Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900635
Status:
RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-02-04
Brief Title:
Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients
Sponsor:
Alexandria University
Organization:
Alexandria University
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:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
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 anemiawill 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 n30 will be treated with oral ferrous glycine sulfate 100mg every other day for 3 months
Intervention arm n40 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 anemiawill 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 n30 will be treated with oral ferrous glycine sulfate 100mg every other day for 3 months
Intervention arm n40 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:
None
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?:
None