CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Omega-3 polyunsaturated fatty acids +1 moredrug
Likely dose
Omega-3 polyunsaturated fatty acids 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01733147
NCT01733147Phase 4Completed
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Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot Study

Mayo Clinic·interventional·Posted Nov 26, 2012·Updated Jan 11, 2022

In Brief

A Phase 4 clinical trial evaluating Omega-3 polyunsaturated fatty acids and Placebo for Barrett's Esophagus and Obesity. Completed, enrolled 60 participants across 1 site.

Detailed Summary

This study is being done to understand the effect of dietary omega-3 fats in decreasing tissue inflammation in Barrett's esophagus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBarrett's Esophagus, Obesity
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 26, 2012
Enrollment StartNov 1, 2012
Primary CompletionSep 12, 2018
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 13.6 years ago

Interventions

Omega-3 polyunsaturated fatty acidsdrug

3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.

Placebodrug

3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal.