Management of Iron Deficiency Anemia in Hemodialysis Patients
NCT07706582 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2026-07-20
Summary
The aim of this interventional study is to assess the effectiveness of oral lactoferrin in improving hemoglobin levels and correcting iron deficiency anemia in patients with end-stage renal disease (ESRD) on dialysis and also evaluate the impact of lactoferrin on bone health by measuring serum calcium and phosphate and other bone health indicators.
The participants will be divided into 3 groups as follow
* The Lactoferrin group will receive treatment of oral lactoferrin at a dose of 100 mg twice daily alongside erythropoiesis-stimulating agent (ESA) therapy for three months.
* The IV Iron group will receive IV Iron therapy with ESA for the same duration
* The Lactoferrin + IV Iron group will receive both oral lactoferrin at a dose of 100 mg twice daily and IV Iron therapy alongside erythropoiesis-stimulating agent (ESA) therapy for three months.
Conditions
- Iron Deficiency Anemia (IDA)
- ESRD (End Stage Renal Disease)
Interventions
- DIETARY_SUPPLEMENT
-
Lactoferrin
oral Lactoferrin - dose : 100 mg twice daily ( total dose= 200 mg daily ) - duration: administered for three months
- DRUG
-
IV iron dextran
IV Iron Dextran will be administered three times weekly for three months
Sponsors & Collaborators
-
Beni-Suef University
lead OTHER
Principal Investigators
-
Marina E Albert, Bachelor of Pharmacy · Beni-Suef University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-02
- Primary Completion
- 2026-09-30
- Completion
- 2027-01-31
Countries
- Egypt
Study Locations
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