xml: <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/NCT05985070</url>
    </required_header>
    <id_info>
      <org_study_id>LUMHS/REC/-86</org_study_id>
      <nct_id>NCT05985070</nct_id>
    </id_info>
    <brief_title>A Comparative Absorption Study of Various Iron Salts Supplements</brief_title>
    <official_title>A Comparative Efficacy and Tolerability Study of Oral Iron Treatment in Healthy Iron Deficient and/or Iron-deficient Anaemic Adults: A Perspective, Randomized, Parallel Group, and Controlled Clinical Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Liaquat University of Medical &amp; Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Liaquat University of Medical &amp; Health Sciences</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>
        This study is conducted on otherwise healthy individuals presenting with symptoms of iron&#xD;
        deficiency anemia, further confirmed by CBC and Iron Profile. The expected outcome is overall&#xD;
        improvement after taking oral iron supplements and is aimed to compare the efficacy and&#xD;
        tolerability of different oral iron supplements by analyzing the changes in red cell&#xD;
        parameters and serum iron concentration in anemic and healthy population in parallel, at a&#xD;
        given time period.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Iron deficiency is commonest cause of anemia in developing countries like Pakistan. Multiple&#xD;
        determinants of iron deficiency anemia have been identified in the literature including&#xD;
        genetic and environmental factors. The predominant factors are lack of proper diet, poor&#xD;
        socioeconomic status, high parity of women, access to poor health.&#xD;
  &#xD;
        Symptomatic anemic cases are often treated with blood transfusion and thereby increasing&#xD;
        burden on already resource restricted healthcare system.&#xD;
  &#xD;
        In order to emphasize the importance of iron supplements this Randomized controlled trial is&#xD;
        conducted to assess the efficacy of three different oral iron supplements formulated with&#xD;
        different salts. Oral iron follows an extensive route of absorption which is primarily&#xD;
        performed through enterocyte cells on the duodenum and upper jejunum of the small intestine,&#xD;
        interacting with dietary inhibitors such as calcium, phytates, polyphenols and enhancers such&#xD;
        as ascorbic acid and proteins which may influence its bioavailability.&#xD;
  &#xD;
        Three Different iron salts supplements;&#xD;
  &#xD;
        1. Ferrous Sulphate, 2. Ferric pyrophosphate and 3. Ferric sodium pyrophosphate, are analyzed&#xD;
        for their efficiency and tolerability when taken on empty stomach daily single oral dose of&#xD;
        30 mg, for up to 6 weeks. There is a parallel healthy control group, given a non-iron&#xD;
        supplement.&#xD;
  &#xD;
        The changes in Red blood cell parameters and serum iron levels are analyzed, at 5 different&#xD;
        times starting from baseline before giving first dose of supplements, Reading 1 (baseline),&#xD;
        Reading 2 (3 hours) , Reading 3 (6 hours), Reading 4 (24 hours) and Reading 5 (6 weeks).&#xD;
  &#xD;
        The expected outcomes are:&#xD;
  &#xD;
        Proportion of the subjects achieving the normal Hb levels Improvement in serum iron levels&#xD;
        Improvement in ferritin levels&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 17, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</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>Change in serum iron concentration</measure>
      <time_frame>6 weeks</time_frame>
      <description>Increase in the circulatory iron levels</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Red Blood Cells</measure>
      <time_frame>6 weeks</time_frame>
      <description>Increase in red blood cell counts</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Number of patients reporting Gastrointestinal side effects</measure>
      <time_frame>6 weeks</time_frame>
      <description>Total number of adverse events in each group</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Iron Deficiency</condition>
    <condition>Iron Deficiency Anemia</condition>
    <arm_group>
      <arm_group_label>Intervention Arm B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferrous Sulphate for 6 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention Arm C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferric Pyrophosphate for 6 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Interventional Arm D</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferric Sodium Pyrophosphate for 6 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects in this arm will receive a daily single dose of oral Vitamin D (200 IU) supplement for 6 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Ferrous sulphate</intervention_name>
