Back to resultsthe Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis
Primary Purpose
Iron-deficiency
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Lactoferrin
Ferric Hydroxide Polymaltose
Sponsored by
About this trial
This is an interventional treatment trial for Iron-deficiency
Eligibility Criteria
Inclusion Criteria:
- children 3-17 years old with chronic tonsillitis
Exclusion Criteria:
- no other causes of Iron Deficiency Anemia
Sites / Locations
- South Valley UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
lactoferrin+ferric hydroxide polymaltose
ferric hydroxide polymaltose
Arm Description
lactoferrin 100 mg /day plus ferric hydroxide polymaltose 6 mg /kilogram body wight for 3 months
6 mg /kilogram body wight of ferric hydroxide poly maltose per day for 3 months
Outcomes
Primary Outcome Measures
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.
Increase in serum ferritin
mean difference in ferritin level between pre treatment and post treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT03748043
First Posted
November 18, 2018
Last Updated
March 17, 2019
Sponsor
South Valley University
1. Study Identification
Unique Protocol Identification Number
NCT03748043
Brief Title
the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis
Official Title
the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
May 30, 2019 (Anticipated)
Study Completion Date
May 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lactoferrin+ferric hydroxide polymaltose
Arm Type
Experimental
Arm Description
lactoferrin 100 mg /day plus ferric hydroxide polymaltose 6 mg /kilogram body wight for 3 months
Arm Title
ferric hydroxide polymaltose
Arm Type
Experimental
Arm Description
6 mg /kilogram body wight of ferric hydroxide poly maltose per day for 3 months
Intervention Type
Drug
Intervention Name(s)
Lactoferrin
Other Intervention Name(s)
(Pravotin sachets, Hygint, Egypt)
Intervention Description
lactoferrin 100 mg per day plus ferric hydroxide polymaltose 6 mg /kilogram of Elemental iron
Intervention Type
Drug
Intervention Name(s)
Ferric Hydroxide Polymaltose
Other Intervention Name(s)
haemojet syrp
Intervention Description
group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron
Primary Outcome Measure Information:
Title
Increase in blood hemoglobin
Description
mean difference in hemoglobin level between pre treatment and post treatment. mean difference in hemoglobin level between pre treatment and post treatment.
Time Frame
1,3 months
Title
Increase in serum ferritin
Description
mean difference in ferritin level between pre treatment and post treatment.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children 3-17 years old with chronic tonsillitis
Exclusion Criteria:
no other causes of Iron Deficiency Anemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shimaa Ahmed, Lecturer
Phone
+201064920445
Email
shimaahaematology@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shimaa Ahmed, MD
Organizational Affiliation
South Valley University
Official's Role
Study Chair
Facility Information:
Facility Name
South Valley University
City
Qinā
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shimaa Ahmed, lecturer
Email
shimaahaematology@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28612425
Citation
Cappellini MD, Comin-Colet J, de Francisco A, Dignass A, Doehner W, Lam CS, Macdougall IC, Rogler G, Camaschella C, Kadir R, Kassebaum NJ, Spahn DR, Taher AT, Musallam KM; IRON CORE Group. Iron deficiency across chronic inflammatory conditions: International expert opinion on definition, diagnosis, and management. Am J Hematol. 2017 Oct;92(10):1068-1078. doi: 10.1002/ajh.24820. Epub 2017 Jul 7.
Results Reference
result
PubMed Identifier
27557596
Citation
Nairz M, Theurl I, Wolf D, Weiss G. Iron deficiency or anemia of inflammation? : Differential diagnosis and mechanisms of anemia of inflammation. Wien Med Wochenschr. 2016 Oct;166(13-14):411-423. doi: 10.1007/s10354-016-0505-7. Epub 2016 Aug 24.
Results Reference
result
Learn more about this trial
the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis
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