<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/NCT03279536</url>
  </required_header>
  <id_info>
    <org_study_id>WHH</org_study_id>
    <nct_id>NCT03279536</nct_id>
  </id_info>
  <brief_title>Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing</brief_title>
  <acronym>TDI</acronym>
  <official_title>Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Woman's Health University Hospital, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Woman's Health University Hospital, Egypt</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study consisted of 60 cases. All the cases of pregnant women are 4 months to 8 months of&#xD;
      pregnancy. The cases divided into 30 pregnant women's were given iron supplementation without&#xD;
      health education and another 30 were given iron supplementation and health education for&#xD;
      comparison between them. Comparative between hemoglobin levels before and after medication.&#xD;
      Treatment of iron deficiency anemia with iron supplementation received for one month.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigator will divide the participants into two groups e.g. group (A) and group (B)&#xD;
      according to Hemoglobin level and receiving of oral supplementation for IDA accompanied with&#xD;
      health education in case of group (A) and without health education in case of group (B). Then&#xD;
      the investigator asked patient to sign the document of her investigations result to receive&#xD;
      iron supplementation.&#xD;
&#xD;
        -  After that, the investigator observes hemoglobin's Level, when it less than &gt;11g/dl, the&#xD;
           patient will be the group (A) who will receive oral iron supplementation and health&#xD;
           education.&#xD;
&#xD;
        -  Group (B) who will receive Total Dose Infusion (TDI) without health education.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</primary_completion_date>
  <phase>Phase 1/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>Group A will receive oral lactoferrin &amp; group B will receive Total dose infusion</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the change in Hb concentration</measure>
    <time_frame>4- 8 weeks</time_frame>
    <description>measure the change in Hb concentration from baseline to week 4 after oral Lactoferrin treatment and relieve of symptoms of anemia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>measure the change in serum iron, serum ferritin</measure>
    <time_frame>4-8 weeks</time_frame>
    <description>measure the change in serum iron, serum ferritin based on comparison between oral lactoferrin with health education &amp; TDI from hospital routine care.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Iron Deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>Oral Lactoferrin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A is 120 mg of Oral lactoferrin for 4 weeks Intervention: The participants 66 will receive oral Lactoferrin 120mg for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Total dose infusion (TDI) iron dextran</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group B is a parenteral total dose infusion (TDI) of LMW iron dextran 20mg/kg body weight for 4 weeks Intervention: The participants 33 will receive parental iron 20mg/kg body weight for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Oral lactoferrin</intervention_name>
    <description>Oral lactoferrin 120 mg twice /day and it's based on fast dissolving through direct swallowing per oral route with fruits flavor taste.</description>
    <arm_group_label>Oral Lactoferrin</arm_group_label>
    <other_name>Oral Fizzing Lactoferrin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>TDI of LMW iron dextran</intervention_name>
    <description>Total Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously</description>
    <arm_group_label>Total dose infusion (TDI) iron dextran</arm_group_label>
    <other_name>Parental dextran</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant Women aged &gt;18 years&#xD;
&#xD;
          2. Hemoglobin&lt;10g/dl&#xD;
&#xD;
          3. Gestational age between 14-28 weeks&#xD;
&#xD;
          4. Singleton pregnancy&#xD;
&#xD;
          5. Willingness to participate and signing the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Anemia predominantly caused by factors other than IDA (e.g. anemia with untreated B12&#xD;
             or foliate deficiency, hemolytic anemia),&#xD;
&#xD;
          2. Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and&#xD;
             haemosidrosis).&#xD;
&#xD;
          3. Decompensated liver cirrhosis and active hepatitis (ALAT&gt;3 times upper limit of&#xD;
             normal).&#xD;
&#xD;
          4. Active acute or chronic infections (assessed by clinical judgment supplied with white&#xD;
             Blood Cells (WBC) and C - reactive protein (CRP).&#xD;
&#xD;
          5. Rheumatoid arthritis with symptoms or signs of active inflammation.&#xD;
&#xD;
          6. Multiple allergies.&#xD;
&#xD;
          7. Known hypersensitivity to parental iron or any recipients in the investigational drug&#xD;
             products.&#xD;
&#xD;
          8. Erythropoietin treatment within 8 weeks prior to the screening visit.&#xD;
