Feasibility Study of Omega-3 Fatty Acids in Dialysis Patients

• Status: Terminated
• Trial end date: 2011-02-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Iowa
• Collaborator: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Age > 18 years old

• Initiated dialysis in past 3 months

• Signed informed consent

• Attending University of Iowa dialysis unit for duration of the study

Exclusion Criteria:

• 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