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

Sponsor
yasmin gamal el gendy (Other)
Overall Status
Completed
CT.gov ID
NCT03940430
Collaborator
(none)
90
1
3
4
22.5

Study Details

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
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

Study Type:
Interventional
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 :
Sep 10, 2018
Actual Primary Completion Date :
Nov 10, 2018
Actual Study Completion Date :
Jan 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 Names:
  • 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 Names:
  • ferrous sulphate
  • Outcome Measures

    Primary Outcome Measures

    1. Management of iron deficiency anemia incidence by using lab measures include iron profile [One month]

      Management of iron deficiency anemia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 29 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 Ain Shams University Cairo Egypt 202

    Sponsors and Collaborators

    • yasmin gamal el gendy

    Investigators

    • Principal Investigator: Yasmin G Elgendy, M.d, Ainshams university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    yasmin gamal el gendy, Yasmin gamel elgendy clinical professor, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03940430
    Other Study ID Numbers:
    • Ain shams
    First Posted:
    May 7, 2019
    Last Update Posted:
    May 28, 2020
    Last Verified:
    May 1, 2020
    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:

    Study Results

    No Results Posted as of May 28, 2020