NCT06379971 Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development
| NCT ID | NCT06379971 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Colorado, Denver |
| Condition | Child Development |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2029-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 140 participants in total. It began in 2024-11-25 with a primary completion date of 2029-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
M. Camille Hoffman, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT06379971 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Child Development. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06379971 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06379971 currently recruiting?
Yes, NCT06379971 is actively recruiting participants. Contact the research team at sharon.hunter@cuanschutz.edu for enrollment information.
Where is the NCT06379971 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06379971 clinical trial?
NCT06379971 is sponsored by University of Colorado, Denver. The principal investigator is M. Camille Hoffman, MD at University of Colorado, Denver. The trial plans to enroll 140 participants.