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

January 26, 2023 updated by: Mai Salah El-Din, Menoufia University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Liposomal iron
30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.
Drug: Ferric Pyrophosphate Liposomal
30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.
Other Names:
  • Novoferr
EXPERIMENTAL: Iron supported Lactoferrin
30 pediatric patients who will receive oral iron supported Lactoferrin iron (Provan) 100 mg/day for 12 weeks.
Drug: Lactoferrin
30 pediatric patients who will receive oral iron supported Lactoferrin (Provan) 100 mg/day for 12 weeks.
Other Names:
  • Provan
EXPERIMENTAL: Iv iron dextran
30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks.
Drug: Iron Dextran Injection
30 pediatric patients who will receive IV iron dextran 50 mg /3 times weekly for 12 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Collaborators

Tanta University

Investigators

  • Study Chair: Sahar K Hagazy, PhD, Tanta University
  • Study Chair: Mohamed SH Al-Haron, Menoufia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2023

Primary Completion (ANTICIPATED)

January 1, 2024

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

January 15, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (ACTUAL)

February 6, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Iron in CKD children

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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