Chronic Kidney Disease Clinical Trial
Official title:
Omega 3 Acids and Cardio - Vascular Complications in Patients With Chronic Kidney Disease in Stage 1-3
The National Register of Nephrology in 2007 shows, similarly to the European data, a problem
of a high mortality rate among Polish dialysis patients.
The main reason of death among chronically dialysis patients are cardio - vascular system
diseases. According to "The Report on the Condition of Renal Replacement Therapy in Poland
in 2007", these diseases are the cause of 53% deaths in Poland. The patients with chronic
kidney disease (PChN) are particularly at risk of cardio - vascular complications. These
complications occur on average 30 times more often than in the whole population, and among
young dialysis people, these complications occur 300 times more often. In the development of
cardio - vascular complications polyunsaturated Omega-3 acids (especially eicosapentaenoic
acid - EPA and docosahexaenoic acid - DHA) take a special position. The reaction of
polyunsaturated Omega-3 acids on the cardiovascular system results from the enrichment of
phospholipids of cell membranes within EPA and DHA. It should be noted that their impact is
dependent on the type of acid and on the dose. Docosahexaenoic acid reacts with lipids and
lipoproteins, blood pressure, heart rate, amount of glucose, and eicosapentaenoic acid is
responsible for antiplatelet effect.
This project is aiming at defining and elaborating on the connection between Omega-3 acids,
and cardiovascular complications, their influence on the functioning of the cardiovascular
system, and moreover, a better understanding of the effects of therapeutic and
pharmacological therapies in patients at different stages of chronic kidney disease.
Carrying out this project will be a good start to shape an international project in this
area.
The survey will cover 90 patients from chronic kidney disease at different stages of the
disease(I-III) and 30 healthy subjects as a comparison group.
At the beginning and at the end of the observation period, besides the clinical test, some
other tests will be carried out: echocardiography, pulse wave velocity (PWV), ambulatory
blood pressure monitoring (ABPM). Blood will be collected for laboratory tests such as:
lipid profile, uric acid, C reactive protein (CRP), blood urea nitrogen (BUN), creatinine,
morphology, calcium (Ca),phosphorus (P), Ca x P, ionogram, xanthine oxidase, monocyte
chemoattractant protein (MPC1),Omega-3 acids, resolvin and protectins - the metabolites of
Omega-3 acids, creatinine excretion, MPC1 excretion and excretion of uric acid. The patients
will be treated with Omega-3 acids as a Gold Omega 3 preparation (2x1 capsule where 1
capsule = 1000 mg) for 6 months.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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