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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
Kidney and Urology Center
Alexandria, Egypt
RECRUITINGComparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Mean change in the level of Hemoglobin measured in gm/dl
Time frame: 3 months
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Mean change in the level of serum Iron measured in ug/mL
Time frame: 3 months
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Mean change in total iron binding capacity (TIBC) measured in ug/mL
Time frame: 3 months
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Mean change in serum transferrin saturation (TSAT) measured in %
Time frame: 3 months
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Mean change in serum hepcidin measured in ng/ml
Time frame: 3 months
Evaluation of tolerability and gastrointestinal adverse events
The subjects will be contacted to be questioned about medications adherence and adverse events
Time frame: 3 months
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