NCT04267653

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

Same day

First QC Date

February 5, 2020

Last Update Submit

February 10, 2020

Conditions

Iron Deficiency Anemia Treatment

Keywords

Iron deficiency anemiaLactoferrinFerrous sulfate

Outcome Measures

Primary Outcomes (2)

  • 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)

    30 days

  • 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)

    30 days

Study Arms (3)

lactoferrin

ACTIVE COMPARATOR

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

Drug: Lactoferrin Bovine

ferrous sulfate

ACTIVE COMPARATOR

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

Drug: Ferrous Sulfate

combined

ACTIVE COMPARATOR

combined therapy (both lactoferrin and ferrous sulfate)

Drug: Lactoferrin BovineDrug: Ferrous Sulfate

Interventions

Lactoferrin BovineDRUG

treatment for 30 days

Also known as: Pravotin sachet
combinedlactoferrin
Ferrous SulfateDRUG

treatment for 30 days

Also known as: ferrovit syrup
combinedferrous sulfate

Eligibility Criteria

Age2 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AssuitU

Asyut, Egypt

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ahmed Gaber Ahmed

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pediatrician

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 13, 2020

Study Start

January 1, 2018

Primary Completion

January 1, 2018

Study Completion

October 30, 2018

Last Updated

February 13, 2020

Record last verified: 2020-02

Locations

EG(1)