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

NCT01733147 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 12-005914
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Omega-3 fatty acid

Outcome Measures

Primary Outcomes (2)

• Change in Serum PGE2 Levels

  Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw

  Baseline, 6 months

• Change in Esophageal Tissue PGE2 Levels

  Percent change from baseline to 6 months in esophageal tissue prostaglandin E2 (PGE2) level obtained from endoscopic esophageal tissue collection

  Baseline, 6 months

Secondary Outcomes (1)

• Change in Esophageal Macrophage Markers

  Baseline, 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Omega-3 polyunsaturated fatty acids

ACTIVE COMPARATOR

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.

Drug: Omega-3 polyunsaturated fatty acids

Interventions

Omega-3 polyunsaturated fatty acids 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.

Also known as: Docosahexaenoic Acid (DHA)/Eicosapentaenoic Acid (EPA)

Omega-3 polyunsaturated fatty acids

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Barrett Esophagus; Obesity

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Dr. Prasad Iyer
• Organization: Mayo Clinic

iyer.Prasad@mayo.edu

507-293-7911

Study Officials

• Prasad Iyer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 26, 2012
• Study Start: November 1, 2012
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-12

Locations

US (1)