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

Phase 4

• Conditions: Iron-deficiency
• Interventions: Drug: Lactoferrin; Drug: Ferric Hydroxide Polymaltose

• Registration Number: NCT03748043
• Lead Sponsor: South Valley University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2018-11-18
• Study First Submitted QC: 2018-11-18
• Study First Posted: 2018-11-20
• Study Start: 2019-02-21
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-17
• Last Update Posted: 2019-03-19
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• children 3-17 years old with chronic tonsillitis

Exclusion Criteria

• no other causes of Iron Deficiency Anemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lactoferrin+ferric hydroxide polymaltose	Ferric Hydroxide Polymaltose	lactoferrin 100 mg /day plus ferric hydroxide polymaltose 6 mg /kilogram body wight for 3 months
ferric hydroxide polymaltose	Ferric Hydroxide Polymaltose	6 mg /kilogram body wight of ferric hydroxide poly maltose per day for 3 months
lactoferrin+ferric hydroxide polymaltose	Lactoferrin	lactoferrin 100 mg /day plus ferric hydroxide polymaltose 6 mg /kilogram body wight for 3 months

Primary Outcome Measures

Name	Time	Method
Increase in blood hemoglobin	1,3 months	mean difference in hemoglobin level between pre treatment and post treatment. mean difference in hemoglobin level between pre treatment and post treatment.
Increase in serum ferritin	3 months	mean difference in ferritin level between pre treatment and post treatment.

Trial Locations

Locations (1)

South Valley University; 🇪🇬 Qinā, Egypt