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临床试验/NCT02147002
NCT02147002Unknown不适用

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

Collegium Medicum w Bydgoszczy2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
cardiovascular complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • without diabetes
  • without Immunosuppressive therapy

研究组 & 干预措施

omega 3 acids 1

Active Comparator

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

干预措施: Gold omega 3 (Dietary Supplement)

omega 3 acids 2

Active Comparator

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

干预措施: Gold omega 3 (Dietary Supplement)

omega 3 acids 3

Active Comparator

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

干预措施: Gold omega 3 (Dietary Supplement)

omega 3 acids 4

Active Comparator

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

干预措施: Gold omega 3 (Dietary Supplement)

结局指标

主要结局

cardiovascular complications

时间窗: 6 months

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

次要结局

未报告次要终点

研究者

发起方
Collegium Medicum w Bydgoszczy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacek Manitius

prof. dr hab. n.med.

Collegium Medicum w Bydgoszczy

研究点 (2)

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