Actively Recruiting
Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development
Led by University of Colorado, Denver · Updated on 2025-02-03
140
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women who report cannabis use during current pregnancy
You will not qualify if you...
- Pregnancies with fetal anomalies like neural tube defects, chromosomal abnormalities, or multiple gestations
- Women with major existing medical illnesses
- Women with a previous fetal death
- Current chronic infections including HIV
- Personal or first-degree family history of trimethylaminuria or homocystinuria
- Primary language other than English or Spanish
- Evidence of noncompliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UC Health
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
M
M. Camille Hoffman, MD
CONTACT
S
Sharon Hunter, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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