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Feasibility Study of Omega-3 Fatty Acids in Dialysis Patients

This study has been terminated.
(Unable to recruit eligible subjects; no data analyzed)
Information provided by (Responsible Party):
Jennifer G. Robinson, University of Iowa Identifier:
First received: October 23, 2009
Last updated: March 22, 2017
Last verified: March 2017
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.

Condition Intervention
Cardiovascular Disease Drug: Omega-3 Acid Ethyl Esters Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider
Primary Purpose: Treatment
Official Title: Feasibility of Omega-3 Fatty Acid Supplementation in Adult Hemodialysis Patients

Resource links provided by NLM:

Further study details as provided by Jennifer G. Robinson, University of Iowa:

Primary Outcome Measures:
  • Determine recruitment and medication adherence rates [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Assess the effectiveness of Omega-3 fatty acid compared to placebo on electrocardiographic parameters. [ Time Frame: 4 months ]

Enrollment: 1
Actual Study Start Date: January 25, 2008
Study Completion Date: February 23, 2011
Primary Completion Date: February 23, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
4 capsules each day for 16 weeks
Drug: Placebo
4 capsules each day for 16 weeks
Active Comparator: Omega-3 Fatty Acid Drug: Omega-3 Acid Ethyl Esters
1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
Other Name: Lovaza 4g capsule


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01002118

United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
  More Information

Responsible Party: Jennifer G. Robinson, Principal Investigator, University of Iowa Identifier: NCT01002118     History of Changes
Other Study ID Numbers: 200801761
Study First Received: October 23, 2009
Last Updated: March 22, 2017

Keywords provided by Jennifer G. Robinson, University of Iowa:
heart rate variability

Additional relevant MeSH terms:
Cardiovascular Diseases processed this record on July 21, 2017