Method of Fish Oil Administration on Patient Compliance

This study has been completed.
Sponsor:
Collaborator:
Walgreen's
Information provided by (Responsible Party):
Daniel Riche, University of Mississippi, Oxford
ClinicalTrials.gov Identifier:
NCT01471366
First received: November 10, 2011
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

Many patients complain of fishy breath, upset stomach, or heartburn when taking the recommended amount of fish oil. A common recommendation made by pharmacists is to freeze the fish oil capsules to help decrease adverse gastrointestinal effects. Compliance with over-the-counter (OTC) fish oil is a concern considering the high number of capsules taken daily. The hypothesis of this study is that taking fish oil with milk will help lead to better patient compliance with no difference in adverse effects versus other administration methods.


Condition Intervention
Adverse Effects
Dietary Supplement: Frozen capsule
Dietary Supplement: Capsule with food
Dietary Supplement: Capsule without food
Dietary Supplement: Capsule with milk

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:


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

Primary Outcome Measures:
  • Adverse Effects [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Subjective survey based patient reported adverse effects


Secondary Outcome Measures:
  • Compliance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Pill count will be performed to assess medication compliance.


Enrollment: 60
Study Start Date: November 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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: 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.
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: 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
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: 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
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: 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
Other Names:
  • Fish Oil Concentrate
  • Natural Fish Oil

Detailed Description:

Fish oil has many proposed health benefits such as lowering triglycerides, decreasing inflammation, and reducing risk factors for cardiovascular disease. In order to take the recommended daily dose for hypertriglyceridemia using an OTC fish oil supplement, the daily recommended dose is at least 2 grams (2 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. Fish oil is known to cause GI-related adverse effects. Although reported to help, freezing fish oil capsules is inconvenient requiring 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 OTC fish oil supplements. The purpose of this study is to determine an ideal method of taking fish oil. This study will include up to 60 patients that are between the ages of 18-65 years who would be considered generally healthy. Patients will be recruited via e-mails sent to faculty and students of the School of Pharmacy, via flyers in Walgreen's 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 instructed to take two capsules three times a day for thirty days with either food, no food, milk, or frozen. At the end of thirty days, the patient will return the bottle with any remaining pills to the investigator and take a survey. The investigators will assess compliance via pill count.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients 18-65 years of age
  • Minimal medication usage and controlled chronic health conditions

Exclusion Criteria:

  • Patients with significant renal, hepatic, autoimmune or gastrointestinal tract disease
  • Patients with uncontrolled chronic health conditions (e.g., diabetes, high blood pressure, high cholesterol or hypothyroidism)
  • Receiving prescription anti-coagulation, prescription anti-platelet, prescription anti-inflammatory drugs, biologics, chronic steroids, chemotherapy, or otherwise excessive medication regimens
  • Pregnant/nursing women, <18 years of age, prisoners, or the mentally ill
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471366

Locations
United States, Mississippi
University of Mississippi School of Pharmacy
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi, Oxford
Walgreen's
Investigators
Principal Investigator: Daniel M Riche, Pharm.D. University of Mississippi Medical Center
  More Information

Publications:

Responsible Party: Daniel Riche, Principal 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: July 25, 2014
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 October 21, 2014