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Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Anemia

Primary Purpose

Iron Deficiency Anemia

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intravenous iron sucrose
Lactoferrin
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Anemia in pregnancy, Lactoferrin, Iron Sucrose

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Pregnant women with iron deficiency anemia. Microcytic hypochromic anemia, moderate anemia (Hb 8 to 9.9 g/dl) and S. Ferritin levels <12 ng/dl as per WHO guidelines Gestational age: - 13-26 weeks. Singleton viable pregnancy Lastly, agreement to participate and sign the informed consent was a basic prerequisite Exclusion Criteria:- Women with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemia trait). Severe anemia <7 g/dl requiring blood transfusion, bronchial asthma, clinical and/or laboratory evidence of hepatic, renal, hematologic or cardiovascular abnormalities. History of peptic ulcer. Hypersensitivity to iron preparations and treatment with any other iron preparation in the last one month before study entry. Suspected acute infection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Intravenous Iron Sucrose group

    Lactoferrin group

    Arm Description

    50 pregnant women will receive 200 mg elemental iron in 100 ml 0.9 NaCl intravenous over 20 -30 minutes daily up to the total dose -The dose of the total iron sucrose to be administrated was calculated from the following formula: Total dose required = weight (kg) x (target Hb in g\dL - actual Hb in g\dL) x 2.4 + 500 mg rounded up to the nearest multiple of 100 mg

    50 pregnant women will receive lactoferrin 100 twice daily orally .

    Outcomes

    Primary Outcome Measures

    evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of ferritin
    estimation serum ferritin level
    evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of hemoglobin
    estimation hemoglobin level

    Secondary Outcome Measures

    evaluation of lactoferrin side effect
    assessment of the incidence rate of nausea, vomiting and GIT upset
    the incidence rate of constipation

    Full Information

    First Posted
    June 19, 2023
    Last Updated
    July 18, 2023
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05921968
    Brief Title
    Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Anemia
    Official Title
    Evaluation of the Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Iron Deficiency Anemia During Pregnancy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 30, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    April 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Iron deficiency is the most common nutritional deficiency and the most common cause of anemia. Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis. The study aims to compare the effect of Lactoferrin versus intravenous iron sucrose for the treatment of iron deficiency anemia during pregnancy.
    Detailed Description
    Iron deficiency is the most common nutritional deficiency and the most common cause of anemia. Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis. The study aims to compare the effect of Lactoferrin versus intravenous iron sucrose for the treatment of iron deficiency anemia during pregnancy. The study will include 100 pregnant women with moderate iron deficiency anemia. They will assigned randomly in to 2 groups. Each group will contain 50 patients. The first group will receive intravenous iron sucrose (sacrofer 100mg/5ml)as 200 mg elemental iron in 100 ml 0.9 NaCl over 20-30 minutes up to the total dose -Total dose will be calculated from this equation=weight(kg)x(target Hb in g/dl-actual Hb in g/dl)x2.4+500 rounded up to the nearest multiple of 100 mg The second group will receive lactoferrin 100 mg twice daily orally before breakfast and before dinner (pravotin 100 mg sachets will be dissolved in ¼ glass of water). Patients will be advised to avoid coffee, milk products and antacid before and after the dose of lactoferrin. 1. Baseline assessment: All women in the study will be submitted to: Complete History Taking Including: Personal history: This included name, age, duration of marriage, last menstrual period, parity, occupation and special habits. 1st day of last menstrual period. Estimated gestational age Contraceptive history Obstetric history Including: Full details of previous pregnancies (Date, outcome, onset and mode of delivery, gestational age at delivery and any associated complication or history of similar disorder, spacing between each pregnancy. General Examination Included: Weight, height, body Mass Index (BMI), temperature, pulse, blood pressure, chest and cardiac examination, signs of anemia Abdominal Examination Fetal monitoring: To confirm fetal maturity and fetal wellbeing by non-stress test and biophysical profile. U/S investigation: To confirm gestational age and exclude associated congenital anomalies. Investigations: Complete blood sample (CBC), total iron binding capacity and Transferrin saturation will be done in Ain Shams Maternity Hospital Labs. Serum ferritin will be sent to any private lab. Kidney function tests and liver function tests. 2. Follow up assessment: Anemic pregnant women will be followed up every 4 weeks until delivery. In between visits, patients will be contacted via phone for monitoring of any side effects. 3. End of study assessment: the same laboratory tests will be done with monitoring of any signs or symptoms of anemia until Hb level > 11 g/dl

