Comparative Study Between Oral Liposomal Iron,Iron Supported Lactoferrin and IV Iron Dextran in CKD Children
Phase 4
Not yet recruiting
- Conditions
- CKD - Chronic Kidney Disease
- Interventions
- Registration Number
- NCT05714176
- Lead Sponsor
- Menoufia University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iv iron dextran Iron Dextran Injection 30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks. Liposomal iron Ferric Pyrophosphate Liposomal 30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks. Iron supported Lactoferrin Lactoferrin 30 pediatric patients who will receive oral iron supported Lactoferrin iron (Provan) 100 mg/day for 12 weeks.
- Primary Outcome Measures
Name Time Method Hemoglobin measure 3 months Measure oxygen in blood by measuring hemoglobin by coloremetric assay
- Secondary Outcome Measures
Name Time Method Biomarkers measure 3 months changes in serum levels of biological biomarkers( measure IL-6, hepcidin and GDF-15 by ELISA assay).