A Pilot Study of Fish Oil Supplementation in Hemodialysis... | NCT00308295

Studies
A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients

NCT00308295

Sponsor

Indiana University

Status

Completed

Last Update Posted

Oct 16, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

End-Stage Renal Disease Patients on Hemodialysis

Interventions

Fish oil capsules
matched placebo capsules

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

May 2006

First Submitted Date

Mar 27, 2006

First Submission Date that Met QC Criteria

Mar 27, 2006

First Posted Date

Mar 29, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2007

Last Update Posted Date

Oct 16, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

82 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allon Friedman, MD	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana University Nephrology Clinics		Indianapolis	Indiana	46202	United States
VeteransAdministration Hospital

ID	Term
D009821	Oils
D008055	Lipids

Name	Type	Description	Arm Group Labels	Other Names
Fish oil capsules	Drug
matched placebo capsules	Drug