A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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End-Stage Renal Disease Patients on Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Fish oil capsules

Intervention Type DRUG

matched placebo capsules

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Allon Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University Nephrology Clinics

Indianapolis, Indiana, United States

Site Status

VeteransAdministration Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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0512-13

Identifier Type: -

Identifier Source: org_study_id