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Completed

NCT Number: NCT01471366

Method of Fish Oil Administration on Patient Compliance

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi School of Pharmacy

Jackson, Mississippi, 39216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frozen capsule

Dietary Supplement

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

Capsule with food

Dietary Supplement

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

Capsule without food

Dietary Supplement

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

Capsule with milk

Dietary Supplement

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

Primary outcomes

  1. Adverse Effects

    Time frame: 4 weeks

    Subjective survey based patient reported adverse effects

Secondary outcomes

  1. Compliance

    Time frame: 4 weeks

    Pill count will be performed to assess medication compliance.

Sponsors and collaborators

Lead sponsor

University of Mississippi, Oxford

Other

Collaborators

  • Walgreens

Registry information

Official study title

What is the Best Way to Take Fish Oil?

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 16, 2011
Registry last updated
Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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