Impact of Choline Supplement on Brain Development in Babies of Cannabis-Using Pregnant Women
Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development
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 |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06379971 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who report using cannabis during their current pregnancy.
Not a fit: Patients who have pregnancies complicated by fetal anomalies or major preexisting medical conditions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aurora, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.