Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01733147
First received: November 20, 2012
Last updated: December 23, 2014
Last verified: December 2014
  Purpose

Will oral supplementation with Omega 3 free fatty acids in obese Barrett's esophagus subjects downregulate pro-neoplastic and pro-inflammatory pathways in the esophagus to anti-inflammatory pathway?


Condition Intervention Phase
Barrett's Esophagus
Obesity
Drug: Omega-3 free fatty acids
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modulation of Esophageal Inflammation in Barrett&Apos;s Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • changes in esophageal inflammation [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Specific Aim 1: To estimate the magnitude and variation of changes in esophageal inflammation and injury in Barrett's esophagus as measured by tissue PGE2 and the esophageal inflammation score, attributable to ω3 FFA supplementation.


Secondary Outcome Measures:
  • variation of changes in esophageal tissue [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Specific Aim 2: To estimate the magnitude and variation of changes in esophageal macrophage infiltration and modulation of esophageal macrophage phenotype attributable to ω3 FFA supplementation.


Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects will be placed on 3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months. Subjects will take 2 capsules with breakfast and 1 capsule with their evening meal.
Drug: Placebo
Baseline assessment: Measure waist and hip circumference, height, weight. Complete Reflux Symptom Questionnaire (RSQ). Blood draw for serum free fatty acid (FFA) profile. Clinical baseline blood draw: INR, LDL, AST and ALT. Single slice CT of abdomen. Endoscopy performed with biopsies. Randomized to ω3 FFA preparation or placebo for six months. Telephone calls will be made every month to subjects to assess for adverse effects and reinforce compliance. Repeat assessment at six months following randomization. This will include anthropometry (similar to baseline), a blood draw as outlined at baseline, and endoscopy with research biopsies as outlined at baseline. Subjects will also fill out the RSQ.
Other Name: Placebo
Active Comparator: Omega-3 free fatty acids
Subjects will be placed on 3 capsules a day of Omega 3 free fatty acids taken orally for six months. Subjects will take 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: Omega-3 free fatty acids
Baseline assessment: Measure waist and hip circumference, height, weight. Complete Reflux Symptom Questionnaire (RSQ). Blood draw for serum free fatty acid (FFA) profile. Clinical baseline blood draw: INR, LDL, AST and ALT. Single slice CT of abdomen. Endoscopy performed with biopsies. Randomized to ω3 FFA preparation or placebo for six months. Telephone calls will be made every month to subjects to assess for adverse effects and reinforce compliance. Repeat assessment at six months following randomization. This will include anthropometry (similar to baseline), a blood draw as outlined at baseline, and endoscopy with research biopsies as outlined at baseline. Subjects will also fill out the RSQ.
Other Names:
  • DHA/EPA
  • Omega-3 fatty acid ethyl esters
  • Ocean Blue® Professional Omega-3 2100™

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733147

Contacts
Contact: Michele L Johnson 507 255-8692 johnson.michele@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michele L Johnson    507-255-8692    johnson.michele@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Prasad Iyer, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01733147     History of Changes
Other Study ID Numbers: 12-005914
Study First Received: November 20, 2012
Last Updated: December 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Barrett's esophagus
Obesity
Omega-3 fatty acid

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on March 03, 2015