Oxidative StressNCT06268184
Effect of Omega 3 on Oxidative Stress and Nutritional Status of Children on Regular Dialysis
A study testing D3 LAB SYRUP in people with Oxidative Stress, run by Tanta University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- D3 LAB SYRUP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2021to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ESRD children and adolescents on regular hemodialysis for at least 3 months
- Age ranging from 6 to18 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Tanta, Gharbia Governorate
Noha sayed ahmed, M.Sc, 01016919217 ext. 01097722167, noooooha1990@gmail.com
rasha gamal elshafaay, MD, 01227405988 ext. 01114277784, rashagamal1978@gmail.com
About this study
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
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
Read the 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.
- Conditions
- Oxidative Stress
- Being tested
- D3 LAB SYRUP, placebo syrup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D3 LAB SYRUPDietary supplement
omega 3 suplementation
placebo syrupDietary supplement
placebo syrup contains purified water, glycerin, xanthan gum, tween 80, methyl paraben, propyl paraben, sorbitol solution70% and apple flavor.
| Study group | Role | What they receive |
|---|---|---|
| omega 3 | Active comparator | D3LAB syrup each 5 ml contain :EPA 825 mg and DHA 550 mg each child receive 3.6 ml every day for 6 months Receives: Dietary Supplement: D3 LAB SYRUP |
| placebo | Placebo comparator | Placebo capsules contain only the standard ingredients of soft gelatin capsules (gelatin, water, glycerin, and vitamin E in minute amounts as preservatives). Receives: Dietary Supplement: placebo syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease oxidative stress
measured by assessment of serum level of Human Thiobarbituric Acid Reactive Substances (TBARS)
Measured: 6 months
increase antioxidant activity
measured by assessment of serum level of Human Glutathione peroxidase (GSH-Px)
Measured: 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
Measured: 6 months
mid upper arm circumference in centimeters
improvement of nutritional status assessed by anthropometric measurements.
Measured: 6 months
triceps skin fold thickness in millimeter's
improvement of nutritional status assessed by anthropometric measurements.
Measured: 6 months
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
including fat mass index ( FMI)
Measured: 6 months
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
fat free mass index (FFMI)
Measured: 6 months
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
total body water percentage (TBW%)
Measured: 6 months
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
Basal metaboic rate (BMR)
Measured: 6 months
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
muscle mass percentage (MM%)
Measured: 6 months
improvement of nutritional status assessed by laboratory investigations.
serum albumin level
Measured: 6 months
s. ionized calcium level
Measured: 6 months
s.phosphorus level
Measured: 6 months
alkaline phosphatase level
Measured: 6 months
parathormone hormone level
Measured: 6 months
25(oh)vitamin D level
improvement of nutritional status assessed by laboratory investigations.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start4 Oct 2021
- Primary completion1 Mar 2024
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group 1: 30 children with ESRD receive omega 3 supplementation group 2:15 children with ESRD receive lpacebo
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NohaSayed Ahmed Hamed Esmaeil, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268184
- Sponsor's protocol ID
- omega3 in oxidative stress
- Status last verified
- Jul 2024
- First submitted
- 29 Jan 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06268184
- Acronym / sponsor ID
- omega3 in oxidative stress
- Conditions
- Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- group 1: 30 children with ESRD receive omega 3 supplementation group 2:15 children with ESRD receive lpacebo
| Arm | Type | Receives |
|---|---|---|
| omega 3 | Active comparator | Dietary Supplement: D3 LAB SYRUPD3LAB syrup each 5 ml contain :EPA 825 mg and DHA 550 mg each child receive 3.6 ml every day for 6 months |
| placebo | Placebo comparator | Dietary Supplement: placebo syrupPlacebo capsules contain only the standard ingredients of soft gelatin capsules (gelatin, water, glycerin, and vitamin E in minute amounts as preservatives). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ESRD children and adolescents on regular hemodialysis for at least 3 months
- Age ranging from 6 to18 years.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D3 LAB SYRUPomega 3 suplementation | Dietary supplement | omega 3 |
| placebo syrupplacebo syrup contains purified water, glycerin, xanthan gum, tween 80, methyl paraben, propyl paraben, sorbitol solution70% and apple flavor. | Dietary supplement | placebo |
Primary outcome
decrease oxidative stress
Time frame: 6 months
measured by assessment of serum level of Human Thiobarbituric Acid Reactive Substances (TBARS)
increase antioxidant activity
Time frame: 6 months
measured by assessment of serum level of Human Glutathione peroxidase (GSH-Px)
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
mid upper arm circumference in centimeters
Time frame: 6 months
improvement of nutritional status assessed by anthropometric measurements.
triceps skin fold thickness in millimeter's
Time frame: 6 months
improvement of nutritional status assessed by anthropometric measurements.
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
Time frame: 6 months
including fat mass index ( FMI)
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
Time frame: 6 months
fat free mass index (FFMI)
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
Time frame: 6 months
total body water percentage (TBW%)
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
Time frame: 6 months
Basal metaboic rate (BMR)
improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)
Time frame: 6 months
muscle mass percentage (MM%)
improvement of nutritional status assessed by laboratory investigations.
Time frame: 6 months
serum albumin level
s. ionized calcium level
Time frame: 6 months
s.phosphorus level
Time frame: 6 months
alkaline phosphatase level
Time frame: 6 months
parathormone hormone level
Time frame: 6 months
25(oh)vitamin D level
Time frame: 6 months
improvement of nutritional status assessed by laboratory investigations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D3 LAB SYRUP in people with Oxidative Stress, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact noha sayed esmaeil, assistenet lecturer (01016919217 ext. 01097722167, noooooha1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease oxidative stress (time frame: 6 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.