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

NCT07127068 | Active Not Recruiting DMC

• 1 other identifier: EDABALCI2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Omega 3 Fatty Acids; Coronary Arterial Disease (CAD); Chronic Kidney Disease(CKD)

Keywords

chronic kidney disease; omega 3 fatty acids; coronary arterial disease; dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Change in serum oxidative stress, inflammation, and lipid profile

  To evaluate changes in serum oxidative stress biomarkers (SOD (Superoxide Dismutase), MDA (Malondialdehyde), inflammation biomarkers (IL-6 (Interleukin-6), TNF-α (Tumor Necrosis Alpha), CRP (C-Reactive Protein) and lipid profile (LDL-C, HDL-C, Total cholesterol, Triglycerides) and homocysteine parameters between baseline and the end of the 12-week intervention.

  Baseline and 12 weeks

Secondary Outcomes (3)

• Weight change

  Baseline and 12 weeks

• Change in dietary intake

  Baseline

• Height

  Baseline

Other Outcomes (1)

• Change in Subjective Global Assessment (SGA) score

  Baseline and 12 week

Study Arms (2)

Patients taking omega 3 fatty acids

EXPERIMENTAL

This 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 provides the daily dose.

Dietary Supplement: Omega-3 Suplementation

Control

EXPERIMENTAL

This group will be the control group. No supplements will be used in this group. Only the appropriate diet list will be applied.

Other: No intervention

Interventions

Omega-3 Suplementation DIETARY_SUPPLEMENT

The intervention group will receive a daily oral supplementation of 2000 mg omega-3, which will not be administered to the control group. Blood samples will be collected from all participants at baseline and at the end of the study to evaluate selected serum parameters. To minimize nutritional variability, individualized diets appropriate for coronary artery disease and chronic kidney disease were prescribed to both groups at the beginning of the study. Unlike many other intervention studies, this trial specifically targets end-stage renal disease patients and includes an evaluation of the intervention's impact in relation to dialysis initiation.

Patients taking omega 3 fatty acids

No intervention OTHER

Participants in the control group will not receive any dietary supplementation. Blood samples will be collected at baseline and at the end of the study to assess selected biochemical parameters. Standard dietary care appropriate for coronary artery disease and chronic kidney disease will be maintained throughout the study.

Control

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with dyslipidemia
• Patients diagnosed with type 2 diabetes
• Patients with a history of coronary artery disease
• Patients with a glomerular filtration rate of 20-60 ml/min
• Patients with stage 2-4 chronic kidney disease
• Patients with a body mass index (BMI) of 18-30 kg/m2
• Patients aged 45-80
• Patients with an LDL cholesterol level of \>70 mg/dl despite taking statin medications at the same dose for at least 3 months

You may not qualify if:

• Those with active inflammatory diseases
• Those taking anti-inflammatory medications, those with chronic inflammation such as active hepatitis or human immunodeficiency virus (HIV)(+)
• Those with liver disease - elevated liver enzymes
• Those undergoing dialysis treatment
• Those planning a transplant
• Those using fish oil or other antioxidant medications within the last 3 months
• Those who are pregnant or breastfeeding
• Those with neurological or psychiatric disorders
• Individuals consuming more than one serving of fish per week
• Patients at high risk of bleeding (those using bivalirudin)
• Patients who have undergone coronary artery bypass surgery within the last 3 months

Sponsors & Collaborators

• University of Beykent: lead

Study Sites (1)

Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Dyslipidemias

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; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• EDA BALCI, lecturer

  İstanbul Beykent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 17, 2025
• Study Start: June 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: November 20, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-02

Locations

TU (1)