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出境医 / 临床实验 / Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students

Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students

Study Description
Brief Summary:
This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Lactoferrin Drug: Ferrous sulfate Phase 2 Phase 3

Detailed Description:

Iron, an essential element for cell growth and proliferation, is a component of fundamental processes such as DNA replication and energy production. However, iron can also be toxic when present in excess for its capacity to donate electrons to oxygen, thus causing the generation of reactive oxygen species (ROS), such as superoxide anions and hydroxyl radicals

Prevalence of iron deficiency anemia is roughly 38% of pregnant women, 29% of non-pregnant women and 29% of all women of reproductive age have anemia globally

Human lactoferrin (hLf), an 80-kDa multifunctional iron-binding cationic glycoprotein, is constitutively secreted by exocrine glands and by neutrophils during inflammation. hLf is recognized as a key element in the host immune defense system

Bovine Lf (bLf), which shares high sequence homology with the human protein, is also a multifunctional glycoprotein with identical antibacterial, antifungal, antiviral, antiparasitic, anti-inflammatory, and immunomodulatory activities of hLf Lactoferrin is synthesized by exocrine glands and neutrophils under conditions of inflammation and at site of infection through its iron binding and formation of reactive oxygen species physiological transport of iron from tissue to circulation, thus curing iron deficiency and iron deficiency anemia

A study done for pregnant women showed an increase of total serum iron in all bovin lactoferrin treated women.

Therefore, the investigators speculated that bLf efficacy in curing AI was presumably not linked to direct iron supplementation, but to a more complex mechanism involving this protein in iron homeostasis

Lactoferrin was also proven useful for prevention of iron deficiency anemia special among female long distance runner

Lactoferrin was more effective than ferrous sulphate over a two months period in pregnant women with iron deficient anemia Aim of the Work

This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students
Actual Study Start Date : September 10, 2018
Actual Primary Completion Date : November 10, 2018
Actual Study Completion Date : January 10, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Lactoferrin in iron deficiency anemia
lactoferrin ( pravotin) 100mg twice daily
Drug: Lactoferrin
This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.

Active Comparator: Ferrous sulfate in iron deficiency anemia
ferrous sulphate (hemojet)
Drug: Ferrous sulfate
This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.
Other Name: ferrous sulphate

Active Comparator: Lactoferrin and ferrous sulfate in iron deficiency anemia
Lactoferrin 100 mg twice daily and ferrous sulfate
Drug: Lactoferrin
This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.

Drug: Ferrous sulfate
This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.
Other Name: ferrous sulphate

Outcome Measures
Primary Outcome Measures :
  1. Management of iron deficiency anemia incidence by using lab measures include iron profile [ Time Frame: One month ]
    Management of iron deficiency anemia


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   19 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female student with iron deficiency anemia

Exclusion Criteria:

  • clinical diagnosis of chronic disease as DM, Malabsorption disease Celiac, blood disease as thalassemia, or haemoglobinopathy

Intervention:

Study participants will be divided into 3 groups; Group 1: 35 participants will be supplemented with iron salt 324 mg (66 mg of elemental iron) orally three time per day before meal for one month Group 2: 35 participants will be supplemented with LF sachet 100 mg twice per day before meal for period of one month.

Group 3: 35 participants will be supplemented with combined iron salt 324 mg (66 mg of elemental iron) orally three time per day before meal for one month, and LF sachet 100 mg twice per day before meal for period of one month.

Contacts and Locations

Locations
Layout table for location information
Egypt
Ain Shams University
Cairo, Egypt, 202
Sponsors and Collaborators
yasmin gamal el gendy
Investigators
Layout table for investigator information
Principal Investigator: Yasmin G Elgendy, M.d Ainshams university
Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 28, 2020
Actual Study Start Date  ICMJE September 10, 2018
Actual Primary Completion Date November 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
Management of iron deficiency anemia incidence by using lab measures include iron profile [ Time Frame: One month ]
Management of iron deficiency anemia
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 Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students
Official Title  ICMJE Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students
Brief Summary This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.
Detailed Description

Iron, an essential element for cell growth and proliferation, is a component of fundamental processes such as DNA replication and energy production. However, iron can also be toxic when present in excess for its capacity to donate electrons to oxygen, thus causing the generation of reactive oxygen species (ROS), such as superoxide anions and hydroxyl radicals

Prevalence of iron deficiency anemia is roughly 38% of pregnant women, 29% of non-pregnant women and 29% of all women of reproductive age have anemia globally

Human lactoferrin (hLf), an 80-kDa multifunctional iron-binding cationic glycoprotein, is constitutively secreted by exocrine glands and by neutrophils during inflammation. hLf is recognized as a key element in the host immune defense system

Bovine Lf (bLf), which shares high sequence homology with the human protein, is also a multifunctional glycoprotein with identical antibacterial, antifungal, antiviral, antiparasitic, anti-inflammatory, and immunomodulatory activities of hLf Lactoferrin is synthesized by exocrine glands and neutrophils under conditions of inflammation and at site of infection through its iron binding and formation of reactive oxygen species physiological transport of iron from tissue to circulation, thus curing iron deficiency and iron deficiency anemia

A study done for pregnant women showed an increase of total serum iron in all bovin lactoferrin treated women.

Therefore, the investigators speculated that bLf efficacy in curing AI was presumably not linked to direct iron supplementation, but to a more complex mechanism involving this protein in iron homeostasis

Lactoferrin was also proven useful for prevention of iron deficiency anemia special among female long distance runner

Lactoferrin was more effective than ferrous sulphate over a two months period in pregnant women with iron deficient anemia Aim of the Work

This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Iron Deficiency Anemia
Intervention  ICMJE
  • Drug: Lactoferrin
    This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.
  • Drug: Ferrous sulfate
    This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.
    Other Name: ferrous sulphate
Study Arms  ICMJE
  • Active Comparator: Lactoferrin in iron deficiency anemia
    lactoferrin ( pravotin) 100mg twice daily
    Intervention: Drug: Lactoferrin
  • Active Comparator: Ferrous sulfate in iron deficiency anemia
    ferrous sulphate (hemojet)
    Intervention: Drug: Ferrous sulfate
  • Active Comparator: Lactoferrin and ferrous sulfate in iron deficiency anemia
    Lactoferrin 100 mg twice daily and ferrous sulfate
    Interventions:
    • Drug: Lactoferrin
    • Drug: Ferrous sulfate
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2019)
90
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 10, 2019
Actual Primary Completion Date November 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • female student with iron deficiency anemia

Exclusion Criteria:

  • clinical diagnosis of chronic disease as DM, Malabsorption disease Celiac, blood disease as thalassemia, or haemoglobinopathy

Intervention:

Study participants will be divided into 3 groups; Group 1: 35 participants will be supplemented with iron salt 324 mg (66 mg of elemental iron) orally three time per day before meal for one month Group 2: 35 participants will be supplemented with LF sachet 100 mg twice per day before meal for period of one month.

Group 3: 35 participants will be supplemented with combined iron salt 324 mg (66 mg of elemental iron) orally three time per day before meal for one month, and LF sachet 100 mg twice per day before meal for period of one month.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 29 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940430
Other Study ID Numbers  ICMJE Ain shams
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 yasmin gamal el gendy, Ain Shams University
Study Sponsor  ICMJE yasmin gamal el gendy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yasmin G Elgendy, M.d Ainshams university
PRS Account Ain Shams University
Verification Date May 2020

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