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

NCT02147002 | Unknown

• 2 other identifiers: KB305/2012BS209
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Cardiovascular Complications

Keywords

Chronic Kidney Disease; Cardiovascular Complications

Outcome Measures

Primary Outcomes (1)

• cardiovascular complications

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

  6 months

Study Arms (4)

omega 3 acids 1

ACTIVE COMPARATOR

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

Dietary Supplement: Gold omega 3

omega 3 acids 2

ACTIVE COMPARATOR

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

Dietary Supplement: Gold omega 3

omega 3 acids 3

ACTIVE COMPARATOR

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

Dietary Supplement: Gold omega 3

omega 3 acids 4

ACTIVE COMPARATOR

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

Dietary Supplement: Gold omega 3

Interventions

Gold omega 3 DIETARY_SUPPLEMENT

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.

Also known as: omega 3 acids

omega 3 acids 1; omega 3 acids 2; omega 3 acids 3; omega 3 acids 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- chronic kidney disease (CKD) stage 1-3

You may not qualify if:

• without diabetes
• without Immunosuppressive therapy

Sponsors & Collaborators

• Collegium Medicum w Bydgoszczy: lead

Study Sites (1)

1Katedra i Klinika Nefrologii, Nadciśnienia Tętniczego i Chorób Wewnętrznych, Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 29349065 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Jacek Manitius, prof.

  Collegium Medicum in Bydgoszcz

  STUDY DIRECTOR

Central Study Contacts

Agnieszka Pluta, dr

CONTACT

693716980; agnieszkapluta@poczta.onet.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr hab. n.med.

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 26, 2014
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 5, 2014

Record last verified: 2014-11

Locations

PL (1)