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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia of Chronic Kidney Disease
• Intervention / Treatment: Drug: Ferrous Glycine Sulfate; Drug: Lactoferrin

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Engy M Emam, Pharm D; Phone Number: 01223534690; Email: engyemam2005@gmail.com
• Study Contact Backup: Name: Noha A Hamdy, PhD; Phone Number: 01005182151; Email: nohaalaaeldine@yahoo.com

Study Locations

• Egypt
  • Alexandria, Egypt, 21548
    • Recruiting
    • Kidney and Urology Center
    • Principal Investigator: Noha A Hamdy, PhD
    • Contact: Ahmed F El Koraie, PhD; Phone Number: 01000304563; Email: drahmed@hotmail.com
    • Contact: Engy m Emam, PharmD; Phone Number: 01223534690; Email: engyemam2005@gmail.com
    • Principal Investigator: Magda A El-Massik, PhD
    • Principal Investigator: Ahmed F El Koraie, PhD
    • Principal Investigator: Engy M Emam, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Ferrous Glycine Sulfate; Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients; Drug: Lactoferrin; Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Ahmed F Elkoraie, Prof, Alexandria University; Principal Investigator: Magda A Elmassik, Prof, Alexandria University; Principal Investigator: Noha A Hamdy, PhD, Alexandria University; Principal Investigator: Engy M Emam, PharmD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): June 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: February 4, 2023
• First Submitted That Met QC Criteria: June 10, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Anemia; Chronic Kidney Disease; Lactoferrin; Oral iron
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Hematologic Diseases; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Glycine Agents; Glycine; Lactoferrin
• Other Study ID Numbers: 0107174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No