Omega-3 Fatty Acid Administration in Dialysis Patients

NCT ID: NCT00655525

Last Updated: 2014-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-06-30

Brief Summary

The overall goal of this study is to examine the role of fish oil supplementation in ameliorating the inflammatory state of uremia and the related muscle protein catabolism associated with this disease state. We hypothesize that if administered for a period of 3 months, fish oil will improve the chronic uremic inflammation. We further hypothesize that fish oil administration will improve the muscle protein breakdown associated with uremia and inflammation.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

fish oil

Intervention Type: DIETARY_SUPPLEMENT

2.9 g of fish oil (2:1 EPA:DHA) administered orally every day for 3 months

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

placebo administered orally every day for 3 months

Interventions

fish oil

2.9 g of fish oil (2:1 EPA:DHA) administered orally every day for 3 months

Intervention Type: DIETARY_SUPPLEMENT

placebo

placebo administered orally every day for 3 months

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

eicosapentaenoic acid/docosahexaenoic acid

Eligibility Criteria

Inclusion Criteria

• Patients on CHD for more than 6 months;
• Ability to read and sign the consent form;
• Have acceptable dialysis adequacy (Kt/V > 1.2);
• Use biocompatible hemodialysis membrane;
• Have a patent, well functioning, arteriovenous dialysis access or permanent dialysis catheter (no other option for arteriovenous access);
• Signs of chronic inflammation (average CRP of ≥ 5 mg/L for 3 consecutive measurements)

Exclusion Criteria

• Pregnancy;
• Intolerance to the study medication;
• Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
• Diabetes mellitus on insulin therapy;
• Hospitalization within 1 month prior to the study;
• Malfunctioning arterial-venous vascular access (recirculation and/or blood flow < 500 ml/min);
• Patients receiving steroids (> 5 mg/day) and/or other immunosuppressive agents;
• Life-expectancy less than 6 months;
• Age less than 18 years old;
• Atrial fibrillation (only for those undergoing the optional Pulse Wave Velocity);
• Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery Doppler).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Alp Ikizler

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alp Ikizler, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

R21AT003844-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

080191

Identifier Type: -

Identifier Source: org_study_id