Status:

TERMINATED

Feasibility Study of Omega-3 Fatty Acids in Dialysis Patients

Lead Sponsor:

University of Iowa

Collaborating Sponsors:

GlaxoSmithKline

Conditions:

Cardiovascular Disease

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief 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 m...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 25 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 23 2011

Estimated Enrollment :

1 Patients enrolled

Trial Details

Trial ID

NCT01002118

Start Date

January 25 2008

End Date

February 23 2011

Last Update

August 9 2017

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Iowa

Iowa City, Iowa, United States, 52242

Feasibility Study of Omega-3 Fatty Acids in Dialysis Patients | DecenTrialz