<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/NCT02228902</url>
  </required_header>
  <id_info>
    <org_study_id>Ironabsorption</org_study_id>
    <nct_id>NCT02228902</nct_id>
  </id_info>
  <brief_title>Iron Absorption Trial</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rijnstate Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rijnstate Hospital</source>
  <brief_summary>
    <textblock>
      Introduction: There are indications that the absorption of oral iron supplementation is&#xD;
      reduced after a Roux- en -Y gastric bypass. Nevertheless, oral preparations are used as&#xD;
      standard therapy for iron deficiency, even in patients who underwent a Roux- en -Y gastric&#xD;
      bypass. Our goal is to evaluate if iron absorption is disturbed after a RYGB, which leads to&#xD;
      a insufficient treatment of oral iron suppletion.&#xD;
&#xD;
      Methods: an iron absorption test will be performed pre- and postoperatively in 24 patients.&#xD;
      Two groups will be created.&#xD;
&#xD;
      Preoperatively group 1 receives a daily dose of ferrous fumarate (600mg) and group 2 receives&#xD;
      a daily dose Losferron (1390mg).&#xD;
&#xD;
      Before intake of the medicines, a fasting blood sample is taken (baseline), serum iron&#xD;
      including ferritin, transferrin and transferrin saturation will be measured. After intake of&#xD;
      losferron/ferrous fumarate blood samples will be taken 1, 2, 3, 4, 5 and 6 hours after&#xD;
      intake, using a drip. An increase of 80 microgram/l is representative for a sufficient iron&#xD;
      absorption. All patients undergo a Roux- en -Y gastric bypass.&#xD;
&#xD;
      Postoperatively; one month postoperatively the same absorption test will be repeated in the&#xD;
      same patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">May 4, 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Iron values in the blood</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>Iron levels in teh blood will be measured before and 1,2,3,4,5 and 6 hours after the administration of oral iron replacement in micrograms / dl. This will take place before surgery and one month after surgery. The primary outcome is de difference between iron values pre- and postoperatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>difference in absorption between ferrous fumarate and ferrous gluconate</measure>
    <time_frame>1 month after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Iron Absorption</condition>
  <condition>Bariatric Surgery</condition>
  <condition>Roux- en -y Gastric Bypass</condition>
  <arm_group>
    <arm_group_label>ferrous fumarate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 patients receive ferrous fumarate, 12 patients receive ferrous gluconate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ferrous gluconate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 patients receive ferrous fumarate and 12 patients receive ferrous gluconate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferrous fumarate</intervention_name>
    <description>one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate</description>
    <arm_group_label>ferrous fumarate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferrous gluconate</intervention_name>
    <description>One group receives ferrous fumarate and one group receives ferrous fumarate.</description>
    <arm_group_label>ferrous gluconate</arm_group_label>
    <other_name>Losferron</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who are eligible for a primary Roux- en -Y gastric bypass and who have no&#xD;
             pre-existing iron deficiency (serum ferritin between 20-200 micrograms/L)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  blood transfusion one month before ans in the study period. The use of iron containing&#xD;
             nutritional supplements, except our standardized multivitamin supplements. Decreased&#xD;
             function of the kidney with a GFR of &lt; 30ml/min and a serum creatinin below 50&#xD;
             micromol/L. Hb&lt; 7.4 mmol/L in females en Hb&lt; 8.4 mmol/L in males. Accumulation of&#xD;
             iron. Hypersensitivity for ons of the medicinal products. Psychiatric illness.&#xD;
             Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rijnstate hospital</name>
      <address>
        <city>Arnhem</city>
        <zip>6800WC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ferrous fumarate</mesh_term>
    <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/NCT02228902
org study id: Ironabsorption
nct id: NCT02228902
lead sponsor: 
Introduction: There are indications that the absorption of oral iron supplementation is
      reduced after a Roux- en -Y gastric bypass. Nevertheless, oral preparations are used as
      standard therapy for iron deficiency, even in patients who underwent a Roux- en -Y gastric
      bypass. Our goal is to evaluate if iron absorption is disturbed after a RYGB, which leads to
      a insufficient treatment of oral iron suppletion.

      Methods: an iron absorption test will be performed pre- and postoperatively in 24 patients.
      Two groups will be created.

      Preoperatively group 1 receives a daily dose of ferrous fumarate (600mg) and group 2 receives
      a daily dose Losferron (1390mg).

      Before intake of the medicines, a fasting blood sample is taken (baseline), serum iron
      including ferritin, transferrin and transferrin saturation will be measured. After intake of
      losferron/ferrous fumarate blood samples will be taken 1, 2, 3, 4, 5 and 6 hours after
      intake, using a drip. An increase of 80 microgram/l is representative for a sufficient iron
      absorption. All patients undergo a Roux- en -Y gastric bypass.

      Postoperatively; one month postoperatively the same absorption test will be repeated in the
      same patients.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Iron values in the blood
time frame: 1 month after surgery
description: Iron levels in teh blood will be measured before and 1,2,3,4,5 and 6 hours after the administration of oral iron replacement in micrograms / dl. This will take place before surgery and one month after surgery. The primary outcome is de difference between iron values pre- and postoperatively.
measure: difference in absorption between ferrous fumarate and ferrous gluconate
time frame: 1 month after surgery
arm group label: ferrous fumarate
arm group type: Active Comparator
description: 12 patients receive ferrous fumarate, 12 patients receive ferrous gluconate
arm group label: ferrous gluconate
arm group type: Active Comparator
description: 12 patients receive ferrous fumarate and 12 patients receive ferrous gluconate
intervention type: Drug
intervention name: Ferrous fumarate
description: one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate
arm group label: ferrous fumarate
intervention type: Drug
intervention name: Ferrous gluconate
description: One group receives ferrous fumarate and one group receives ferrous fumarate.
arm group label: ferrous gluconate
other name: Losferron
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Ferrous fumarate
mesh term: Ferrous gluconate