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Omega-3 Fatty Acids

Omega-3 Fatty Acid Supplements for Preterm Labor Prevention in Smokers (INFANTS Trial)

Phase 2
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 16 or ≤ 40 years of age
Between 12 and 24 weeks gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at delivery
Awards & highlights

INFANTS Trial Summary

This trial will test whether or not supplementing with n-3 LCPUFAs (a type of Omega-3 fatty acid) can help pregnant smokers quit smoking and/or reduce the risk of preterm labor.

Who is the study for?
This trial is for pregnant smokers aged 16-40, who are between 12 and 24 weeks gestation, smoke at least one cigarette per day (previously ten before pregnancy), and have a carbon monoxide reading of at least 8 ppm. They must not be using fish oil supplements or have allergies to fish, substance abuse issues, certain medical conditions like chronic hypertension or clotting disorders, nor plans to move from Middle-Tennessee within nine months.Check my eligibility
What is being tested?
The study tests if Omega-3 acids in fish oil can help prevent premature labor in pregnant women who smoke by potentially reducing nicotine cravings and cigarette use. It's a double-blinded study with two groups: one taking fish oil and the other olive oil as a placebo. The effects on both preterm labor risk and smoking behavior will be monitored.See study design
What are the potential side effects?
While the side effects aren't detailed here, typical ones associated with Omega-3 supplements may include an upset stomach, nausea, or a fishy aftertaste. Olive oil is generally well-tolerated but could cause similar digestive discomfort.

INFANTS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 16 and 40 years old.
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I am between 3 and 6 months pregnant.

INFANTS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cigarettes per day
Gestational age at delivery
Secondary outcome measures
Apgar score
Individualized birth weight Z-score (adjusted for gestational age and maternal weight)
Percent of neonates with a congenital abnormality
+9 more

INFANTS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fish OilExperimental Treatment1 Intervention
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Group II: Olive OilPlacebo Group1 Intervention
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
671,797 Total Patients Enrolled
1 Trials studying Tobacco Use Disorder
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,672,182 Total Patients Enrolled
3 Trials studying Tobacco Use Disorder
4,225 Patients Enrolled for Tobacco Use Disorder

Media Library

Fish Oil (Containing Omega-3 Acids) (Omega-3 Fatty Acids) Clinical Trial Eligibility Overview. Trial Name: NCT04417595 — Phase 2
Tobacco Use Disorder Research Study Groups: Olive Oil, Fish Oil
Tobacco Use Disorder Clinical Trial 2023: Fish Oil (Containing Omega-3 Acids) Highlights & Side Effects. Trial Name: NCT04417595 — Phase 2
Fish Oil (Containing Omega-3 Acids) (Omega-3 Fatty Acids) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04417595 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new enrolments being accepted for this experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical study is actively enrolling participants since its first post date of November 10 2020. The current goal is to recruit 400 patients at a single site for trial participation."

Answered by AI

What is the intended outcome of this clinical research?

"This clinical trial shall last 12 weeks and investigate the gestational age at birth as their primary outcome. Secondary objectives include assessing cesarean delivery rate, birth weight Z-score (factoring in maternal weight), and Apgar score. Data collection will be conducted by blinded study personnel reviewing patient's medical records to ascertain these variables which are both categorical or numerical depending on the variable type."

Answered by AI

How many volunteers are currently participating in this clinical research?

"Affirmative. According to clinicaltrials.gov, this research program is actively seeking participants and was initially made public on November 10th 2020 before being revised on the 29th of November 2021. 400 people are required for this investigation taking place at one site."

Answered by AI

What criteria must one meet to be considered a viable participant in this medical experiment?

"Researchers are currently looking for 400 participants aged 16 to 40, who have tobacco dependence and meet the following criteria: Between 12 and 24 weeks gestation; Daily cigarette use of at least one per day (10 or more prior to pregnancy); A cell phone number or land line that can be contacted directly."

Answered by AI

Does this clinical experiment represent a pioneering effort?

"The initial examination of the therapeutic potential of Fish Oil (Containing Omega-3 Acids) was carried out in 2005 under Abbott's sponsorship, leading to Phase 4 drug approval after 15480 participants. At present, 24 trials are being conducted across 12 nations and 24 urban areas."

Answered by AI

Do people below a certain age have access to this trial?

"According to the specifications for this medical trial, individuals aged 16 and above but below 40 are permitted to enroll."

Answered by AI

Are there any preceding investigations that have examined the efficacy of Omega-3 fatty acids derived from Fish Oil?

"At this time, 24 scientific trials concerning Fish Oil (Containing Omega-3 Acids) are ongoing; 6 of these studies have reached the third stage. The majority of sites conducting research on Fish Oil (Containing Omega-3 Acids) can be found in Boston Massachusetts, however 57 other locations across America also host clinical investigations into its efficacy."

Answered by AI

Is Fish Oil (Containing Omega-3 Acids) sanctioned by the FDA?

"After careful consideration our team at Power assigned an evaluation score of 2 to Fish Oil (Containing Omega-3 Acids). This is due to the existence of data that confirms its safety, but no evidence yet supporting efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
65+
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Vanderbilt University Medical Center: < 48 hours
Recent research and studies
TrialsJournal
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, Harvey J., Robert A. Greevy, Reesha S. Sanghani, Katherine E. Hartmann, Tina V. Hartert, Cornelia R. Graves, Scott S. Lee, and Hilary A. Tindle. 2021. “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”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05865-7.
clinicaltrials.govStudy
Investigating N-3 Fatty Acids to Prevent Neonatal Tobacco-related outcomeS
Harvey Murff 2020. "Investigating N-3 Fatty Acids to Prevent Neonatal Tobacco-related outcomeS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04417595.
~19 spots leftby Jun 2024
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