<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/NCT02245321</url>
  </required_header>
  <id_info>
    <org_study_id>1R01HL10580901</org_study_id>
    <nct_id>NCT02245321</nct_id>
  </id_info>
  <brief_title>Strategies to Reduce Iron Deficiency</brief_title>
  <acronym>STRIDE</acronym>
  <official_title>Caring for Those Who Share: Mitigating Iron Deficiency In Regular Blood Donors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Westat</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Versiti</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American National Red Cross</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Institute for Transfusion Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Westat</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of iron deficiency in blood donors has been demonstrated to be a direct&#xD;
      consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is&#xD;
      priority to implement programs to remediate iron deficiency issues associated with blood&#xD;
      donations. To explore this issue, the study's aims to:&#xD;
&#xD;
        1. Determine whether regular blood donors provided with accurate information about their&#xD;
           iron status and written recommended courses of action will take steps to&#xD;
           prevent/mitigate iron deficiency on their own without being given iron supplements by&#xD;
           the blood center; and&#xD;
&#xD;
        2. Determine if two different amounts of iron provided by the blood center will&#xD;
           prevent/mitigate iron deficiency in regular blood donors.&#xD;
&#xD;
      To conduct this randomized, placebo controlled study, participant donors will be assigned to&#xD;
      one of two arms and followed for a 24 month period. Each subject will provide additional&#xD;
      blood samples of 7 ml and 4.5 ml at each study visit for the purpose of tracking hemoglobin&#xD;
      (Hgb), ferritin, soluble transferrin receptor (sTfR), and hematology laboratory results.&#xD;
&#xD;
      Under the two study arms, subjects are to be randomized into one of the following five&#xD;
      blinded categories:&#xD;
&#xD;
        -  Receive a thank you letter after each blood donation.&#xD;
&#xD;
        -  Receive a letter informing them of their ferritin result at each visit, along with&#xD;
           recommendations for blood donation.&#xD;
&#xD;
        -  Receive pills to take daily that contain no iron (a placebo or inert pill).&#xD;
&#xD;
        -  Receive pills to take daily that contain 19 mg of iron (the typical amount in a&#xD;
           multivitamin with iron).&#xD;
&#xD;
        -  Receive pills to take daily that contain 38 mg iron (the typical amount in an&#xD;
           over-the-counter iron supplement).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion Criteria&#xD;
&#xD;
        -  Donors who have donated whole blood or double red cells ≥ 2 times in the last 12 months&#xD;
           if female, or, ≥ 3 times in the last 12 months if male.&#xD;
&#xD;
        -  Commitment to meet the donation frequency requirement for the study for two more years,&#xD;
           give a blood sample at each visit, and complete baseline and follow-up surveys.&#xD;
&#xD;
      Exclusion Criteria&#xD;
&#xD;
        -  Subjects &lt; 18 years of age.&#xD;
&#xD;
        -  Subjects taking iron supplements (including multivitamins with iron) up to one month&#xD;
           prior to enrollment.&#xD;
&#xD;
        -  Females who are pregnant or plan to become pregnant in the following 2 years.&#xD;
&#xD;
        -  Subjects unwilling to meet the requirements of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin (HgB)</measure>
    <time_frame>Change from baseline in HgB over 2 years</time_frame>
    <description>a protein responsible for transporting oxygen in the blood</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ferritin</measure>
    <time_frame>Change from baseline in ferritin over 2 years</time_frame>
    <description>a protein that stores iron and releases it when your body needs it</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble transferrin receptor (sTfR)</measure>
    <time_frame>Change from baseline in sTfR over 2 years</time_frame>
    <description>a protein receptor that is used as a measure of functional iron status and the investigation of iron deficiency anemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Hematology results</measure>
    <time_frame>Change from baseline in Laboratory hematology results over 2 years.</time_frame>
    <description>Hemoglobin, Hematocrit, Mean Corpuscular Value (MCV), Mean Corpuscular Hemoglobin (MCH)</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">702</enrollment>
  <condition>Iron Deficiency</condition>
  <arm_group>
    <arm_group_label>Letter Group- No information</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Receive a thank you letter after each blood donation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Letter Group- Information Provided</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ferrous gluconate- 0 mg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Receive pills to take daily that contain no iron (a placebo or inert pill).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ferrous gluconate- 19 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ferrous gluconate- 38 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ferrous gluconate- 19 mg</intervention_name>
