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NCT04417595 · ClinicalTrials.gov registry record · Phase 2
Omega-3 Fatty Acids for Smoking Cessation in Pregnancy
A Phase 2 study of Tobacco Use Disorder and Preterm Labor, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
- 1
- Study location
NCT04417595 is a Phase 2 study of Tobacco Use Disorder and Preterm Labor that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 400 participants, above the 234-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (71% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04417595, a Phase 2 study of Tobacco Use Disorder and Preterm Labor, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
Smoking is the most important modifiable risk factor for adverse pregnancy outcomes including preterm birth, neonatal death, and maternal complications. Rates of smoking cessation during pregnancy are low, particularly in underserved populations, and currently approved pharmacotherapies for smoking cessation either are considered unsafe in pregnancy or have uncertain effectiveness. Identifying safe and effective interventions, which might mitigate the adverse effects of smoking on maternal-fetal outcomes, is a major public health priority. We hypothesize that smoking-induced n-3 LCPUFA relative deficiencies may be an important mechanism contributing to tobacco-related adverse pregnancy outcomes and that n-3 LCPUFA supplementation specifically targeted to pregnant smokers may reduce these complications. Support for this hypothesis comes from a recent secondary analysis of the Omega-3 Fatty Acids Supplementation to Prevent Preterm Birth trial that found that only smokers taking n-3 LCPUFAs had a reduction in preterm labor risk as compared to non-smokers. While compelling, this study was a post hoc analysis that included only a small sample of smokers and did not collect data on smoking behaviors during follow up. Yet the ascertainment of longitudinal smoking behavior is critical, as some clinical studies have found that supplemental n-3 LCPUFAs might also reduce nicotine cravings, and lower daily cigarette use. Thus, smokers may doubly benefit from replenishing n-3 LCPUFAs via lower risk of preterm labor and/or increased smoking cessation. To address these knowledge gaps, we are proposing a multi-center, randomized, placebo-controlled, double-blinded study of n-3 LCPUFA supplementation in 400 pregnant smokers. We will collect detailed information on smoking behavior, validated biological markers of cigarette exposure (urinary cotinine, end-expiratory carbon monoxide) and biomarkers of n-3 LCPUFA status (red blood cell phospholipid membrane fatty acids). Our specific a
Conditions Studied
Interventions
- DRUG Fish Oil (Containing Omega-3 Acids)
- DRUG Olive Oil
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2020-11-10 |
| Est. Completion | 2026-01-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04417595
The ClinicalTrials.gov registry entry for NCT04417595 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 234-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (71% higher). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Tobacco Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Fish Oil (Containing Omega-3 Acids) is the first listed.
NCT04417595 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT04417595 about?
NCT04417595 is a clinical study titled "Omega-3 Fatty Acids for Smoking Cessation in Pregnancy". Smoking is the most important modifiable risk factor for adverse pregnancy outcomes including preterm birth, neonatal death, and maternal complications. Rates of smoking cessation during pregnancy are low, particularly in underserved populations, and currently approved pharmacotherapies for smoking ...
What is the current status of trial NCT04417595?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2020-11-10. Estimated completion is 2026-01-08.
What conditions does trial NCT04417595 study?
This clinical trial studies the following conditions: Tobacco Use Disorder, Preterm Labor.
What interventions are being tested in trial NCT04417595?
The interventions under investigation include: Fish Oil (Containing Omega-3 Acids) (DRUG), Olive Oil (DRUG).
Who is sponsoring clinical trial NCT04417595?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04417595 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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