<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/NCT01706419</url>
  </required_header>
  <id_info>
    <org_study_id>FORISCA</org_study_id>
    <nct_id>NCT01706419</nct_id>
  </id_info>
  <brief_title>Fortified Rice for School Children in Cambodia</brief_title>
  <acronym>FORISCA</acronym>
  <official_title>Fortified Rice for School Children in Cambodia: Effects on Micronutrient Status, Growth, Cognition and Health.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Recherche pour le Developpement</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Fisheries Post-harvest Technologies and Quality Control</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>World Food Program Cambodia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut de Recherche pour le Developpement</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rice fortification has been shown to be safe and effective in improving micronutrient status&#xD;
      in many studies around the world. However, most studies have been done in Latin America,&#xD;
      Africa and India. There are no studies available from Cambodia. Moreover, there is no data&#xD;
      available on whether fortified rice can reduce the prevalence of anemia in school children in&#xD;
      Cambodia, nor whether there will be additional benefits, such as better learning capability&#xD;
      of school children or fewer days missed due to better health. To inform WFP, Cambodian policy&#xD;
      and the public on the potential benefits of fortified rice on health and development for&#xD;
      Cambodian school children, an intervention study will be conducted in Kampung Speu province&#xD;
      during the 2012 - 2013 school year. The study will be conducted by IRD, PATH and WFP. Sixteen&#xD;
      schools will be selected to receive either the normal rice provided by the WFP school meal&#xD;
      program, or fortified rice instead of normal rice. Three (3) different types of fortified&#xD;
      rice will be tested, to identify the best type of fortified rice. In addition, 4 schools with&#xD;
      no school meal program will be selected to serve as control. School attendance and morbidity&#xD;
      will be followed in all children in the participating schools over the whole school year.&#xD;
      Biochemical indicators of micronutrient status will be determined in a subgroup of children&#xD;
      (25% of the children), which requires collection of blood, urine and stool samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Micronutrient deficiencies are a major health problem in many developing countries, including&#xD;
      Cambodia. Micronutrient deficiency results in poor health, with a much higher risk for&#xD;
      mortality in vulnerable groups such as pregnant women and young infants, and delayed physical&#xD;
      and cognitive development, resulting in retarded growth and stunting. It thereby prevents&#xD;
      children from reaching their full potential as micronutrients play an important role in&#xD;
      children's cognitive and motor development.&#xD;
&#xD;
      The UN World Food Program (WFP) provides a daily school meal to ~500,000 school children in&#xD;
      Cambodia. The main objective of the school meal program is to increase school attendance.&#xD;
      Although the school meal provides salt fortified with iodine, and vegetable oil fortified&#xD;
      with vitamin A, the school meal provides an excellent opportunity to improve micronutrient&#xD;
      status of school children by providing them with rice fortified with vitamins and minerals&#xD;
      such as zinc, vitamin A, iron, folic acid and vitamin B12. This is likely to reduce the&#xD;
      prevalence of anemia in school children and improve health and school performance. Anemia is&#xD;
      a major problem in school children in Cambodia. A recent study by WFP showed that more than&#xD;
      half of the school children were anemic.&#xD;
&#xD;
      Rice fortification has been shown to be safe and effective in improving micronutrient status&#xD;
      in many studies. However, most studies have been done in Latin America, Africa and India.&#xD;
      There are no studies available from Cambodia, except for an acceptability study of fortified&#xD;
      rice conducted by WFP and the Institute of Research for Development (IRD) in 2010 in Kampung&#xD;
      Speu. This acceptability study showed that fortified rice has an excellent acceptability&#xD;
      among school children, parents and teachers. However, there is no data available on whether&#xD;
      fortified rice can reduce the prevalence of anemia in school children in Cambodia, nor&#xD;
      whether there will be additional benefits, such as better learning capability of school&#xD;
      children or fewer days missed due to better health.&#xD;
&#xD;
      To inform WFP, Cambodian policy and the public on the potential benefits of fortified rice on&#xD;
      health and development for Cambodian school children, an intervention study will be conducted&#xD;
      in Kampung Speu province during the 2012 - 2013 school year. The study will be conducted by&#xD;
      IRD, PATH and WFP. Sixteen (16) schools will be selected to receive either the normal rice&#xD;
      provided by the WFP school meal program, or fortified rice instead of normal rice. Three (3)&#xD;
      different types of fortified rice will be tested, to identify the best type of fortified&#xD;
      rice. In addition, 4 schools with no school meal program will be selected to serve as&#xD;
      control. School attendance and morbidity will be followed in all children in the&#xD;
      participating schools over the whole school year. Biochemical indicators of micronutrient&#xD;
      status will be determined in a subgroup of children (25% of the children), which requires&#xD;
      collection of blood, urine and stool samples.&#xD;
&#xD;
      The study will be submitted to the Ethical Committee of the Ministry of Health for approval,&#xD;
      and the Ethical Review Board of PATH, USA. Furthermore, approval will be obtained from the&#xD;
      Ministries of Health, Education and Planning prior to the commencement of the study.&#xD;
&#xD;
      Potential benefits of the study includes the immediate treatment of school children found to&#xD;
      have severe anemia (hemoglobin &lt; 70 g/L) and improved health and cognitive development for&#xD;
      all children receiving fortified rice. Potential disadvantages and risks of the study include&#xD;
      side effects of blood taking in the subgroup of children and the disruption of classes for a&#xD;
      few days during the data collection.&#xD;
