Feasibility Study of Omega-3 Fatty Acids in Dialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT01002118
First received: October 23, 2009
Last updated: October 26, 2009
Last verified: October 2009
  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: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the effectiveness of Omega-3 fatty acid compared to placebo on electrocardiographic parameters. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002118

Contacts
Contact: Heather A Muster, MD, MS 319-384-8197 Heather-muster@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Heather A Muster, MD MS       heather-muster@uiowa.edu   
Sponsors and Collaborators
University of Iowa
GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Heather Ann Muster, MD, MS, University of Iowa
ClinicalTrials.gov Identifier: NCT01002118     History of Changes
Other Study ID Numbers: 200801761
Study First Received: October 23, 2009
Last Updated: October 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
heart rate variability
Dialysis

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014