<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/NCT03771092</url>
  </required_header>
  <id_info>
    <org_study_id>CREAM-IRON</org_study_id>
    <nct_id>NCT03771092</nct_id>
  </id_info>
  <brief_title>Comparing the Efficacy of Different Iron Formulations: Sucrosomal Ferric Pyrophosphate, SunActive®Fe and Intravenous Ferric Gluconate</brief_title>
  <official_title>CONTROLLED RANDOMIZED PILOT STUDY TO COMPARE THE EFFICACY OF DIFFERENT IRON FORMULATIONS: SUCROSOMAL FERRIC PYROPHOSPHATE, SUNACTIVE Fe AND INTRAVENOUS FERRIC GLUCONATE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Palermo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Palermo</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>
      The purpose of the study is to evaluate the effects of martial therapy, comparing different&#xD;
      formulations, sucrosomal ferric pyrophosphate, SunActive®Fe micronized and ferric gluconate&#xD;
      and different ways of administration, orally and intravenous, in subjects affected by&#xD;
      sideropenic microcytic hypochromic anemia identified by the simultaneous presence of anemia,&#xD;
      microcytosis and hypoferremia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Iron deficiency anemia (IDA) still remains universally a worldwide problematics.&#xD;
      Anemia is defined as a hemoglobin value &lt;12.0 g/dL (7.45 mmol/L). Management of IDA is based&#xD;
      on martial iron supplementation. The purpose of the study is to evaluate the effects of&#xD;
      martial therapy, comparing different formulations, sucrosomal ferric pyrophosphate,&#xD;
      SunActive®Fe micronized and ferric gluconate and different ways of administration, orally and&#xD;
      intravenous, in subjects affected by sideropenic microcytic hypochromic anemia identified by&#xD;
      the simultaneous presence of anemia, microcytosis and hypoferremia.&#xD;
&#xD;
      Trial Design, Methods and Findings: Clinical data from 106 outpatients (82.8% female and&#xD;
      17.2% male, mean age 50.4 years) were collected at Department of Internal Medicine, National&#xD;
      Relevance and High Specialization Hospital Trust, ARNAS Civico-Di Cristina-Benfratelli,&#xD;
      Palermo, Italy. The study envisaged five arms (2 + 3). At the first two arms were assigned&#xD;
      patients with non-severe anemia Hb&gt; 10 g/dl (Hb &lt;12 g/dl for women and Hb &lt;13 g/dl for men),&#xD;
      treated with SunActive®Fe micronized or Lipofer®. At the other three arms were assigned&#xD;
      patients with severe anemia (Hb &lt;10 g/dl) treated respectively with SunActive®Fe micronized,&#xD;
      Lipofer® or with intravenous ferric gluconate infusions according to departmental protocols.&#xD;
      The followed methodology is defined in the PROBE project (acronym of Prospective Randomized&#xD;
      Open Blinded End-point). The end points will be blinded with respect to the three treatments,&#xD;
      as it will be the statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2015</start_date>
  <completion_date type="Actual">October 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 30, 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HB</measure>
    <time_frame>Three months</time_frame>
    <description>Mean change of hemoglobin concentration at three months</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Iron Deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>Patients with non-severe anemia treated with SunActive®Fe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with non-severe anemia Hb&gt; 10 g/dl (Hb &lt;12 g/dl for women and Hb &lt;13 g/dl for men), treated with SunActive®Fe micronized</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with non-severe anemia treated with Lipofer®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with non-severe anemia Hb&gt; 10 g/dl (Hb &lt;12 g/dl for women and Hb &lt;13 g/dl for men), treated with Lipofer®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with severe anemia with Lipofer®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with severe anemia (Hb &lt;10 g/dl) treated respectively with Lipofer®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with severe anemia with SunActive®Fe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with severe anemia (Hb &lt;10 g/dl) treated respectively with SunActive®Fe micronized</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with severe anemia with intravenous ferric gluconate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with severe anemia (Hb &lt;10 g/dl) treated respectively with intravenous ferric gluconate according to departmental protocols</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>SunActive®Fe</intervention_name>
    <description>SunActive® Fe is a colorless, odorless, tasteless iron fortifier in a powder form. This product is most commonly used to increase the amount of iron in food, beverage, and dietary supplement applications.</description>
    <arm_group_label>Patients with non-severe anemia treated with SunActive®Fe</arm_group_label>
    <arm_group_label>Patients with severe anemia with SunActive®Fe</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lipofer®</intervention_name>
    <description>Lipofer® is a micronized and microencapsulated source of iron, enhances the bioavailability of iron and does not taste metallic or oxidize unsaturated fats.</description>
    <arm_group_label>Patients with non-severe anemia treated with Lipofer®</arm_group_label>
    <arm_group_label>Patients with severe anemia with Lipofer®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Intravenous ferric gluconate</intervention_name>
    <description>Sodium ferric gluconate complex is an iron replacement product for treatment of iron deficiency anemia. The stable macromolecular complex is negatively charged at alkaline pH with an apparent molecular weight of 289,000 - 440,000 daltons on gel chromatography. It is composed of iron (III) oxide hydrate directly bonded to sucrose with a chelating gluconate function in a molar ratio of two iron molecules to one gluconate.</description>
    <arm_group_label>Patients with severe anemia with intravenous ferric gluconate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of iron deficiency anemia, microcytic and hypochromic&#xD;
&#xD;
          -  Age &gt;18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Celiac Disease&#xD;
&#xD;
          -  Patients who refuse to sign the informed consent&#xD;
&#xD;
          -  Clinically relevant cognitive Turbe&#xD;
&#xD;
          -  Hemodynamic instability defined by the presence of low blood pressure SBP &lt;100 FC&gt; 100&#xD;
&#xD;
          -  Dyspnea after modest effort worsening over the past 10 days&#xD;
&#xD;
          -  Oxygen peripheral saturation values &lt;94%&#xD;
&#xD;
          -  Ischemic heart Recent and / or lower limbs&#xD;
&#xD;
          -  Acute conditions with subacute or at recruitment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Palermo</investigator_affiliation>
    <investigator_full_name>Salvatore Corrao, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Iron</keyword>
  <keyword>Iron Deficiency Anemia</keyword>
  <keyword>Anemia</keyword>
  <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 gluconate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03771092
org study id: CREAM-IRON
nct id: NCT03771092
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate the effects of martial therapy, comparing different
      formulations, sucrosomal ferric pyrophosphate, SunActive®Fe micronized and ferric gluconate
      and different ways of administration, orally and intravenous, in subjects affected by
      sideropenic microcytic hypochromic anemia identified by the simultaneous presence of anemia,
      microcytosis and hypoferremia.
