Choline Supplementation for Cannabis Use During Pregnancy

Overseen By M. Camille Hoffman, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Colorado, Denver

Disqualifiers: Fetal anomaly, Major morbidities, Fetal death, Chronic infections, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

Duration: Approximately 24 weeks

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the nutritional supplement phosphatidylcholine (a form of choline) can enhance brain development in babies whose mothers used cannabis during pregnancy. Pregnant participants will receive either the supplement or a placebo from about 16 weeks into their pregnancy until birth. Researchers will assess the baby's brain response to sounds at 4 weeks old and their behavior at 3 months old. The study seeks pregnant women who have used cannabis products during their current pregnancy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this potentially beneficial supplement.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that choline, tested as phosphatidylcholine in this trial, is safe for use during pregnancy. Previous studies have found that higher choline levels in pregnant women link to better attention and brain development in their children. This suggests that choline might support healthy brain development without causing serious side effects.

Researchers are also examining choline's potential to reduce pregnancy risks, such as issues with brain and nerve development in babies. Studies indicate that low choline intake in pregnant women can increase the risk of neural tube defects, which affect the baby's brain and spine. Therefore, adequate choline intake is important.

Overall, the treatment appears well-tolerated, with no major safety concerns reported. However, as this trial is still in its early stages, researchers continue to gather more information about its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about choline supplementation during pregnancy for cannabis users because it offers a natural approach that directly supports brain development in the fetus. Unlike other treatments that might focus on reducing cannabis dependency, choline specifically targets the potential cognitive impacts on the developing baby by providing an essential nutrient for brain health. This approach is unique because it leverages phosphatidylcholine, a form of choline, to potentially mitigate cognitive risks without relying on pharmaceutical interventions.

What evidence suggests that choline supplementation could be effective for improving brain development in infants exposed to cannabis during pregnancy?

Research has shown that higher levels of choline in pregnant women might lessen cannabis's impact on a baby's brain development. One study found that taking choline supplements during pregnancy led to better thinking skills in children. Another study suggested a link between choline and improved brain growth and mental function in children. In this trial, participants will receive either a phosphatidylcholine supplement or a placebo to evaluate choline's potential benefits for supporting healthier brain development if cannabis is used during pregnancy. Overall, choline appears to offer potential benefits for newborns' brain development. ^{2 3 4 6 7}

Who Is on the Research Team?

M. Camille Hoffman, MD

Principal Investigator

University of Colorado, Denver

Sharon Hunter, PhD

Principal Investigator

University of Colorado School of Medicine

Are You a Good Fit for This Trial?

This trial is for pregnant women who have used cannabis during their current pregnancy. It aims to see if a nutritional supplement, phosphatidylcholine, can improve their baby's brain development in the first 18 months after birth.

Inclusion Criteria

Pregnant women who report cannabis use during current pregnancy

Exclusion Criteria

Pregnancies complicated by fetal anomaly, including neural tube defect or chromosomal abnormality, or multiple gestations due to increased obstetrical risks

I have significant health issues unrelated to my pregnancy.

Evidence of noncompliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either phosphatidylcholine or placebo from approximately 16 weeks gestation through birth

Approximately 24 weeks

Visits at enrollment, and approximately at weeks 16, 22, 28, 34

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Assessments at 1 month and 3 months corrected age

What Are the Treatments Tested in This Trial?

Interventions

• Choline

Trial Overview The study tests whether taking phosphatidylcholine from about 16 weeks of pregnancy until birth affects the child's early brain responses and behaviors at various stages up to 18 months old, compared with a placebo.

How Is the Trial Designed?

Group I: Phosphatidylcholine Active Control 1 Intervention

Participants will take 8 900mg capsules of phosphatidylcholine every day, the equivalent of approximately 1028 mg of choline per day until delivery

Group II: Placebo Placebo Group 1 Intervention

Participants will take 8 placebo capsules each containing 1100mg Rice Bran Oil and 150mg Pumpkin Seed Oil every day in place of phosphatidylcholine supplement.

Choline is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Choline for:

• Dietary supplement

Approved in European Union as Choline for:

• Dietary supplement

Approved in Canada as Choline for:

• Dietary supplement

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

Choline supplementation during pregnancy has been shown to improve cognitive outcomes in children, highlighting its importance as a non-pharmacological intervention for enhancing child development.

This systematic review analyzed 9 studies on various forms of choline supplementation (like choline chloride and phosphatidylcholine) and confirmed its effectiveness in promoting better cognitive abilities in offspring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Importance of choline during pregnancy and lactation: A systematic review]. Heras-Sola, J., Gallo-Vallejo, JL.[2023]

Prenatal choline supplementation of 550 mg/d significantly increased maternal plasma levels of choline and its metabolites, such as betaine and phosphatidylcholine, compared to a lower dose of 25 mg/d, indicating enhanced choline metabolism during pregnancy.

