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

Phase 4

Completed

• Conditions: Iron Deficiency Anemia Treatment
• Interventions: Drug: Lactoferrin Bovine; Drug: Ferrous Sulfate

• Registration Number: NCT04267653
• Lead Sponsor: Assiut University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-10-30
• Status Verified: 2020-02
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-13
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined	Ferrous Sulfate	combined therapy (both lactoferrin and ferrous sulfate)
lactoferrin	Lactoferrin Bovine	Oral bovine lactoferrin (bfl) 100 mg once daily on empty stomach
ferrous sulfate	Ferrous Sulfate	Oral ferrous sulfate 3-6 mg/kg of elemental iron/day in divided doses
combined	Lactoferrin Bovine	combined therapy (both lactoferrin and ferrous sulfate)

Primary Outcome Measures

Name	Time	Method
comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.	30 days	Complete blood count will be done before and after therapy to detect the effect of the therapy on serum hemoglobin(g/d)
Comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.	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)

Trial Locations

Locations (1)

AssuitU; 🇪🇬 Assiut, Egypt