Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy

Study Procedures:

All patients will undergo the following:

Informed consent will be obtained from all the participants in this study before enrolling in this study and all participants will be subjected to a detailed clinical assessment including: a detailed history, general, abdominal examinations, Investigations.

1. History taking:

   • Personal history: name, age, occupation and address.
   • Menstrual and obstetric history: Date of LMP, expected date of delivery which will be calculated according to Naegle's rule and gestational age. In addition to history of presence of any menstrual irregularities, duration.
   • Past History: of Anemia in previous pregnancy, other diseases like Thalassemia, sickle cell anemia, liver or renal diseases or any other condition that may affect hemoglobin.

2. Medical examination:

   • General: Assessment of complexion and vital data (blood pressure, pulse, capillary refill)
   • Abdominal examination to assess fundal height.
3. Investigations to perform will include:

Laboratory: Complete blood count (microcytic hypochromic anemia) Imaging: Ultrasound to assess biometry to exclude fetal growth restriction. Women will be divided in two groups with 20 in each group, the first group will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks and the second group will receive lactoferrin sachets 100mg with ferrous gluconate 300mg twice per day for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.

Women will be told to record side effects as nausea, vomiting, abdominal discomfort and constipation.

Women will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.

Study Overview

• Status: Completed
• Conditions: Lactoferrin With Ferrous Gluconate More Superior Than Ferrous Gluconate Alone in Treatment of Iron Deficiency Anemia
• Intervention / Treatment: Drug: Ferrous Gluconate 300 MG; Drug: ferrous gluconate with lactoferrin

Detailed Description

This study included two groups:

Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.

Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.

hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 6825344
    • Ain Shams University Maternity Hospital

Participation Criteria

Eligibility Criteria

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

Description

• The study will include women with the following inclusion and exclusion criteria:

Inclusion criteria:

1. Pregnant women with single fetus
2. Microcytic hypochromic anemia, mild anemia Hb 10 to 10.5 g/dl) and moderate anemia (Hb 7 to 9.9 g/dl)
3. Gestational age (14 - 35 weeks)
4. Serum ferritin level <24 ng/dl

Exclusion Criteria:

1. Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).
2. Associated bleeding disorder
3. Anaemia requiring blood tranfusion (Hb < 7gm/dL)
4. Hypersensitivity to iron preparations
5. Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)

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
Active Comparator: group I; the first group 20 patients will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.	Drug: Ferrous Gluconate 300 MG; iron salt one tab 300 mg contain 35 mg of elemental iron given 2 doses 600 mg per day; Other Names: (Ferrous-Gluconate®, tab.300mg glucofer, Egypt
Active Comparator: group II; 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.	Drug: ferrous gluconate with lactoferrin; Lactoferrin is a glycoprotein from the transferrin family consist of 691 amino acids,Lactoferrin is a protein found in cow milk and human milk; Other Names: Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Hemoglobin (Hb) level	hemoglobin will be measured before and after treatment by 4 weeks (HB in gm/dl)	4 weeks
serum ferritin	serum ferritin will be measured before and after treatment by 4 weeks (ferritin in ug/l )	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gastrointestinal side effects	(nausea , vomiting , constipation ) will be assessed before and after treatment	4 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: AMR Saad, doctoral, Faculty of Medicine Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Estimated): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: lactoferrin; iron deficiency anemia during pregnancy; ferrous gluconate
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases; Iron Deficiencies; Anti-Infective Agents; Hematinics; Lactoferrin; Ferrous gluconate
• Other Study ID Numbers: FMASU MS298/2023

Drug and device information, study documents

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