<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/NCT02990988</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR1265</org_study_id>
    <nct_id>NCT02990988</nct_id>
  </id_info>
  <brief_title>Microbiome of Donor Iron Deficient Study</brief_title>
  <official_title>Microbiome of Donor Iron Deficient Study (DIDS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this pilot study is to test whether the microbiome is affected by intravenous&#xD;
      iron repletion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The colonic microbiome, the community of bacteria living in our gut, is essential in human&#xD;
      health and disease. Iron is an essential nutrient for both bacteria and humans. In the United&#xD;
      States, of the donors who provided the ~15 million units of red blood cells that were&#xD;
      collected for transfusion, 69% were repeat donors. Although iron deficiency is surprisingly&#xD;
      prevalent in first-time donors, its prevalence is even higher in these particularly&#xD;
      altruistic frequent donors, (i.e., up to 49% and 66% of male and female repeat donors,&#xD;
      respectively), manifested as iron depletion or iron-deficient erythropoiesis. Iron deficiency&#xD;
      from blood donation is associated with fatigue, restless leg syndrome, decreased physical&#xD;
      endurance and work capacity, and impaired concentration, attention, and other neurocognitive&#xD;
      functions; however, these conclusions are not based on definitive studies and have not yet&#xD;
      changed blood donation policy. The goal is to conduct a prospective, double-blind, randomized&#xD;
      controlled trial, recruiting 60 healthy regular donors who meet donation standards, while&#xD;
      exhibiting iron-deficient erythropoiesis by laboratory test criteria. In this ancillary&#xD;
      study, we will determine what effect donor iron deficiency and IV iron repletion have on the&#xD;
      gut microbiome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">June 3, 2022</completion_date>
  <primary_completion_date type="Actual">June 3, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in overall diversity of fecal flora</measure>
    <time_frame>Baseline, 5-days, 4-weeks, 5 months</time_frame>
    <description>Stool samples will be collected and processed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fecal indoles</measure>
    <time_frame>Baseline, 5-days, 4-weeks, 5 months</time_frame>
    <description>Indole concentrations measured in fecal samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fecal iron</measure>
    <time_frame>Baseline, 5-days, 4-weeks, 5 months</time_frame>
    <description>Iron concentrations measured in fecal samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Bray-Curtis indices</measure>
    <time_frame>Baseline, 5-days, 4-weeks, 5 months</time_frame>
    <description>Calculation of Bray-Curtis index will determine the relative abundance of specific taxa (e.g., Firmicutes, Bacteroidetes, Proteobacteria) for each subject. Means (of the differences in %) and standard deviations will be calculated for all comparisons, and a multivariable generalized estimating equations (GEE) model will be used to test for significance.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Iron Deficiency</condition>
  <arm_group>
    <arm_group_label>Iron repletion</arm_group_label>
    <description>Subjects participating in the associated study under the Iron Repletion arm will also provide stool collection and answers to questionnaire and diet diary.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <description>Subjects participating in the associated study under the Placebo arm will also provide stool collection and answers to questionnaire and diet diary.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool collection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with iron deficiency from blood donation will be recruited over 5 years in the&#xD;
        associated randomized controlled trial conducted at Columbia University Medical Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current participant of the associated randomized controlled trial conducted at&#xD;
             Columbia University Medical Center (therefore invited to participate in this optional&#xD;
             ancillary study).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not a current participant of the associated randomized controlled trial conducted at&#xD;
             Columbia University Medical Center.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eldad Hod, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor of Pathology and Cell Biology, Dept of Pathology&amp;Cell Biology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Smith GA, Fisher SA, Doree C, Roberts DJ. A systematic review of factors associated with the deferral of donors failing to meet low haemoglobin thresholds. Transfus Med. 2013 Oct;23(5):309-20. doi: 10.1111/tme.12046. Epub 2013 Jul 5.</citation>
    <PMID>23829880</PMID>
  </reference>
  <reference>
    <citation>Newman B. Iron depletion by whole-blood donation harms menstruating females: the current whole-blood-collection paradigm needs to be changed. Transfusion. 2006 Oct;46(10):1667-81. doi: 10.1111/j.1537-2995.2006.00969.x. No abstract available.</citation>
    <PMID>17002622</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Cable RG, Glynn SA, Kiss JE, Mast AE, Steele WR, Murphy EL, Wright DJ, Sacher RA, Gottschall JL, Tobler LH, Simon TL; NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II). Iron deficiency in blood donors: the REDS-II Donor Iron Status Evaluation (RISE) study. Transfusion. 2012 Apr;52(4):702-11. doi: 10.1111/j.1537-2995.2011.03401.x. Epub 2011 Oct 24.</citation>
    <PMID>22023513</PMID>
  </reference>
  <reference>
    <citation>Brittenham GM. Iron deficiency in whole blood donors. Transfusion. 2011 Mar;51(3):458-61. doi: 10.1111/j.1537-2995.2011.03062.x. No abstract available.</citation>
    <PMID>21388389</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>September 15, 2022</last_update_submitted>
  <last_update_submitted_qc>September 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood donation</keyword>
  <keyword>Iron repletion</keyword>
  <keyword>Transfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Survey Report</doc_type>
      <doc_url>https://www.hhs.gov/oidp/topics/blood-tissue-safety/surveys/national-blood-collection-and-utilization-survey/index.html</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT02990988
org study id: AAAR1265
nct id: NCT02990988
lead sponsor: 
has dmc: No
The goal of this pilot study is to test whether the microbiome is affected by intravenous
      iron repletion.
