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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)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Jennifer G. Robinson, University of Iowa
ClinicalTrials.gov Identifier:
NCT01002118
First received: October 23, 2009
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
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 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002118

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

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

Keywords provided by University of Iowa:
heart rate variability
Dialysis

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2017