Clinical trial NCT06252103: Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy
Official title: Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lactoferrin With Ferrous Gluconate More Superior Than Ferrous Gluconate Alone in Treatment of Iron Deficiency Anemia
Keywords: iron deficiency anemia during pregnancy
ferrous gluconate
lactoferrin
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Total 40 females from 14 to 35 weeks of pregnancy with Hemoglobin level between 8.5 to 10.5 gm/dl, recruited from the obstetric inpatient/outpatient clinic at Ain Shams University, Maternity hospital.

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
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility 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 \&amp;lt;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 \&amp;lt; 7gm/dL)
4. Hypersensitivity to iron preparations
5. Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)

Primary outcomes:
measure: • Hemoglobin (Hb) level
timeFrame: 4 weeks
measure: serum ferritin
timeFrame: 4 weeks
Secondary outcomes:
measure: gastrointestinal side effects
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university maternity hospital
Study officials:
affiliation: faculty of medicine Ain shams university
name: AMR Saad, doctoral
role: STUDY_DIRECTOR
References: