Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Child Development, Cannabis Use

In brief

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.

Key facts

Study ID

NCT06379971

Run by

University of Colorado, Denver

People needed

140

Starts

2024-11-25

Expected to finish

2029-04-30

Last updated by the study team

2025-02-03

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant women who report cannabis use during current pregnancy

You may not qualify if…

• 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 it is running

• UC Health — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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