<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/NCT03762148</url>
  </required_header>
  <id_info>
    <org_study_id>Fe_GOS_2</org_study_id>
    <nct_id>NCT03762148</nct_id>
  </id_info>
  <brief_title>Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C</brief_title>
  <acronym>Fe_GOS_2</acronym>
  <official_title>The Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores: Determination of a Dose-dependent Effect of Galacto-oligosaccharides on Iron Absorption, With and Without Addition of Ascorbic Acid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isabelle Herter-Aeberli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Burgerstein Vitamine</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Swiss Federal Institute of Technology</source>
  <oversight_info>
    <has_dmc>No</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>
      Iron deficiency is still the most common and widespread nutritional disorder in the world&#xD;
      according to WHO.&#xD;
&#xD;
      In a recent iron absorption study in adult women with low iron stores in our lab (publication&#xD;
      under review), we found that 15 g of GOS given with an iron supplement in the form of iron&#xD;
      fumarate acutely increased iron absorption when given with water and a bread based meal. The&#xD;
      dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study&#xD;
      mentioned above, we want to investigate: 1) if acute iron absorption is affected by lower&#xD;
      doses of GOS; 2) whether this acute effect occurs for other commonly used iron compounds as&#xD;
      well, such as iron sulphate and iron phosphate; and 3) if there are potential interactions on&#xD;
      absorption with other enhancers of iron absorption, such as vitamin c.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Iron is an important mineral in our body and fulfills essential functions such as for example&#xD;
      oxygen transport from the lungs to the tissues. Iron deficiency is still the most common and&#xD;
      widespread nutritional disorder in the world according to WHO. Common iron supplements all&#xD;
      have their limitations in terms of availability and compatibility. Prebiotic fibers, such as&#xD;
      galacto-oligosaccharides (GOS), selectively enhance growth of beneficial colonic bacteria.&#xD;
      Prebiotics in general enhance the production of short-chain fatty acids (SCFAs) and thereby&#xD;
      decrease luminal pH. Through the reduction in pH, prebiotics can enhance absorption of&#xD;
      minerals such as calcium and magnesium and they have been proposed to potentially improve&#xD;
      iron absorption.&#xD;
&#xD;
      In a recent iron absorption study in adult women with low iron stores in our lab (publication&#xD;
      under review), we found that 15 g of GOS given with an iron supplement in the form of iron&#xD;
      fumarate acutely increased iron absorption when given with water and a bread based meal. The&#xD;
      dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study&#xD;
      mentioned above, we want to investigate: 1) if acute iron absorption is affected by lower&#xD;
      doses of GOS; 2) whether this acute effect occurs for other commonly used iron compounds as&#xD;
      well, such as iron sulphate and iron phosphate; and 3) if there are potential interactions on&#xD;
      absorption with other enhancers of iron absorption, such as vitamin c.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">June 11, 2019</completion_date>
  <primary_completion_date type="Actual">June 11, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fractional iron absorption</measure>
    <time_frame>2 months</time_frame>
    <description>Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of several isotopically labelled iron supplements.Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.</description>
  </primary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Iron-deficiency</condition>
  <arm_group>
    <arm_group_label>ferrous fumarate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>labelled iron as ferrous fumarate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ferrous sulphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>labelled iron as ferrous sulphate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ferric pyrophosphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>labelled iron as ferric pyrophosphate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ferrous fumarate + 3.5 g GOS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>labelled iron as ferrous fumarate + prebiotics in the form of 3.5 g GOS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ferrous fumarate + 7 g GOS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ferrous sulphate + 15 g GOS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>labelled iron as ferrous sulphate + prebiotics in the form of 15 g GOS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ferrous fumarate + Vitamin C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>labelled iron as ferrous fumarate + Vitamin C</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ferric pyrophosphate + 15 g GOS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>labelled iron as ferric pyrophosphate + prebiotics in the form of 15 g GOS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ferrous fumarate + 7 g GOS + Vitamin C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS + Vitamin C</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ferrous fumarate</intervention_name>
    <description>nutritional iron (14 mg) supplement in form of ferrous fumarate</description>
    <arm_group_label>ferrous fumarate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ferrous sulphate</intervention_name>
    <description>nutritional iron (14 mg) supplement in form of ferrous sulphate</description>
    <arm_group_label>ferrous sulphate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ferric pyrophosphate</intervention_name>
