CClinicalTrials.gg
CompletedNCT04267653Updated Feb 13, 2020

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

A Phase 4 interventional study of Lactoferrin Bovine and Ferrous Sulfate in Iron Deficiency Anemia Treatment, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2020-02-13.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jan 2018, registered Feb 2020).
Phase
Phase 4
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
2 Years to 15 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Iron Deficiency Anemia Treatment

Keywords

  • Iron deficiency anemia
  • Lactoferrin
  • Ferrous sulfate
03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 96 is close to the median of 94 across 1,291 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
96 participants (actual)

Study arms

  • Active comparator
    lactoferrin

    Oral bovine lactoferrin (bfl) 100 mg once daily on empty stomach

    Drug: Lactoferrin Bovine

  • Active comparator
    ferrous sulfate

    Oral ferrous sulfate 3-6 mg/kg of elemental iron/day in divided doses

    Drug: Ferrous Sulfate

  • Active comparator
    combined

    combined therapy (both lactoferrin and ferrous sulfate)

    Drug: Lactoferrin Bovine · Drug: Ferrous Sulfate

Interventions

  • DrugLactoferrin Bovine

    treatment for 30 days

    Also known as: Pravotin sachet

  • DrugFerrous Sulfate

    treatment for 30 days

    Also known as: ferrovit syrup

06

What researchers measure

Primary outcomes

  1. comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.

    Complete blood count will be done before and after therapy to detect the effect of the therapy on serum hemoglobin(g/d)

    Time frame: 30 days

  2. Comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.

    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)

    Time frame: 30 days

07

Study locations

1 site
  • AssuitU
    Assiut, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04267653
Lead sponsor
Assiut University
Responsible party
Ahmed Gaber Ahmed (pediatrician, Assiut University) — Principal investigator
First posted
Feb 13, 2020
Start date
Jan 1, 2018
Primary completion
Jan 1, 2018
Completion
Oct 30, 2018
Last update
Feb 13, 2020

Study contacts

Ahmed Gaber Ahmed
principal investigator · Assiut University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion