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/NCT05989984</url>
    </required_header>
    <id_info>
      <org_study_id>IBSAFE_CLI22</org_study_id>
      <nct_id>NCT05989984</nct_id>
    </id_info>
    <brief_title>Efficacy Evaluation of an ODF Iron Supplement vs an Iron Supplement in Capsules in Subjects With Mild Anemia</brief_title>
    <official_title>Monocentric, Prospective, Randomized Study to Evaluate the Efficacy of a New Iron Supplement With Orodispersible Formulation vs an Iron Supplement in Capsules in Subjects With Mild Anemia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IBSA Farmaceutici Italia Srl</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Informapro Srl</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>IBSA Farmaceutici Italia Srl</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible&#xD;
        formulation vs an iron supplement in capsules in subjects with mild anemia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible&#xD;
        formulation in modulating peripheral blood biomarkers of iron levels in subjects with mild&#xD;
        anemia after 8 weeks of supplementation, compared to baseline values and also aims to&#xD;
        evaluate its acceptability. For the evaluation, an iron supplement in capsules will be used&#xD;
        as a comparison supplement.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 4, 2023</start_date>
    <completion_date type="Anticipated">December 20, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 20, 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>
      <intervention_model_description>Monocentric, prospective, randomized study</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>No masking procedure will be applied</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product)</measure>
      <time_frame>Day 0, Week 8</time_frame>
      <description>Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with ODF iron supplement</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in blood concentration of hemoglobin with test product</measure>
      <time_frame>Day 0, Week 4</time_frame>
      <description>Change from baseline in blood concentration of hemoglobin after 4 weeks of supplementation with test product</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in blood concentration of hemoglobin with Iron supplement in capsule (reference product)</measure>
      <time_frame>Day 0, Week4, Week 8</time_frame>
      <description>Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with Iron supplement in capsule</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in blood concentration of hematocrit</measure>
      <time_frame>Day 0, Week4, Week 8</time_frame>
      <description>Evalution of the change from baseline of hematocrit after administration of test versus reference product</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in blood concentration of ferritin</measure>
      <time_frame>Day 0, Week4, Week 8</time_frame>
      <description>Evalution of the change from baseline of ferritin after administration of test versus reference product</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in blood concentration of transferrin</measure>
      <time_frame>Day 0, Week4, Week 8</time_frame>
      <description>Evalution of the change from baseline of transferrin after administration of test versus reference product</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in blood concentration of transferrin receptor</measure>
      <time_frame>Day 0, Week4, Week 8</time_frame>
      <description>Evalution of the change from baseline of transferrin receptor after administration of test versus reference product</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in blood concentration of folic acid</measure>
      <time_frame>Day 0, Week4, Week 8</time_frame>
      <description>Evalution of the change from baseline of folic acid after administration of test versus reference product</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in blood concentration of serum iron</measure>
      <time_frame>Day 0, Week4, Week 8</time_frame>
      <description>Evalution of the change from baseline of serum iron after administration of test versus reference product</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in mean corpuscolar volume (MCV)</measure>
      <time_frame>Day 0, Week4, Week 8</time_frame>
      <description>Evalution of the change from baseline of MCV after administration of test versus reference product</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Iron Deficiencies</condition>
    <arm_group>
      <arm_group_label>ODF Iron Supplement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ODF iron supplement contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 400 μg of folic acid.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Iron Supplement in Capsule</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Iron supplement in capsule contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 70 mg of vitamin C.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>ODF Iron Supplement</intervention_name>
      <description>ODF iron supplement will be admistered daily for 8 weeks.</description>
      <arm_group_label>ODF Iron Supplement</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Iron Supplement in Capsules</intervention_name>
      <description>Iron supplement in capsule will be admistered daily for 8 weeks.</description>
      <arm_group_label>Iron Supplement in Capsule</arm_group_label>
      <other_name>Sucrosomial iron</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Written informed consent signed prior to inclusion in the study&#xD;
  &#xD;
            -  18-55 years&#xD;
  &#xD;
            -  Ability to understand the nature and the purpose of the study, including possible&#xD;
               risks and side effects&#xD;
  &#xD;
            -  Capability to collaborate with the investigator and meet the requirements of the&#xD;
               entire study&#xD;
  &#xD;
            -  Subjects with mild anemia (with WHO hemoglobin values between 11-11.9 g/dl for women&#xD;
               and between 11-12.9 g/dl for men)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Clinically significant abnormalities in the ECG evaluation&#xD;
  &#xD;
            -  Clinically significant abnormal laboratory values indicative of disease&#xD;