      <description>Daily single oral dose of 30 mg</description>
      <arm_group_label>Intervention Arm B</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Ferric pyrophosphate</intervention_name>
      <description>Daily single oral dose of 30 mg</description>
      <arm_group_label>Intervention Arm C</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Ferric sodium pyrophosphate</intervention_name>
      <description>Daily single oral dose of 30 mg</description>
      <arm_group_label>Interventional Arm D</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Vitamin D3</intervention_name>
      <description>Daily single oral dose of 200 IU</description>
      <arm_group_label>Control Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Outpatients&#xD;
  &#xD;
            -  Age: 18 - 45 years, both gender&#xD;
  &#xD;
            -  Haemoglobin level &lt; 12 g/dL&#xD;
  &#xD;
            -  Serum ferritin levels &lt; 30 µg/L.&#xD;
  &#xD;
            -  Transferrin Saturation (TSAT) &lt; 20 %&#xD;
  &#xD;
            -  Able to provide informed written consent.&#xD;
  &#xD;
            -  Able to adhere to the study protocol and willing to cooperate with the study&#xD;
               investigators.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other causes of anaemia, apart from iron deficiency.&#xD;
  &#xD;
            -  Pregnant or lactating women, or women intending to become pregnant during the study.&#xD;
  &#xD;
            -  Administration of any iron-containing drugs during the last 3 months.&#xD;
  &#xD;
            -  History of erythropoietin drugs administration.&#xD;
  &#xD;
            -  People with cancer, chronic liver disease, chronic kidney disease, HIV, cardiovascular&#xD;
               disease, pulmonary disease, mental health disorder, inflammatory disease such as IBD,&#xD;
               any GI disease or disorder likely to affect the nutritional intestinal absorption.&#xD;
  &#xD;
            -  Subjects on Antacids (aluminium, calcium, magnesium preparations), anti-inflammatory&#xD;
               drugs (NSAIDs, salicylates), antibiotic medications (aminoglycosides), cholesterol&#xD;
               lowering medication (Bile acid-sequestrants), Ulcer medication (histamine H2&#xD;
               Antagonists), PPIs etc.&#xD;
  &#xD;
            -  Concomitant diseases and conditions, which, in the investigator's opinion, pose risk&#xD;
               to a subject's safety in case of his/her participation in the study, or able to affect&#xD;
               the safety data analysis in case of exacerbation of this disease/condition during the&#xD;
               study.&#xD;
  &#xD;
            -  Hypersensitivity to iron therapy (both Oral and/or IV administration) and other&#xD;
               components of the study drugs.&#xD;
  &#xD;
            -  Hormone therapy (including the use of androgens/anabolic steroids) or administration&#xD;
               of drugs that inhibit blood formation, less than 3 months before the start of the&#xD;
               study.&#xD;
  &#xD;
            -  History of severe allergic reactions or drug intolerance.&#xD;
  &#xD;
            -  Blood donation / blood transfusion within 30 days prior to screening or planned blood&#xD;
               transfusion at time of screening.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Bilawal Medical College Hospital</name>
        <address>
          <city>Kotri</city>
          <state>Sindh</state>
          <zip>76000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nazia Mumtaz, M.B.B.S, F.C.P.S</last_name>
        <phone>03453001262</phone>
        <email>Drnaziahafeez@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Liaquat University of Medical &amp; Health Sciences</investigator_affiliation>
      <investigator_full_name>Nazia Mumtaz</investigator_full_name>
      <investigator_title>Assistant Professor Pathology</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>Vitamin D</mesh_term>
      <mesh_term>Cholecalciferol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985070
  org study id: LUMHS/REC/-86
  nct id: NCT05985070
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is conducted on otherwise healthy individuals presenting with symptoms of iron
        deficiency anemia, further confirmed by CBC and Iron Profile. The expected outcome is overall
        improvement after taking oral iron supplements and is aimed to compare the efficacy and
        tolerability of different oral iron supplements by analyzing the changes in red cell
        parameters and serum iron concentration in anemic and healthy population in parallel, at a
        given time period.
  Iron deficiency is commonest cause of anemia in developing countries like Pakistan. Multiple
        determinants of iron deficiency anemia have been identified in the literature including
        genetic and environmental factors. The predominant factors are lack of proper diet, poor
        socioeconomic status, high parity of women, access to poor health.
  
