NCT04417595: INFANTS

Omega-3 Fatty Acids for Smoking Cessation in Pregnancy

Active, enrolled Phase 2 Last updated 15 December 2025

What this trial tests

Phase 2 trial testing Fish Oil (Containing Omega-3 Acids) in Preterm Labor in 400 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 November 2020

Primary endpoint
30 November 2024

8 January 2026

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	400
Start date	10 November 2020
Primary completion	30 November 2024
Estimated completion	8 January 2026
Sites	1 location across United States

Drugs / interventions tested

• Fish Oil (Containing Omega-3 Acids) — full drug profile →
• Olive Oil — full drug profile →

Conditions studied

• Preterm Labor — all drugs for Preterm Labor →
• Tobacco Use Disorder — all drugs for Tobacco Use Disorder →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 16 to 40, female only, with Preterm Labor or Tobacco Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 aims of this proposal are to 1) determine the effect of supplemental n-3 LCPUFAs on gestational age at delivery and preterm labor in pregnant smokers and 2) determine the effect of n-3 LCPUFA supplementation on tobacco use in pregnant smokers. We will recruit potential participants from eight obstetrics clinics across the Middle-Tennessee area. Our study could have a major translational impact on both adverse tobacco-related birth outcomes and smoking cessation efforts.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Investigating N-3 Fatty Acids to prevent Neonatal Tobacco-related outcomeS (INFANTS): study protocol for a double-blind, randomized, placebo-controlled parallel clinical trial of n-3 polyunsaturated fatty acids in pregnant smokers.
   Murff HJ, Greevy RA, Sanghani RS, Hartmann KE, et al · · 2021 · PMID 34906201 · DOI 10.1186/s13063-021-05865-7