Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:41 PM
Study NCT ID:
NCT05900635
Status:
UNKNOWN
Last Update Posted:
2023-06-12
First Post:
2023-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients
Sponsor:
Alexandria University
Organization:
Study Overview
Official Title:
Effect of Adding Lactoferrin to Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: