Clinical trial NCT02147002: Omega-3 Acids and Cardio - Vascular Complications in Patients With Chronic Kidney Disease in Stage 1-3
Official title: Omega 3 Acids and Cardio - Vascular Complications in Patients With Chronic Kidney Disease in Stage 1-3
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Cardiovascular Complications
Keywords: Chronic Kidney Disease
Cardiovascular Complications
Lead sponsor: Collegium Medicum w Bydgoszczy
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

- chronic kidney disease (CKD) stage 1-3

Exclusion Criteria:

* without diabetes
* without Immunosuppressive therapy

Primary outcomes:
measure: cardiovascular complications
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: 1Katedra i Klinika Nefrologii, Nadciśnienia Tętniczego i Chorób Wewnętrznych, Bydgoszcz
state: Kujawsko-pomorskie
Study officials:
affiliation: Collegium Medicum in Bydgoszcz
name: Jacek Manitius, prof.
role: STUDY_DIRECTOR
References:
citation: Pluta A, Strozecki P, Kesy J, Lis K, Sulikowska B, Odrowaz-Sypniewska G, Manitius J. Beneficial Effects of 6-Month Supplementation with Omega-3 Acids on Selected Inflammatory Markers in Patients with Chronic Kidney Disease Stages 1-3. Biomed Res Int. 2017;2017:1680985. doi: 10.1155/2017/1680985. Epub 2017 Nov 19.