The study suggests that higher choline intake supports metabolic adaptations necessary for both maternal and fetal health, with specific biomarkers identified for monitoring nutritional status during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choline metabolome response to prenatal choline supplementation across pregnancy: A randomized controlled trial. Taesuwan, S., McDougall, MQ., Malysheva, OV., et al.[2022]

In a pilot study of 16 pregnant women in Jamaica, the average dietary choline intake was found to be significantly below the recommended level of 450 mg/day, with a mean intake of only 278.5 mg.

The mean plasma choline concentration in these women was 8.4 micromol/L, which is lower than the normal levels for both non-pregnant individuals and pregnant women, suggesting potential nutritional inadequacy that could affect fetal development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intake of choline and plasma choline concentrations in pregnant women in Jamaica. Gossell-Williams, M., Fletcher, H., McFarlane-Anderson, N., et al.[2022]

Choline is essential during pregnancy for critical functions such as brain development, neurotransmission, and gene expression, highlighting its importance for both maternal and fetal health.

Most pregnant women in the U.S. do not meet the recommended choline intake of 450 mg/day, suggesting that dietary or supplemental increases in choline could improve pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choline: Exploring the Growing Science on Its Benefits for Moms and Babies. Korsmo, HW., Jiang, X., Caudill, MA.[2020]

Low maternal choline intake is linked to a higher risk of neural tube defects (NTDs), with a pooled estimate indicating a 36% increased odds for NTDs among mothers with low choline levels based on a meta-analysis of 5 case-control studies involving over 5,500 mothers.

Higher maternal choline intake during pregnancy (550 mg to 1 g/day) and early postnatal periods is associated with improved neurocognitive outcomes in children, suggesting that increasing choline intake could enhance memory, attention, and learning abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Maternal Choline, Fetal Brain Development, and Child Neurocognition: Systematic Review and Meta-Analysis of Human Studies. Obeid, R., Derbyshire, E., Schön, C.[2023]

Choline requirements are significantly higher for preterm infants (50-60 mg/kg/day) compared to term infants (17-18 mg/kg/day), highlighting the importance of adequate choline intake during rapid organ growth in the third trimester.

Most infant formulas do not provide sufficient choline or the appropriate types of choline components found in breast milk, indicating a need for reformulation and clearer labeling to ensure infants receive adequate choline for healthy development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choline Content of Term and Preterm Infant Formulae Compared to Expressed Breast Milk-How Do We Justify the Discrepancies? Shunova, A., Böckmann, KA., Minarski, M., et al.[2021]

Betaine supplementation did not effectively increase serum choline levels in non-pregnant women, whether given as a single dose or over a week, indicating it cannot replace phosphatidylcholine for boosting choline levels.

In contrast, phosphatidylcholine supplements significantly raised serum choline concentrations after both single and repeated doses, confirming their efficacy in increasing choline levels essential for fetal brain development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of phosphatidylcholine and betaine supplements on women's serum choline. Hoffman, MC., Olincy, A., D'Alessandro, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7055467/

Interaction of maternal choline levels and prenatal Marijuana's ... This study investigated whether higher maternal choline levels mitigate effects of marijuana on fetal brain development.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11901549/

Choline During Pregnancy and Child Neurodevelopment Animal studies suggest that choline supplementation during pregnancy improves cognitive outcomes in the offspring. This review aims to determine whether higher ...

3. trialx.com trialx.com/clinical-trials/listings/306852/maternal-choline-supplementation-and-cannabis-use-during-pregnancy-impact-on-early-brain-development/

Maternal Choline Supplementation and Cannabis Use ... Problems in behavioral and cognitive development into childhood have been reported in children of mothers who used cannabis during gestation.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323000868

Association between Maternal Choline, Fetal Brain ... We studied associations between prenatal and early postnatal choline intake, brain development, and neurocognitive function of children.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00332124

Safety and Effectiveness of Taking Choline Supplements ... Study Details | NCT00332124 | Safety and Effectiveness of Taking Choline Supplements During Pregnancy for Improving Infant Brain Development | ClinicalTrials. ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8310535/

Prenatal choline, cannabis, and infection, and their ... Increased maternal plasma choline concentrations in the early second trimester of pregnancy were associated with decreased problems in attention in both sexes ...

7. mdpi.com mdpi.com/2072-6643/17/5/886

Choline During Pregnancy and Child Neurodevelopment Animal studies suggest that choline supplementation during pregnancy improves cognitive outcomes in the offspring. This review aims to determine whether higher ...