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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01733147
Other study ID # 12-005914
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2012
Est. completion date September 12, 2018

Study information

Verified date December 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 12, 2018
Est. primary completion date September 12, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 ?3 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

Study Design


Intervention

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 ?3 FFA preparation containing 675 mg EPA and 300 mg DHA.
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.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Change in Esophageal Macrophage Markers Percent change from baseline to 6 months in esophageal macrophage markers MCP-1 (Pro-inflammatory, M1 marker), CD 206 (Anti-inflammatory, M2 marker), and IL-10 (Anti-inflammatory, M2 marker) obtained from endoscopic esophageal tissue collection Baseline, 6 months
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