Carnitine supplementation for children on hemodialysis
Carnitine Deficiency and Benefits of Its Supplementation in Pediatric Hemodialysis Patients
This study is testing if giving L-carnitine to children on hemodialysis can help improve their health problems like anemia, heart issues, and muscle cramps.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05948124 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the prevalence of carnitine deficiency in pediatric patients undergoing hemodialysis and to evaluate the effectiveness of L-carnitine supplementation in addressing related health issues such as renal anemia, cardiac dysfunction, and muscle cramps. The study will involve administering intravenous levocarnitine to children diagnosed with carnitine deficiency after regular hemodialysis sessions. By monitoring various health parameters, the study seeks to determine if carnitine supplementation can improve the quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates include children aged 16 years or younger who have been on hemodialysis for over three months and exhibit symptoms of carnitine deficiency.
Not a fit: Patients with known allergies to L-carnitine, certain metabolic disorders, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the health and quality of life for pediatric patients on hemodialysis suffering from carnitine deficiency.
How similar studies have performed: While there is existing evidence supporting the use of carnitine supplementation in adult dialysis patients, this specific approach in pediatric populations is less explored and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients on regular hemodialysis for more than three months with L-carnitine deficiency. * Anemia (hemoglobin \[Hb\] \< 11 g/dl; hematocrit \[Hct\] \< 30%) resistant to erythropoietin defined as Anemia that require recombinant human erythropoietin (rHuEPO) doses \>300 units/kg/week intravenously in spite of adequate iron stores (transferrin saturation \>20%, ferritin \>100 ng/mL), and without any other identifiable cause of anemia. * Recurrent intradialytic complications (cramping, muscular pain, hypotension) * Cardiomyopathy with reduced left ventricular ejection fraction. * Sex: both males and females. * Age: 16 years old or less. Exclusion criteria: * Patients known to be allergic to L-carnitine. * Patients with inborn error of metabolism. * Patients on lipid lowering therapy. * Patients with Diabetes mellitus. * Patients with Associated congenital heart disease. * Patients with Thyroid disorder, or malignancy. * Patients received L-carnitine within the past 6 months. * Patients received Blood transfusion 4 weeks prior to study.
Where this trial is running
Cairo
- Ain Shams university — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Fady LAbib
- Email: Fadygeorguos@gmail.com
- Phone: +201023811345/201282657642
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.