the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2018
CompletedFirst Posted
Study publicly available on registry
November 20, 2018
CompletedStudy Start
First participant enrolled
February 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2019
CompletedMarch 19, 2019
March 1, 2019
3 months
November 18, 2018
March 17, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
Increase in serum ferritin
mean difference in ferritin level between pre treatment and post treatment.
3 months
Study Arms (2)
lactoferrin+ferric hydroxide polymaltose
EXPERIMENTALlactoferrin 100 mg /day plus ferric hydroxide polymaltose 6 mg /kilogram body wight for 3 months
ferric hydroxide polymaltose
EXPERIMENTAL6 mg /kilogram body wight of ferric hydroxide poly maltose per day for 3 months
Interventions
lactoferrin 100 mg per day plus ferric hydroxide polymaltose 6 mg /kilogram of Elemental iron
group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron
Eligibility Criteria
You may qualify if:
- children 3-17 years old with chronic tonsillitis
You may not qualify if:
- no other causes of Iron Deficiency Anemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Valley University
Qina, Egypt
Related 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: 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.
PMID: 28612425RESULTNairz 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.
PMID: 27557596RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
shimaa Ahmed, MD
South Valley University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
November 18, 2018
First Posted
November 20, 2018
Study Start
February 21, 2019
Primary Completion
May 30, 2019
Study Completion
May 30, 2019
Last Updated
March 19, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share