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

Primary Purpose

Chronic Kidney Disease, Cardiovascular Complications

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Gold omega 3
Sponsored by
Collegium Medicum w Bydgoszczy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Cardiovascular Complications

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- chronic kidney disease (CKD) stage 1-3

Exclusion Criteria:

  • without diabetes
  • without Immunosuppressive therapy

Sites / Locations

  • 1Katedra i Klinika Nefrologii, Nadciśnienia Tętniczego i Chorób Wewnętrznych, BydgoszczRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

omega 3 acids 1

omega 3 acids 2

omega 3 acids 3

omega 3 acids 4

Arm Description

Patients with CKD stage I (GFR 90 and more ml/min/1,73 m2)

Patients with CKD stage II (GFR 80-89 ml/min/1,73 m2)

Patients with CKD stage III (GFR 30-59 ml/min/1,73 m2)

Patients without diabetes mellitus, hypertensions,CKD with normal level of creatinine in serum

Outcomes

Primary Outcome Measures

cardiovascular complications
Primary measurement before the supplementation and the second measurement after 6 months of supplementation with omega-3 acid.

Secondary Outcome Measures

Full Information

First Posted
May 22, 2014
Last Updated
November 4, 2014
Sponsor
Collegium Medicum w Bydgoszczy
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1. Study Identification

Unique Protocol Identification Number
NCT02147002
Brief Title
Omega-3 Acids and Cardio - Vascular Complications in Patients With Chronic Kidney Disease in Stage 1-3
Acronym
Omega-3 acids
Official Title
Omega 3 Acids and Cardio - Vascular Complications in Patients With Chronic Kidney Disease in Stage 1-3
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Collegium Medicum w Bydgoszczy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Cardiovascular Complications
Keywords
Chronic Kidney Disease, Cardiovascular Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
omega 3 acids 1
Arm Type
Active Comparator
Arm Description
Patients with CKD stage I (GFR 90 and more ml/min/1,73 m2)
Arm Title
omega 3 acids 2
Arm Type
Active Comparator
Arm Description
Patients with CKD stage II (GFR 80-89 ml/min/1,73 m2)
Arm Title
omega 3 acids 3
Arm Type
Active Comparator
Arm Description
Patients with CKD stage III (GFR 30-59 ml/min/1,73 m2)
Arm Title
omega 3 acids 4
Arm Type
Active Comparator
Arm Description
Patients without diabetes mellitus, hypertensions,CKD with normal level of creatinine in serum
Intervention Type
Dietary Supplement
Intervention Name(s)
Gold omega 3
Other Intervention Name(s)
omega 3 acids
Intervention Description
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.
Primary Outcome Measure Information:
Title
cardiovascular complications
Description
Primary measurement before the supplementation and the second measurement after 6 months of supplementation with omega-3 acid.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - chronic kidney disease (CKD) stage 1-3 Exclusion Criteria: without diabetes without Immunosuppressive therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnieszka Pluta, dr
Phone
693716980
Ext
0048
Email
agnieszkapluta@poczta.onet.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Manitius, prof.
Organizational Affiliation
Collegium Medicum in Bydgoszcz
Official's Role
Study Director
Facility Information:
Facility Name
1Katedra i Klinika Nefrologii, Nadciśnienia Tętniczego i Chorób Wewnętrznych, Bydgoszcz
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-094
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Pluta, dr
Phone
693716980
Ext
0048
Email
agnieszkapluta@poczta.onet.pl
First Name & Middle Initial & Last Name & Degree
Paweł Stróżecki, dr

12. IPD Sharing Statement

Citations:
PubMed Identifier
29349065
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.
Results Reference
derived

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

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