<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/NCT03009578</url>
  </required_header>
  <id_info>
    <org_study_id>OFB-IDA</org_study_id>
    <nct_id>NCT03009578</nct_id>
  </id_info>
  <brief_title>Iron Sucrose Versus Ferrous Bis-glycinate for Treatment of Iron Deficiency Anemia</brief_title>
  <official_title>Intravenous Iron Sucrose Versus Oral Ferrous Bis-glycinate for Treatment of Postpartum Iron Deficiency Anemia: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive&#xD;
      ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated&#xD;
      pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care&#xD;
      programmes in numerous developing and underdeveloped nations.&#xD;
&#xD;
      Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum&#xD;
      period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due&#xD;
      to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and&#xD;
      postpartum hemorrhage are important causes of postpartum anemia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">June 5, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the percentage of patients achieving Hb rise 3 gm or more</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean rise of Hb from baseline to 6 weeks.</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Intravenous iron</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women will receive iron sucrose (sacrofer ampules 100 mg/5ml) A patient's total body iron deficit will be calculated using the Ganzoni formula (total iron dose = [body weight (kilogram)× (15-actual Hemoglobin)] × 2.4 + 500 mg) then the total dose will be divided on 3 settings</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral ferrous bis-glycinate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iron Sucrose Injection</intervention_name>
    <description>iron Intramuscular injections</description>
    <arm_group_label>Intravenous iron</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferrous Bisglycinate</intervention_name>
    <description>oral iron tablets</description>
    <arm_group_label>Oral ferrous bis-glycinate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Hemoglobin level 7-11.5 gm/dl. No chronic diseases. Breastfeeding. Delivered at gestational&#xD;
        age &gt;38 weeks. Within 24-72 hours postpartum. Women who accept to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe anemia &lt; 7 gm/dl.&#xD;
&#xD;
          2. Women received iron therapy during pregnancy.&#xD;
&#xD;
          3. Intolerance to iron preparations&#xD;
&#xD;
          4. Anemia due to other causes&#xD;
&#xD;
          5. Peripartum blood transfusion.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut Faculty of Medicine</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>June 30, 2018</last_update_submitted>
  <last_update_submitted_qc>June 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed Abbas</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <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>Ferric Oxide, Saccharated</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03009578
org study id: OFB-IDA
nct id: NCT03009578
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive
      ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated
      pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care
      programmes in numerous developing and underdeveloped nations.

      Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum
      period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due
      to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and
      postpartum hemorrhage are important causes of postpartum anemia
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the percentage of patients achieving Hb rise 3 gm or more
time frame: 6 weeks
measure: Mean rise of Hb from baseline to 6 weeks.
time frame: 6 weeks
arm group label: Intravenous iron
arm group type: Experimental
description: Women will receive iron sucrose (sacrofer ampules 100 mg/5ml) A patient's total body iron deficit will be calculated using the Ganzoni formula (total iron dose = [body weight (kilogram)× (15-actual Hemoglobin)] × 2.4 + 500 mg) then the total dose will be divided on 3 settings
arm group label: Oral ferrous bis-glycinate
arm group type: Active Comparator
description: Women will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets
intervention type: Drug
intervention name: Iron Sucrose Injection
description: iron Intramuscular injections
arm group label: Intravenous iron
intervention type: Drug
intervention name: Ferrous Bisglycinate
description: oral iron tablets
arm group label: Oral ferrous bis-glycinate
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohamed Abbas
investigator title: Dr
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Ferric Oxide, Saccharated
sharing ipd: Undecided