Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients

Alexandria University

Status and phase: Enrolling; Phase 4

Conditions: Anemia of Chronic Kidney Disease

Treatments: Drug: Lactoferrin; Drug: Ferrous Glycine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT05900635

0107174

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control

Experimental group

Description:

Patients in this group will initiate treatment with oral ferrous glycine sulfate (100mg) every other day for 3 months

Treatment:

Drug: Ferrous Glycine Sulfate

Intervention

Active Comparator group

Description:

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

Treatment:

Drug: Ferrous Glycine Sulfate

Drug: Lactoferrin