A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

Indiana University27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

End-Stage Renal Disease Patients on Hemodialysis

Interventions

Fish oil capsulesDRUG

matched placebo capsulesDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 82 Years

Medical Language ↔ Plain English

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

Locations (2)

Indiana University Nephrology Clinics

Indianapolis, Indiana, United States

VeteransAdministration Hospital

Indianapolis, Indiana, United States

Outcomes

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

Data from ClinicalTrials.gov

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