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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: Recruiting Phase 1 study of Cannabis Use and Child Development, sponsored by University of Colorado, Denver.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Orienting/Regulation Index is derived by adding the maternal rating of the infant's duration of attention, distractibility, soothability, cuddling, and smiling on the 91-item IBQ-r
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 |
What NCT06379971 shows while recruiting
NCT06379971 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 276-participant average among 44 other Cannabis Use trials with a reported enrollment target (49% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cannabis Use
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06379971's enrollment target sits among peer trials
140 18th of 44 higher than 27 of 44 other Cannabis Use trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cannabis Use trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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