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Feasibility Study of Omega-3 Fatty Acids in Dialysis Patients

NCT01002118 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-08-09

Study results available
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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.

Conditions

Interventions

DRUG

Omega-3 Acid Ethyl Esters

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

DRUG

Placebo

4 capsules each day for 16 weeks

Sponsors & Collaborators

Principal Investigators

  • Jennifer Robinson, MD MPH · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-25
Primary Completion
2011-02-23
Completion
2011-02-23

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01002118 on ClinicalTrials.gov