We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308295
First Posted: March 29, 2006
Last Update Posted: October 16, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Indiana University
  Purpose
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.

Condition Intervention
End-Stage Renal Disease Patients on Hemodialysis Drug: Fish oil capsules Drug: matched placebo capsules

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Indiana University:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 27
Study Start Date: April 2006
Estimated Study Completion Date: May 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 82 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308295


Locations
United States, Indiana
Indiana University Nephrology Clinics
Indianapolis, Indiana, United States, 46202
VeteransAdministration Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Allon Friedman, MD Indiana University
  More Information

ClinicalTrials.gov Identifier: NCT00308295     History of Changes
Other Study ID Numbers: 0512-13
First Submitted: March 27, 2006
First Posted: March 29, 2006
Last Update Posted: October 16, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases