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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00955227
• Other study ID #: B2009:054
• Status: Active, not recruiting
• Phase: N/A
• First received: August 6, 2009
• Last updated: December 2, 2014
• Start date: July 2009
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Flax seed oil (ALA)
2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks

Drug:
• Ezetimibe
In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks

Locations

Country	Name	City	State
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
Canada	St. Boniface General Hospital Research Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of circulating omega-3 fatty acid (ALA)		6 weeks after enrollment of patient	No
Secondary	The n6:n3 fatty acid ratio will be calculated Total cholesterol, LDL, HDL, and triglyceride levels will also be measured		6 weeks after patient enrollment	No