Clinical trial NCT06268184: Effect of Omega 3 on Oxidative Stress and Nutritional Status of Children on Regular Dialysis
Official title: Effect of Omega 3 Supplementation on Nutritional Status and Oxidative Stress in Children and Adolescents With End Stage Renal Disease on Regular Hemodialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oxidative Stress
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group 1: 30 children with ESRD receive omega 3 supplementation group 2:15 children with ESRD receive lpacebo
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: decrease oxidative stress
timeFrame: 6 months
measure: increase antioxidant activity
timeFrame: 6 months
measure: improvement of nutritional status assessed by anthropometric measurements.
timeFrame: 6 months
measure: mid upper arm circumference in centimeters
timeFrame: 6 months
measure: triceps skin fold thickness in millimeter's
timeFrame: 6 months
measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
timeFrame: 6 months
measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
timeFrame: 6 months
measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
timeFrame: 6 months
measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
timeFrame: 6 months
measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
timeFrame: 6 months
measure: improvement of nutritional status assessed by laboratory investigations.
timeFrame: 6 months
measure: s. ionized calcium level
timeFrame: 6 months
measure: s.phosphorus level
timeFrame: 6 months
measure: alkaline phosphatase level
timeFrame: 6 months
measure: parathormone hormone level
timeFrame: 6 months
measure: 25(oh)vitamin D level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine
state: Gharbia
Study officials:
References: