Back to resultsOmega-3 Fatty Acid Administration in Dialysis Patients
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fish oil
placebo
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring inflammation, end stage renal disease
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).
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC)
A decrease in muscle protein breakdown
Secondary Outcome Measures
A decrease in concentration of acute phase reactants (serum C-reactive protein and plasma pro-inflammatory cytokines)
An increase in concentration of nutritional biomarkers (serum albumin and serum prealbumin)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00655525
Brief Title
Omega-3 Fatty Acid Administration in Dialysis Patients
Official Title
Omega-3 Fatty Acid Administration in Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
inflammation, end stage renal disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
fish oil
Other Intervention Name(s)
eicosapentaenoic acid/docosahexaenoic acid
Intervention Description
2.9 g of fish oil (2:1 EPA:DHA) administered orally every day for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
placebo administered orally every day for 3 months
Primary Outcome Measure Information:
Title
A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC)
Time Frame
3 months
Title
A decrease in muscle protein breakdown
Time Frame
3 months
Secondary Outcome Measure Information:
Title
A decrease in concentration of acute phase reactants (serum C-reactive protein and plasma pro-inflammatory cytokines)
Time Frame
3 months
Title
An increase in concentration of nutritional biomarkers (serum albumin and serum prealbumin)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alp Ikizler, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Omega-3 Fatty Acid Administration in Dialysis Patients
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