<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/NCT03835377</url>
  </required_header>
  <id_info>
    <org_study_id>CI-441</org_study_id>
    <nct_id>NCT03835377</nct_id>
  </id_info>
  <brief_title>Iron-Biofortified Beans Intervention in Mexico</brief_title>
  <official_title>A Randomized Feeding Trial of Iron-Biofortified Beans in School Children in Mexico</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Nacional de Salud Publica, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cornell University</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>
      The objective of this cluster-randomized efficacy feeding trial was to determine the effects&#xD;
      of consuming iron-biofortified beans (Fe-Beans) on iron status in children, compared to&#xD;
      control beans (Control-Beans). A cluster-randomized trial of biofortified beans (Phaseolus&#xD;
      vulgaris L), bred to enhance iron content, was conducted for 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Iron deficiency is the most common single nutrient deficiency worldwide, with the highest&#xD;
      burden in children and women of reproductive age. Global estimates of anemia prevalence in&#xD;
      school-aged children range between 25% and 46%, and iron deficiency accounts for a majority&#xD;
      of anemia cases. In Mexico, the national nutrition and health survey (2006) reported a&#xD;
      prevalence of anemia of 16.6% and iron deficiency of 17.6% (serum ferritin &lt;12.0 µg/L),&#xD;
      posing a considerable health risk for children.&#xD;
&#xD;
      Interventions, including micronutrient supplementation and food fortification, have improved&#xD;
      iron status and reduced the prevalence of anemia in some settings. However, iron deficiency&#xD;
      remains an urgent public health problem and threat to child health and development. Young&#xD;
      children are particularly at high risk due to rapid growth, inadequate dietary intake, and&#xD;
      high risk of infection in resource-limited settings. Iron deficiency has been associated with&#xD;
      impaired cognitive function in children, and long-term impairments in physical work capacity&#xD;
      into adulthood.&#xD;
&#xD;
      One novel approach to reducing micronutrient malnutrition is to enhance the nutrient quality&#xD;
      of the diet through biofortification of staple crops that are already locally accepted and&#xD;
      consumed. Biofortification has consequently been recognized by the Copenhagen Consensus of&#xD;
      2008 as one of the top five solutions to current global health and nutrition challenges. The&#xD;
      success and challenges of biofortification have been documented previously. We recently&#xD;
      reviewed the published evidence from the three randomized efficacy trials of different&#xD;
      iron-biofortified crops that demonstrated varied benefits in populations, including rice in&#xD;
      adult Filipino women, pearl millet in school-aged children in India, and beans in women of&#xD;
      reproductive age in Rwanda. Findings demonstrated improvements in serum ferritin&#xD;
      concentrations and total body iron concentrations, with additional potential to benefit in&#xD;
      individuals who were iron deficient at baseline. Given this limited evidence and with no&#xD;
      studies from Latin America, more studies with diverse populations and locally relevant crops&#xD;
      are warranted before implementation of a potentially important public health intervention.&#xD;
&#xD;
      In order to target at-risk populations in Latin America, the Centro Internacional de&#xD;
      Agricultura Tropical (CIAT) in Colombia bred and biofortified a common black bean variety&#xD;
      (Phaseolus vulgaris L), the standard black bean currently consumed widely in Central America&#xD;
      and Mexico. In Mexico, beans have been ranked highly among the most consumed foods by&#xD;
      school-aged children nationwide, according to Encuesta Nacional de Salud y Nutrición, a&#xD;
      nationally representative nutrition survey in 2006. Biofortification has nearly doubled the&#xD;
      iron concentration (~100 versus ~50 mg/kg) of the standard bean variety. We hypothesized that&#xD;
      daily consumption of iron-biofortified beans (Fe-Beans) would improve hemoglobin, serum&#xD;
      ferritin, and total body iron in 6 months, compared to control beans (Control-Beans). In&#xD;
      order to examine this hypothesis, we conducted the first randomized efficacy trial of&#xD;
      iron-biofortified beans and iron status in primary school-aged children in a low-income&#xD;
      setting in Mexico. Special consideration was applied to assess indicators of iron status with&#xD;
      and without anemia and measured inflammatory markers, which can mask iron deficiency,&#xD;
      particularly in similar settings where the prevalence of infection is high.&#xD;
&#xD;
      The objective of this cluster-randomized efficacy feeding trial was to determine the effects&#xD;
      of consuming iron-biofortified beans (Fe-Beans) on iron status in children, compared to&#xD;
      control beans (Control-Beans).&#xD;
&#xD;
      The long-term goal of this study is to determine if iron bio-fortification of beans is an&#xD;
      efficacious and potentially effective strategy to improve iron status of at-risk populations&#xD;
