Clincosm LogoSign in Get a demo

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

Sponsor
South Valley University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03748043
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
3.2
Anticipated Duration (Months)
31.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
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

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 21, 2019
Anticipated Primary Completion Date :
May 30, 2019
Anticipated Study Completion Date :
May 30, 2019

Arms and Interventions

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 Names:
  • (Pravotin sachets, Hygint, Egypt)

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Increase in blood hemoglobin [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 [3 months]

      mean difference in ferritin level between pre treatment and post treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • children 3-17 years old with chronic tonsillitis
    Exclusion Criteria:
    • no other causes of Iron Deficiency Anemia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South Valley University Qinā Egypt

    Sponsors and Collaborators

    • South Valley University

    Investigators

    • Study Chair: shimaa Ahmed, MD, South Valley University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shimaa Abdallah Ahmed, principal investigator, South Valley University
    ClinicalTrials.gov Identifier:
    NCT03748043
    Other Study ID Numbers:
    • 171984
    First Posted:
    Nov 20, 2018
    Last Update Posted:
    Mar 19, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tonsillitis
    Anemia, Iron-Deficiency
    Lactoferrin
    Teferrol

    Study Results

    No Results Posted as of Mar 19, 2019