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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Lactoferrin With Ferrous Gluconate More Superior Than Ferrous Gluconate Alone in Treatment of Iron Deficiency Anemia

Treatments: Drug: Ferrous Gluconate 300 MG; Drug: ferrous gluconate with lactoferrin

Study type: Interventional

Funder types: Other

Identifiers

NCT06252103

FMASU MS298/2023

Details and patient eligibility

About

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Women will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.

Full 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

Enrollment: 40 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

group I

Active Comparator group

Description:

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.

Treatment:

Drug: Ferrous Gluconate 300 MG

group II

Active Comparator group

Description:

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.

Treatment:

Drug: ferrous gluconate with lactoferrin