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

Menoufia University

Status and phase: Not yet enrolling; Phase 4

Conditions: CKD - Chronic Kidney Disease

Treatments: Drug: Iron Dextran Injection; Drug: Lactoferrin; Drug: Ferric Pyrophosphate Liposomal

Study type: Interventional

Funder types: Other

Identifiers

NCT05714176

Iron in CKD children

Details and patient eligibility

About

This is a randomized, parallel study that will be conducted on pediatric patients with CKD.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Liposomal iron

Experimental group

Description:

30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.

Treatment:

Drug: Ferric Pyrophosphate Liposomal

Iron supported Lactoferrin

Experimental group

Description:

30 pediatric patients who will receive oral iron supported Lactoferrin iron (Provan) 100 mg/day for 12 weeks.

Treatment:

Drug: Lactoferrin

Iv iron dextran

Experimental group

Description:

30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks.

Treatment:

Drug: Iron Dextran Injection