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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 23, 2009

Last Updated Date

October 26, 2009

Start Date ^ICMJE

October 2009

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine recruitment and medication adherence rates [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01002118 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Feasibility Study of Omega-3 Fatty Acids in Dialysis Patients

Official Title ^ICMJE

Feasibility of Omega-3 Fatty Acid Supplementation in Adult Hemodialysis Patients

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 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Cardiovascular Disease

Intervention ^ICMJE

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
Drug: Placebo
4 capsules each day for 16 weeks

Study Arm (s)

Placebo Comparator: Placebo
4 capsules each day for 16 weeks

Intervention: Drug: Placebo
Active Comparator: Omega-3 Fatty Acid
Intervention: Drug: Omega-3 Acid Ethyl Esters

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Heather A Muster, MD, MS

319-384-8197

Heather-muster@uiowa.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01002118

Other Study ID Numbers ^ICMJE

200801761

Has Data Monitoring Committee

Responsible Party

Heather Ann Muster, MD, MS, University of Iowa

Study Sponsor ^ICMJE

University of Iowa

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Not Provided

Information Provided By

University of Iowa

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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