Clinical trial NCT05900635: Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients
Official title: Effect of Adding Lactoferrin to Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anemia of Chronic Kidney Disease
Keywords: Lactoferrin
Anemia
Chronic Kidney Disease
Oral iron
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, open-labeled, parallel, randomised controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Males and Females aged ≥ 18 years old
2. Patients with eGFR ≥30 and ≤60 mL/min/1.73m2.
3. Absolute iron deficiency anemia (Hgb \<10g/dL, serum ferritin \<300ng/ml and Transferrin Saturation \< 30% )

Exclusion Criteria:

1. Patients on intermittent hemodialysis (IHD)
2. Patients with any known cause of anemia other than iron deficiency or CKD (e.g., sickle cell anemia)
3. Patients who received EPO 4 weeks ago
4. Patients who received IV Iron 8 weeks ago
5. Patients who received blood Transfusion 8 weeks ago
6. Current history of GI bleeding
7. Malignancy history
8. Pregnancy or lactation in female participants
9. Patients non-adherent to at least 80% of the regimen

Primary outcomes:
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of tolerability and gastrointestinal adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Kidney and Urology Center
Study officials:
affiliation: Alexandria University
name: Ahmed F Elkoraie, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Magda A Elmassik, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Noha A Hamdy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Engy M Emam, PharmD
role: PRINCIPAL_INVESTIGATOR
References: