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Effect of Adding Lactoferrin to Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Kidney and Urology Center
Alexandria, Egypt
Start Date
October 1, 2022
Primary Completion Date
June 1, 2023
Completion Date
September 1, 2023
Last Updated
June 12, 2023
60
ESTIMATED participants
Lactoferrin
DRUG
Ferrous Glycine Sulfate
DRUG
Lead Sponsor
Alexandria University
NCT05515367
NCT05082584
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06352138