Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
All participants should agree to take part in this clinical study and will provide informed consent.
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.
All patients will be subjected directly at time of enrollment to the following; Complete history taking and demographic data (age, sex, …)
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.
All patients will be followed up and treated during the study time. All relevant routine investigations and medications will be recorded.
At each visit, the subjects will be questioned about study compliance (diet and medications), concomitant medications, and adverse events.
The results obtained from the work will be tabulated and statistically analyzed using the appropriate statistical methods.
The findings will be discussed in view of the achievement of the aim, their significance and their comparison with other available works and information.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | Patients in this group will initiate treatment with oral ferrous glycine sulfate (100mg) every other day for 3 months |
|
| Intervention | Active Comparator | Patients in this group will initiate treatment with oral lactoferrin (one sachet that contains 100mg) with oral ferrous glycine sulfate (100mg) every other day for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoferrin | Drug | Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 Hemoglobin measured in gm/dl | 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 | 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 | 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 % | 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of tolerability and gastrointestinal adverse events | The subjects will be contacted to be questioned about medications adherence and adverse events | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Engy M Emam, Pharm D | Contact | 01223534690 | engyemam2005@gmail.com | |
| Noha A Hamdy, PhD | Contact | 01005182151 | nohaalaaeldine@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed F Elkoraie, Prof | Alexandria University | Principal Investigator |
| Magda A Elmassik, Prof | Alexandria University | Principal Investigator |
| Noha A Hamdy, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kidney and Urology Center | Recruiting | Alexandria | 21548 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007781 | Lactoferrin |
| C030676 | ferroglycine sulfate |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
Not provided
Not provided
Prospective, open-labeled, parallel, randomised controlled trial
Not provided
Not provided
open labeled
Not provided
| Ferrous Glycine Sulfate | Drug | Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients |
|
| Alexandria University |
| Principal Investigator |
| Engy M Emam, PharmD | Alexandria University | Principal Investigator |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |