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Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04267653
Recruitment Status : Completed
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Gaber Ahmed, Assiut University

Brief Summary:
Lactoferrin (Lf) is a mammalian cationic iron binding glycoprotein belonging to the transferrin family which was discovered 70 years ago, and isolated simultaneously from human and bovine milks in 1960. It is widely distributed in all biological fluids and is also expressed by immune cells, which release it under stimulation by pathogens

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Treatment Drug: Lactoferrin Bovine Drug: Ferrous Sulfate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Active Comparator: lactoferrin
Oral bovine lactoferrin (bfl) 100 mg once daily on empty stomach
Drug: Lactoferrin Bovine
treatment for 30 days
Other Name: Pravotin sachet

Active Comparator: ferrous sulfate
Oral ferrous sulfate 3-6 mg/kg of elemental iron/day in divided doses
Drug: Ferrous Sulfate
treatment for 30 days
Other Name: ferrovit syrup

Active Comparator: combined
combined therapy (both lactoferrin and ferrous sulfate)
Drug: Lactoferrin Bovine
treatment for 30 days
Other Name: Pravotin sachet

Drug: Ferrous Sulfate
treatment for 30 days
Other Name: ferrovit syrup




Primary Outcome Measures :
  1. comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia. [ Time Frame: 30 days ]
    Complete blood count will be done before and after therapy to detect the effect of the therapy on serum hemoglobin(g/d)

  2. Comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia. [ Time Frame: 30 days ]
    Total serum iron(ug/d) will be done before and after therapy to detect effect of the therapy on total serum iron level (ug/d)



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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:all patients with iron deficiency anemia from 2 to 15 years old

-

Exclusion Criteria:

  • Anemia rather than iron deficiency anemia.
  • Family history of blood disease.
  • Patients with thalassemia trait.
  • Patients with chronic illness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267653


Locations
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Egypt
AssuitU
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Ahmed Gaber Ahmed Assiut University
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Responsible Party: Ahmed Gaber Ahmed, pediatrician, Assiut University
ClinicalTrials.gov Identifier: NCT04267653    
Other Study ID Numbers: 17100915
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Gaber Ahmed, Assiut University:
Iron deficiency anemia
Lactoferrin
Ferrous sulfate
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Lactoferrin
Anti-Infective Agents