Back to resultsA Pilot Study of Fish Oil Supplementation in Hemodialysis Patients
Primary Purpose
End-Stage Renal Disease Patients on Hemodialysis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fish oil capsules
matched placebo capsules
Sponsored by
About this trial
This is an interventional treatment trial for End-Stage Renal Disease Patients on Hemodialysis
Eligibility 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
Sites / Locations
- Indiana University Nephrology Clinics
- VeteransAdministration Hospital
Outcomes
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
Full Information
NCT ID
NCT00308295
First Posted
March 27, 2006
Last Updated
October 15, 2007
Sponsor
Indiana University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00308295
Brief Title
A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients
Official Title
A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Indiana University School of Medicine
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease Patients on Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
27 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fish oil capsules
Intervention Type
Drug
Intervention Name(s)
matched placebo capsules
Primary Outcome Measure Information:
Title
To determine whether AHA-recommended fish oil therapy beneficially affects the pro-inflammatory/anti-inflammatory blood fatty acid balance
Secondary Outcome Measure Information:
Title
To test the safety and tolerability of fish oil therapy in hemodialysis patients
Title
To measure the effects of fish oil treatment on cardiovascular and inflammatory risk factors
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allon Friedman, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Nephrology Clinics
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
VeteransAdministration Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients
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