    <description>Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).</description>
    <arm_group_label>Ferrous gluconate- 19 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ferrous gluconate- 38 mg</intervention_name>
    <description>Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).</description>
    <arm_group_label>Ferrous gluconate- 38 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Letter Group- Information Provided</intervention_name>
    <description>Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.</description>
    <arm_group_label>Letter Group- Information Provided</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Letter - No Information Provided</intervention_name>
    <description>Receive a letter thanking the participant for their participation.</description>
    <arm_group_label>Letter Group- No information</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Receive pills to take daily that contain 0 mg iron.</description>
    <arm_group_label>Ferrous gluconate- 0 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Repeat donors who have previously participated in RISE study and have continued to&#xD;
             donate at a required frequency (donated whole blood or double red cells ≥ 2 times in&#xD;
             the last 12 months if female, or, ≥ 3 times in the last 12 months if male)&#xD;
&#xD;
          -  Non-RISE donors who have donated whole blood or double red cells ≥ 2 times in the last&#xD;
             12 months if female, or, ≥ 3 times in the last 12 months if male&#xD;
&#xD;
          -  commitment to meet the donation frequency requirement for this study for two more&#xD;
             years, give a blood sample at each visit, and complete baseline and follow-up surveys&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects &lt; 18 years of age&#xD;
&#xD;
          -  subjects taking iron supplements (including multivitamins with iron) up to one month&#xD;
             prior to enrollment&#xD;
&#xD;
          -  females who are pregnant or plan to become pregnant in the following 2 years&#xD;
&#xD;
          -  subjects unwilling to meet the requirements of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan Mast, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BloodCenters of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>American Red Cross, Connecticut Region</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westat</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Institute for Transfusion Medicince</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BloodCenter of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Bialkowski W, Kiss JE, Wright DJ, Cable R, Birch R, D'Andrea P, Bryant BJ, Spencer BR, Mast AE. Estimates of total body iron indicate 19 mg and 38 mg oral iron are equivalent for the mitigation of iron deficiency in individuals experiencing repeated phlebotomy. Am J Hematol. 2017 Sep;92(9):851-857. doi: 10.1002/ajh.24784. Epub 2017 Jun 9.</citation>
    <PMID>28494509</PMID>
  </results_reference>
  <results_reference>
    <citation>Chansky MC, King MR, Bialkowski W, Bryant BJ, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Mast AE. Qualitative assessment of pica experienced by frequent blood donors. Transfusion. 2017 Apr;57(4):946-951. doi: 10.1111/trf.13981. Epub 2017 Feb 5.</citation>
    <PMID>28164344</PMID>
  </results_reference>
  <results_reference>
    <citation>Mast AE, Bialkowski W, Bryant BJ, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR. A randomized, blinded, placebo-controlled trial of education and iron supplementation for mitigation of iron deficiency in regular blood donors. Transfusion. 2016 Jun;56(6 Pt 2):1588-97. doi: 10.1111/trf.13469. Epub 2016 Jan 26.</citation>
    <PMID>26813849</PMID>
  </results_reference>
  <results_reference>
    <citation>Bialkowski W, Bryant BJ, Schlumpf KS, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Vij V, Mast AE. The strategies to reduce iron deficiency in blood donors randomized trial: design, enrolment and early retention. Vox Sang. 2015 Feb;108(2):178-85. doi: 10.1111/vox.12210. Epub 2014 Dec 3.</citation>
    <PMID>25469720</PMID>
  </results_reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>May 22, 2017</last_update_submitted>
  <last_update_submitted_qc>May 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hemoglobin recovery</keyword>
  <keyword>iron recovery</keyword>
  <keyword>iron supplements</keyword>
  <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>Ferrous gluconate</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/NCT02245321
org study id: 1R01HL10580901
nct id: NCT02245321
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The prevalence of iron deficiency in blood donors has been demonstrated to be a direct
      consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is
      priority to implement programs to remediate iron deficiency issues associated with blood
      donations. To explore this issue, the study's aims to:

