NCT01733147

Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Barrett's Esophagus
• Obesity

Interventions

Type	Name	Description
DRUG	Omega-3 polyunsaturated fatty acids	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.
DRUG	Placebo	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.

Timeline

• Start date: 2012-11-01
• Primary completion: 2018-09-12
• Completion: 2018-09-12
• First posted: 2012-11-26
• Last updated: 2022-01-11
• Results posted: 2022-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study