&#xD;
      If the results of the study show improved health and cognition for school children receiving&#xD;
      fortified rice, provision of fortified rice to all 500,000 Cambodian school children taking&#xD;
      part in the WFP school meal program in Cambodia could become a priority.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anthropometry</measure>
    <time_frame>6 months</time_frame>
    <description>Weight, height and skinfold thickness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Micronutrient status</measure>
    <time_frame>6 months</time_frame>
    <description>iron, zinc, iodine and vitamin A status using plasma and urine concentrations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognition</measure>
    <time_frame>6 months</time_frame>
    <description>Raven's colored matrices test and WISC III tests</description>
  </primary_outcome>
  <primary_outcome>
    <measure>absentism</measure>
    <time_frame>6 months</time_frame>
    <description>days out of class</description>
  </primary_outcome>
  <primary_outcome>
    <measure>morbidity</measure>
    <time_frame>6 months</time_frame>
    <description>days and number of episodes ill</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parasite infestation</measure>
    <time_frame>6 months</time_frame>
    <description>number of parasite eggs in stools</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gut inflammation</measure>
    <time_frame>6 months</time_frame>
    <description>calprotectin concentrations in stool samples</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">9500</enrollment>
  <condition>Micronutrient Status</condition>
  <arm_group>
    <arm_group_label>no school meal</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group receiving no school meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal school meal</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>school meal without fortified rice, placebo group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cold extruded fortified rice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>school meal with fortified rice using cold extrusion kernels</description>
  </arm_group>
  <arm_group>
    <arm_group_label>warm extrusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>school meal with fortified rice using warm extrusion kernels</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hot extruded</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>school meal with fortified rice using hot extrusion kernels</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fortified rice cold extruded kernel</intervention_name>
    <arm_group_label>cold extruded fortified rice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>fortified rice warm extruded kernel</intervention_name>
    <arm_group_label>warm extrusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>fortiified rice hot extruded kernel</intervention_name>
    <arm_group_label>hot extruded</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed informed consent by parent / caretaker&#xD;
&#xD;
          -  age between 6 and 14 yrs&#xD;
&#xD;
          -  visiting selected school&#xD;
&#xD;
          -  taking part in school meal program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any chronic illness affecting growth (such as HIV)&#xD;
&#xD;
          -  no informed consent&#xD;
&#xD;
          -  severe anemia which will require direct treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank T Wieringa, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Recherche pour le Developpement</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration</name>
      <address>
        <city>Phnom Penh</city>
        <country>Cambodia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cambodia</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>December 16, 2014</last_update_submitted>
  <last_update_submitted_qc>December 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut de Recherche pour le Developpement</investigator_affiliation>
    <investigator_full_name>Frank Wieringa</investigator_full_name>
    <investigator_title>Senior Researcher</investigator_title>
  </responsible_party>
  <keyword>vitamin A</keyword>
  <keyword>iron</keyword>
  <keyword>zinc</keyword>
  <keyword>school children</keyword>
  <keyword>fortified rice</keyword>
  <keyword>morbidity</keyword>
  <keyword>growth</keyword>
  <!-- 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/NCT01706419
org study id: FORISCA
nct id: NCT01706419
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Rice fortification has been shown to be safe and effective in improving micronutrient status
      in many studies around the world. However, most studies have been done in Latin America,
      Africa and India. There are no studies available from Cambodia. Moreover, there is no data
      available on whether fortified rice can reduce the prevalence of anemia in school children in
      Cambodia, nor whether there will be additional benefits, such as better learning capability
      of school children or fewer days missed due to better health. To inform WFP, Cambodian policy
      and the public on the potential benefits of fortified rice on health and development for
      Cambodian school children, an intervention study will be conducted in Kampung Speu province
      during the 2012 - 2013 school year. The study will be conducted by IRD, PATH and WFP. Sixteen
      schools will be selected to receive either the normal rice provided by the WFP school meal
      program, or fortified rice instead of normal rice. Three (3) different types of fortified
      rice will be tested, to identify the best type of fortified rice. In addition, 4 schools with
      no school meal program will be selected to serve as control. School attendance and morbidity
      will be followed in all children in the participating schools over the whole school year.
      Biochemical indicators of micronutrient status will be determined in a subgroup of children
      (25% of the children), which requires collection of blood, urine and stool samples.
Micronutrient deficiencies are a major health problem in many developing countries, including
      Cambodia. Micronutrient deficiency results in poor health, with a much higher risk for
      mortality in vulnerable groups such as pregnant women and young infants, and delayed physical
      and cognitive development, resulting in retarded growth and stunting. It thereby prevents
      children from reaching their full potential as micronutrients play an important role in
      children's cognitive and motor development.

