Text Size

Effect of Changes in Fish Oil Administration on Patient Compliance

This study is currently recruiting participants.
Verified August 2012 by University of Mississippi, Oxford
Sponsor:
Information provided by (Responsible Party):
Andrew A. Mays, University of Mississippi, Oxford
ClinicalTrials.gov Identifier:
NCT01471366
First received: November 10, 2011
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

Fish oil has many proposed health benefits such as lowering triglycerides, decreasing inflammation, and reducing risk factors for cardiovascular disease. However in order to take the recommended daily dose for hypertriglyceridemia using an over-the-counter fish oil supplement, the daily recommended dose is two 1 gram capsules three times a day. The American Heart Association recommends 2-4 grams of omega-3 fatty acid a day to aid in triglyceride reduction. Many patients complain of fishy breath, upset stomach, or heartburn when taking the recommended amount of fish oil. The current recommendation made by pharmacists is to freeze the fish oil capsules to help decrease adverse gastrointestinal effects. Freezing fish oil capsules is inconvenient because this requires access to a freezer three times a day. Currently there is a lack of literature to specify the best administration technique or patient compliance data for over-the-counter fish oil supplements. By conducting this study, we are hoping to determine if taking fish oil with milk will help lead to better patient compliance over the current recommendation. This study will include up to 60 patients that are between the ages of 18-50 with health conditions and medications indicated at the initial visit. Patients will be excluded if they are taking any medications that may possibly interact with fish oil such as anticoagulants, platelet inhibitors, or thrombolytic agents. Patients will be recruited via e-mails sent to faculty and students of the School of Pharmacy, via flyers in Walgreens stores, and through word of mouth. The patients will be randomly assigned to one of four treatment groups. Each treatment group will be given 180 capsules and be instructed to take two capsules three times a day for thirty days with either food, no food, milk, or to freeze the capsule prior to ingestion. At the end of thirty days, the patient will return the bottle with any remaining pills to the investigator and take a short exit survey. The investigators will then take a pill count of each bottle to determine which treatment group was most compliant.


Condition Intervention
Adverse Effects
 Dietary Supplement: Omega-3 Fish Oil Concentrate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: What is the Best Way to Take Fish Oil?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Mississippi, Oxford:

Primary Outcome Measures:
  • Number of patients with adverse effects as a measure of tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjective survey based patient reported problems (dyspepsia, eructation, nausea, heartburn)


Secondary Outcome Measures:
  • Patient compliance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Final capsule count will be done to determine patient compliance. A final survey will also determine patient problems with fish oil administration.


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Frozen capsule
Two frozen fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water without food or dairy products
 Dietary Supplement: Omega-3 Fish Oil Concentrate
Two frozen fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water without food or dairy products.
Other Names:
  • Fish Oil Concentrate
  • Natural Fish Oil
Active Comparator: Capsule with food
Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with food but no dairy products
 Dietary Supplement: Omega-3 Fish Oil Concentrate
Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with food but no dairy products
Other Names:
  • Fish Oil Concentrate
  • Natural Fish Oil
Active Comparator: Capsule without food
Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with no food or dairy products
 Dietary Supplement: Omega-3 Fish Oil Concentrate
Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with no food or dairy products
Other Names:
  • Fish Oil Concentrate
  • Natural Fish Oil
Active Comparator: Capsule with milk
Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of milk with no food or additional dairy products
 Dietary Supplement: Omega-3 Fish Oil Concentrate
Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of milk with no food or additional dairy products
Other Names:
  • Fish Oil Concentrate
  • Natural Fish Oil

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients 18-50 years of age
  • Minimal medication usage and health conditions determined by consent form

Exclusion Criteria:

  • Patients with significant renal, hepatic, or gastrointestinal tract disease
  • Patients with diabetes, high blood pressure, or hypothyroidism
  • Receiving anti-coagulation, anti-platelet, or anti-inflammatory therapy
  • Pregnant/nursing women, < 18 years of age, prisoners, or mentally ill
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471366

Contacts
Contact: Andrew A Mays, Pharm.D. 601-984-2639 amays@nmhs.net
Contact: Omayma A Kishk, Pharm.D. 601-984-2639

Locations
United States, Mississippi
University of Mississippi School of Pharmacy Recruiting
Jackson, Mississippi, United States, 39216
Contact: Sara Roberts, Pharm.D., Candidate     601-984-2639     smrober4@gmail.com    
Contact: Daniel M Riche, Pharm.D.     601-984-2639     driche@umc.edu    
Principal Investigator: Andrew A Mays, Pharm.D.            
Sub-Investigator: Daniel M Riche, Pharm.D.            
Sub-Investigator: Sara Roberts, Pharm.D. Candidate            
Sponsors and Collaborators
Andrew A. Mays
Investigators
Principal Investigator: Andrew A Mays, Pharm.D. University of Mississippi Medical Center
Study Director: Daniel M Riche, Pharm.D. University of Mississippi Medical Center
  More Information

Publications:

Responsible Party: Andrew A. Mays, Principle Investigator, University of Mississippi, Oxford
ClinicalTrials.gov Identifier: NCT01471366     History of Changes
Other Study ID Numbers: UMO-0003
Study First Received: November 10, 2011
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi, Oxford:
Hyperlipidemias
Dyslipidemias
Fatty Acids, Omega-3
Fish Oils

ClinicalTrials.gov processed this record on May 22, 2013