      in resource-limited settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2010</start_date>
  <completion_date type="Actual">August 15, 2010</completion_date>
  <primary_completion_date type="Actual">June 25, 2010</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The study was a double-blind, cluster-randomized controlled trial (with randomization at the school level) of: (1) iron-biofortified black beans, compared to (2) a commercial variety of beans, with the intervention randomized at the school level. School administrators, children, research staff (i.e. managing the intervention, food weighing, assessment of outcomes), and laboratory staff were blinded to the intervention group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in hemoglobin</measure>
    <time_frame>6 months</time_frame>
    <description>Hemoglobin (Hb)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum ferritin</measure>
    <time_frame>6 months</time_frame>
    <description>Serum ferritin (SF)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in sTfR</measure>
    <time_frame>6 months</time_frame>
    <description>Soluble transferrin receptor (sTfR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anemia</measure>
    <time_frame>6 months</time_frame>
    <description>Hb &lt;115 g/L for &lt;12 y; &lt;120 g/L for &gt;=12 y</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iron deficiency (SF)</measure>
    <time_frame>6 months</time_frame>
    <description>Serum ferritin &lt;15.0 µg/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in TBI</measure>
    <time_frame>6 months</time_frame>
    <description>Total body iron (TBI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron deficiency (TBI)</measure>
    <time_frame>6 months</time_frame>
    <description>TBI &lt;0.0 mg/kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron deficiency (sTfr)</measure>
    <time_frame>6 months</time_frame>
    <description>sTfr &gt;8.3 μg/mL</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">574</enrollment>
  <condition>Iron-deficiency</condition>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Iron-biofortified beans</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Iron-biofortified beans (Phaseolus vulgaris L MIB465)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control beans</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control beans (Phaseolus vulgaris L Jamapa variety)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Iron-biofortified beans</intervention_name>
    <description>Iron-biofortified beans (Phaseolus vulgaris L MIB465)</description>
    <arm_group_label>Iron-biofortified beans</arm_group_label>
    <other_name>Fe-Beans</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control beans</intervention_name>
    <description>Control beans (Phaseolus vulgaris L Jamapa variety), identical in color and size</description>
    <arm_group_label>Control beans</arm_group_label>
    <other_name>Control-Beans</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Boarding schools for children (5-12 y)&#xD;
&#xD;
          -  Located in a rural area approximately 60 kilometers east of the city of Oaxaca&#xD;
&#xD;
          -  A high prevalence of anemia (&gt;=15.0%) on the baseline survey&#xD;
&#xD;
          -  Adequate infrastructure to sustain a 6-month feeding trial. Exclusion criteria were a&#xD;
             prevalence of anemia of less than 15% on the baseline survey, and inadequate&#xD;
             infrastructure to sustain a 6-month feeding trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A prevalence of anemia &lt;15.0% on the baseline survey&#xD;
&#xD;
          -  Inadequate infrastructure to sustain a 6-month feeding trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salvador Villalpando, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Salud Publica (INSP)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Salud Publica (INSP)</name>
      <address>
        <city>Cuernavaca</city>
        <state>Morelos</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Iron</keyword>
  <keyword>Biofortification</keyword>
  <keyword>Iron deficiency</keyword>
  <keyword>Anemia</keyword>
  <keyword>Children</keyword>
  <keyword>Mexico</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>
  <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/NCT03835377
org study id: CI-441
nct id: NCT03835377
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this cluster-randomized efficacy feeding trial was to determine the effects
      of consuming iron-biofortified beans (Fe-Beans) on iron status in children, compared to
      control beans (Control-Beans). A cluster-randomized trial of biofortified beans (Phaseolus
      vulgaris L), bred to enhance iron content, was conducted for 6 months.
Iron deficiency is the most common single nutrient deficiency worldwide, with the highest
      burden in children and women of reproductive age. Global estimates of anemia prevalence in
      school-aged children range between 25% and 46%, and iron deficiency accounts for a majority
      of anemia cases. In Mexico, the national nutrition and health survey (2006) reported a
      prevalence of anemia of 16.6% and iron deficiency of 17.6% (serum ferritin <12.0 µg/L),
      posing a considerable health risk for children.

