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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2018-09-12

Brief Summary

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

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Detailed Description

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Conditions

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Barrett's Esophagus Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive a placebo which looks exactly like the study drug, but contains no active ingredient, to be taken orally for six months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Omega-3 polyunsaturated fatty acids

Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive Omega-3 free fatty acids supplements to be taken orally for six months.

Group Type ACTIVE_COMPARATOR

Omega-3 polyunsaturated fatty acids

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Docosahexaenoic Acid (DHA)/Eicosapentaenoic Acid (EPA)

Eligibility Criteria

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Inclusion Criteria

* Presence of BE defined as ≥ 1 cm of visible columnar mucosa in the distal esophagus with intestinal metaplasia on histology.
* Absence of high grade dysplasia or EAC on baseline histology.
* BMI \> 30 kg/m2 or waist circumference \> 102 cm in men, \> 88 cm in women.
* Ability to give informed consent.

Exclusion Criteria

* Allergy to ω3 FFAs, fish or shellfish.
* Presence of high grade dysplasia or cancer on histology.
* Pregnant and or breastfeeding women
* Presence of esophagitis on initial endoscopy or symptoms of refractory GERD (heartburn or regurgitation ≥ 2 times a week) indicative of uncontrolled gastroesophageal reflux.
* Inability to give informed consent.
* Currently taking Omega3 FFA as prescription.
* Anti-coagulant therapy (Plavix, Warfarin, Coumadin)
* AST or ALT level \> three times upper limit of normal at baseline
* LDL \> 200 mg/dl at baseline.
* INR \> 2

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No