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

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 Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Drug: Lactoferrin; Drug: Ferrous sulfate

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: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 202
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 27 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Management of iron deficiency anemia incidence by using lab measures include iron profile	Management of iron deficiency anemia	One month

Collaborators and Investigators

• Sponsor: yasmin gamal el gendy
• Investigators: Principal Investigator: Yasmin G Elgendy, M.d, Ainshams university

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): November 10, 2018
• Study Completion (Actual): January 10, 2019

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: May 5, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: Ain shams

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No