The colonic microbiome, the community of bacteria living in our gut, is essential in human
      health and disease. Iron is an essential nutrient for both bacteria and humans. In the United
      States, of the donors who provided the ~15 million units of red blood cells that were
      collected for transfusion, 69% were repeat donors. Although iron deficiency is surprisingly
      prevalent in first-time donors, its prevalence is even higher in these particularly
      altruistic frequent donors, (i.e., up to 49% and 66% of male and female repeat donors,
      respectively), manifested as iron depletion or iron-deficient erythropoiesis. Iron deficiency
      from blood donation is associated with fatigue, restless leg syndrome, decreased physical
      endurance and work capacity, and impaired concentration, attention, and other neurocognitive
      functions; however, these conclusions are not based on definitive studies and have not yet
      changed blood donation policy. The goal is to conduct a prospective, double-blind, randomized
      controlled trial, recruiting 60 healthy regular donors who meet donation standards, while
      exhibiting iron-deficient erythropoiesis by laboratory test criteria. In this ancillary
      study, we will determine what effect donor iron deficiency and IV iron repletion have on the
      gut microbiome.
observational model: Other
time perspective: Prospective
measure: Change in overall diversity of fecal flora
time frame: Baseline, 5-days, 4-weeks, 5 months
description: Stool samples will be collected and processed.
measure: Change in fecal indoles
time frame: Baseline, 5-days, 4-weeks, 5 months
description: Indole concentrations measured in fecal samples
measure: Change in fecal iron
time frame: Baseline, 5-days, 4-weeks, 5 months
description: Iron concentrations measured in fecal samples
measure: Mean Bray-Curtis indices
time frame: Baseline, 5-days, 4-weeks, 5 months
description: Calculation of Bray-Curtis index will determine the relative abundance of specific taxa (e.g., Firmicutes, Bacteroidetes, Proteobacteria) for each subject. Means (of the differences in %) and standard deviations will be calculated for all comparisons, and a multivariable generalized estimating equations (GEE) model will be used to test for significance.
arm group label: Iron repletion
description: Subjects participating in the associated study under the Iron Repletion arm will also provide stool collection and answers to questionnaire and diet diary.
arm group label: Placebo
description: Subjects participating in the associated study under the Placebo arm will also provide stool collection and answers to questionnaire and diet diary.
Stool collection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eldad Hod, MD
role: Principal Investigator
affiliation: Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology
facility: 
country: United States
citation: Smith GA, Fisher SA, Doree C, Roberts DJ. A systematic review of factors associated with the deferral of donors failing to meet low haemoglobin thresholds. Transfus Med. 2013 Oct;23(5):309-20. doi: 10.1111/tme.12046. Epub 2013 Jul 5.
PMID: 23829880
citation: Newman B. Iron depletion by whole-blood donation harms menstruating females: the current whole-blood-collection paradigm needs to be changed. Transfusion. 2006 Oct;46(10):1667-81. doi: 10.1111/j.1537-2995.2006.00969.x. No abstract available.
PMID: 17002622
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
citation: Cable RG, Glynn SA, Kiss JE, Mast AE, Steele WR, Murphy EL, Wright DJ, Sacher RA, Gottschall JL, Tobler LH, Simon TL; NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II). Iron deficiency in blood donors: the REDS-II Donor Iron Status Evaluation (RISE) study. Transfusion. 2012 Apr;52(4):702-11. doi: 10.1111/j.1537-2995.2011.03401.x. Epub 2011 Oct 24.
PMID: 22023513
citation: Brittenham GM. Iron deficiency in whole blood donors. Transfusion. 2011 Mar;51(3):458-61. doi: 10.1111/j.1537-2995.2011.03062.x. No abstract available.
PMID: 21388389
responsible party type: Sponsor
mesh term: Iron Deficiencies
sharing ipd: No
study doc: 