A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

October 15, 2007 updated by: Indiana University School of Medicine
The main goal of this study is to determine whether the American Heart Association-recommended fish oil dose is efficacious, safe, and tolerable in hemodialysis patients. The secondary objective is to test the effects of fish oil supplementation on inflammatory and cardiovascular markers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Nephrology Clinics
      • Indianapolis, Indiana, United States, 46202
        • VeteransAdministration Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Exclusion Criteria:

  1. Age <18
  2. Pregnant individuals
  3. Fish oil or omega-3 supplementation in past 6 months
  4. Fish, corn, soybean, gelatin, or vanilla allergies
  5. Currently enrolled in a dietary or investigational drug study
  6. Life expectancy < 3 months
  7. Ongoing active illness requiring hospitalization
  8. Malabsorption syndromes
  9. Chronic heparin or coumadin anticoagulation (??)
  10. Active bleeding issues

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine whether AHA-recommended fish oil therapy beneficially affects the pro-inflammatory/anti-inflammatory blood fatty acid balance

Secondary Outcome Measures

Outcome Measure
To test the safety and tolerability of fish oil therapy in hemodialysis patients
To measure the effects of fish oil treatment on cardiovascular and inflammatory risk factors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Investigators

  • Principal Investigator: Allon Friedman, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 29, 2006

Study Record Updates

Last Update Posted (Estimate)

October 16, 2007

Last Update Submitted That Met QC Criteria

October 15, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0512-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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