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron Deficiency Anemia
    Keywords
    Anemia in pregnancy, Lactoferrin, Iron Sucrose

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    prospective,randomized,open-label,parallel-group study
    Masking
    None (Open Label)
    Masking Description
    100 opaque envelopes will be numbered serially and the corresponding letter which denotes the allocation will be put according to the electronic randomization table. Then all envelopes will be closed and put in one box. When the first patient arrives, the envelope will be opened and the patient will be allocated according to the letter inside
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravenous Iron Sucrose group
    Arm Type
    Active Comparator
    Arm Description
    50 pregnant women will receive 200 mg elemental iron in 100 ml 0.9 NaCl intravenous over 20 -30 minutes daily up to the total dose -The dose of the total iron sucrose to be administrated was calculated from the following formula: Total dose required = weight (kg) x (target Hb in g\dL - actual Hb in g\dL) x 2.4 + 500 mg rounded up to the nearest multiple of 100 mg
    Arm Title
    Lactoferrin group
    Arm Type
    Active Comparator
    Arm Description
    50 pregnant women will receive lactoferrin 100 twice daily orally .
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous iron sucrose
    Other Intervention Name(s)
    Intravenous iron sucrose(Sacrofer 100mg/5ml) was manufactured by Amoun company for pharmaceutical and chemical industry ,Egypt.
    Intervention Description
    200 mg elemental iron in 100 ml 0.9 NaCl intravenous over 20 -30 minutes daily up to the total dose) o The dose of the total iron sucrose to be administrated was calculated from the following formula: Total dose required = weight (kg) x (target Hb in g\dL - actual Hb in g\dL) x 2.4 + 500 mg rounded up to the nearest multiple of 100 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Lactoferrin
    Other Intervention Name(s)
    lactoferrin 100 mg (Pravotin100 mg sachet)was manufactured by Hygint company for pharmaceutical and chemical industry,Egypt. Egypt) twice daily orally .
    Intervention Description
    100 mg twice daily orally before breakfast and dinner
    Primary Outcome Measure Information:
    Title
    evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of ferritin
    Description
    estimation serum ferritin level
    Time Frame
    4 weeks
    Title
    evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of hemoglobin
    Description
    estimation hemoglobin level
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    evaluation of lactoferrin side effect
    Description
    assessment of the incidence rate of nausea, vomiting and GIT upset
    Time Frame
    4 weeks
    Title
    the incidence rate of constipation
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pregnant women with iron deficiency anemia. Microcytic hypochromic anemia, moderate anemia (Hb 8 to 9.9 g/dl) and S. Ferritin levels <12 ng/dl as per WHO guidelines Gestational age: - 13-26 weeks. Singleton viable pregnancy Lastly, agreement to participate and sign the informed consent was a basic prerequisite Exclusion Criteria:- Women with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemia trait). Severe anemia <7 g/dl requiring blood transfusion, bronchial asthma, clinical and/or laboratory evidence of hepatic, renal, hematologic or cardiovascular abnormalities. History of peptic ulcer. Hypersensitivity to iron preparations and treatment with any other iron preparation in the last one month before study entry. Suspected acute infection.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amal Elkholy, PhD
    Phone
    +201060355448
    Email
    amalanas9@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lina EL-Saeed, master
    Phone
    +201092554407
    Email
    linanabil1990@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nagwa Sabri, professor
    Organizational Affiliation
    Department of Clinical Pharmacy
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34440102
    Citation
    Artym J, Zimecki M, Kruzel ML. Lactoferrin for Prevention and Treatment of Anemia and Inflammation in Pregnant Women: A Comprehensive Review. Biomedicines. 2021 Jul 27;9(8):898. doi: 10.3390/biomedicines9080898.
    Results Reference
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    Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Anemia

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