CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 125 enrolled
Drug / intervention
Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01078909
NCT01078909Phase 3Completed
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Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation

Penn State University·interventional·Posted Mar 2, 2010·Updated Aug 21, 2023

In Brief

A Phase 3 clinical trial evaluating Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) for Cardiovascular Disease and Inflammation. Completed, enrolled 125 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the inflammatory response to in vivo and ex vivo endotoxin challenge as measured by the production over time of several inflammatory markers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Disease, Inflammation
CountriesUnited States
CollaboratorsUnited States Department of Agriculture (USDA)

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2010
Enrollment StartOct 1, 2011
Primary CompletionNov 1, 2012
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.3 years ago

Interventions

Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)biological

Comparison of 4 doses of EPA+DHA on in vivo and ex vivo (monocytes) response to an inflammatory stimulus (endotoxin) following a 6 month supplementation period