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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03940430

Recruitment Status Completed

First Posted May 7, 2019

Last update posted May 28, 2020

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:Iron Deficiency Anemia
  • Intervention/Treatment: Drug: Lactoferrin
    Drug: Ferrous sulfate
  • 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: September 2018
  • Actual Primary Completion Date: November 2018
  • Actual Study Completion Date: January 2019
Arms and interventions
Arm Intervention/treatment
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.
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.
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
  • Ages Eligible for Study: 19 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
Contacts
Locations

Egypt
Ain Shams University
Cairo

Sponsors and Collaborators

yasmin gamal el gendy

Investigators

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

More Information
  • Responsible Party: yasmin gamal el gendy
  • ClinicalTrials.gov Identifier: NCT03940430 History of Changes
  • Other Study ID Numbers: Ain shams
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 28, 2020
  • Last Verified: May 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • 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: Anemia, Iron-Deficiency
    Deficiency Diseases
    Anemia