Background: Iron deficiency anemia (IDA) still remains universally a worldwide problematics.
      Anemia is defined as a hemoglobin value <12.0 g/dL (7.45 mmol/L). Management of IDA is based
      on martial iron supplementation. The purpose of the study is to evaluate the effects of
      martial therapy, comparing different formulations, sucrosomal ferric pyrophosphate,
      SunActive®Fe micronized and ferric gluconate and different ways of administration, orally and
      intravenous, in subjects affected by sideropenic microcytic hypochromic anemia identified by
      the simultaneous presence of anemia, microcytosis and hypoferremia.

      Trial Design, Methods and Findings: Clinical data from 106 outpatients (82.8% female and
      17.2% male, mean age 50.4 years) were collected at Department of Internal Medicine, National
      Relevance and High Specialization Hospital Trust, ARNAS Civico-Di Cristina-Benfratelli,
      Palermo, Italy. The study envisaged five arms (2 + 3). At the first two arms were assigned
      patients with non-severe anemia Hb> 10 g/dl (Hb <12 g/dl for women and Hb <13 g/dl for men),
      treated with SunActive®Fe micronized or Lipofer®. At the other three arms were assigned
      patients with severe anemia (Hb <10 g/dl) treated respectively with SunActive®Fe micronized,
      Lipofer® or with intravenous ferric gluconate infusions according to departmental protocols.
      The followed methodology is defined in the PROBE project (acronym of Prospective Randomized
      Open Blinded End-point). The end points will be blinded with respect to the three treatments,
      as it will be the statistical analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: HB
time frame: Three months
description: Mean change of hemoglobin concentration at three months
arm group label: Patients with non-severe anemia treated with SunActive®Fe
arm group type: Experimental
description: Patients with non-severe anemia Hb> 10 g/dl (Hb <12 g/dl for women and Hb <13 g/dl for men), treated with SunActive®Fe micronized
arm group label: Patients with non-severe anemia treated with Lipofer®
arm group type: Experimental
description: Patients with non-severe anemia Hb> 10 g/dl (Hb <12 g/dl for women and Hb <13 g/dl for men), treated with Lipofer®
arm group label: Patients with severe anemia with Lipofer®
arm group type: Experimental
description: Patients with severe anemia (Hb <10 g/dl) treated respectively with Lipofer®
arm group label: Patients with severe anemia with SunActive®Fe
arm group type: Experimental
description: Patients with severe anemia (Hb <10 g/dl) treated respectively with SunActive®Fe micronized
arm group label: Patients with severe anemia with intravenous ferric gluconate
arm group type: Experimental
description: Patients with severe anemia (Hb <10 g/dl) treated respectively with intravenous ferric gluconate according to departmental protocols
intervention type: Dietary Supplement
intervention name: SunActive®Fe
description: SunActive® Fe is a colorless, odorless, tasteless iron fortifier in a powder form. This product is most commonly used to increase the amount of iron in food, beverage, and dietary supplement applications.
arm group label: Patients with non-severe anemia treated with SunActive®Fe
arm group label: Patients with severe anemia with SunActive®Fe
intervention type: Dietary Supplement
intervention name: Lipofer®
description: Lipofer® is a micronized and microencapsulated source of iron, enhances the bioavailability of iron and does not taste metallic or oxidize unsaturated fats.
arm group label: Patients with non-severe anemia treated with Lipofer®
arm group label: Patients with severe anemia with Lipofer®
intervention type: Dietary Supplement
intervention name: Intravenous ferric gluconate
description: Sodium ferric gluconate complex is an iron replacement product for treatment of iron deficiency anemia. The stable macromolecular complex is negatively charged at alkaline pH with an apparent molecular weight of 289,000 - 440,000 daltons on gel chromatography. It is composed of iron (III) oxide hydrate directly bonded to sucrose with a chelating gluconate function in a molar ratio of two iron molecules to one gluconate.
arm group label: Patients with severe anemia with intravenous ferric gluconate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Palermo
investigator full name: Salvatore Corrao, MD
investigator title: Professor
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Ferric gluconate
sharing ipd: No