A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00308295
First received: March 27, 2006
Last updated: October 15, 2007
Last verified: October 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 82 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on October 20, 2014