Omega-3 Fatty Acid Administration in Dialysis Patients

NCT00655525 | Completed Phase 2 DMC

• 2 other identifiers: 080191R21AT003844-01A2
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

inflammation; end stage renal disease

Outcome Measures

Primary Outcomes (2)

• A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC)

  3 months

• A decrease in muscle protein breakdown

  3 months

Secondary Outcomes (2)

• A decrease in concentration of acute phase reactants (serum C-reactive protein and plasma pro-inflammatory cytokines)

  3 months

• An increase in concentration of nutritional biomarkers (serum albumin and serum prealbumin)

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Dietary Supplement: fish oil

2

PLACEBO COMPARATOR

Dietary Supplement: placebo

Interventions

fish oil DIETARY_SUPPLEMENT

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

Also known as: eicosapentaenoic acid/docosahexaenoic acid

1

placebo DIETARY_SUPPLEMENT

placebo administered orally every day for 3 months

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Alp Ikizler, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

US (1)