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NCT03028857 · ClinicalTrials.gov registry record · Phase 1
Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal
A Phase 1 study of Child Development and Prenatal Stress, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 216
- Enrollment target
- 2
- Study locations
NCT03028857 is a Phase 1 study of Child Development and Prenatal Stress that has completed, run by University of Colorado, Denver. The registered enrollment target is 216 participants, below the 1,086-participant average among 32 other Child Development trials with a reported enrollment target (80% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03028857, a Phase 1 study of Child Development and Prenatal Stress, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 216 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women improves early brain development with improved brain-related development during the first four years of life. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcome is the child's behavior at four years of age as reported by the primary caregiver. Secondary outcomes include motor development, socio-emotional development, language development, and cognitive development. Potential contributors beyond the supplement, including maternal stress and placental function will also be assessed.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Choline
Study Locations (2)
Colorado
- UCHealth - Aurora
- Saint Joseph Hospital - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2025-12-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03028857
The ClinicalTrials.gov registry entry for NCT03028857 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,086-participant average among 32 other Child Development trials with a reported enrollment target (80% 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 Child Development appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03028857 reports 2 study locations spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT03028857 about?
NCT03028857 is a clinical study titled "Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal". The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women improves early brain development with improved brain-related development during the first four years of life. Participating pregnant women will receive either phosphatidylcholine or a placebo from ...
What is the current status of trial NCT03028857?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 216 participants. The study started on 2017-06-12. Estimated completion is 2025-12-22.
What conditions does trial NCT03028857 study?
This clinical trial studies the following conditions: Child Development, Prenatal Stress.
What interventions are being tested in trial NCT03028857?
The interventions under investigation include: Placebo (DRUG), Choline (DRUG).
Who is sponsoring clinical trial NCT03028857?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03028857 being conducted?
This trial has 2 study locations 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
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