| Trial ID: | L0525 |
| Source ID: | NCT05900635
|
| Associated Drug: |
Lactoferrin
|
| Title: |
Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia of Chronic Kidney Disease
|
| Interventions: |
DRUG: Lactoferrin|DRUG: Ferrous Glycine Sulfate
|
| Outcome Measures: |
Primary: 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 | Secondary: Evaluation of tolerability and gastrointestinal adverse events, The subjects will be contacted to be questioned about medications adherence and adverse events, 3 months
|
| Sponsor/Collaborators: |
Sponsor: Alexandria University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-10-01
|
| Completion Date: |
2023-09
|
| Results First Posted: |
|
| Last Update Posted: |
2023-06-12
|
| Locations: |
Kidney and Urology Center, Alexandria, 21548, Egypt
|
| URL: |
https://clinicaltrials.gov/show/NCT05900635
|
