drugset / Trial / NCT06379971

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

NCT06379971

Phase 1 Recruiting 140 enrolled University of Colorado, Denver
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2024-11-25
Primary completion
2029-04-30
Completion
2029-04-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Choline Other / unclassified 1028 mg Oral

Indications

No indication recorded.