        Symptomatic anemic cases are often treated with blood transfusion and thereby increasing
        burden on already resource restricted healthcare system.
  
        In order to emphasize the importance of iron supplements this Randomized controlled trial is
        conducted to assess the efficacy of three different oral iron supplements formulated with
        different salts. Oral iron follows an extensive route of absorption which is primarily
        performed through enterocyte cells on the duodenum and upper jejunum of the small intestine,
        interacting with dietary inhibitors such as calcium, phytates, polyphenols and enhancers such
        as ascorbic acid and proteins which may influence its bioavailability.
  
        Three Different iron salts supplements;
  
        1. Ferrous Sulphate, 2. Ferric pyrophosphate and 3. Ferric sodium pyrophosphate, are analyzed
        for their efficiency and tolerability when taken on empty stomach daily single oral dose of
        30 mg, for up to 6 weeks. There is a parallel healthy control group, given a non-iron
        supplement.
  
        The changes in Red blood cell parameters and serum iron levels are analyzed, at 5 different
        times starting from baseline before giving first dose of supplements, Reading 1 (baseline),
        Reading 2 (3 hours) , Reading 3 (6 hours), Reading 4 (24 hours) and Reading 5 (6 weeks).
  
        The expected outcomes are:
  
        Proportion of the subjects achieving the normal Hb levels Improvement in serum iron levels
        Improvement in ferritin levels
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in serum iron concentration
  time frame: 6 weeks
  description: Increase in the circulatory iron levels
  measure: Change in Red Blood Cells
  time frame: 6 weeks
  description: Increase in red blood cell counts
  measure: Number of patients reporting Gastrointestinal side effects
  time frame: 6 weeks
  description: Total number of adverse events in each group
  arm group label: Intervention Arm B
  arm group type: Experimental
  description: Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferrous Sulphate for 6 weeks
  arm group label: Intervention Arm C
  arm group type: Experimental
  description: Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferric Pyrophosphate for 6 weeks
  arm group label: Interventional Arm D
  arm group type: Experimental
  description: Subjects in this arm will receive a daily single dose of oral 30mg elemental iron supplement as Ferric Sodium Pyrophosphate for 6 weeks
  arm group label: Control Arm
  arm group type: Active Comparator
  description: Subjects in this arm will receive a daily single dose of oral Vitamin D (200 IU) supplement for 6 weeks
  intervention type: Dietary Supplement
  intervention name: Ferrous sulphate
  description: Daily single oral dose of 30 mg
  arm group label: Intervention Arm B
  intervention type: Dietary Supplement
  intervention name: Ferric pyrophosphate
  description: Daily single oral dose of 30 mg
  arm group label: Intervention Arm C
  intervention type: Dietary Supplement
  intervention name: Ferric sodium pyrophosphate
  description: Daily single oral dose of 30 mg
  arm group label: Interventional Arm D
  intervention type: Dietary Supplement
  intervention name: Vitamin D3
  description: Daily single oral dose of 200 IU
  arm group label: Control Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Liaquat University of Medical & Health Sciences
  investigator full name: Nazia Mumtaz
  investigator title: Assistant Professor Pathology
  mesh term: Anemia, Iron-Deficiency
  mesh term: Iron Deficiencies
  mesh term: Vitamin D
  mesh term: Cholecalciferol
  sharing ipd: No