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

NCT ID: NCT05900635

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-09-30

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.

Conditions

Anemia of Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: EXPERIMENTAL

Ferrous Glycine Sulfate

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Lactoferrin

Intervention Type: DRUG

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

Ferrous Glycine Sulfate

Intervention Type: DRUG

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

Interventions

Lactoferrin

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

Intervention Type: DRUG

Ferrous Glycine Sulfate

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed F Elkoraie, Prof

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Magda A Elmassik, Prof

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Noha A Hamdy, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Engy M Emam, PharmD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

Kidney and Urology Center

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Engy M Emam, Pharm D

Role: CONTACT

engyemam2005@gmail.com

01223534690

Noha A Hamdy, PhD

Role: CONTACT

nohaalaaeldine@yahoo.com

01005182151

Facility Contacts

Ahmed F El Koraie, PhD

Role: primary

drahmed@hotmail.com

01000304563

Engy m Emam, PharmD

Role: backup

engyemam2005@gmail.com

01223534690

Other Identifiers

0107174

Identifier Type: -

Identifier Source: org_study_id