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

Oxidative Stress Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268184
• Other study ID #: omega3 in oxidative stress
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: February 2024
• Source: Tanta University
• Contact: noha sayed esmaeil, assistenet lecturer
• Phone: 01016919217
• Email: noooooha1990[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Dietary Supplement:
• D3 LAB SYRUP
omega 3 suplementation
• placebo capsule
placebo capsule contain only the standard ingredients of soft gelatin capsules

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease oxidative stress	measured by assessment of serum level of Human Thiobarbituric Acid Reactive Substances (TBARS)	6 months
Primary	increase antioxidant activity	measured by assessment of serum level of Human Glutathione peroxidase (GSH-Px)	6 months
Primary	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
Primary	mid upper arm circumference in centimeters	improvement of nutritional status assessed by anthropometric measurements.	6 months
Primary	triceps skin fold thickness in millimeter's	improvement of nutritional status assessed by anthropometric measurements.	6 months
Primary	improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)	including fat mass index ( FMI)	6 months
Primary	improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)	fat free mass index (FFMI)	6 months
Primary	improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)	total body water percentage (TBW%)	6 months
Primary	improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)	Basal metaboic rate (BMR)	6 months
Primary	improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)	muscle mass percentage (MM%)	6 months
Primary	improvement of nutritional status assessed by laboratory investigations.	serum albumin level	6 months
Primary	s. ionized calcium level		6 months
Primary	s.phosphorus level		6 months
Primary	alkaline phosphatase level		6 months
Primary	parathormone hormone level		6 months
Primary	25(oh)vitamin D level	improvement of nutritional status assessed by laboratory investigations.	6 months