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| Name | Class |
|---|---|
| Tanta University | OTHER |
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This is a randomized, parallel study that will be conducted on pediatric patients with CKD.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal iron | Experimental | 30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks. |
|
| Iron supported Lactoferrin | Experimental | 30 pediatric patients who will receive oral iron supported Lactoferrin iron (Provan) 100 mg/day for 12 weeks. |
|
| Iv iron dextran | Experimental | 30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Pyrophosphate Liposomal | Drug | 30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin measure | Measure oxygen in blood by measuring hemoglobin by coloremetric assay | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mai SE Koura, MSc | Contact | 201274117967 | dr.pharmasist@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Sahar K Hagazy, PhD | Tanta University | Study Chair |
| Mohamed SH Al-Haron | Menoufia University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35675292 | Background | 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. | |
| 31939529 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2022 | Jan 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D007781 | Lactoferrin |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Lactoferrin | Drug | 30 pediatric patients who will receive oral iron supported Lactoferrin (Provan) 100 mg/day for 12 weeks. |
|
|
| Iron Dextran Injection | Drug | 30 pediatric patients who will receive IV iron dextran 50 mg /3 times weekly for 12 weeks. |
|
| 28302014 | Background | 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. |
| 35448476 | Background | 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. |
| 33392212 | Background | 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. |
| 39910177 | Derived | Hegazy SK, Koura MSE, Elharoun MS. Oral lactoferrin as a treatment of pediatrics' anemia resulted from chronic kidney diseases: a randomized controlled trial. Sci Rep. 2025 Feb 5;15(1):4380. doi: 10.1038/s41598-025-88506-2. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
| D011134 | Polysaccharides |