Impact of Choline Supplement on Brain Development in Babies of Cannabis-Using Pregnant Women
Official title: Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development
Run by University of Colorado, Denver · NCT06379971 · Data updated 2026-11-12
This study is testing if giving a choline supplement to pregnant women who used cannabis can help improve their babies' brain development in the first few months of life.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 140 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | November 25, 2024 |
| Main results expected | April 30, 2029 |
| Study ends | April 30, 2029 |
| Registry record updated | February 3, 2025 |
| Trial ID | NCT06379971 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women who report using cannabis during their current pregnancy.
✕Probably not a fit
Patients who have pregnancies complicated by fetal anomalies or major preexisting medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate whether providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis during their pregnancy can enhance their babies' brain development in the first three months of life. Pregnant participants will be randomly assigned to receive either the choline supplement or a placebo from around 16 weeks of gestation until delivery. The primary outcomes will focus on the infants' brain responses to sound at four weeks and behavioral assessments at three months, while secondary outcomes will include various aspects of motor, socio-emotional, language, and cognitive development. The study will also monitor maternal health and potential side effects throughout the intervention.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive and behavioral outcomes in infants born to mothers who used cannabis during pregnancy.
How similar studies have gone: While some studies have suggested benefits of maternal choline on child development, this specific approach of combining choline supplementation with cannabis use during pregnancy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 * 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
Where it's running
-
UC Health
Aurora, Colorado, United States Recruiting
Study contacts
- Principal investigator: M. Camille Hoffman, MD — University of Colorado, Denver
- Study coordinator: M. Camille Hoffman, MD
- Email: sharon.hunter@cuanschutz.edu
- Phone: 303-724-6205
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.