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Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal
NCT03028857 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,447 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03028857 reports 2 study locations spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03028857?
The interventions under investigation include: Placebo (DRUG), Choline (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03028857?
This trial is sponsored by University of Colorado, Denver, which has 1,447 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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