Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy
Condition: Lactoferrin With Ferrous Gluconate More Superior Than Ferrous Gluconate Alone in Treatment of Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 4

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
    

Intervention name(s): Ferrous Gluconate 300 MG; ferrous gluconate with lactoferrin
Intervention type(s): Drug; Drug
Intervention description(s): iron salt one tab 300 mg contain 35 mg of elemental iron given 2 doses 600 mg per day; 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 intervention name(s): (Ferrous-Gluconate®, tab.300mg glucofer, Egypt; Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.
Intervention MeSH terms: Lactoferrin; Ferrous gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
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
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: iron deficiency anemia during pregnancy; ferrous gluconate; lactoferrin