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NCT06379971 · ClinicalTrials.gov registry record · Phase 1
Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development
A Phase 1 study of Cannabis Use and Child Development, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT06379971 is a Phase 1 study of Cannabis Use and Child Development that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 140 participants, below the 276-participant average among 44 other Cannabis Use trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06379971, a Phase 1 study of Cannabis Use and Child Development, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Choline
Study Locations (1)
Colorado
- UC Health - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2024-11-25 |
| Est. Completion | 2029-04-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06379971
The ClinicalTrials.gov registry entry for NCT06379971 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 276-participant average among 44 other Cannabis Use trials with a reported enrollment target (49% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cannabis Use appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06379971 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT06379971 about?
NCT06379971 is a clinical study titled "Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development". 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 recei...
What is the current status of trial NCT06379971?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2024-11-25. Estimated completion is 2029-04-30.
What conditions does trial NCT06379971 study?
This clinical trial studies the following conditions: Cannabis Use, Child Development.
What interventions are being tested in trial NCT06379971?
The interventions under investigation include: Placebo (DRUG), Choline (DRUG).
Who is sponsoring clinical trial NCT06379971?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06379971 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.