Status:
COMPLETED
The Effects of Omega-3 Fatty Acids on Aspirin Resistance
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
GlaxoSmithKline
American College of Clinical Pharmacy
Conditions:
Increased Drug Resistance
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if omega-3 fatty acids enhance the antiplatelet effects of aspirin.
Detailed Description
Although aspirin has been a stalwart treatment in the prevention and treatment of myocardial infarction and stroke, it does not have its expected effects in a significant proportion of the population....
Eligibility Criteria
Inclusion
- Willing to participate by providing informed consent and committing to complete the study. This includes adhering to the study diet.
- No chronic disease by history and based on a complete blood count and comprehensive metabolic profile.
- Commitment to not taking aspirin, non-steroidal anti-inflammatory medications, and to limit fish intake to ≤2 meals during the 7 days prior to each CRC study period. They will also need to abstain from taking a list of over-the-counter medications that include aspirin. For the duration of the study, they will also be asked to abstain from taking fish and flax seed oil supplements.
Exclusion
- Reports the presence of chronic disease (e.g. cardiovascular, renal, hepatic, neurodegenerative, neoplastic, metabolic {diabetes}, hypertension).
- Reports taking a systemic medication chronically.
- History of serious adverse reaction or allergy to aspirin or fish oil.
- Baseline platelet count \<100 000 or \>500 000, hematocrit \<30%, or white blood cell count \>20 000.
- Any abnormality from a screening CBC and complete blood count that suggests acute or chronic disease.
- Nicotine user.
- History of alcohol abuse
- Pregnancy by history or urine/serum pregnancy test
- History of intestinal malabsorption syndrome including gastric bypass surgery
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00771914
Start Date
November 1 2008
End Date
January 1 2009
Last Update
November 6 2012
Active Locations (1)
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1
University of Rochester School of Medicine and Dentistry
Rochester, New York, United States, 14642