CKD - Chronic Kidney Disease
Conditions
Brief summary
This is a randomized, parallel study that will be conducted on pediatric patients with CKD.
Detailed description
The study will be conducted on 90 pediatric patients with CKD who will be divided into 3 groups: Group l: 30 pediatric patients who will receive oral liposomal iron 30 mg/day for 12 weeks. Group 2: 30 pediatric patients who will receive oral iron supported iron 1 mg+ lactoferrin 100 mg/day for 12 weeks. Group 3: 30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks.
Interventions
30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.
DRUGLactoferrin
30 pediatric patients who will receive oral iron supported Lactoferrin (Provan) 100 mg/day for 12 weeks.
30 pediatric patients who will receive IV iron dextran 50 mg /3 times weekly for 12 weeks.
Sponsors
Tanta University
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* A) Pediatrics ≤18 year old male and female patients. B) Pediatrics with CKD stages 3-5.
Exclusion criteria
* A) CKD patients' ≥18 year old. B) Active bleeding C) Malignancy D) Anemia due to any disease other than CKD E) Blood Transfusions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin measure | 3 months | Measure oxygen in blood by measuring hemoglobin by coloremetric assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers measure | 3 months | changes in serum levels of biological biomarkers( measure IL-6, hepcidin and GDF-15 by ELISA assay). |
Contacts
Primary ContactMai SE Koura, MSc
Outcome results
None listed