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

Trial Summary

What is the purpose of this trial?

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.

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 choline supplementation safe for pregnant women?

Choline supplementation during pregnancy is generally considered safe and is important for fetal brain development. Studies suggest that higher maternal choline intake is associated with better child neurocognition and may reduce the risk of neural tube defects. ^{1 2 3 4 5}

How does choline supplementation differ from other treatments for cannabis use during pregnancy?

Choline supplementation is unique because it is a non-drug treatment that focuses on providing an essential nutrient to support fetal brain development and improve cognitive outcomes in children, rather than directly addressing cannabis use. Unlike other treatments, it involves increasing the intake of choline, which is often below recommended levels in pregnant women, to meet the increased demands during pregnancy. ^{1 2 3 6 7}

Research Team

Sharon Hunter, PhD

Principal Investigator

University of Colorado School of Medicine

M. Camille Hoffman, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. Jamaica pubmed.ncbi.nlm.nih.gov

Dietary intake of choline and plasma choline concentrations in pregnant women in Jamaica. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

[Importance of choline during pregnancy and lactation: A systematic review]. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of phosphatidylcholine and betaine supplements on women's serum choline. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Choline Content of Term and Preterm Infant Formulae Compared to Expressed Breast Milk-How Do We Justify the Discrepancies? [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Choline metabolome response to prenatal choline supplementation across pregnancy: A randomized controlled trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Choline: Exploring the Growing Science on Its Benefits for Moms and Babies. [2020]