A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00308295

Enrollment

Registered

2006-03-29

Start date

2006-04-30

Completion date

2006-05-31

Last updated

2007-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease Patients on Hemodialysis

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.

Interventions

DRUGFish oil capsules

DRUGmatched placebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 82 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026