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CompletedNCT00308295Updated Oct 16, 2007

A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

An interventional study of Fish oil capsules and matched placebo capsules in End-Stage Renal Disease Patients on Hemodialysis, sponsored by Indiana University School of Medicine. Completed at 2 sites in United States. Open to participants aged 18 Years to 82 Years. Per ClinicalTrials.gov, last updated 2007-10-16.

Sponsored by Indiana University School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 82 Years
Sex
All
01

Study 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.

02

Conditions studied

  • End-Stage Renal Disease Patients on Hemodialysis
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 27 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 82 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
27 participants

Interventions

  • DrugFish oil capsules
  • Drugmatched placebo capsules
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  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

07

Study locations

2 sites
  • Indiana University Nephrology Clinics
    Indianapolis, Indiana 46202, United States
  • VeteransAdministration Hospital
    Indianapolis, Indiana 46202, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00308295
Lead sponsor
Indiana University School of Medicine
First posted
Mar 29, 2006
Start date
Apr 2006
Completion
May 2006
Last update
Oct 16, 2007

Study contacts

Allon Friedman, MD
principal investigator · Indiana University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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