    <description>nutritional iron (14 mg) supplement in form of ferric pyrophosphate</description>
    <arm_group_label>ferric pyrophosphate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ferrous fumarate + 3.5 g GOS</intervention_name>
    <description>nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (3.5 g GOS)</description>
    <arm_group_label>ferrous fumarate + 3.5 g GOS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ferrous fumarate + 7 g GOS</intervention_name>
    <description>nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS)</description>
    <arm_group_label>ferrous fumarate + 7 g GOS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ferrous sulphate + 15 g GOS</intervention_name>
    <description>nutritional iron (14 mg) supplement in form of ferrous sulphate with addition of prebiotics (15 g GOS)</description>
    <arm_group_label>ferrous sulphate + 15 g GOS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ferrous fumarate + Vitamin C</intervention_name>
    <description>nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of Vitamin C</description>
    <arm_group_label>ferrous fumarate + Vitamin C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ferric pyrophosphate + 15 g GOS</intervention_name>
    <description>nutritional iron (14 mg) supplement in form of ferric pyrophosphate with addition of prebiotics (15 g GOS)</description>
    <arm_group_label>ferric pyrophosphate + 15 g GOS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ferrous fumarate + 7 g GOS + Vitamin C</intervention_name>
    <description>nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS) and Vitamin C</description>
    <arm_group_label>ferrous fumarate + 7 g GOS + Vitamin C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female, 18 to 45 years old&#xD;
&#xD;
          -  SF levels &lt;30 µg/L&#xD;
&#xD;
          -  Normal body Mass Index (18.5-24.9 kg/m2)&#xD;
&#xD;
          -  Body weight &lt;70 kg&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe anaemia (Hb &lt; 80 g/L)&#xD;
&#xD;
          -  Elevated CRP &gt;10.0 mg/L&#xD;
&#xD;
          -  Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal&#xD;
             failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular&#xD;
             diseases (according to the participants own statement)&#xD;
&#xD;
          -  Continuous/long-term use of medication during the whole studies (except for&#xD;
             contraceptives)&#xD;
&#xD;
          -  Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement&#xD;
             administration, including pre- and-or probiotics supplements (excluding foods and&#xD;
             beverages with life cultures such as yoghurt, raw milk cheese and kombucha)&#xD;
&#xD;
          -  Blood transfusion, blood donation or significant blood loss (accident, surgery) over&#xD;
             the past 4 months&#xD;
&#xD;
          -  Difficulties with blood sampling&#xD;
&#xD;
          -  Use of antibiotics over the past month&#xD;
&#xD;
          -  Known hypersensitivity to iron supplements in the given amount, GOS, or lactose&#xD;
&#xD;
          -  Women who are pregnant or breast feeding&#xD;
&#xD;
          -  Women who intend become pregnant during the course of the study&#xD;
&#xD;
          -  Lack of safe contraception, defined as: Female participants of childbearing potential,&#xD;
             not using and not willing to continue using a medically reliable method of&#xD;
             contraception for the entire study duration, such as oral, inject-able, or implantable&#xD;
             contraceptives, or intrauterine contraceptive devices, or who are not using any other&#xD;
             method considered sufficiently reliable by the investigator in individual cases&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse -&#xD;
&#xD;
          -  Smokers (&gt; 1 cigarette per week)&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems, self--&#xD;
             reported psychological disorders, etc. of the participant&#xD;
&#xD;
          -  Enrollment of the investigator, his/her family members, employees and other dependent&#xD;
             persons&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only female participants are being studied</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabelle Herter-Aeberli, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Human Nutrition Laboratory, ETH Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8092</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Swiss Federal Institute of Technology</investigator_affiliation>
    <investigator_full_name>Isabelle Herter-Aeberli</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>iron-deficiency</keyword>
  <keyword>prebiotics</keyword>
  <keyword>galacto-oligosaccharides</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>Vitamins</mesh_term>
    <mesh_term>Ascorbic Acid</mesh_term>
    <mesh_term>Ferrous fumarate</mesh_term>
    <mesh_term>Iron</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/NCT03762148
org study id: Fe_GOS_2
nct id: NCT03762148
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Iron deficiency is still the most common and widespread nutritional disorder in the world
      according to WHO.

      In a recent iron absorption study in adult women with low iron stores in our lab (publication
      under review), we found that 15 g of GOS given with an iron supplement in the form of iron
      fumarate acutely increased iron absorption when given with water and a bread based meal. The
      dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study
      mentioned above, we want to investigate: 1) if acute iron absorption is affected by lower
      doses of GOS; 2) whether this acute effect occurs for other commonly used iron compounds as
      well, such as iron sulphate and iron phosphate; and 3) if there are potential interactions on
      absorption with other enhancers of iron absorption, such as vitamin c.
