Omega 3 Fatty Acids in Patients With Chronic Renal Disease

Study Overview
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Brief Summary
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To study the tolerance and efficacy of an omega 3 fatty acids supplement on renal and vascular function and inflammatory parameters in patients with chronic renal disease

Detailed Description
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In a double blind trial in patients with chronic renal disease, the effects of a 3.7 g supplement of docosahexanoic and eicosapentanoic acids or a supplement of a similar dose of corn oil during 12 weeks, will be assessed on the following parameters: Urine albumin excretion Renal function measured with serum creatinine, cystatin C and beta-2 microglobulin Carotid intima media thickness and pulse wave velocity Inflammation status assessed measuring serum levels of C reactive protein and interleukin 6 Metabolic control of diabetes Serum lipid levels

Official Title
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Effects of the Supplementation With Omega 3 Fatty Acids in Patients With Chronic Renal Disease

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Dietary Supplement: Omega 3 fatty acids
* Dietary Supplement: Corn oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Urinary albumin excretion over 30 mg/g creatinin Chronic renal failure stage 2 to 4 Absence of serious conditions such as cáncer, decompensated heart failure, chronic infections and severe arterial lesions Exclusion Criteria: Blood glucose levels over 180 mg/dl or glycosilated hemoglobin over 8% Presence of cognitive impairment that does not allow to sigin a written informed consent Alcohol or illicit drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly selected to receive 3.7 g of a supplement containing docosahexanoic and eicosapentanoic acids or a supplement containing corn oil. The supplements will be provided for 12 weeks
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega 3 fatty acids<br>Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks | Dietary Supplement: Omega 3 fatty acids<br>* Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids<br>|
| Placebo Comparator: Corn oil<br>Supplementation of 3.7 g of corn oil per day during 12 weeks | Dietary Supplement: Corn oil<br>* Corn oil will be the placebo comparator for omega 3 fatty acids supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Urine Albumin Excretion Decrease of 20% or More | Number of participants in whom urine albumin excretion in a spot urine sample at the end of follow up, expressed as mg/g creatinine, decreased by 20% or more | At baseline and 12 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in C Reactive Protein Levels at 12 Weeks of Intervention | Blood C reactive protein measured at baseline and the end of the intervention. | At baseline and 12 weeks of intervention | 
| Change in Pulse Wave Velocity at 12 Weeks of Intervention | Measurement of pulse wave velocity using a oscillometric device measured at baseline and end of follow up and expressed ad m/s | At baseline and 12 weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Albuminuria, Carotid Intima-Media Thickness, Pulse Wave Velocity, Inflammation