NCT00308295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

October 16, 2007

Status Verified

October 1, 2007

First QC Date

March 27, 2006

Last Update Submit

October 15, 2007

Conditions

End-Stage Renal Disease Patients on Hemodialysis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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

Interventions

Fish oil capsulesDRUG
matched placebo capsulesDRUG

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University Nephrology Clinics

Indianapolis, Indiana, 46202, United States

Location

VeteransAdministration Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Allon Friedman, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 29, 2006

Study Start

April 1, 2006

Study Completion

May 1, 2006

Last Updated

October 16, 2007

Record last verified: 2007-10

Locations

US(2)