Iron is an important mineral in our body and fulfills essential functions such as for example
      oxygen transport from the lungs to the tissues. Iron deficiency is still the most common and
      widespread nutritional disorder in the world according to WHO. Common iron supplements all
      have their limitations in terms of availability and compatibility. Prebiotic fibers, such as
      galacto-oligosaccharides (GOS), selectively enhance growth of beneficial colonic bacteria.
      Prebiotics in general enhance the production of short-chain fatty acids (SCFAs) and thereby
      decrease luminal pH. Through the reduction in pH, prebiotics can enhance absorption of
      minerals such as calcium and magnesium and they have been proposed to potentially improve
      iron absorption.

      In a recent iron absorption study in adult women with low iron stores in our lab (publication
      under review), we found that 15 g of GOS given with an iron supplement in the form of iron
      fumarate acutely increased iron absorption when given with water and a bread based meal. The
      dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study
      mentioned above, we want to investigate: 1) if acute iron absorption is affected by lower
      doses of GOS; 2) whether this acute effect occurs for other commonly used iron compounds as
      well, such as iron sulphate and iron phosphate; and 3) if there are potential interactions on
      absorption with other enhancers of iron absorption, such as vitamin c.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: fractional iron absorption
time frame: 2 months
description: Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of several isotopically labelled iron supplements.Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
arm group label: ferrous fumarate
arm group type: Experimental
description: labelled iron as ferrous fumarate
arm group label: ferrous sulphate
arm group type: Experimental
description: labelled iron as ferrous sulphate
arm group label: ferric pyrophosphate
arm group type: Experimental
description: labelled iron as ferric pyrophosphate
arm group label: ferrous fumarate + 3.5 g GOS
arm group type: Experimental
description: labelled iron as ferrous fumarate + prebiotics in the form of 3.5 g GOS
arm group label: ferrous fumarate + 7 g GOS
arm group type: Experimental
description: labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS
arm group label: ferrous sulphate + 15 g GOS
arm group type: Experimental
description: labelled iron as ferrous sulphate + prebiotics in the form of 15 g GOS
arm group label: ferrous fumarate + Vitamin C
arm group type: Experimental
description: labelled iron as ferrous fumarate + Vitamin C
arm group label: ferric pyrophosphate + 15 g GOS
arm group type: Experimental
description: labelled iron as ferric pyrophosphate + prebiotics in the form of 15 g GOS
arm group label: ferrous fumarate + 7 g GOS + Vitamin C
arm group type: Experimental
description: labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS + Vitamin C
intervention type: Dietary Supplement
intervention name: ferrous fumarate
description: nutritional iron (14 mg) supplement in form of ferrous fumarate
arm group label: ferrous fumarate
intervention type: Dietary Supplement
intervention name: ferrous sulphate
description: nutritional iron (14 mg) supplement in form of ferrous sulphate
arm group label: ferrous sulphate
intervention type: Dietary Supplement
intervention name: ferric pyrophosphate
description: nutritional iron (14 mg) supplement in form of ferric pyrophosphate
arm group label: ferric pyrophosphate
intervention type: Dietary Supplement
intervention name: ferrous fumarate + 3.5 g GOS
description: nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (3.5 g GOS)
arm group label: ferrous fumarate + 3.5 g GOS
intervention type: Dietary Supplement
intervention name: ferrous fumarate + 7 g GOS
description: nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS)
arm group label: ferrous fumarate + 7 g GOS
intervention type: Dietary Supplement
intervention name: ferrous sulphate + 15 g GOS
description: nutritional iron (14 mg) supplement in form of ferrous sulphate with addition of prebiotics (15 g GOS)
arm group label: ferrous sulphate + 15 g GOS
intervention type: Dietary Supplement
intervention name: ferrous fumarate + Vitamin C
description: nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of Vitamin C
arm group label: ferrous fumarate + Vitamin C
intervention type: Dietary Supplement
intervention name: ferric pyrophosphate + 15 g GOS
description: nutritional iron (14 mg) supplement in form of ferric pyrophosphate with addition of prebiotics (15 g GOS)
arm group label: ferric pyrophosphate + 15 g GOS
intervention type: Dietary Supplement
intervention name: ferrous fumarate + 7 g GOS + Vitamin C
description: nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS) and Vitamin C
arm group label: ferrous fumarate + 7 g GOS + Vitamin C
criteria: 
gender: Female
gender based: Yes
gender description: Only female participants are being studied
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Isabelle Herter-Aeberli, Dr.
role: Principal Investigator
affiliation: University of Zurich
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Swiss Federal Institute of Technology
investigator full name: Isabelle Herter-Aeberli
investigator title: PhD
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Vitamins
mesh term: Ascorbic Acid
mesh term: Ferrous fumarate
mesh term: Iron
sharing ipd: No