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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omega 3 | Active Comparator | D3LAB syrup each 5 ml contain :EPA 825 mg and DHA 550 mg each child receive 3.6 ml every day for 6 months |
|
| placebo | Placebo Comparator | Placebo capsules contain only the standard ingredients of soft gelatin capsules (gelatin, water, glycerin, and vitamin E in minute amounts as preservatives). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D3 LAB SYRUP | Dietary Supplement | omega 3 suplementation |
| |
| placebo syrup |
| Measure | Description | Time Frame |
|---|---|---|
| decrease oxidative stress | measured by assessment of serum level of Human Thiobarbituric Acid Reactive Substances (TBARS) | 6 months |
| increase antioxidant activity | measured by assessment of serum level of Human Glutathione peroxidase (GSH-Px) | 6 months |
| improvement of nutritional status assessed by anthropometric measurements. | including weight measure in kilograms ,height in meters, BMI calculated by division of weight on (height in meters)2 | 6 months |
| mid upper arm circumference in centimeters | improvement of nutritional status assessed by anthropometric measurements. | 6 months |
| triceps skin fold thickness in millimeter's | improvement of nutritional status assessed by anthropometric measurements. | 6 months |
| improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) | including fat mass index ( FMI) | 6 months |
| improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) | fat free mass index (FFMI) | 6 months |
| improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| noha sayed esmaeil, assistenet lecturer | Contact | 01016919217 | 01097722167 | noooooha1990@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Recruiting | Tanta | Gharbia Governorate | Egypt |
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group 1: 30 children with ESRD receive omega 3 supplementation group 2:15 children with ESRD receive lpacebo
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| Dietary Supplement |
placebo syrup contains purified water, glycerin, xanthan gum, tween 80, methyl paraben, propyl paraben, sorbitol solution70% and apple flavor. |
|
total body water percentage (TBW%) |
| 6 months |
| improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) | Basal metaboic rate (BMR) | 6 months |
| improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) | muscle mass percentage (MM%) | 6 months |
| improvement of nutritional status assessed by laboratory investigations. | serum albumin level | 6 months |
| s. ionized calcium level | 6 months |
| s.phosphorus level | 6 months |
| alkaline phosphatase level | 6 months |
| parathormone hormone level | 6 months |
| 25(oh)vitamin D level | improvement of nutritional status assessed by laboratory investigations. | 6 months |