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

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

Study Overview

• Status: Recruiting
• Conditions: Oxidative Stress
• Intervention / Treatment: Dietary supplement: D3 LAB SYRUP; Dietary supplement: placebo syrup

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: noha sayed esmaeil, assistenet lecturer; Phone Number: 01097722167 01016919217; Email: noooooha1990@gmail.com

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt
      • Recruiting
      • Faculty of Medicine
      • Contact: Noha sayed ahmed, M.Sc; Phone Number: 01097722167 01016919217; Email: noooooha1990@gmail.com
      • Contact: rasha gamal elshafaay, MD; Phone Number: 01114277784 01227405988; Email: rashagamal1978@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: omega 3; D3LAB syrup each 5 ml contain :EPA 825 mg and DHA 550 mg each child receive 3.6 ml every day for 6 months	Dietary supplement: D3 LAB SYRUP; omega 3 suplementation
Placebo Comparator: placebo; Placebo capsules contain only the standard ingredients of soft gelatin capsules (gelatin, water, glycerin, and vitamin E in minute amounts as preservatives).	Dietary supplement: placebo syrup; placebo syrup contains purified water, glycerin, xanthan gum, tween 80, methyl paraben, propyl paraben, sorbitol solution70% and apple flavor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): March 1, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: omega3 in oxidative stress

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No