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The aim of this interventional study is to assess the effectiveness of oral lactoferrin in improving hemoglobin levels and correcting iron deficiency anemia in patients with end-stage renal disease (ESRD) on dialysis and also evaluate the impact of lactoferrin on bone health by measuring serum calcium and phosphate and other bone health indicators.
The participants will be divided into 3 groups as follow
The goal of this clinical trial is to evaluate the therapeutic impact of oral Lactoferrin on correcting iron deficiency anemia and improving bone health in patients diagnosed with end-stage renal disease.
AS End-stage renal disease (ESRD) represents a serious medical, social, and economic burden on any society and requires continuous medical attention and comprehensive healthcare services. Without appropriate treatment, it can be life-threatening.
Anemia is a common complication in individuals with chronic kidney disease (CKD) and has been linked to negative cardiovascular outcomes . Managing anemia often involves the use of erythropoiesis-stimulating agents (ESAs); however, targeting normal hemoglobin levels through ESA therapy has been associated with a heightened risk of cardiovascular events and mortality. To achieve effective anemia control, iron supplementation alongside ESAs plays a crucial role. Iron therapy not only helps elevate hemoglobin levels, but also lowers the necessary dosage of ESAs . However, Iron One of the drawbacks of intravenous (IV) iron administration in hemodialysis patients is its potential link to an increased risk of infections, as suggested by some observational studies-though the evidence remains conflicting and inconclusive.
Lactoferrin, also known as the "red protein," is a cationic glycoprotein from the transferrin family with an exceptionally high affinity for iron-approximately 300 times greater than transferrin. Its red color results from this strong iron-binding property. Its production increases during infection and inflammation It contributes to intestinal iron regulation, enhances the body's defense against microbial infections, acts as an anti-inflammatory agent, Thus, and in contrast to iron therapy, lactoferrin offers several advantages over conventional iron supplements, including better gastrointestinal tolerance, fewer side effects associated with high-dose iron intake, and added anti-inflammatory and antimicrobial properties.
Another complication associated with patients with ESRD is Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD), which is a complex, multifactorial condition characterized by disruptions in mineral metabolism, particularly involving calcium, phosphate, vitamin D and parathyroid hormone (PTH). Impaired kidney function leads to phosphate retention, decreased calcitriol synthesis, and calcium imbalance, triggering secondary hyperparathyroidism. Altogether, these hormonal and biochemical changes contribute to both skeletal complications and cardiovascular risks in CKD patients.
Lactoferrin also promotes bone growth by stimulating osteoblast proliferation, preventing cell death, and inhibiting osteoclast formation. These properties suggest its potential as a therapeutic agent for bone healing and osteoporosis Thus, the current study aims to assess the effect of lactoferrin use in patients with ESRD and receiving dialysis assessing its therapeutic potential in enhancing bone mineral density and correcting anemia in patients with chronic kidney disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactoferrin Arm | Active Comparator | The Lactoferrin Arm (36 participants) will receive a treatment of oral lactoferrin at a dose of 100 mg twice daily alongside Erythropoiesis-Stimulating Agent (ESA) therapy for three months. |
|
| IV Iron Arm | Active Comparator | The IV Iron arm (36 participants) will receive IV Iron therapy ( Iron Dextran) three times weekly with ESA for three months |
|
| Lactoferrin + IV Iron Arm | Active Comparator | The Lactoferrin + IV Iron arm (36 participants) will receive both oral Lactoferrin 100 mg twice daily and IV Iron alongside ESA therapy for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoferrin | Dietary Supplement | oral Lactoferrin - dose : 100 mg twice daily ( total dose= 200 mg daily ) - duration: administered for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure the change in hemoglobin concentration (g/dL) from baseline to 3 months, assessing the efficacy of lactoferrin in correcting anemia. | Hemoglobin concentration (g/dL) will be measured using automated hematology analyzer as a part of routine complete blood count (CBC) by collecting blood samples at baseline ( before the intervention) and after 3 months | Hemoglobin concentration (g/dL) will be measured at baseline and after three months ( the end of the study) |
| Measure | Description | Time Frame |
|---|---|---|
| -Measure the change in other complete blood count parameters including Red Blood Cells, Hematocrit and Mean Corpuscular Volume. -Measure the change in Iron Profile and also in Bone health indicators (Serum calcium and phosphate) | Iron profile parameters will be measured after serum separation by centrifugation then serum iron and Total Iron Binding Capacity will be determined by automated colorimetric assay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marina E Albert, Bachelor of Pharmacy | Beni-Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theodor Bilharz Research Institute (TBRI) | Giza | El-Nile Street, Imbaba, Warrak El Hader | Egypt |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic 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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the study included 3 groups , the first group will receive oral lactoferrin 100mg twice daily alongside with erythropoiesis-stimulating agents (ESAs) for three months , the second group will receive IV Iron with ESAs for the same duration and the third group will receive both Lactoferrin and IV Iron with ESAs for the same duration
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| IV iron dextran | Drug | IV Iron Dextran will be administered three times weekly for three months |
|
| All these parameters will be measured at baseline and also after three months |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |