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

Effect of Omega 3 Supplementation on Nutritional Status and Oxidative Stress in Children and Adolescents With End Stage Renal Disease on Regular Hemodialysis

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06268184
Enrollment
45
Registered
2024-02-20
Start date
2021-10-04
Completion date
2024-08-15
Last updated
2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

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.

Interventions

DIETARY_SUPPLEMENTD3 LAB SYRUP

omega 3 suplementation

DIETARY_SUPPLEMENTplacebo syrup

placebo syrup contains purified water, glycerin, xanthan gum, tween 80, methyl paraben, propyl paraben, sorbitol solution70% and apple flavor.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

group 1: 30 children with ESRD receive omega 3 supplementation group 2:15 children with ESRD receive lpacebo

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
decrease oxidative stress6 monthsmeasured by assessment of serum level of Human Thiobarbituric Acid Reactive Substances (TBARS)
increase antioxidant activity6 monthsmeasured by assessment of serum level of Human Glutathione peroxidase (GSH-Px)
improvement of nutritional status assessed by anthropometric measurements.6 monthsincluding weight measure in kilograms ,height in meters, BMI calculated by division of weight on (height in meters)2
mid upper arm circumference in centimeters6 monthsimprovement of nutritional status assessed by anthropometric measurements.
triceps skin fold thickness in millimeter's6 monthsimprovement of nutritional status assessed by anthropometric measurements.
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)6 monthsincluding fat mass index ( FMI)
improvement of nutritional status assessed by laboratory investigations.6 monthsserum albumin level
s. ionized calcium level6 months
s.phosphorus level6 months
alkaline phosphatase level6 months
parathormone hormone level6 months
25(oh)vitamin D level6 monthsimprovement of nutritional status assessed by laboratory investigations.

Countries

Egypt

Contacts

Primary Contactnoha sayed esmaeil, assistenet lecturer
noooooha1990@gmail.com01016919217

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026