Feasibility Study of Omega-3 Fatty Acids in Dialysis Patients

Stopped early · Not applicable · Has a placebo group

Conditions studied: Cardiovascular Disease

In brief

Cardiovascular disease and mortality is the largest comorbidity within the dialysis population. Nearly 50% of hemodialysis patients will have congestive heart failure at initiation. According to the most recent United States Renal Data System (USRDS), 40% of incident dialysis patients will have a cardiovascular event or die within the first 9 months of dialysis. It has been postulated that Omega-3 fatty acids could provide beneficial cardioprotection in hemodialysis patients. The investigators propose to evaluate Omega-3 fatty acid doses on cardiovascular parameters in an incident hemodialysis population. Initially, this will be a pilot study. Ultimately, the information will be used to adequately plan for a larger intervention trial using Omega-3 fatty acids in incident hemodialysis patients.

Key facts

Study ID

NCT01002118

Run by

University of Iowa

People needed

1

Starts

2008-01-25

Expected to finish

2011-02-23

Last updated by the study team

2017-08-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years old
• Initiated dialysis in past 3 months
• Signed informed consent
• Attending University of Iowa dialysis unit for duration of the study

You may not qualify if…

• Age >70
• Unable to provide consent
• Currently taking fish oil supplementation
• rhythm other than sinus
• implantable cardioverter-defibrillator
• pacemaker
• myocardial infarction,revascularization or unstable angina in past 3 months
• other hospitalization in past 3 months
• symptomatic heart failure
• known left ventricular ejection fraction < 30%
• history of a significant bleeding disorder
• severe bleeding episode requiring hospitalization in past 3 months (GI bleed or hemorrhagic stroke)
• unexplained HgB drop > 2 gm/dl in past 3 months
• chronic warfarin or anti-coagulation therapy (such as Lovenox)
• pregnant or nursing mothers
• allergic to fish, fish oil or fish products
• Participation in other trials of investigational products
• other characteristics as determined by the investigator that would make sudy participation inappropriate

Where it is running

• University of Iowa — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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