Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa

Summary

The purpose of this study is to determine the effect of two doses purified EPA (an omega-3 fatty acid), on apoptosis (natural cell death) and cell proliferation (formation of new cells) in the lining of the colon for patients with a history of colonic polyps.

Conditions

• Adenomatous Polyps

Interventions

DRUG

Eicosapentaenoic Acid (EPA)

Either 2 x 500mg EPA capsules in the morning and evening (2g per day EPA) or 1 x 500mg EPA and 1 x placebo in the morning and evening (1g per day EPA)

PROCEDURE

Endoscopy

At baseline, month 3 and month 6.

PROCEDURE

Biopsies taken

9 biopsies taken for measurement of apoptosis (3 biopsies), cell proliferation (3 biopsies) and fatty acid levels (3 biopsies) at baseline, month 3 and month 6.

PROCEDURE

Clinical chemistry

Full blood count at baseline, month 3 and month 6.

PROCEDURE

Haematology

Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.

PROCEDURE

Physical examination

Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.

PROCEDURE

Vital signs

Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.

PROCEDURE

Urine pregnancy test

For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.

PROCEDURE

Completion of patient diary card

Subjects are requested to complete when study medication is taken and in any new or unusual symptoms are experienced on a daily basis for 6 months.

Sponsors & Collaborators

• S.L.A. Pharma AG

  lead INDUSTRY

Principal Investigators

• Nicholas J West, MB BS FRCS · St. George's Hospital Medical School, London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2008-06-30

Completion

2008-06-30

Countries

• Italy
• United Kingdom

Study Locations