Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney

Status Recruiting

Clinical Trial Summary

The aim of this study is to evaluate the effects of adding lactoferrin to the every-other-day oral iron supplementation in iron deficiency anemia and chronic kidney disease patients.

Clinical Trial Description

1. Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University. 2. All participants should agree to take part in this clinical study and will provide informed consent. 3. Sixty chronic kidney disease patients with iron defficiency anemia,will be recruited from the Kidney and Urology Center (KUC) and Alexandria main university hospital (AMUH). The 60 participants will be randomly assigned into 2 arms. Control arm (n=30): will be treated with oral ferrous glycine sulfate (100mg) every other day for 3 months Intervention arm (n=40): will be treated with oral lactoferrin (one sachet that contains 100mg) with oral ferrous glycine sulfate (100mg) every other day for 3 months. 4. All patients will be subjected directly at time of enrollment to the following; Complete history taking and demographic data (age, sex, …) 5. Blood samples will be drawn to measure the initial values of hemoglobin, hematocrit, serum iron, TIBC, Serum Transferrin Saturation (TSAT), and Hepcidin as primary outcome. 6. All patients will be followed up and treated during the study time. All relevant routine investigations and medications will be recorded. 7. At each visit, the subjects will be questioned about study compliance (diet and medications), concomitant medications, and adverse events. 8. The results obtained from the work will be tabulated and statistically analyzed using the appropriate statistical methods. 9. The findings will be discussed in view of the achievement of the aim, their significance and their comparison with other available works and information. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05900635
Study type	Interventional
Source	Alexandria University
Contact	Engy M Emam, Pharm D
Phone	01223534690
Email	engyemam2005@gmail.com
Status	Recruiting
Phase	Phase 4
Start date	October 1, 2022
Completion date	September 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms