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NCT01149538 · ClinicalTrials.gov registry record · Phase 1
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
A Phase 1 study of Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT01149538 is a Phase 1 study of Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome that has completed, run by University of Minnesota. The registered enrollment target is 60 participants, below the 100-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01149538, a Phase 1 study of Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning.
Conditions Studied
Interventions
- DRUG Choline bitartrate
- DIETARY_SUPPLEMENT Placebo for choline bitartrate
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01149538
The ClinicalTrials.gov registry entry for NCT01149538 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 100-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (40% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Fetal Alcohol Spectrum Disorders appearing as the primary indexed condition, and to 2 interventions - of which Choline bitartrate is the first listed.
NCT01149538 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT01149538 about?
NCT01149538 is a clinical study titled "Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure". The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning.
What is the current status of trial NCT01149538?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2010-07. Estimated completion is 2014-09.
What conditions does trial NCT01149538 study?
This clinical trial studies the following conditions: Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol Related Neurodevelopmental Disorder, Prenatal Alcohol Exposure.
What interventions are being tested in trial NCT01149538?
The interventions under investigation include: Choline bitartrate (DRUG), Placebo for choline bitartrate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01149538?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01149538 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.