Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa
NCT ID: NCT00432913
Last Updated: 2008-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2006-10-31
2008-06-30
Brief Summary
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Detailed Description
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Recent work at St George's Hospital Medical School, London, has shown significant beneficial effects on cell proliferation and apoptosis rates in the lining of the colon in subjects with a history of colonic adenomas using a highly purified, free-fatty acid form of eicosapentaenoic acid (EPA).
Comparator(s): 2g EPA per day for 6 months and 1g EPA per day for 6 months will be compared against placebo for 6 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1g EPA per day
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)
Endoscopy
At baseline, month 3 and month 6.
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.
Clinical chemistry
Full blood count at baseline, month 3 and month 6.
Haematology
Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.
Physical examination
Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.
Vital signs
Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.
Urine pregnancy test
For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.
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.
2g EPA per day
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)
Endoscopy
At baseline, month 3 and month 6.
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.
Clinical chemistry
Full blood count at baseline, month 3 and month 6.
Haematology
Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.
Physical examination
Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.
Vital signs
Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.
Urine pregnancy test
For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.
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.
Placebo
Endoscopy
At baseline, month 3 and month 6.
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.
Clinical chemistry
Full blood count at baseline, month 3 and month 6.
Haematology
Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.
Physical examination
Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.
Vital signs
Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.
Urine pregnancy test
For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.
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.
Interventions
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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)
Endoscopy
At baseline, month 3 and month 6.
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.
Clinical chemistry
Full blood count at baseline, month 3 and month 6.
Haematology
Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.
Physical examination
Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.
Vital signs
Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.
Urine pregnancy test
For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients of child-bearing potential must demonstrate a negative pregnancy test at screening, and should use a reliable form of contraception during the trial and for 1 month afterwards, e.g:
* Oral contraceptive + condom
* Intra-uterine device (IUD)+ condom
* Diaphragm with spermicide + condom
* Male partners of women of child bearing potential should use a reliable form of contraception during the trial and for 1 month afterwards, e.g:
* Oral contraceptive + condom
* Intra-uterine device (IUD)+ condom
* Diaphragm with spermicide + condom
* Patients must have a known history of colorectal adenomata and be under clinical follow-up for these, or be found to have one or more of these at the time of colonoscopy
* Patients must have provided written informed consent to participate
Exclusion Criteria
* Patients who have diabetes mellitus
* Patients who are pregnant or breast-feeding
* Patients taking aspirin or other non-steroidal anti-inflammatory drugs on a regular basis
* Patients who have aspirin-sensitive asthma
* Patients suffering from haemorrhagic disorders
* Patients who are taking warfarin or other anticoagulants
* Patients who have significant abnormalities on their screening blood tests
* Patients taking lipid lowering medication
* Patients with known inflammatory bowel disease (IBD), or previously unknown IBD until discovered at the time of their colonoscopy
* Patients with gastrointestinal malabsorptive disease
* Patients belonging to a known polyposis syndrome (e.g. FAP, HNPCC)
* Patients with a previous colonic resection for colorectal cancer
* Patients who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study
* Patients who are deemed mentally incompetent, or have a history of anorexia nervosa or bulimia
* Patients with a history of alcohol or drug abuse, including laxative abuse
* Patients considered by their physician unlikely to be able to comply with the protocol.
* Patients who have taken part in an experimental drug study in the preceding 2 months.
18 Years
ALL
No
Sponsors
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S.L.A. Pharma AG
INDUSTRY
Principal Investigators
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Nicholas J West, MB BS FRCS
Role: PRINCIPAL_INVESTIGATOR
St. George's Hospital Medical School, London
Locations
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S. Orsola Hospital
Bologna, , Italy
St. George's Hospital Medical School
London, , United Kingdom
Countries
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Other Identifiers
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EPA/POL/02
Identifier Type: -
Identifier Source: org_study_id