Effect of Omega 3 on Oxidative Stress and Nutritional Status of Children on Regular Dialysis

Tanta University

Status: Enrolling

Conditions: Oxidative Stress

Treatments: Dietary Supplement: placebo syrup; Dietary Supplement: D3 LAB SYRUP

Study type: Interventional

Funder types: Other

Identifiers

NCT06268184

omega3 in oxidative stress

Details and patient eligibility

About

evaluaion the effects of oral omega-3 supplementation on nutritional status and oxidative stress in pediatric patients with end stage renal disease on regular hemodialysis

Full description

Chronic Kidney Disease (CKD) is a medically challenging and economically demanding health issue that adds to child morbidity and mortality.

The prevalence of pediatric CKD has been reported to be ranging from 15 to 74.7 cases per million children.

With an earlier age of onset of CKD, there is a greater risk of comorbidities associated with the disease including: malnutrition, growth.

retardation, joint pain, dental problems, hypertension, dyslipidemia and cardiovascular disease.

Kidney wasting disease is a common and serious complication of CKD, affects approximately one-third of end stage renal disease (ESRD) patients on hemodialysis. Contributing factors to this malnutrition include poor appetite, various co-morbidities, dietary restrictions, inflammation, infection, metabolic acidosis and oxidative stress. Oxidative stress (OS), defined as disturbances in the pro-

/antioxidant balance, is harmful to cells due to the excessive generation of highly reactive oxygen (ROS) and nitrogen (RNS) species.When the balance is not disturbed, OS has a role in physiological adaptations and signal transduction. The kidney is a highly metabolic organ, rich in oxidation reactions in mitochondria, which makes it vulnerable to damage caused by OS, in turn, OS is associated with kidney disease progression. Several complications of CKD are linked to increased levels of OS. Also, in ESRD, increased OS is associated with complications such as hypertension, atherosclerosis, inflammation, and anemia. The 'oxidative' link between CKD and its complications is achieved through several mechanisms, such as uremic toxin-induced endothelial nitric oxide synthase (eNOS) uncoupling and increased nicotinamide adenine dinucleotide phosphate-oxidases [NADPH oxidases (NOX)] activity. but also antioxidant losses due to dietary restrictions, diuretics use, protein energy wasting, and/or decreased intestinal absorption.

In CKD patients, lifestyle factors, such as aerobic exercise and dietary interventions, have been shown to exert anti-inflammatory effects. however, the adherence for CKD patients is often poor, thus leading to pharmacological therapy as a potential alternative. The use of statins, and angiotensin-converting enzyme inhibitors, as well as angiotensin II type 1 blockers, have been shown to exert some anti-inflammatory effects. In addition to the conventional therapy, the use of supplements has gathered interest in scientific research. Numerous studies have shown the possibility of using compounds with anti-inflammatory and antioxidant activities in the treatment of CKD.

Omega-3 fatty acids including Eicosapentaenoic acid and docosahexaenoic acid can modify abnormal lipid metabolism, decrease platelet aggregation, and improve endothelium function, blood pressure, heart rate, oxidative stress, and inflammation. Patients with ESRD have substantially lower blood levels of n-3 polyunsaturated fatty acids (n-3 PUFA) compared with the general population, probably due to lower dietary intake, inflammation, malabsorption, metabolic changes, and loss of n-3 PUFA during the dialysis process.

Enrollment: 45 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ESRD children and adolescents on regular hemodialysis for at least 3 months
• Age ranging from 6 to18 years.

Exclusion criteria

• Systematic disease other than CKD eg SLE
• Severe active infection.
• Allergies to any of the ingredients in omega-3 product used in this study (e.g. fish oil, bovine gelatin).
• Omega-3 fatty acid or any other antioxidants consumption within the last 6 months.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups, including a placebo group

omega 3

Active Comparator group

Description:

D3LAB syrup each 5 ml contain :EPA 825 mg and DHA 550 mg each child receive 3.6 ml every day for 6 months

Treatment:

Dietary Supplement: D3 LAB SYRUP

placebo

Placebo Comparator group

Description:

Placebo capsules contain only the standard ingredients of soft gelatin capsules (gelatin, water, glycerin, and vitamin E in minute amounts as preservatives).

Treatment:

Dietary Supplement: placebo syrup