Investigation of the Effects of Omega-3 Supplementation in Chronic Kidney Disease Patients Diagnosed With Coronary Artery Disease and Dyslipidemia

Brief summary (registry, in English)

Chronic kidney disease (CKD) is characterized by the slow, progressive, and irreversible loss of kidney function. Uremic toxins in CKD patients trigger an inflammatory response driven by various cytokines, chemokines, and other inflammatory molecules. As a result, increased oxidative stress and tissue damage are observed. In such an inflammatory environment, CKD patients are at higher risk of mortality due to the occurrence of adverse cardiovascular events. Omega-3 fatty acids are long-chain polyunsaturated fatty acids such as α-linolenic acid (ALA, 18:3), eicosapentaenoic acid (EPA, 20:5), and docosahexaenoic acid (DHA, 22:6). Omega-3 fatty acids are essential fatty acids because they cannot be synthesized in the body. There is increasing evidence that omega-3 fatty acids play a role in regulating inflammation and immune response by reducing the production of monocyte proinflammatory cytokines interleukin-1 (IL-1), IL-6, and TNF-α. Omega-3 has also been shown to alter abnormal lipid metabolism, reduce platelet aggregation, improve homocysteine levels, and improve endothelial function, blood pressure, heart rate, and oxidative stress. This study, which aims to observe the effectiveness of omega-3 supplementation in individuals who must have a diet low in omega-3 fatty acids due to certain dietary restrictions (especially fish), will be conducted at the Health Sciences University Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital. 60 patients between the ages of 50-75 with chronic kidney disease diagnosed with coronary artery disease and dyslipidemia will be included in the study. The study will include patients with stage 2-4 chronic kidney disease who have a history of dyslipidemia and coronary artery disease, a glomerular filtration rate (GFR) of 20-60 ml/min, a body mass index (BMI) of 18-30 kg/m2, are 50-75 years old, and have LDL cholesterol \>70 mg/dl despite using equal doses of statins for at least 3 months. Ethics committee approval for the study was obtained from the Istanbul Medipol University "Non-Interventional Clinical Research" ethics committee. Randomly selected participants of similar sizes will be randomly divided into 2 groups. Group A (intervention group) will be asked to use 2 capsules containing 2000 mg (720 mg EPA, 480 mg DHA) omega 3 daily for 12 weeks. The total of these capsules taken in the morning and evening will provide the daily dose. Group B will be the control group. No supplement will be used in this group. Clinical, biochemical and functional status data of each participant will be obtained at the beginning of the study and after the 12-week intervention. Apart from the parameters checked in routine tests (Total cholesterol (mg/dL), LDL-C (mg/dL), HDL-C (mg/dL), triglyceride (mg/dL), CRP (mg/L), fasting blood glucose (mg/dL), calcium (mg/dL), phosphorus (mg/dL), sodium (mg/dL), potassium (mg/dL), Creatine, Urea, Uric acid), Homocysteine, IL-6, TNF-a, Superoxide dismutase (SOD) and Malondialdehyde (MDA) levels will be analyzed in Istanbul Beykent University Multidisciplinary Laboratory. Anthropometric measurements (height, weight) of the patients will be taken. In addition, the food consumption records and food consumption frequencies of the patients will be evaluated with the BeBIS program.

What you commit to

• Study type: Interventional
• Participants enrolled: 60
• From 1 Jun 2024 to the primary completion date, 30 Mar 2025
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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