&#xD;
          9. Other iron treatment within 8 weeks prior to the screening visit.&#xD;
&#xD;
         10. Planned elective surgery during the study.&#xD;
&#xD;
         11. Participation in any other clinical within 3 months prior to the screening.&#xD;
&#xD;
         12. Any other medical condition e.g. malignancy, uncontrolled hypertension, unstable&#xD;
             ischemic heart disease, or uncontrolled diabetes mellitus.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Warda Helmy, BSN</last_name>
    <role>Principal Investigator</role>
    <affiliation>WHH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Women Health Hospital</name>
      <address>
        <city>Asyut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>October 23, 2020</last_update_submitted>
  <last_update_submitted_qc>October 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Woman's Health University Hospital, Egypt</investigator_affiliation>
    <investigator_full_name>Howieda Fouly</investigator_full_name>
    <investigator_title>PhD of Obstetric &amp; Gynecologic Nursing</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>
    <mesh_term>Deficiency Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lactoferrin</mesh_term>
    <mesh_term>Dextrans</mesh_term>
    <mesh_term>Iron-Dextran Complex</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Publishing</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>3-6 months</ipd_time_frame>
    <ipd_access_criteria>Introduction, Methodology, data analysis, Findings, Discussion &amp; Conclusion</ipd_access_criteria>
  </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/NCT03279536
org study id: WHH
nct id: NCT03279536
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study consisted of 60 cases. All the cases of pregnant women are 4 months to 8 months of
      pregnancy. The cases divided into 30 pregnant women's were given iron supplementation without
      health education and another 30 were given iron supplementation and health education for
      comparison between them. Comparative between hemoglobin levels before and after medication.
      Treatment of iron deficiency anemia with iron supplementation received for one month.
The investigator will divide the participants into two groups e.g. group (A) and group (B)
      according to Hemoglobin level and receiving of oral supplementation for IDA accompanied with
      health education in case of group (A) and without health education in case of group (B). Then
      the investigator asked patient to sign the document of her investigations result to receive
      iron supplementation.

        -  After that, the investigator observes hemoglobin's Level, when it less than >11g/dl, the
           patient will be the group (A) who will receive oral iron supplementation and health
           education.

        -  Group (B) who will receive Total Dose Infusion (TDI) without health education.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group A will receive oral lactoferrin & group B will receive Total dose infusion
primary purpose: Treatment
masking: Single (Participant)
measure: the change in Hb concentration
time frame: 4- 8 weeks
description: measure the change in Hb concentration from baseline to week 4 after oral Lactoferrin treatment and relieve of symptoms of anemia
measure: measure the change in serum iron, serum ferritin
time frame: 4-8 weeks
description: measure the change in serum iron, serum ferritin based on comparison between oral lactoferrin with health education & TDI from hospital routine care.
arm group label: Oral Lactoferrin
arm group type: Experimental
description: Group A is 120 mg of Oral lactoferrin for 4 weeks Intervention: The participants 66 will receive oral Lactoferrin 120mg for 4 weeks
arm group label: Total dose infusion (TDI) iron dextran
arm group type: Active Comparator
description: Group B is a parenteral total dose infusion (TDI) of LMW iron dextran 20mg/kg body weight for 4 weeks Intervention: The participants 33 will receive parental iron 20mg/kg body weight for 4 weeks
intervention type: Combination Product
intervention name: Oral lactoferrin
description: Oral lactoferrin 120 mg twice /day and it's based on fast dissolving through direct swallowing per oral route with fruits flavor taste.
arm group label: Oral Lactoferrin
other name: Oral Fizzing Lactoferrin
intervention type: Combination Product
intervention name: TDI of LMW iron dextran
description: Total Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously
arm group label: Total dose infusion (TDI) iron dextran
other name: Parental dextran
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Warda Helmy, BSN
role: Principal Investigator
affiliation: WHH
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Woman's Health University Hospital, Egypt
investigator full name: Howieda Fouly
investigator title: PhD of Obstetric & Gynecologic Nursing
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Deficiency Diseases
mesh term: Lactoferrin
mesh term: Dextrans
mesh term: Iron-Dextran Complex
sharing ipd: Yes
ipd description: Publishing
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 3-6 months
ipd access criteria: Introduction, Methodology, data analysis, Findings, Discussion & Conclusion