NCT05714176

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CKD - Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Ferric Pyrophosphate Liposomal	30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.
DRUG	Lactoferrin	30 pediatric patients who will receive oral iron supported Lactoferrin (Provan) 100 mg/day for 12 weeks.
DRUG	Iron Dextran Injection	30 pediatric patients who will receive IV iron dextran 50 mg /3 times weekly for 12 weeks.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-01-01
• Completion: 2024-12-31
• First posted: 2023-02-06
• Last updated: 2023-02-06