Effects of Omega-3 on Oxidative Stress and Nutrition in Children on Dialysis
Effect of Omega 3 Supplementation on Nutritional Status and Oxidative Stress in Children and Adolescents With End Stage Renal Disease on Regular Hemodialysis
This study tests if giving omega-3 supplements to children on dialysis can help improve their nutrition and reduce stress on their bodies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbia Governorate) |
| Trial ID | NCT06268184 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of oral omega-3 supplementation on the nutritional status and oxidative stress levels in pediatric patients suffering from end-stage renal disease (ESRD) who are undergoing regular hemodialysis. Chronic Kidney Disease (CKD) poses significant health challenges for children, leading to various comorbidities such as malnutrition and growth retardation. The trial aims to determine whether omega-3 can mitigate oxidative stress, which is known to exacerbate complications associated with CKD. Participants will receive either omega-3 or a placebo syrup over a specified period to assess the outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 6 to 18 years who have been on regular hemodialysis for at least three months due to end-stage renal disease.
Not a fit: Patients with systemic diseases other than CKD, severe active infections, or allergies to the omega-3 product may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the nutritional status and reduce oxidative stress in children with ESRD, potentially enhancing their overall health and quality of life.
How similar studies have performed: While the specific application of omega-3 in this context may be novel, previous studies have indicated potential benefits of omega-3 supplementation in managing oxidative stress and nutritional issues in various populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tanta, Gharbia Governorate
- Faculty of Medicine — Tanta, Gharbia Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: noha sayed esmaeil, assistenet lecturer
- Email: noooooha1990@gmail.com
- Phone: 01016919217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.