  &#xD;
            -  Known allergy or presumed hypersensitivity to the food supplement investigated (iron)&#xD;
               and / or to the excipients of the two formulations&#xD;
  &#xD;
            -  History of anaphylaxis from drugs, dietary supplements or allergic reactions in&#xD;
               general, which the investigator believed could influence the outcome of the study&#xD;
  &#xD;
            -  Significant history of kidney, liver, gastrointestinal, cardiovascular, respiratory,&#xD;
               skin, haematological, endocrine or neurological diseases that may interfere with the&#xD;
               purpose of the study&#xD;
  &#xD;
            -  Taking herbal remedies and dietary supplements (including iron supplements,&#xD;
               supplements with vitamin C, supplements with folic acid, supplements with vitamin B12,&#xD;
               multivitamins) in the 2 weeks prior to the start of the study&#xD;
  &#xD;
            -  Taking corticosteroids, thyroid hormones, antibiotics, antiepileptics&#xD;
  &#xD;
            -  Alcohol abuse&#xD;
  &#xD;
            -  Any clinical condition that in the investigator's judgment is deemed incompatible with&#xD;
               study participation&#xD;
  &#xD;
            -  Women who are pregnant or breastfeeding&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Silvia Angeletti</last_name>
      <role>Principal Investigator</role>
      <affiliation>Operative Research Unit of Clinical Laboratory</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Silvia Angeletti</last_name>
      <phone>+3906225411461</phone>
      <email>S.Angeletti@policlinicocampus.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fondazione Policlinico Universitario Campus Bio-Medico di Roma</name>
        <address>
          <city>Roma</city>
          <zip>00128</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Silvia Angeletti</last_name>
        <email>S.Angeletti@policlinicocampus.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Iron Deficiencies</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Iron</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05989984
  org study id: IBSAFE_CLI22
  nct id: NCT05989984
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible
        formulation vs an iron supplement in capsules in subjects with mild anemia.
  The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible
        formulation in modulating peripheral blood biomarkers of iron levels in subjects with mild
        anemia after 8 weeks of supplementation, compared to baseline values and also aims to
        evaluate its acceptability. For the evaluation, an iron supplement in capsules will be used
        as a comparison supplement.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Monocentric, prospective, randomized study
  primary purpose: Other
  masking: None (Open Label)
  masking description: No masking procedure will be applied
  measure: Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product)
  time frame: Day 0, Week 8
  description: Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with ODF iron supplement
  measure: Change from baseline in blood concentration of hemoglobin with test product
  time frame: Day 0, Week 4
  description: Change from baseline in blood concentration of hemoglobin after 4 weeks of supplementation with test product
  measure: Change from baseline in blood concentration of hemoglobin with Iron supplement in capsule (reference product)
  time frame: Day 0, Week4, Week 8
  description: Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with Iron supplement in capsule
  measure: Change from baseline in blood concentration of hematocrit
  time frame: Day 0, Week4, Week 8
  description: Evalution of the change from baseline of hematocrit after administration of test versus reference product
  measure: Change from baseline in blood concentration of ferritin
  time frame: Day 0, Week4, Week 8
  description: Evalution of the change from baseline of ferritin after administration of test versus reference product
  measure: Change from baseline in blood concentration of transferrin
  time frame: Day 0, Week4, Week 8
  description: Evalution of the change from baseline of transferrin after administration of test versus reference product
  measure: Change from baseline in blood concentration of transferrin receptor
  time frame: Day 0, Week4, Week 8
  description: Evalution of the change from baseline of transferrin receptor after administration of test versus reference product
  measure: Change from baseline in blood concentration of folic acid
  time frame: Day 0, Week4, Week 8
  description: Evalution of the change from baseline of folic acid after administration of test versus reference product
  measure: Change from baseline in blood concentration of serum iron
  time frame: Day 0, Week4, Week 8
  description: Evalution of the change from baseline of serum iron after administration of test versus reference product
  measure: Change from baseline in mean corpuscolar volume (MCV)
  time frame: Day 0, Week4, Week 8
  description: Evalution of the change from baseline of MCV after administration of test versus reference product
  arm group label: ODF Iron Supplement
  arm group type: Experimental
  description: ODF iron supplement contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 400 μg of folic acid.
  arm group label: Iron Supplement in Capsule
  arm group type: Active Comparator
  description: Iron supplement in capsule contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 70 mg of vitamin C.
  intervention type: Dietary Supplement
  intervention name: ODF Iron Supplement
  description: ODF iron supplement will be admistered daily for 8 weeks.
  arm group label: ODF Iron Supplement
  intervention type: Dietary Supplement
  intervention name: Iron Supplement in Capsules
  description: Iron supplement in capsule will be admistered daily for 8 weeks.
  arm group label: Iron Supplement in Capsule
  other name: Sucrosomial iron
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: No
  last name: Silvia Angeletti
  role: Principal Investigator
  affiliation: Operative Research Unit of Clinical Laboratory
  last name: Silvia Angeletti
  phone: +3906225411461
  email: S.Angeletti@policlinicocampus.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Iron Deficiencies
  mesh term: Iron