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Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development
Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development
Who can join
Ages 18 to 45 · Women · Healthy volunteers welcome
Full 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
About the study
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.
What is being tested
- Placebo (drug)
- Choline (drug)
Sponsor: University of Colorado, Denver · Participants: 140 · Started: Nov 25, 2024
Contact the study team
- M. Camille Hoffman, MD · Phone: 303-724-6205
- Sharon Hunter, PhD · Phone: 303-724-6246
Official record on ClinicalTrials.gov — NCT06379971
Locations in the U.S.
| Colorado | UC Health, Aurora |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.