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NCT03748043 Clinical Trial

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

Iron-deficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03748043
Other study ID # 171984
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date February 21, 2019
Est. completion date May 30, 2019

Study information
Verified date March 2019
Source South Valley University
Contact shimaa Ahmed, Lecturer
Phone +201064920445
Email shimaahaematology@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date May 30, 2019
Est. primary completion date May 30, 2019
Accepts healthy volunteers No
Gender All
Age group 3 Years to 17 Years
Eligibility Inclusion Criteria:

- children 3-17 years old with chronic tonsillitis

Exclusion Criteria:

- no other causes of Iron Deficiency Anemia

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lactoferrin
lactoferrin 100 mg per day plus ferric hydroxide polymaltose 6 mg /kilogram of Elemental iron
• Ferric Hydroxide Polymaltose
group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron

Locations
Country Name City State
Egypt South Valley University Qina

Sponsors (1)
Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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: Internatio — View 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. Epub 2016 Aug 24. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Increase in serum ferritin mean difference in ferritin level between pre treatment and post treatment. 3 months
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