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

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ClinicalTrials.gov Identifier: NCT03748043
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Shimaa Abdallah Ahmed, South Valley University

Tracking Information
First Submitted Date  ICMJE November 18, 2018
First Posted Date  ICMJE November 20, 2018
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE February 21, 2019
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2018)
  • Increase in blood hemoglobin [ Time Frame: 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.
  • Increase in serum ferritin [ Time Frame: 3 months ]
    mean difference in ferritin level between pre treatment and post treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis
Official Title  ICMJE the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Iron-deficiency
Intervention  ICMJE
  • Drug: Lactoferrin
    lactoferrin 100 mg per day plus ferric hydroxide polymaltose 6 mg /kilogram of Elemental iron
    Other Name: (Pravotin sachets, Hygint, Egypt)
  • Drug: Ferric Hydroxide Polymaltose
    group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron
    Other Name: haemojet syrp
Study Arms  ICMJE
  • Experimental: lactoferrin+ferric hydroxide polymaltose
    lactoferrin 100 mg /day plus ferric hydroxide polymaltose 6 mg /kilogram body wight for 3 months
    Interventions:
    • Drug: Lactoferrin
    • Drug: Ferric Hydroxide Polymaltose
  • Experimental: ferric hydroxide polymaltose
    6 mg /kilogram body wight of ferric hydroxide poly maltose per day for 3 months
    Intervention: Drug: Ferric Hydroxide Polymaltose
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 18, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2019
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • children 3-17 years old with chronic tonsillitis

Exclusion Criteria:

  • no other causes of Iron Deficiency Anemia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: shimaa Ahmed, Lecturer +201064920445 shimaahaematology@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03748043
Other Study ID Numbers  ICMJE 171984
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shimaa Abdallah Ahmed, South Valley University
Study Sponsor  ICMJE South Valley University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: shimaa Ahmed, MD South Valley University
PRS Account South Valley University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP