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| ID | Type | Description | Link |
|---|---|---|---|
| IHC00072 | Other Identifier | the general organization for teaching hospitals and institutes (GOTHI) |
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This study will be conducted to determine the efficacy and safety of lactoferrin versus oral iron versus lactoferrin plus oral iron as an add on therapy in reduced ejection fraction heart failure patients with iron deficiency.
•Patients will be randomly distributed into the three groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group "oral iron" | Experimental |
| |
| group "lactoferrin" | Experimental |
| |
| group "lactoferrin and oral iron" | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral Iron | Drug | oral iron once daily during or after meals as add-on therapy for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in health-related quality of life (HR-QoL) | • Change in health-related quality of life (HR-QoL) as evaluated by Minnesota Living with Heart Failure Questionnaire (MLHFQ) minimum score:0 maximum score:105 minimum score is a better outcome | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
1. Arrythmia including atrial fibrillation (AF) with poorly controlled ventricular rate at rest (> 100 beats/min).
2. Recent cardiac related hospitalizations in the past 3 months. 3. Known active infection. 4. Associated chronic medical disorder (chronic kidney disease (creatinine clearance < 60 ml/min), liver disease (ALT or AST > 3× upper limit of normal), peptic ulcer or chronic blood loss).
5. Associated bleeding disorder. 6. Previous iron supplement in past 3 months. 7. Anemia requiring blood transfusion (haemoglobin (Hb) < 7 g/dL). 8. Folic acid or vitamin B12 deficiency. 9. Hypersensitivity to lactoferrin or iron. 10. Haemoglobinopathies (G6PD, thalassemia's, sickle cell disease). 11. Pregnancy and lactation.
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D007501 | Iron |
| D007781 | Lactoferrin |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| Lactoferrin | Drug | lactoferrin twice daily before meals as add-on therapy for 12 weeks. |
|
| lactoferrin and oral iron | Drug | lactoferrin twice daily before meals and oral iron once daily during or after meals as add-on therapy for 12 weeks. |
|
| D002318 | Cardiovascular Diseases |
| D008670 |
| Metals |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| 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 |