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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: Completed Phase 2 study, sponsored by Vanderbilt University Medical Center.
NCT03077724 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in total number of cigarettes per day from baseline to 4-weeks
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 |
What the finished NCT03077724 record still lists
NCT03077724 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03077724 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03077724's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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