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

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ClinicalTrials.gov Identifier: NCT03748043
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Shimaa Abdallah Ahmed, 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

Condition or disease Intervention/treatment Phase
Iron-deficiency Drug: Lactoferrin Drug: Ferric Hydroxide Polymaltose Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: lactoferrin+ferric hydroxide polymaltose
lactoferrin 100 mg /day plus ferric hydroxide polymaltose 6 mg /kilogram body wight for 3 months
Drug: Lactoferrin
lactoferrin 100 mg per day plus ferric hydroxide polymaltose 6 mg /kilogram of Elemental iron
Other Name: (Pravotin sachets, Hygint, Egypt)

Drug: Ferric Hydroxide Polymaltose
group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron
Other Name: haemojet syrp

Experimental: ferric hydroxide polymaltose
6 mg /kilogram body wight of ferric hydroxide poly maltose per day for 3 months
Drug: Ferric Hydroxide Polymaltose
group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron
Other Name: haemojet syrp




Primary Outcome Measures :
  1. Increase in blood hemoglobin [ Time Frame: 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.

  2. Increase in serum ferritin [ Time Frame: 3 months ]
    mean difference in ferritin level between pre treatment and post treatment.



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children 3-17 years old with chronic tonsillitis

Exclusion Criteria:

  • no other causes of Iron Deficiency Anemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748043


Contacts
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Contact: shimaa Ahmed, Lecturer +201064920445 shimaahaematology@yahoo.com

Locations
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Egypt
South Valley University Recruiting
Qinā, Egypt
Contact: shimaa Ahmed, lecturer       shimaahaematology@yahoo.com   
Sponsors and Collaborators
South Valley University
Investigators
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Study Chair: shimaa Ahmed, MD South Valley University

Publications of Results:
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Responsible Party: Shimaa Abdallah Ahmed, principal investigator, South Valley University
ClinicalTrials.gov Identifier: NCT03748043     History of Changes
Other Study ID Numbers: 171984
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tonsillitis
Anemia, Iron-Deficiency
Anemia
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Lactoferrin
Ferric Compounds
Teferrol
Anti-Infective Agents
Hematinics