Method of Fish Oil Administration on Patient Compliance
Condition: Adverse Effects
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Frozen capsule; Capsule with food; Capsule without food; Capsule with milk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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; 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; 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 intervention name(s): Fish Oil Concentrate; Natural Fish Oil; Fish Oil Concentrate; Natural Fish Oil; Fish Oil Concentrate; Natural Fish Oil; Fish Oil Concentrate; Natural Fish Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Hyperlipidemias; Dyslipidemias; Fatty Acids, Omega-3; Fish Oils