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

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Lactoferrin
Ferrous sulfate
Sponsored by
yasmin gamal el gendy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia

Eligibility Criteria

19 Years - 29 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lactoferrin in iron deficiency anemia

Ferrous sulfate in iron deficiency anemia

Lactoferrin and ferrous sulfate in iron deficiency anemia

Arm Description

lactoferrin ( pravotin) 100mg twice daily

ferrous sulphate (hemojet)

Lactoferrin 100 mg twice daily and ferrous sulfate

Outcomes

Primary Outcome Measures

Management of iron deficiency anemia incidence by using lab measures include iron profile
Management of iron deficiency anemia

Secondary Outcome Measures

Full Information

First Posted
April 12, 2019
Last Updated
May 27, 2020
Sponsor
yasmin gamal el gendy
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1. Study Identification

Unique Protocol Identification Number
NCT03940430
Brief Title
Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students
Official Title
Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
November 10, 2018 (Actual)
Study Completion Date
January 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
yasmin gamal el gendy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactoferrin in iron deficiency anemia
Arm Type
Active Comparator
Arm Description
lactoferrin ( pravotin) 100mg twice daily
Arm Title
Ferrous sulfate in iron deficiency anemia
Arm Type
Active Comparator
Arm Description
ferrous sulphate (hemojet)
Arm Title
Lactoferrin and ferrous sulfate in iron deficiency anemia
Arm Type
Active Comparator
Arm Description
Lactoferrin 100 mg twice daily and ferrous sulfate
Intervention Type
Drug
Intervention Name(s)
Lactoferrin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ferrous sulfate
Other Intervention Name(s)
ferrous sulphate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Management of iron deficiency anemia incidence by using lab measures include iron profile
Description
Management of iron deficiency anemia
Time Frame
One month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasmin G Elgendy, M.d
Organizational Affiliation
Ainshams university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
202
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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