drugset / Trial / NCT06379971
Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Choline | Other / unclassified | 1028 mg | Oral |
Indications
No indication recorded.