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A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT00308295
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : October 16, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
End-Stage Renal Disease Patients on Hemodialysis Drug: Fish oil capsules Drug: matched placebo capsules

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients
Study Start Date : April 2006
Estimated Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Fish oil
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. To test the safety and tolerability of fish oil therapy in hemodialysis patients
  2. To measure the effects of fish oil treatment on cardiovascular and inflammatory risk factors

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: March 29, 2006    Key Record Dates
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