Effect of Omega 3 on Oxidative Stress and Nutritional Status of Children on Regular Dialysis
- Conditions
- Oxidative Stress
- Interventions
- Dietary Supplement: placebo syrupDietary Supplement: D3 LAB SYRUP
- Registration Number
- NCT06268184
- Lead Sponsor
- Tanta University
- Brief Summary
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
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- ESRD children and adolescents on regular hemodialysis for at least 3 months
- Age ranging from 6 to18 years.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo syrup Placebo capsules contain only the standard ingredients of soft gelatin capsules (gelatin, water, glycerin, and vitamin E in minute amounts as preservatives). omega 3 D3 LAB SYRUP D3LAB syrup each 5 ml contain :EPA 825 mg and DHA 550 mg each child receive 3.6 ml every day for 6 months
- Primary Outcome Measures
Name Time Method increase antioxidant activity 6 months measured by assessment of serum level of Human Glutathione peroxidase (GSH-Px)
mid upper arm circumference in centimeters 6 months improvement of nutritional status assessed by anthropometric measurements.
triceps skin fold thickness in millimeter's 6 months improvement of nutritional status assessed by anthropometric measurements.
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) 6 months muscle mass percentage (MM%)
improvement of nutritional status assessed by laboratory investigations. 6 months serum albumin level
s.phosphorus level 6 months decrease oxidative stress 6 months measured by assessment of serum level of Human Thiobarbituric Acid Reactive Substances (TBARS)
alkaline phosphatase level 6 months improvement of nutritional status assessed by anthropometric measurements. 6 months including weight measure in kilograms ,height in meters, BMI calculated by division of weight on (height in meters)2
s. ionized calcium level 6 months 25(oh)vitamin D level 6 months improvement of nutritional status assessed by laboratory investigations.
parathormone hormone level 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Faculty of Medicine
🇪🇬Tanta, Gharbia, Egypt