A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

Indiana University School of Medicine

Status: Completed

Conditions: End-Stage Renal Disease Patients on Hemodialysis

Treatments: Drug: matched placebo capsules; Drug: Fish oil capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT00308295

0512-13

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 82 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind