Method of Fish Oil Administration on Patient Compliance

July 25, 2014 updated by: Daniel Riche, University of Mississippi, Oxford

What is the Best Way to Take Fish Oil?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi School of Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Effects
Time Frame: 4 weeks
Subjective survey based patient reported adverse effects
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: 4 weeks
Pill count will be performed to assess medication compliance.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi, Oxford

Collaborators

Walgreen's

Investigators

  • Principal Investigator: Daniel M Riche, Pharm.D., University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (Estimate)

November 16, 2011

Study Record Updates

Last Update Posted (Estimate)

July 28, 2014

Last Update Submitted That Met QC Criteria

July 25, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UMO-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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