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

NCT ID: NCT03748043

Last Updated: 2019-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-21

Study Completion Date

2019-05-30

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

Conditions

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Iron-deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lactoferrin+ferric hydroxide polymaltose

lactoferrin 100 mg /day plus ferric hydroxide polymaltose 6 mg /kilogram body wight for 3 months

Group Type EXPERIMENTAL

Lactoferrin

Intervention Type DRUG

lactoferrin 100 mg per day plus ferric hydroxide polymaltose 6 mg /kilogram of Elemental iron

Ferric Hydroxide Polymaltose

Intervention Type DRUG

group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron

ferric hydroxide polymaltose

6 mg /kilogram body wight of ferric hydroxide poly maltose per day for 3 months

Group Type EXPERIMENTAL

Ferric Hydroxide Polymaltose

Intervention Type DRUG

group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron

Interventions

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Lactoferrin

lactoferrin 100 mg per day plus ferric hydroxide polymaltose 6 mg /kilogram of Elemental iron

Intervention Type DRUG

Ferric Hydroxide Polymaltose

group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron

Intervention Type DRUG

Other Intervention Names

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(Pravotin sachets, Hygint, Egypt) haemojet syrp

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Shimaa Abdallah Ahmed

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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shimaa Ahmed, MD

Role: STUDY_CHAIR

South Valley University

Locations

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South Valley University

Qina, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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shimaa Ahmed, Lecturer

Role: CONTACT

+201064920445

Facility Contacts

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shimaa Ahmed, lecturer

Role: primary

References

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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.

Reference Type RESULT
PMID: 28612425 (View on PubMed)

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.

Reference Type RESULT
PMID: 27557596 (View on PubMed)

Other Identifiers

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171984

Identifier Type: -

Identifier Source: org_study_id

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