 4 capsules at dinner. Increased awareness Increased awareness of the benefits of choline by obstetricians and pregnant women, as well as our published results from an observational study showing a wide distribution of plasma choline concentration, is a more apt independent variable for analyses.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will take 8 placebo capsules each containing 1100mg Rice Bran Oil and 150mg Pumpkin Seed Oil every day in place of phosphatidylcholine supplement. Receives: Drug: Placebo |
| Phosphatidylcholine | Active comparator | Participants will take 8 900mg capsules of phosphatidylcholine every day, the equivalent of approximately 1028 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.
Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index
The Orienting/Regulation Index is derived by adding the maternal rating of the infant's duration of attention, distractibility, soothability, cuddling, and smiling on the 91-item IBQ-r
Measured: 3 months corrected age
Auditory Sensory Gating (P50)
Inhibition of the P50 cerebral auditory evoked response is collected during a paired stimulus auditory sensory gating paradigm
Measured: 1 month corrected age
Secondary outcomes (3)
Maternal Plasma Choline Levels
Plasma choline levels will be used to assess the effects of supplementation throughout gestation
Measured: approximately 16, 22, 28, 34 weeks gestation
Bayley Scales of Infant and Toddler Development
The Bayley Scales are a standardized assessment of language, cognitive and motor development
Measured: 1, 3 and 6 months corrected age
Child Behavior Checklist (CBCL) 1 1/2-5
The CBCL assesses a wide range of parent reported behaviors in children on a normative scale for comparison with others, including those assessed in need of clinical interventions for behavioral problems
Measured: 18 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start25 Nov 2024
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phosphatidylcholine versus placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M. Camille Hoffman, MD, Principal investigator, University of Colorado, DenverSharon Hunter, PhD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379971
- Sponsor's protocol ID
- 23-2327
- Status last verified
- Jan 2025
- First submitted
- 18 Apr 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development
- ClinicalTrials.gov ID
- NCT06379971
- Acronym / sponsor ID
- 23-2327
- Conditions
- Child Development, Cannabis Use
- Keywords
- phosphatidylcholine, choline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 23 Apr 2024 (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.
The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring\'s brain-related development during the first 3 months. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcomes are the child\'s brain responses to sound at 4 weeks corrected age and infant behaviors at 3 months corrected age as reported by the primary caregiver. Secondary outcomes include motor, socio-emotional, language and cognitive development.
Detailed description
Phosphatidylcholine (PC) is a form of choline, a nutrient that is sometimes referred to as Vitamin B4 or Vitamin J. Choline is for normal growth everywhere in the body, including in the brain. PC is a naturally occurring substance and can be found in many different kinds of food including milk, liver, and eggs so most people get enough choline. However, when a woman is pregnant and her baby is growing many new cells, more PC may be needed. Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development and may have long-lasting positive effects on cognitive function. Problems in behavioral and cognitive development into childhood have been reported in children of mothers who used cannabis during gestation. Alternatively, two studies of maternal choline levels during pregnancy have reported beneficial effects of higher levels on childhood behavioral and cognitive development. This study assesses whether a higher dose of choline taken during pregnancy will have positive results on offspring development.
Participants in this double-blind study will be randomly assigned to receive either placebo or 1028 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 16, 22, 28, 34. Children will be followed and assessed until 3 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phosphatidylcholine versus placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will take 8 placebo capsules each containing 1100mg Rice Bran Oil and 150mg Pumpkin Seed Oil every day in place of phosphatidylcholine supplement. |
| Phosphatidylcholine | Active comparator | Drug: CholineParticipants will take 8 900mg capsules of phosphatidylcholine every day, the equivalent of approximately 1028 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 (1 listed)
- Pregnant women who report cannabis use during current pregnancy
Key exclusion criteria (7 listed)
- Pregnancies complicated by fetal anomaly, including neural tube defect or chromosomal abnormality, or multiple gestations due to increased obstetrical risks
- Women with major preexisting maternal medical morbidities
- Women with a 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 or homocystinuria
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 |
|---|---|---|
| PlaceboAlso: rice bran oil and pumpkin seed oilPregnant women are instructed to take the capsules twice per day, 4 placebo capsules at breakfast and 4 placebo capsules at dinner. Increased awareness of the benefits of choline by obstetricians and pregnant women, as well as our published results from an observational study showing a wide distribution of plasma choline concentration, is a more apt independent variable for analyses. | Drug | Placebo |
| CholineAlso: PhosphatidylcholinePregnant women are instructed to take the capsules twice per day, 4 900mg phosphatidylcholine capsules at breakfast and 4 capsules at dinner. Increased awareness Increased awareness of the benefits of choline by obstetricians and pregnant women, as well as our published results from an observational study showing a wide distribution of plasma choline concentration, is a more apt independent variable for analyses. | Drug | Phosphatidylcholine |
Primary outcome
Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index
Time frame: 3 months corrected age
The Orienting/Regulation Index is derived by adding the maternal rating of the infant's duration of attention, distractibility, soothability, cuddling, and smiling on the 91-item IBQ-r
Auditory Sensory Gating (P50)
Time frame: 1 month corrected age
Inhibition of the P50 cerebral auditory evoked response is collected during a paired stimulus auditory sensory gating paradigm
3 secondary outcomes
Maternal Plasma Choline Levels
Time frame: approximately 16, 22, 28, 34 weeks gestation
Bayley Scales of Infant and Toddler Development
Time frame: 1, 3 and 6 months corrected age
Child Behavior Checklist (CBCL) 1 1/2-5
Time frame: 18 months corrected age
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 3 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
M. Camille Hoffman, MD principal investigator
University of Colorado, Denver
Sharon Hunter, PhD principal investigator
University of Colorado School of Medicine
1 site 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 Cannabis Use, run by University of Colorado, Denver 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 1 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: looking for participants now, as of the sponsor's last update on 3 Feb 2025. 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 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?
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 M. Camille Hoffman, MD (303-724-6205, sharon.hunter@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index (time frame: 3 months corrected age). 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?
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 3 Feb 2025.