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| Name | Class |
|---|---|
| Khyber Teaching Hospital | OTHER |
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This study aims to compare the efficacy of two iron preparation for the management of children presented with iron deficiency anemia. Ferrous sulphate and lron polymaltose (ferric form) are most commonly used preparations. Both drugs are easily available in market and are often recommended by pediatriclans. The efficacy, bioavail.tbilily, side effects and cost of these preparations vary. This study is designed to find out a drug with better efficacy that can be used for treatment of iron deficiency anemia in local population.
Anemia remains a condition with high prevalence in populations worldwide. It is predominantly associated with nutritional status and socioeconomic conditions or hereditary diseases. The majority of anemia cases are linked to iron deficiency-named iron-deficiency anemia resulting from low intake of iron-rich foods in the diet, or from substantial blood loss.
This study aims to compare the efficacy of two iron preparation for the management of children presented with iron deficiency anemia. Ferrous sulphate and lron polymaltose (ferric form) are most commonly used preparations. Both drugs are easily available in market and are often recommended by pediatriclans. The efficacy, bioavail.tbilily, side effects and cost of these preparations vary. This study is designed to find out a drug with better efficacy that can be used for treatment of iron deficiency anemia in local population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Ferrous sulphate) | Active Comparator | Group A will be given Ferrous sulphate in a dose of 6mg/kg/day of elemental iron once daily for 8 weeks orally in syrup form. |
|
| Group B (Iron Polymaltose complex) | Active Comparator | Group B will be given Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous sulfate | Drug | ferrous sulphate in a dose of 6mg/kg/day of elemental iron once daily for 8 weeks orally in syrup form. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase Of Hemoglobin Level | Increase in Hemoglobin level measured by a Complete Blood Count as compared to pre treatment Hemoglobin | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aimal Khan, MBBS | Contact | 03481903336 | aimalkhan871207@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khyber Teaching Hospital | Recruiting | Peshawar | KPK | 25000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34684433 | Background | Montoro-Huguet MA, Santolaria-Piedrafita S, Canamares-Orbis P, Garcia-Erce JA. Iron Deficiency in Celiac Disease: Prevalence, Health Impact, and Clinical Management. Nutrients. 2021 Sep 28;13(10):3437. doi: 10.3390/nu13103437. | |
| 31652803 | Background | Martin-Masot R, Nestares MT, Diaz-Castro J, Lopez-Aliaga I, Alferez MJM, Moreno-Fernandez J, Maldonado J. Multifactorial Etiology of Anemia in Celiac Disease and Effect of Gluten-Free Diet: A Comprehensive Review. Nutrients. 2019 Oct 23;11(11):2557. doi: 10.3390/nu11112557. |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
| C013276 | teferrol |
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Brief history and demographic data including age, gender, duration of pallor, residence, weight, educational level of mother, socioeconomic status of father will be noted. Under aseptic techniques 5cc venous sample will be drawn and send to hospital laboratory for baseline hemoglobin and serum ferritin level. All patients will be dewormed before starting therapy by giving oral albendazole l0 ml stat dose. Patients will be divided randomly in two groups using blocked randomization generated by computer software. Group A will be given ferrous sulphate in a dose of 6mg/kg/day of elemental iron once daily for 8 weeks orally in syrup form. Group B will be given Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks. Both the groups will be called for follow up. Hemoglobin level will be assessed after 8 week of therapy.
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Patients will be divided randomly in two groups using blocked randomization generated by computer software.
| Iron Polymaltose Complex | Drug | Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks. |
|
| 32828801 | Background | Rockey DC, Altayar O, Falck-Ytter Y, Kalmaz D. AGA Technical Review on Gastrointestinal Evaluation of Iron Deficiency Anemia. Gastroenterology. 2020 Sep;159(3):1097-1119. doi: 10.1053/j.gastro.2020.06.045. Epub 2020 Aug 21. No abstract available. |
| 34684422 | Background | Zheng J, Liu J, Yang W. Association of Iron-Deficiency Anemia and Non-Iron-Deficiency Anemia with Neurobehavioral Development in Children Aged 6-24 Months. Nutrients. 2021 Sep 28;13(10):3423. doi: 10.3390/nu13103423. |
| 34249504 | Background | Orsango AZ, Habtu W, Lejisa T, Loha E, Lindtjorn B, Engebretsen IMS. Iron deficiency anemia among children aged 2-5 years in southern Ethiopia: a community-based cross-sectional study. PeerJ. 2021 Jun 28;9:e11649. doi: 10.7717/peerj.11649. eCollection 2021. |
| 33946398 | Result | Paulino CTDS, Nishijima M, Sarti FM. Association of Iron Supplementation Programs with Iron-Deficiency Anemia Outcomes among Children in Brazil. Nutrients. 2021 Apr 30;13(5):1524. doi: 10.3390/nu13051524. |
| D019189 |
| Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |