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

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05900635

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia of Chronic Kidney Disease	Drug: Lactoferrin Drug: Ferrous Glycine Sulfate	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, open-labeled, parallel, randomised controlled trialProspective, open-labeled, parallel, randomised controlled trial

Masking:

None (Open Label)

Masking Description:

open labeled

Primary Purpose:

Treatment

Official Title:

Effect of Adding Lactoferrin to Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control Patients in this group will initiate treatment with oral ferrous glycine sulfate (100mg) every other day for 3 months	Drug: Ferrous Glycine Sulfate Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
Active Comparator: Intervention 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	Drug: Lactoferrin Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients Drug: Ferrous Glycine Sulfate Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients

Arm

Intervention/Treatment

Experimental: Control

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

Drug: Ferrous Glycine Sulfate

Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients

Active Comparator: Intervention

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

Drug: Lactoferrin

Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients

Drug: Ferrous Glycine Sulfate

Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients

Outcome Measures

Primary Outcome Measures

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 [3 months]
Mean change in the level of Hemoglobin measured in gm/dl
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 [3 months]
Mean change in the level of serum Iron measured in ug/mL
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 [3 months]
Mean change in total iron binding capacity (TIBC) measured in ug/mL
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 [3 months]
Mean change in serum transferrin saturation (TSAT) measured in %
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 [3 months]
Mean change in serum hepcidin measured in ng/ml

Secondary Outcome Measures

Evaluation of tolerability and gastrointestinal adverse events [3 months]
The subjects will be contacted to be questioned about medications adherence and adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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