Completed

NCT Number: NCT00308295

A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

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.

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Key information

Conditions

End-Stage Renal Disease Patients on Hemodialysis

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Nephrology Clinics, Indianapolis, Indiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish oil capsules

Drug

matched placebo capsules

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start: 2006
Study completion: 2006
First posted: Mar 29, 2006
Registry last updated: Oct 16, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.