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
University of Colorado, Denver
140 participants
Nov 25, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- Pregnant women who report cannabis use during current pregnancy
Exclusion Criteria7
- 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
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Interventions
Pregnant women are instructed to take the capsules twice per day, 4 placebo capsules at breakfast and 4 placebo capsules at dinner. Increased awareness of the benefits of choline by obstetricians and pregnant women, as well as our published results from an observational study showing a wide distribution of plasma choline concentration, is a more apt independent variable for analyses.
Pregnant women are instructed to take the capsules twice per day, 4 900mg phosphatidylcholine capsules at breakfast and 4 capsules at dinner. Increased awareness Increased awareness of the benefits of choline by obstetricians and pregnant women, as well as our published results from an observational study showing a wide distribution of plasma choline concentration, is a more apt independent variable for analyses.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06379971