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A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

Not Applicable
Completed
Conditions
End-Stage Renal Disease Patients on Hemodialysis
Registration Number
NCT00308295
Lead Sponsor
Indiana University School of Medicine
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
27
Inclusion Criteria

Not provided

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
To determine whether AHA-recommended fish oil therapy beneficially affects the pro-inflammatory/anti-inflammatory blood fatty acid balance
Secondary Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (2)

VeteransAdministration Hospital

🇺🇸

Indianapolis, Indiana, United States

Indiana University Nephrology Clinics

🇺🇸

Indianapolis, Indiana, United States

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