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NCT03576989 · ClinicalTrials.gov registry record · NA

Impact of Omega-3 Fatty Acid Oral Therapy on Healing of Chronic Venous Leg Ulcers in Older Adults

A NA study, sponsored by Ohio State University.

Completed
Registry status
NA
Development phase
96
Enrollment target

NCT03576989: Completed NA study, sponsored by Ohio State University.

NCT03576989 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 96 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03576989, a NA study, has completed, sponsored by Ohio State University.

COMPLETED
Registry status
NA
Development phase
96 participants
Enrollment target

Study Summary

The purpose of this study is to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil to promote healing of chronic venous leg ulcers (CVLUs) by reducing the chronic inflammation at wound sites that prevents healing progression. If this systemic, nutrient intervention is found to alter the microenvironment of CVLUs, the science of wound healing and care of patients with CVLUs will be vastly improved.

Primary Outcome

Intervention effects on plasma levels of lipid mediator of inflammation HEPE5 measured in pg/mL at Weeks 4, 8 and 12. 5-HEPE (5-hydroxy-eicosapentaenoic acid) is an eicosanoid derived from eicosapentaenoic acid (EPA) via the 5-lipoxygenase pathway. It functions as an anti-inflammatory lipid mediator, in part through the generation of reactive oxygen species. Plasma levels of 5-HEPE (also known as HEPE5) were measured using liquid chromatography-mass spectrometry.

Interventions

  • OTHER placebo
  • DIETARY_SUPPLEMENT EPA+DHA

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2019-04-15
Est. Completion 2024-12-18
Phase NA
Ohio State University

552 total trials

What the finished NCT03576989 record still lists

NCT03576989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT03576989 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03576989 about?

NCT03576989 is a clinical study titled "Impact of Omega-3 Fatty Acid Oral Therapy on Healing of Chronic Venous Leg Ulcers in Older Adults". The purpose of this study is to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil to promote healing of chronic venous leg ulcers (CVLUs) by reducing the chronic inflammation at wound sites that prevents healing progression. If this systemic, nutrien...

What is the current status of trial NCT03576989?

This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2019-04-15. Estimated completion is 2024-12-18.

What interventions are being tested in trial NCT03576989?

The interventions under investigation include: placebo (OTHER), EPA+DHA (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT03576989?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03576989's enrollment target sits among peer trials

96 925th of 2000 higher than 1,070 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT03576989, the US trial registry maintained by the National Library of Medicine. NCT03576989 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.