Omega-3 Acids and Cardio - Vascular Complications in Patients With Chronic Kidney Disease in Stage 1-3

Chronic Kidney Disease Clinical Trial

— Omega-3 acids  

Official title:

Omega 3 Acids and Cardio - Vascular Complications in Patients With Chronic Kidney Disease in Stage 1-3

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02147002
• Other study ID #: KB305/2012
• Secondary ID: BS209
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2014
• Last updated: November 4, 2014
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: Collegium Medicum w Bydgoszczy
• Contact: Agnieszka Pluta, dr
• Phone: 693716980
• Email: agnieszkapluta[@]poczta.onet.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• chronic kidney disease (CKD) stage 1-3

Exclusion Criteria:

• without diabetes

• without Immunosuppressive therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Complications
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Gold omega 3
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, CRP, BUN, creatinine, morphology, Ca, P, Ca x P, ionogram, xanthine oxidase, 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.

Locations

Country	Name	City	State
Poland	1Katedra i Klinika Nefrologii, Nadcisnienia Tetniczego i Chorób Wewnetrznych, Bydgoszcz	Bydgoszcz	Kujawsko-pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Collegium Medicum w Bydgoszczy

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular complications	Primary measurement before the supplementation and the second measurement after 6 months of supplementation with omega-3 acid.	6 months	No