Comparative Study Between Oral Liposomal Iron,Iron Supported Lactoferrin and IV Iron Dextran in CKD Children

Study Overview
=================
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.

Official Title
-----------------
Comparative Clinical Study to Evaluate the Efficacy and Safety of Oral Liposomal Iron, Oral Iron Supported Lactoferrin and IV Iron Dextran in Children With Chronic Kidney Disease

Conditions
-----------------
CKD - Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Ferric Pyrophosphate Liposomal
* Drug: Lactoferrin
* Drug: Iron Dextran Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal iron<br>30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks. | Drug: Ferric Pyrophosphate Liposomal<br>* 30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.<br>* Other names: Novoferr;|
| Experimental: Iron supported Lactoferrin<br>30 pediatric patients who will receive oral iron supported Lactoferrin iron (Provan) 100 mg/day for 12 weeks. | Drug: Lactoferrin<br>* 30 pediatric patients who will receive oral iron supported Lactoferrin (Provan) 100 mg/day for 12 weeks.<br>* Other names: Provan;|
| Experimental: Iv iron dextran<br>30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks. | Drug: Iron Dextran Injection<br>* 30 pediatric patients who will receive IV iron dextran 50 mg /3 times weekly for 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin measure | Measure oxygen in blood by measuring hemoglobin by coloremetric assay | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers measure | changes in serum levels of biological biomarkers( measure IL-6, hepcidin and GDF-15 by ELISA assay). | 3 months |