        1. Determine whether regular blood donors provided with accurate information about their
           iron status and written recommended courses of action will take steps to
           prevent/mitigate iron deficiency on their own without being given iron supplements by
           the blood center; and

        2. Determine if two different amounts of iron provided by the blood center will
           prevent/mitigate iron deficiency in regular blood donors.

      To conduct this randomized, placebo controlled study, participant donors will be assigned to
      one of two arms and followed for a 24 month period. Each subject will provide additional
      blood samples of 7 ml and 4.5 ml at each study visit for the purpose of tracking hemoglobin
      (Hgb), ferritin, soluble transferrin receptor (sTfR), and hematology laboratory results.

      Under the two study arms, subjects are to be randomized into one of the following five
      blinded categories:

        -  Receive a thank you letter after each blood donation.

        -  Receive a letter informing them of their ferritin result at each visit, along with
           recommendations for blood donation.

        -  Receive pills to take daily that contain no iron (a placebo or inert pill).

        -  Receive pills to take daily that contain 19 mg of iron (the typical amount in a
           multivitamin with iron).

        -  Receive pills to take daily that contain 38 mg iron (the typical amount in an
           over-the-counter iron supplement).
Inclusion Criteria

        -  Donors who have donated whole blood or double red cells ≥ 2 times in the last 12 months
           if female, or, ≥ 3 times in the last 12 months if male.

        -  Commitment to meet the donation frequency requirement for the study for two more years,
           give a blood sample at each visit, and complete baseline and follow-up surveys.

      Exclusion Criteria

        -  Subjects < 18 years of age.

        -  Subjects taking iron supplements (including multivitamins with iron) up to one month
           prior to enrollment.

        -  Females who are pregnant or plan to become pregnant in the following 2 years.

        -  Subjects unwilling to meet the requirements of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Hemoglobin (HgB)
time frame: Change from baseline in HgB over 2 years
description: a protein responsible for transporting oxygen in the blood
measure: Ferritin
time frame: Change from baseline in ferritin over 2 years
description: a protein that stores iron and releases it when your body needs it
measure: Soluble transferrin receptor (sTfR)
time frame: Change from baseline in sTfR over 2 years
description: a protein receptor that is used as a measure of functional iron status and the investigation of iron deficiency anemia
measure: Laboratory Hematology results
time frame: Change from baseline in Laboratory hematology results over 2 years.
description: Hemoglobin, Hematocrit, Mean Corpuscular Value (MCV), Mean Corpuscular Hemoglobin (MCH)
arm group label: Letter Group- No information
arm group type: Placebo Comparator
description: Receive a thank you letter after each blood donation.
arm group label: Letter Group- Information Provided
arm group type: Experimental
description: Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
arm group label: Ferrous gluconate- 0 mg
arm group type: Placebo Comparator
description: Receive pills to take daily that contain no iron (a placebo or inert pill).
arm group label: Ferrous gluconate- 19 mg
arm group type: Experimental
description: Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).
arm group label: Ferrous gluconate- 38 mg
arm group type: Experimental
description: Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).
intervention type: Dietary Supplement
intervention name: Ferrous gluconate- 19 mg
description: Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).
arm group label: Ferrous gluconate- 19 mg
intervention type: Dietary Supplement
intervention name: Ferrous gluconate- 38 mg
description: Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).
arm group label: Ferrous gluconate- 38 mg
intervention type: Other
intervention name: Letter Group- Information Provided
description: Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
arm group label: Letter Group- Information Provided
intervention type: Other
intervention name: Letter - No Information Provided
description: Receive a letter thanking the participant for their participation.
arm group label: Letter Group- No information
intervention type: Dietary Supplement
intervention name: Placebo
description: Receive pills to take daily that contain 0 mg iron.
arm group label: Ferrous gluconate- 0 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alan Mast, MD, PhD
role: Principal Investigator
affiliation: BloodCenters of Wisconsin
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Bialkowski W, Kiss JE, Wright DJ, Cable R, Birch R, D'Andrea P, Bryant BJ, Spencer BR, Mast AE. Estimates of total body iron indicate 19 mg and 38 mg oral iron are equivalent for the mitigation of iron deficiency in individuals experiencing repeated phlebotomy. Am J Hematol. 2017 Sep;92(9):851-857. doi: 10.1002/ajh.24784. Epub 2017 Jun 9.
PMID: 28494509
citation: Chansky MC, King MR, Bialkowski W, Bryant BJ, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Mast AE. Qualitative assessment of pica experienced by frequent blood donors. Transfusion. 2017 Apr;57(4):946-951. doi: 10.1111/trf.13981. Epub 2017 Feb 5.
PMID: 28164344
citation: Mast AE, Bialkowski W, Bryant BJ, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR. A randomized, blinded, placebo-controlled trial of education and iron supplementation for mitigation of iron deficiency in regular blood donors. Transfusion. 2016 Jun;56(6 Pt 2):1588-97. doi: 10.1111/trf.13469. Epub 2016 Jan 26.
PMID: 26813849
citation: Bialkowski W, Bryant BJ, Schlumpf KS, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Vij V, Mast AE. The strategies to reduce iron deficiency in blood donors randomized trial: design, enrolment and early retention. Vox Sang. 2015 Feb;108(2):178-85. doi: 10.1111/vox.12210. Epub 2014 Dec 3.
PMID: 25469720
responsible party type: Sponsor
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Ferrous gluconate