Method of Fish Oil Administration on Patient Compliance
What is the Best Way to Take Fish Oil?
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 10, 2011
CompletedFirst Posted
Study publicly available on registry
November 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJuly 28, 2014
July 1, 2014
2.7 years
November 10, 2011
July 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Effects
Subjective survey based patient reported adverse effects
4 weeks
Secondary Outcomes (1)
Compliance
4 weeks
Study Arms (4)
Frozen capsule
ACTIVE COMPARATORTwo 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
Capsule with food
ACTIVE COMPARATORTwo 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
Capsule without food
ACTIVE COMPARATORTwo 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
Capsule with milk
ACTIVE COMPARATORTwo 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients 18-65 years of age
- Minimal medication usage and controlled chronic health conditions
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Mississippi, Oxfordlead
- Walgreenscollaborator
Study Sites (1)
University of Mississippi School of Pharmacy
Jackson, Mississippi, 39216, United States
Related Publications (7)
Oelrich B, Dewell A, Gardner CD. Effect of fish oil supplementation on serum triglycerides, LDL cholesterol and LDL subfractions in hypertriglyceridemic adults. Nutr Metab Cardiovasc Dis. 2013 Apr;23(4):350-7. doi: 10.1016/j.numecd.2011.06.003. Epub 2011 Sep 15.
PMID: 21924882BACKGROUNDEslick GD, Howe PR, Smith C, Priest R, Bensoussan A. Benefits of fish oil supplementation in hyperlipidemia: a systematic review and meta-analysis. Int J Cardiol. 2009 Jul 24;136(1):4-16. doi: 10.1016/j.ijcard.2008.03.092. Epub 2008 Sep 6.
PMID: 18774613BACKGROUNDKris-Etherton PM, Harris WS, Appel LJ; American Heart Association. Nutrition Committee. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation. 2002 Nov 19;106(21):2747-57. doi: 10.1161/01.cir.0000038493.65177.94. No abstract available.
PMID: 12438303BACKGROUNDDietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Lancet. 1999 Aug 7;354(9177):447-55.
PMID: 10465168BACKGROUNDMiller M, Stone NJ, Ballantyne C, Bittner V, Criqui MH, Ginsberg HN, Goldberg AC, Howard WJ, Jacobson MS, Kris-Etherton PM, Lennie TA, Levi M, Mazzone T, Pennathur S; American Heart Association Clinical Lipidology, Thrombosis, and Prevention Committee of the Council on Nutrition, Physical Activity, and Metabolism; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011 May 24;123(20):2292-333. doi: 10.1161/CIR.0b013e3182160726. Epub 2011 Apr 18. No abstract available.
PMID: 21502576BACKGROUNDZabel R, Ash S, King N, Bauer J. Adherence to fish oil intervention in patients with chronic kidney disease. J Ren Nutr. 2010 Sep;20(5):329-33. doi: 10.1053/j.jrn.2010.01.003. Epub 2010 Mar 19.
PMID: 20303787BACKGROUNDMalinowski SS, Barber KE, Kishk OA, Mays AA, Jones SR, Turner AL, Riche DM. Effect of fish oil supplement administration method on tolerability and adherence: a randomized pilot clinical trial. Pilot Feasibility Stud. 2019 Jan 8;5:3. doi: 10.1186/s40814-018-0387-0. eCollection 2019.
PMID: 30637118DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel M Riche, Pharm.D.
University of Mississippi Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 10, 2011
First Posted
November 16, 2011
Study Start
November 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
July 28, 2014
Record last verified: 2014-07