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NCT03077724 · ClinicalTrials.gov registry record · Phase 2
Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study
A Phase 2 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT03077724 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 28 participants.
The verdict
NCT03077724, a Phase 2 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of this feasibility study is to obtain pilot data in preparation for an upcoming R01 submission. The goals of that submission will be to conduct a clinical trial of n-3 LCPUFAs for smoking cessation in pregnant women. For this proposal, the investigators will develop, test, and refine the recruitment strategy and collect data demonstrating the investigators ability to successfully recruit pregnant women who are actively smoking. The investigators will collect side effect, tolerability, and adherence data regarding the intervention. Finally, the investigators hope to gather preliminary effect size data to allow more formal estimates of sample size. The investigators hypothesize that pregnant smokers randomized to n-3 LCPUFA supplementation will have higher smoking cessation rates and less nicotine cravings compared to women allocated to placebo. The investigators intend to use this preliminary data to inform a future randomized, double-blind, placebo-controlled trial of n-3 LCPUFA supplementation for tobacco cessation.
Interventions
- DRUG Placebos
- DRUG Fish oil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-03-02 |
| Est. Completion | 2018-09-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03077724
The ClinicalTrials.gov registry entry for NCT03077724 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03077724 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03077724 about?
NCT03077724 is a clinical study titled "Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study". The purpose of this feasibility study is to obtain pilot data in preparation for an upcoming R01 submission. The goals of that submission will be to conduct a clinical trial of n-3 LCPUFAs for smoking cessation in pregnant women. For this proposal, the investigators will develop, test, and refine th...
What is the current status of trial NCT03077724?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2017-03-02. Estimated completion is 2018-09-05.
What interventions are being tested in trial NCT03077724?
The interventions under investigation include: Placebos (DRUG), Fish oil (DRUG).
Who is sponsoring clinical trial NCT03077724?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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