the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis

Study Overview
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Brief Summary
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the investigators will compare the response to iron deficiency anemia to lactoferrin plus ferrous poly maltose versus ferrous poly maltose in Children With Chronic Tonsillitis

Detailed Description
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Iron deficiency is frequently present with chronic inflammatory disease.(1) Iron deficiency anemia results from decreased body's iron content due to blood loss, poor dietary iron intake, malabsorption, or increased iron requirement. Immune activation drives a diversion of iron to storage sites, particularly the mononuclear phagocytes system in liver and spleen leads to poor hemoglobinization and anemia. Iron deficiency and immune activation lead to disturbances of iron homeostasis.(2) this trial will compare the response to iron deficiency anemia to lactoferrin plus ferrous poly maltose versus ferrous poly maltose in Children With Chronic Tonsillitis

Official Title
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the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis

Conditions
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Iron-deficiency

Intervention / Treatment
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* Drug: Lactoferrin
* Drug: Ferric Hydroxide Polymaltose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children 3-17 years old with chronic tonsillitis Exclusion Criteria: no other causes of Iron Deficiency Anemia

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lactoferrin+ferric hydroxide polymaltose<br>lactoferrin 100 mg /day plus ferric hydroxide polymaltose 6 mg /kilogram body wight for 3 months | Drug: Lactoferrin<br>* lactoferrin 100 mg per day plus ferric hydroxide polymaltose 6 mg /kilogram of Elemental iron<br>* Other names: (Pravotin sachets, Hygint, Egypt);Drug: Ferric Hydroxide Polymaltose<br>* group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron<br>* Other names: haemojet syrp;|
| Experimental: ferric hydroxide polymaltose<br>6 mg /kilogram body wight of ferric hydroxide poly maltose per day for 3 months | Drug: Ferric Hydroxide Polymaltose<br>* group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron<br>* Other names: haemojet syrp;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in blood hemoglobin | mean difference in hemoglobin level between pre treatment and post treatment. mean difference in hemoglobin level between pre treatment and post treatment. | 1,3 months | 
| Increase in serum ferritin | mean difference in ferritin level between pre treatment and post treatment. | 3 months |