      Interventions, including micronutrient supplementation and food fortification, have improved
      iron status and reduced the prevalence of anemia in some settings. However, iron deficiency
      remains an urgent public health problem and threat to child health and development. Young
      children are particularly at high risk due to rapid growth, inadequate dietary intake, and
      high risk of infection in resource-limited settings. Iron deficiency has been associated with
      impaired cognitive function in children, and long-term impairments in physical work capacity
      into adulthood.

      One novel approach to reducing micronutrient malnutrition is to enhance the nutrient quality
      of the diet through biofortification of staple crops that are already locally accepted and
      consumed. Biofortification has consequently been recognized by the Copenhagen Consensus of
      2008 as one of the top five solutions to current global health and nutrition challenges. The
      success and challenges of biofortification have been documented previously. We recently
      reviewed the published evidence from the three randomized efficacy trials of different
      iron-biofortified crops that demonstrated varied benefits in populations, including rice in
      adult Filipino women, pearl millet in school-aged children in India, and beans in women of
      reproductive age in Rwanda. Findings demonstrated improvements in serum ferritin
      concentrations and total body iron concentrations, with additional potential to benefit in
      individuals who were iron deficient at baseline. Given this limited evidence and with no
      studies from Latin America, more studies with diverse populations and locally relevant crops
      are warranted before implementation of a potentially important public health intervention.

      In order to target at-risk populations in Latin America, the Centro Internacional de
      Agricultura Tropical (CIAT) in Colombia bred and biofortified a common black bean variety
      (Phaseolus vulgaris L), the standard black bean currently consumed widely in Central America
      and Mexico. In Mexico, beans have been ranked highly among the most consumed foods by
      school-aged children nationwide, according to Encuesta Nacional de Salud y Nutrición, a
      nationally representative nutrition survey in 2006. Biofortification has nearly doubled the
      iron concentration (~100 versus ~50 mg/kg) of the standard bean variety. We hypothesized that
      daily consumption of iron-biofortified beans (Fe-Beans) would improve hemoglobin, serum
      ferritin, and total body iron in 6 months, compared to control beans (Control-Beans). In
      order to examine this hypothesis, we conducted the first randomized efficacy trial of
      iron-biofortified beans and iron status in primary school-aged children in a low-income
      setting in Mexico. Special consideration was applied to assess indicators of iron status with
      and without anemia and measured inflammatory markers, which can mask iron deficiency,
      particularly in similar settings where the prevalence of infection is high.

      The objective of this cluster-randomized efficacy feeding trial was to determine the effects
      of consuming iron-biofortified beans (Fe-Beans) on iron status in children, compared to
      control beans (Control-Beans).

      The long-term goal of this study is to determine if iron bio-fortification of beans is an
      efficacious and potentially effective strategy to improve iron status of at-risk populations
      in resource-limited settings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The study was a double-blind, cluster-randomized controlled trial (with randomization at the school level) of: (1) iron-biofortified black beans, compared to (2) a commercial variety of beans, with the intervention randomized at the school level. School administrators, children, research staff (i.e. managing the intervention, food weighing, assessment of outcomes), and laboratory staff were blinded to the intervention group.
measure: Change in hemoglobin
time frame: 6 months
description: Hemoglobin (Hb)
measure: Change in serum ferritin
time frame: 6 months
description: Serum ferritin (SF)
measure: Change in sTfR
time frame: 6 months
description: Soluble transferrin receptor (sTfR)
measure: Anemia
time frame: 6 months
description: Hb <115 g/L for <12 y; <120 g/L for >=12 y
measure: Iron deficiency (SF)
time frame: 6 months
description: Serum ferritin <15.0 µg/L
measure: Change in TBI
time frame: 6 months
description: Total body iron (TBI)
measure: Iron deficiency (TBI)
time frame: 6 months
description: TBI <0.0 mg/kg
measure: Iron deficiency (sTfr)
time frame: 6 months
description: sTfr >8.3 μg/mL
arm group label: Iron-biofortified beans
arm group type: Experimental
description: Iron-biofortified beans (Phaseolus vulgaris L MIB465)
arm group label: Control beans
arm group type: Active Comparator
description: Control beans (Phaseolus vulgaris L Jamapa variety)
intervention type: Other
intervention name: Iron-biofortified beans
description: Iron-biofortified beans (Phaseolus vulgaris L MIB465)
arm group label: Iron-biofortified beans
other name: Fe-Beans
intervention type: Other
intervention name: Control beans
description: Control beans (Phaseolus vulgaris L Jamapa variety), identical in color and size
arm group label: Control beans
other name: Control-Beans
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Salvador Villalpando, MD PhD
role: Principal Investigator
affiliation: Instituto Nacional de Salud Publica (INSP)
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
sharing ipd: No