Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia

February 10, 2020 updated by: Ahmed Gaber Ahmed, Assiut University
Lactoferrin (Lf) is a mammalian cationic iron binding glycoprotein belonging to the transferrin family which was discovered 70 years ago, and isolated simultaneously from human and bovine milks in 1960. It is widely distributed in all biological fluids and is also expressed by immune cells, which release it under stimulation by pathogens

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • AssuitU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:all patients with iron deficiency anemia from 2 to 15 years old

-

Exclusion Criteria:

  • Anemia rather than iron deficiency anemia.
  • Family history of blood disease.
  • Patients with thalassemia trait.
  • Patients with chronic illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lactoferrin
Oral bovine lactoferrin (bfl) 100 mg once daily on empty stomach
Drug: Lactoferrin Bovine
treatment for 30 days
Other Names:
  • Pravotin sachet
Active Comparator: ferrous sulfate
Oral ferrous sulfate 3-6 mg/kg of elemental iron/day in divided doses
Drug: Ferrous Sulfate
treatment for 30 days
Other Names:
  • ferrovit syrup
Active Comparator: combined
combined therapy (both lactoferrin and ferrous sulfate)
Drug: Lactoferrin Bovine
treatment for 30 days
Other Names:
  • Pravotin sachet
Drug: Ferrous Sulfate
treatment for 30 days
Other Names:
  • ferrovit syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.
Time Frame: 30 days
Complete blood count will be done before and after therapy to detect the effect of the therapy on serum hemoglobin(g/d)
30 days
Comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.
Time Frame: 30 days
Total serum iron(ug/d) will be done before and after therapy to detect effect of the therapy on total serum iron level (ug/d)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ahmed Gaber Ahmed, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

October 30, 2018

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17100915

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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