Back to resultsLactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia
Primary Purpose
Iron Deficiency Anemia Treatment
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Lactoferrin Bovine
Ferrous Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia Treatment focused on measuring Iron deficiency anemia, Lactoferrin, Ferrous sulfate
Eligibility 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.
Sites / Locations
- AssuitU
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
lactoferrin
ferrous sulfate
combined
Arm Description
Oral bovine lactoferrin (bfl) 100 mg once daily on empty stomach
Oral ferrous sulfate 3-6 mg/kg of elemental iron/day in divided doses
combined therapy (both lactoferrin and ferrous sulfate)
Outcomes
Primary Outcome Measures
comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.
Complete blood count will be done before and after therapy to detect the effect of the therapy on serum hemoglobin(g/d)
Comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04267653
Brief Title
Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia
Official Title
Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia Treatment
Keywords
Iron deficiency anemia, Lactoferrin, Ferrous sulfate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lactoferrin
Arm Type
Active Comparator
Arm Description
Oral bovine lactoferrin (bfl) 100 mg once daily on empty stomach
Arm Title
ferrous sulfate
Arm Type
Active Comparator
Arm Description
Oral ferrous sulfate 3-6 mg/kg of elemental iron/day in divided doses
Arm Title
combined
Arm Type
Active Comparator
Arm Description
combined therapy (both lactoferrin and ferrous sulfate)
Intervention Type
Drug
Intervention Name(s)
Lactoferrin Bovine
Other Intervention Name(s)
Pravotin sachet
Intervention Description
treatment for 30 days
Intervention Type
Drug
Intervention Name(s)
Ferrous Sulfate
Other Intervention Name(s)
ferrovit syrup
Intervention Description
treatment for 30 days
Primary Outcome Measure Information:
Title
comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.
Description
Complete blood count will be done before and after therapy to detect the effect of the therapy on serum hemoglobin(g/d)
Time Frame
30 days
Title
Comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.
Description
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)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Gaber Ahmed
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AssuitU
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia
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