Method of Fish Oil Administration on Patient Compliance

University of Mississippi, Oxford

Status: Completed

Conditions: Adverse Effects

Treatments: Dietary Supplement: Capsule with food; Dietary Supplement: Capsule without food; Dietary Supplement: Frozen capsule; Dietary Supplement: Capsule with milk

Study type: Interventional

Funder types: Other

Identifiers

NCT01471366

UMO-0003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 4 patient groups

Frozen capsule

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Frozen capsule

Capsule with food

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Capsule with food

Capsule without food

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Capsule without food

Capsule with milk

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Capsule with milk