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NCT Number: NCT06268184

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

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

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Key information

Conditions

Oxidative Stress

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

D3 LAB SYRUP

Dietary Supplement

omega 3 suplementation

Placebo syrup

Dietary Supplement

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

Primary outcomes

  1. decrease oxidative stress

    Time frame: 6 months

    measured by assessment of serum level of Human Thiobarbituric Acid Reactive Substances (TBARS)

  2. increase antioxidant activity

    Time frame: 6 months

    measured by assessment of serum level of Human Glutathione peroxidase (GSH-Px)

  3. improvement of nutritional status assessed by anthropometric measurements.

    Time frame: 6 months

    including weight measure in kilograms ,height in meters, BMI calculated by division of weight on (height in meters)2

  4. mid upper arm circumference in centimeters

    Time frame: 6 months

    improvement of nutritional status assessed by anthropometric measurements.

  5. triceps skin fold thickness in millimeter's

    Time frame: 6 months

    improvement of nutritional status assessed by anthropometric measurements.

  6. improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)

    Time frame: 6 months

    including fat mass index ( FMI)

  7. improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)

    Time frame: 6 months

    fat free mass index (FFMI)

  8. improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)

    Time frame: 6 months

    total body water percentage (TBW%)

  9. improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)

    Time frame: 6 months

    Basal metaboic rate (BMR)

  10. improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)

    Time frame: 6 months

    muscle mass percentage (MM%)

  11. improvement of nutritional status assessed by laboratory investigations.

    Time frame: 6 months

    serum albumin level

  12. s. ionized calcium level

    Time frame: 6 months

  13. s.phosphorus level

    Time frame: 6 months

  14. alkaline phosphatase level

    Time frame: 6 months

  15. parathormone hormone level

    Time frame: 6 months

  16. 25(oh)vitamin D level

    Time frame: 6 months

    improvement of nutritional status assessed by laboratory investigations.

Study contacts

Contact information is provided by the study sponsor or research team.

noha sayed esmaeil, assistenet lecturer

CONTACT

[email protected]

01016919217 ext. 01097722167

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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