Omega-3 Fatty Acid Administration in Dialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

Omega-3 Fatty Acid Administration in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655525
• Other study ID #: 080191
• Secondary ID: R21AT003844-01A2
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2008
• Last updated: April 22, 2014
• Start date: April 2008
• Est. completion date: June 2011

Study information

• Verified date: April 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC)		3 months	No
Primary	A decrease in muscle protein breakdown		3 months	No
Secondary	A decrease in concentration of acute phase reactants (serum C-reactive protein and plasma pro-inflammatory cytokines)		3 months	No
Secondary	An increase in concentration of nutritional biomarkers (serum albumin and serum prealbumin)		3 months	No