A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients - Full Text View

Sponsored by:	Indiana University School of Medicine
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00308295

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

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Fish oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

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

Ages Eligible for Study:	18 Years to 82 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308295

Locations

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

Sponsors and Collaborators

Indiana University School of Medicine

Investigators

Principal Investigator:

Allon Friedman, MD

Indiana University

More Information

Study ID Numbers:	0512-13
Study First Received:	March 27, 2006
Last Updated:	October 15, 2007
ClinicalTrials.gov Identifier:	NCT00308295
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 14, 2009