<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/NCT03830034</url>
  </required_header>
  <id_info>
    <org_study_id>IDA</org_study_id>
    <nct_id>NCT03830034</nct_id>
  </id_info>
  <brief_title>Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial</brief_title>
  <official_title>Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anemia is the commonest hematological disorder that occurs in pregnancy. According to the&#xD;
      recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration&#xD;
      in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is&#xD;
      lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid&#xD;
      chelate and that of iron salts (ferrous fumarat).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anemia is the commonest hematological disorder that occurs in pregnancy. According to the&#xD;
      recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration&#xD;
      in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is&#xD;
      lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid&#xD;
      chelate and that of iron salts (ferrous fumarat).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 2, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2019</primary_completion_date>
  <phase>Phase 4</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobine (Hb) Rise</measure>
    <time_frame>after 12 weeks of treatment.</time_frame>
    <description>follow up CBC after 12 weeks of treatment given</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobine (Hb) Rise</measure>
    <time_frame>after 4,8 weeks of treatment.</time_frame>
    <description>Follow up CBC after 4,8 weeks of treatment given</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects of the medication given</measure>
    <time_frame>3months</time_frame>
    <description>constipation, nausea, allergy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Iron Deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>Amino Acid chelated iron tab 15 mg group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) prepared by egyptian pharmaceutical company (nerhadou) once daily (a dose recommended by the company of the product).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Contain 75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb&lt;9g/dl) this dose can be doubled as recommended by the company of the product.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amino Acid chelated iron tab 15 mg</intervention_name>
    <description>Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) a dose recommended by the company of the product.&#xD;
Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption.&#xD;
Substances that inhibit absorption such as tannins &amp; milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption.&#xD;
Follow up will be done for all the pregnant women included in our studies at baseline &amp; then 4, 8 &amp; 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.</description>
    <arm_group_label>Amino Acid chelated iron tab 15 mg group</arm_group_label>
    <other_name>Ferrotron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferrous Fumarate tab 350 mg( 115 mg elemental iron)</intervention_name>
    <description>75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb&lt;9g/dl) this dose can be doubled as recommended by the company of the product.&#xD;
Some instructions will be given to all the pregnant women included in our study as follow: Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption.&#xD;
Substances that inhibit absorption such as tannins &amp; milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption.&#xD;
Follow up will be done for all the pregnant women included in our studies at baseline &amp; then 4, 8 &amp; 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.</description>
    <arm_group_label>Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group</arm_group_label>
    <other_name>Haemacaps</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women at 14 -18 weeks of gestation calculated from the first day of their&#xD;
             last menstrual period and confirmed or modified by ultrasound&#xD;
&#xD;
          -  Hemoglobin level 8-10.5 g/dL&#xD;
&#xD;
          -  Serum ferritin&lt;15µg/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The presence of anemia from causes other than iron deficiency(e.g: Folat deficiency&#xD;
             anemia,Vitamin B12 deficiency, ect…).&#xD;
&#xD;
          -  Multiple gestations&#xD;
&#xD;
          -  The presence of clinical and/or laboratory evidence of hepatic, renal, hematological&#xD;
             or cardiovascular disease&#xD;
&#xD;
          -  Patients with known gastritis&#xD;
&#xD;
          -  History of mal-absorption syndrome&#xD;
&#xD;
          -  Those with known hypersensitivity to iron preparations&#xD;
&#xD;
          -  Those under current iron supplementation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>this trial conducted on treatment of iron deficiency anemia in pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Elshahawy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Elshahawy, MD</last_name>
    <phone>+01223266380</phone>
    <email>ahmedshafy@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ain shams university maternity hospital</name>
      <address>
        <city>Cairo</city>
        <zip>25187</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed A Elshahawy, MD</last_name>
      <phone>+201223266380</phone>
      <email>ahmedshafy@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 2, 2019</last_update_submitted>
  <last_update_submitted_qc>February 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ahmed Abdel Shafy El Shahawy</investigator_full_name>
    <investigator_title>lecturer</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>Iron</mesh_term>
    <mesh_term>Ferrous fumarate</mesh_term>
    <mesh_term>Iron Chelating Agents</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03830034
org study id: IDA
nct id: NCT03830034
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Anemia is the commonest hematological disorder that occurs in pregnancy. According to the
      recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration
      in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is
      lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid
      chelate and that of iron salts (ferrous fumarat).
Anemia is the commonest hematological disorder that occurs in pregnancy. According to the
      recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration
      in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is
      lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid
      chelate and that of iron salts (ferrous fumarat).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Hemoglobine (Hb) Rise
time frame: after 12 weeks of treatment.
description: follow up CBC after 12 weeks of treatment given
measure: Hemoglobine (Hb) Rise
time frame: after 4,8 weeks of treatment.
description: Follow up CBC after 4,8 weeks of treatment given
measure: Adverse effects of the medication given
time frame: 3months
description: constipation, nausea, allergy.
arm group label: Amino Acid chelated iron tab 15 mg group
arm group type: Experimental
description: Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) prepared by egyptian pharmaceutical company (nerhadou) once daily (a dose recommended by the company of the product).
arm group label: Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group
arm group type: Active Comparator
description: Contain 75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb<9g/dl) this dose can be doubled as recommended by the company of the product.
intervention type: Drug
intervention name: Amino Acid chelated iron tab 15 mg
description: Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) a dose recommended by the company of the product.
Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption.
Substances that inhibit absorption such as tannins & milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption.
Follow up will be done for all the pregnant women included in our studies at baseline & then 4, 8 & 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.
arm group label: Amino Acid chelated iron tab 15 mg group
other name: Ferrotron
intervention type: Drug
intervention name: Ferrous Fumarate tab 350 mg( 115 mg elemental iron)
description: 75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb<9g/dl) this dose can be doubled as recommended by the company of the product.
Some instructions will be given to all the pregnant women included in our study as follow: Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption.
Substances that inhibit absorption such as tannins & milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption.
Follow up will be done for all the pregnant women included in our studies at baseline & then 4, 8 & 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.
arm group label: Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group
other name: Haemacaps
criteria: 
gender: Female
gender based: Yes
gender description: this trial conducted on treatment of iron deficiency anemia in pregnant women
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ahmed Elshahawy, MD
role: Principal Investigator
affiliation: Ain Shams University
last name: Ahmed Elshahawy, MD
phone: +01223266380
email: ahmedshafy@hotmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ahmed Abdel Shafy El Shahawy
investigator title: lecturer
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Deficiency Diseases
mesh term: Iron
mesh term: Ferrous fumarate
mesh term: Iron Chelating Agents