<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759353</url>
  </required_header>
  <id_info>
    <org_study_id>LactvsFerr</org_study_id>
    <nct_id>NCT03759353</nct_id>
  </id_info>
  <brief_title>Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy</brief_title>
  <official_title>A Comparative Study Between Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption&#xD;
      from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy&#xD;
      is dose related and common (up to 20% of patients), and this frequently leads to poor&#xD;
      compliance.&#xD;
&#xD;
      Lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a&#xD;
      transferrin family, thus belonging to those proteins capable of binding and transferring&#xD;
      iron. It represents an attractive and promising alternative to ferrous sulphate oral&#xD;
      administration as pregnant women receiving lactoferrin did not experience any adverse&#xD;
      effects.&#xD;
&#xD;
      This study aims to compare between lactoferrin and ferrous sulphate for therapy of iron&#xD;
      deficiency in pregnant women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">November 20, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in serum ferritin level</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in serum ferritin level between enrollment and 4 weeks post-treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nausea and/or vomiting</measure>
    <time_frame>4 weeks</time_frame>
    <description>Incidence of treatment-related nausea and/or vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspepsia</measure>
    <time_frame>4 weeks</time_frame>
    <description>Incidence of treatment-related dyspepsia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to treatment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of missed doses of treatment from the assigned 30 doses</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Iron Deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>Lactoferrin Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Includes 49 pregnant women receiving lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin (R) , Hygint pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ferrous Sulfate Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Includes 49 pregnant women receiving 200 mg of dried ferrous sulfate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset (Feosol (R) , Meda pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Baseline ferritin level</intervention_name>
    <description>At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.</description>
    <arm_group_label>Ferrous Sulfate Group</arm_group_label>
    <arm_group_label>Lactoferrin Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lactoferrin</intervention_name>
    <description>lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).</description>
    <arm_group_label>Lactoferrin Group</arm_group_label>
    <other_name>Pravotin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferrous Sulfate</intervention_name>
    <description>200 mg of dried ferrous sulphate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset.</description>
    <arm_group_label>Ferrous Sulfate Group</arm_group_label>
    <other_name>Feosol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Follow up ferritin level</intervention_name>
    <description>Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.</description>
    <arm_group_label>Ferrous Sulfate Group</arm_group_label>
    <arm_group_label>Lactoferrin Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women with single fetus.&#xD;
&#xD;
          -  Second trimester (14-20weeks of gestation).&#xD;
&#xD;
          -  Normal Hemoglobin level: more than10g\dl.&#xD;
&#xD;
          -  Serum ferritin less than 15 mcg / L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other type than iron-deficiency anemia (thalassemia, hemolytic anemia … etc.)&#xD;
&#xD;
          -  Any other chronic diseases (bronchial asthma, renal or hepatic, hematological or&#xD;
             cardiovascular diseases … etc.)&#xD;
&#xD;
          -  Having hypersensitivity to iron preparations.&#xD;
&#xD;
          -  Treatment with any other iron preparation in the last month.&#xD;
&#xD;
          -  History of peptic ulcer, oesophagitis or hiatal hernia.&#xD;
&#xD;
          -  Medical disorders with pregnancy.&#xD;
&#xD;
          -  Need for alternative parenteral route to blood transfusion when rapid increase is&#xD;
             required (perioperative anemia-severe anemia in late pregnancy-postpartum anemia) .&#xD;
&#xD;
          -  Bleeding in early pregnancy.&#xD;
&#xD;
          -  Refusal to participate in the study.&#xD;
&#xD;
          -  Family history of thalassemia-sickle cell anemia or malabsorption syndrome.&#xD;
&#xD;
          -  Recent blood transfusion.&#xD;
&#xD;
          -  Inflammatory bowel disease as intolerance of oral therapy but tolerated to parenteral&#xD;
             route.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ghada Mohamed, MBBCh</last_name>
    <role>Principal Investigator</role>
    <affiliation>G Darwish</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain SHams Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <state>Abbaseya</state>
        <zip>002</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ghada Mohamed Ahmed</investigator_full_name>
    <investigator_title>Resident of O&amp;G</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lactoferrin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759353
org study id: LactvsFerr
nct id: NCT03759353
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption
      from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy
      is dose related and common (up to 20% of patients), and this frequently leads to poor
      compliance.

      Lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a
      transferrin family, thus belonging to those proteins capable of binding and transferring
      iron. It represents an attractive and promising alternative to ferrous sulphate oral
      administration as pregnant women receiving lactoferrin did not experience any adverse
      effects.

      This study aims to compare between lactoferrin and ferrous sulphate for therapy of iron
      deficiency in pregnant women.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group
primary purpose: Treatment
masking: None (Open Label)
measure: Change in serum ferritin level
time frame: 4 weeks
description: Change in serum ferritin level between enrollment and 4 weeks post-treatment.
measure: Nausea and/or vomiting
time frame: 4 weeks
description: Incidence of treatment-related nausea and/or vomiting
measure: Dyspepsia
time frame: 4 weeks
description: Incidence of treatment-related dyspepsia
measure: Compliance to treatment
time frame: 4 weeks
description: Number of missed doses of treatment from the assigned 30 doses
arm group label: Lactoferrin Group
arm group type: Active Comparator
description: Includes 49 pregnant women receiving lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin (R) , Hygint pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.
arm group label: Ferrous Sulfate Group
arm group type: Active Comparator
description: Includes 49 pregnant women receiving 200 mg of dried ferrous sulfate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset (Feosol (R) , Meda pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.
intervention type: Diagnostic Test
intervention name: Baseline ferritin level
description: At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.
arm group label: Ferrous Sulfate Group
arm group label: Lactoferrin Group
intervention type: Drug
intervention name: Lactoferrin
description: lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).
arm group label: Lactoferrin Group
other name: Pravotin
intervention type: Drug
intervention name: Ferrous Sulfate
description: 200 mg of dried ferrous sulphate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset.
arm group label: Ferrous Sulfate Group
other name: Feosol
intervention type: Diagnostic Test
intervention name: Follow up ferritin level
description: Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.
arm group label: Ferrous Sulfate Group
arm group label: Lactoferrin Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: No
last name: Ghada Mohamed, MBBCh
role: Principal Investigator
affiliation: G Darwish
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ghada Mohamed Ahmed
investigator title: Resident of O&G
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Lactoferrin
sharing ipd: No