Comparative Study Between Oral Liposomal Iron,Iron Supported Lactoferrin and IV Iron Dextran in CKD Children
NCT ID: NCT05714176
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2023-02-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Liposomal iron
30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.
Ferric Pyrophosphate Liposomal
30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.
Iron supported Lactoferrin
30 pediatric patients who will receive oral iron supported Lactoferrin iron (Provan) 100 mg/day for 12 weeks.
Lactoferrin
30 pediatric patients who will receive oral iron supported Lactoferrin (Provan) 100 mg/day for 12 weeks.
Iv iron dextran
30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks.
Iron Dextran Injection
30 pediatric patients who will receive IV iron dextran 50 mg /3 times weekly for 12 weeks.
Interventions
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Ferric Pyrophosphate Liposomal
30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.
Lactoferrin
30 pediatric patients who will receive oral iron supported Lactoferrin (Provan) 100 mg/day for 12 weeks.
Iron Dextran Injection
30 pediatric patients who will receive IV iron dextran 50 mg /3 times weekly for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Months
18 Years
ALL
No
Sponsors
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Tanta University
OTHER
Menoufia University
OTHER
Responsible Party
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Mai Salah El-Din
Critical care clinical pharmacist
Principal Investigators
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Sahar K Hagazy, PhD
Role: STUDY_CHAIR
Tanta University
Mohamed SH Al-Haron
Role: STUDY_CHAIR
Menoufia University
Central Contacts
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References
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Amanullah F, Malik AA, Zaidi Z. Chronic kidney disease causes and outcomes in children: Perspective from a LMIC setting. PLoS One. 2022 Jun 8;17(6):e0269632. doi: 10.1371/journal.pone.0269632. eCollection 2022.
Ammirati AL. Chronic Kidney Disease. Rev Assoc Med Bras (1992). 2020 Jan 13;66Suppl 1(Suppl 1):s03-s09. doi: 10.1590/1806-9282.66.S1.3.
Ueda N, Takasawa K. Role of Hepcidin-25 in Chronic Kidney Disease: Anemia and Beyond. Curr Med Chem. 2017;24(14):1417-1452. doi: 10.2174/0929867324666170316120538.
Moscheo C, Licciardello M, Samperi P, La Spina M, Di Cataldo A, Russo G. New Insights into Iron Deficiency Anemia in Children: A Practical Review. Metabolites. 2022 Mar 25;12(4):289. doi: 10.3390/metabo12040289.
Wojtaszek E, Glogowski T, Malyszko J. Iron and Chronic Kidney Disease: Still a Challenge. Front Med (Lausanne). 2020 Dec 18;7:565135. doi: 10.3389/fmed.2020.565135. eCollection 2020.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Iron in CKD children
Identifier Type: -
Identifier Source: org_study_id
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