Omega 3 Fatty Acids in Patients With Chronic Renal Disease

University of Chile100 enrolled

Overview

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

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: 1. Urine albumin excretion 2. Renal function measured with serum creatinine, cystatin C and beta-2 microglobulin 3. Carotid intima media thickness and pulse wave velocity 4. Inflammation status assessed measuring serum levels of C reactive protein and interleukin 6 5. Metabolic control of diabetes 6. Serum lipid levels

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Renal Insufficiency, Chronic

Interventions

Omega 3 fatty acidsDIETARY_SUPPLEMENT

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

Corn oilDIETARY_SUPPLEMENT

Corn oil will be the placebo comparator for omega 3 fatty acids supplement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Nutrition and Food Technology University of Chile

Santiago, Santiago Metropolitan, Chile

Outcomes

Primary Outcomes

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

Time frame: At baseline and 12 weeks of intervention

Secondary Outcomes

Change in C Reactive Protein Levels at 12 Weeks of Intervention

Blood C reactive protein measured at baseline and the end of the intervention.

Time frame: 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

Time frame: At baseline and 12 weeks of intervention

Data from ClinicalTrials.gov

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