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Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Grant Pierce, University of Manitoba
ClinicalTrials.gov Identifier:
NCT00955227
First received: August 6, 2009
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  Purpose

The objective of this study is to determine if the administration of a cholesterol lowering drug like ezetimibe will reduce circulating omega-3 fatty acid (ALA) levels in patients with heart disease and hypercholesterolemia.

The investigators hypothesize that their data will discover that patients receiving ezetimibe require additional dietary supplementation with omega-3 supplements to insure that these beneficial fatty acids are available to these patients.


Condition Intervention
Hypercholesterolemia
Hyperlipidemia
 Dietary Supplement: Flax seed oil (ALA)
Drug: Ezetimibe

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Levels of circulating omega-3 fatty acid (ALA) [ Time Frame: 6 weeks after enrollment of patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The n6:n3 fatty acid ratio will be calculated Total cholesterol, LDL, HDL, and triglyceride levels will also be measured [ Time Frame: 6 weeks after patient enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Statins only
In this arm- 15 Patients with heart disease and hypercholesterolemia will receive standard statin treatment as determined by the Cardiologist. Patients in this arm will be excluded if they are on ezetimibe.
Active Comparator: Statins and ezetimibe
In this arm- 15 Patients with heart disease and hypercholesterolemia will receive standard statin treatment as determined by the Cardiologist. In addition, these patients will be on ezetimibe.
 Drug: Ezetimibe
In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks
Experimental: Statins and flax oil only
In this arm- 15 Patients receiving standard statin treatment as determined by their cardiologist will also receive two flaxseed oil capsules/day each containing 500 mg of ALA.
 Dietary Supplement: Flax seed oil (ALA)
2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks
Other Name: Jamieson Flax seed oil (ALA)- capsules.
Experimental: Statins and ezetimibe and flax oil
In this arm- 15 Patients with heart disease and hypercholesterolemia that are on standard statin treatment as determined by their cardiologist, will also receive (as an intervention) ezetimibe and flaxseed oil capsules containing 500mg of ALA.
 Dietary Supplement: Flax seed oil (ALA)
2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks
Other Name: Jamieson Flax seed oil (ALA)- capsules.
Drug: Ezetimibe
In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks

Detailed Description:

All patients will undergo drug therapy as required to treat their clinical symptoms including the use of other classes of cholesterol-lowering drugs like statins (that will not interfere with intestinal cholesterol levels). One group of patients will be those who in addition to there existing drug therapy are prescribed ezetimibe to lower circulating cholesterol concentrations. A second group of patients will be those who are not prescribed ezetimibe as part of their normal course of therapy. Blood samples will be taken from all patients at the study baseline. All patients will be fasted for 12 hours prior to the blood sample being taken. After 6 weeks a second blood sample will be taken. This will determine if the drug intervention (ezetimibe) influenced the circulating omega-3 fatty acid concentration.

It will also be of interest to determine if drug administration (ezetimibe) will influence this process when higher levels of omega-3 fatty acids are given to the patients by dietary supplements of ALA. Two additional groups of patients will consume a flaxseed oil supplement containing 1g of ALA in the form of two capsules daily

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is between 18-80 years old
  • The subject lives in Winnipeg area
  • The subject is willing to seize intake of oils/ salad dressings/ seafood
  • The subject is willing to comply with the study schedule

Exclusion Criteria:

  • The subject had been taking flax oil in the last month
  • The subject is not willing to undergo dietary restrictions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955227

Locations
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
St. Boniface General Hospital Research Centre
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
Canadian Institutes of Health Research (CIHR)
Investigators
Study Director: Grant N Pierce, PhD St. Boniface General Hospital Research Centre
Principal Investigator: Davinder Jassal St. Boniface General Hospital Research Centre
  More Information

No publications provided

Responsible Party: Dr. Grant Pierce, Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT00955227     History of Changes
Other Study ID Numbers: B2009:054
Study First Received: August 6, 2009
Last Updated: August 10, 2012
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University of Manitoba:
Omega-3 Fatty acid
ALA (alpha linolenic acid)
Ezetimibe
Flaxseed oil capsules

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Ezetimibe
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013