NCT01002118

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2011

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

August 9, 2017

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

3.1 years

First QC Date

October 23, 2009

Results QC Date

May 2, 2017

Last Update Submit

August 7, 2017

Conditions

Cardiovascular Disease

Keywords

heart rate variabilityDialysis

Outcome Measures

Primary Outcomes (1)

  • Determine Recruitment Rates

    Determine recruitment by number eligible/number enrolled

    4 months

Secondary Outcomes (2)

  • Assess the Effectiveness of Omega-3 Fatty Acid Compared to Placebo on Electrocardiographic Parameters.

    4 months

  • Medication Adherence

    4 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

4 capsules inert oil Placebo each day for 16 weeks

Drug: Placebo

Omega-3 Fatty Acid Ethyl Esters

ACTIVE COMPARATOR

4 capsules Omega-3 Fatty Acid Esters each day for 16 weeks

Drug: Omega-3 Acid Ethyl Esters

Interventions

Omega-3 Acid Ethyl EstersDRUG

1 gram capsules Omega-3 Acid Ethyl Esters for a total of 4 grams (4 capsules) per day for 16 weeks

Also known as: Lovaza Omega-3 Acid Ethyl Esters 4g capsule
Omega-3 Fatty Acid Ethyl Esters
PlaceboDRUG

4 capsules each day for 16 weeks

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years old
  • Initiated dialysis in past 3 months
  • Signed informed consent
  • Attending University of Iowa dialysis unit for duration of the study

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Omacor

Results Point of Contact

Title
Jennifer Robinson
Organization
University of Iowa
jennifer-g-robinson@uiowa.edu
319-384-1563

Study Officials

  • Jennifer Robinson, MD MPH

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2009

First Posted

October 27, 2009

Study Start

January 25, 2008

Primary Completion

February 23, 2011

Study Completion

February 23, 2011

Last Updated

August 9, 2017

Results First Posted

August 9, 2017

Record last verified: 2017-08

Locations

US(1)