      The UN World Food Program (WFP) provides a daily school meal to ~500,000 school children in
      Cambodia. The main objective of the school meal program is to increase school attendance.
      Although the school meal provides salt fortified with iodine, and vegetable oil fortified
      with vitamin A, the school meal provides an excellent opportunity to improve micronutrient
      status of school children by providing them with rice fortified with vitamins and minerals
      such as zinc, vitamin A, iron, folic acid and vitamin B12. This is likely to reduce the
      prevalence of anemia in school children and improve health and school performance. Anemia is
      a major problem in school children in Cambodia. A recent study by WFP showed that more than
      half of the school children were anemic.

      Rice fortification has been shown to be safe and effective in improving micronutrient status
      in many studies. However, most studies have been done in Latin America, Africa and India.
      There are no studies available from Cambodia, except for an acceptability study of fortified
      rice conducted by WFP and the Institute of Research for Development (IRD) in 2010 in Kampung
      Speu. This acceptability study showed that fortified rice has an excellent acceptability
      among school children, parents and teachers. However, there is no data available on whether
      fortified rice can reduce the prevalence of anemia in school children in Cambodia, nor
      whether there will be additional benefits, such as better learning capability of school
      children or fewer days missed due to better health.

      To inform WFP, Cambodian policy and the public on the potential benefits of fortified rice on
      health and development for Cambodian school children, an intervention study will be conducted
      in Kampung Speu province during the 2012 - 2013 school year. The study will be conducted by
      IRD, PATH and WFP. Sixteen (16) schools will be selected to receive either the normal rice
      provided by the WFP school meal program, or fortified rice instead of normal rice. Three (3)
      different types of fortified rice will be tested, to identify the best type of fortified
      rice. In addition, 4 schools with no school meal program will be selected to serve as
      control. School attendance and morbidity will be followed in all children in the
      participating schools over the whole school year. Biochemical indicators of micronutrient
      status will be determined in a subgroup of children (25% of the children), which requires
      collection of blood, urine and stool samples.

      The study will be submitted to the Ethical Committee of the Ministry of Health for approval,
      and the Ethical Review Board of PATH, USA. Furthermore, approval will be obtained from the
      Ministries of Health, Education and Planning prior to the commencement of the study.

      Potential benefits of the study includes the immediate treatment of school children found to
      have severe anemia (hemoglobin < 70 g/L) and improved health and cognitive development for
      all children receiving fortified rice. Potential disadvantages and risks of the study include
      side effects of blood taking in the subgroup of children and the disruption of classes for a
      few days during the data collection.

      If the results of the study show improved health and cognition for school children receiving
      fortified rice, provision of fortified rice to all 500,000 Cambodian school children taking
      part in the WFP school meal program in Cambodia could become a priority.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Anthropometry
time frame: 6 months
description: Weight, height and skinfold thickness
measure: Micronutrient status
time frame: 6 months
description: iron, zinc, iodine and vitamin A status using plasma and urine concentrations
measure: Cognition
time frame: 6 months
description: Raven's colored matrices test and WISC III tests
measure: absentism
time frame: 6 months
description: days out of class
measure: morbidity
time frame: 6 months
description: days and number of episodes ill
measure: Parasite infestation
time frame: 6 months
description: number of parasite eggs in stools
measure: gut inflammation
time frame: 6 months
description: calprotectin concentrations in stool samples
arm group label: no school meal
arm group type: No Intervention
description: control group receiving no school meal
arm group label: normal school meal
arm group type: Placebo Comparator
description: school meal without fortified rice, placebo group
arm group label: cold extruded fortified rice
arm group type: Experimental
description: school meal with fortified rice using cold extrusion kernels
arm group label: warm extrusion
arm group type: Experimental
description: school meal with fortified rice using warm extrusion kernels
arm group label: hot extruded
arm group type: Experimental
description: school meal with fortified rice using hot extrusion kernels
intervention type: Dietary Supplement
intervention name: Fortified rice cold extruded kernel
arm group label: cold extruded fortified rice
intervention type: Dietary Supplement
intervention name: fortified rice warm extruded kernel
arm group label: warm extrusion
intervention type: Dietary Supplement
intervention name: fortiified rice hot extruded kernel
arm group label: hot extruded
criteria: 
gender: All
minimum age: 6 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frank T Wieringa, MD PhD
role: Principal Investigator
affiliation: Institut de Recherche pour le Developpement
facility: 
country: Cambodia
responsible party type: Principal Investigator
investigator affiliation: Institut de Recherche pour le Developpement
investigator full name: Frank Wieringa
investigator title: Senior Researcher