<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/NCT02196337</url>
  </required_header>
  <id_info>
    <org_study_id>EK 2013-N-82</org_study_id>
    <nct_id>NCT02196337</nct_id>
  </id_info>
  <brief_title>Salt Iodization: Meeting the Needs of Pregnancy, Lactation and Infancy</brief_title>
  <acronym>SIMPLIFY</acronym>
  <official_title>Salt Iodization and the 1st 1000 Days: Does a USI Program Cover the Iodine Requirement of Pregnant and Lactating Women and Infants?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Zagreb</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Luke's Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Global Alliance for Improved Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UNICEF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanxi Institute for Prevention and Treatment of Endemic Disease</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swiss Federal Institute of Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether universal salt iodization (USI) meets the&#xD;
      iodine requirements of pregnant women, lactating women and infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Because pregnant women, lactating women and infants are the groups most vulnerable to iodine&#xD;
      deficiency and its irreversible consequences, programs should focus on these groups. But like&#xD;
      other mass fortification strategies, it is uncertain whether USI can meet the increased&#xD;
      dietary requirements of pregnant women, lactating women and infants. Objective of this study&#xD;
      to test whether USI can meet the dietary requirements of iodine in women of reproductive age,&#xD;
      pregnant women, lactating women and infants up to 2 years of age without causing excess&#xD;
      iodine intake in school children and non-pregnant non-lactating women. The study hypothesis&#xD;
      is that USI, when fortified at adequate levels and applied to all salt consumed, including&#xD;
      both household salt and salt used for processed foods, provides adequate dietary iodine for&#xD;
      all population groups, except for weaning infants; while not posing any risk of excessive&#xD;
      iodine intakes in other age groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary iodine concentration (µg/L)</measure>
    <time_frame>1 day</time_frame>
    <description>Participants will be assessed only once. However, for 30% of the study participants urinary iodine concentration will be assessed in spot samples collected on two different days, spread over an expected average of 5 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thyroglobulin (µg/L)</measure>
    <time_frame>1 day</time_frame>
    <description>Thyroglobulin will be measured in all population groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast milk iodine concentration (µg/L)</measure>
    <time_frame>1 day</time_frame>
    <description>Breast milk iodine concentration will be measured in lactating women.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Thyroid function (TSH, T4)</measure>
    <time_frame>1 day</time_frame>
    <description>Thyroid function (TSH, T4) will be measured where relevant.</description>
  </other_outcome>
  <other_outcome>
    <measure>Urinary sodium excretion (mg/day)</measure>
    <time_frame>1 day</time_frame>
    <description>Urinary sodium excretion will be assessed in school age children and women of reproductive age. Participants will be assessed only once. However, for urinary sodium excretion 30% of the study participants will be assessed in spot samples collected on two different days, spread over an expected average of 5 days</description>
  </other_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Actual">8000</enrollment>
  <condition>Iodine Deficiency</condition>
  <arm_group>
    <arm_group_label>Women of reproductive age</arm_group_label>
    <description>Age: 18-44 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
    <description>Age: 18-44 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lactating women</arm_group_label>
    <description>Age: 18-44 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Young infants</arm_group_label>
    <description>Age: younger than 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Toddlers</arm_group_label>
    <description>Age: between 6 and 24 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>School-aged children</arm_group_label>
    <description>Age: 6-12 years</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine, dried blood spots, breast milk&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        In each of the four study countries, six population groups will be studied:&#xD;
&#xD;
          -  women of reproductive age&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  lactating women&#xD;
&#xD;
          -  young infants&#xD;
&#xD;
          -  toddlers&#xD;
&#xD;
          -  school-aged children&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  living at study area for at least 6 months&#xD;
&#xD;
          -  generally healthy&#xD;
&#xD;
          -  no chronic medication&#xD;
&#xD;
          -  no history of thyroid disease in the family&#xD;
&#xD;
          -  no use of iodine containing dietary supplements during the last 6 months&#xD;
&#xD;
          -  no use of iodine containing disinfectants for the last 6 months&#xD;
&#xD;
          -  no use of X-ray / CT contrast agent or iodine containing medication within the last&#xD;
             year&#xD;
&#xD;
          -  in addition for women of reproductive age, pregnant women and breastfeeding women: age&#xD;
             between 18 and 44 years old&#xD;
&#xD;
          -  in addition for pregnant women: healthy pregnancy, singleton pregnancy (no twins or&#xD;
             multiple pregnancy)&#xD;
&#xD;
          -  in addition for breastfeeding women and breastfed infants: healthy pregnancy,&#xD;
             singleton pregnancy (no twins or multiple pregnancy), baby born at full-term (in&#xD;
             pregnancy week 38 to 42), the baby had normal birth weight (≥ 2500 g), baby not older&#xD;
             than 6 months, baby currently completely breastfed (except for water, tea and juices)&#xD;
&#xD;
          -  in addition for toddlers: between 6 and 24 months old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Weeks</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Andersson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ETH Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanxi Institute for Prevention and Treatment of Endemic Disease</name>
      <address>
        <city>Linfen</city>
        <state>Shanxi</state>
        <zip>041000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Santo Tomas Hospital</name>
      <address>
        <city>Manila</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ETH Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8092</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Croatia</country>
    <country>Philippines</country>
    <country>Switzerland</country>
  </location_countries>
  <removed_countries>
    <country>Ghana</country>
  </removed_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>June 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>April 18, 2016</last_update_submitted>
  <last_update_submitted_qc>April 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Swiss Federal Institute of Technology</investigator_affiliation>
    <investigator_full_name>Maria Andersson</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Iodine deficiency</keyword>
  <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/NCT02196337
org study id: EK 2013-N-82
nct id: NCT02196337
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether universal salt iodization (USI) meets the
      iodine requirements of pregnant women, lactating women and infants.
Because pregnant women, lactating women and infants are the groups most vulnerable to iodine
      deficiency and its irreversible consequences, programs should focus on these groups. But like
      other mass fortification strategies, it is uncertain whether USI can meet the increased
      dietary requirements of pregnant women, lactating women and infants. Objective of this study
      to test whether USI can meet the dietary requirements of iodine in women of reproductive age,
      pregnant women, lactating women and infants up to 2 years of age without causing excess
      iodine intake in school children and non-pregnant non-lactating women. The study hypothesis
      is that USI, when fortified at adequate levels and applied to all salt consumed, including
      both household salt and salt used for processed foods, provides adequate dietary iodine for
      all population groups, except for weaning infants; while not posing any risk of excessive
      iodine intakes in other age groups.
time perspective: Cross-Sectional
measure: Urinary iodine concentration (µg/L)
time frame: 1 day
description: Participants will be assessed only once. However, for 30% of the study participants urinary iodine concentration will be assessed in spot samples collected on two different days, spread over an expected average of 5 days.
measure: Thyroglobulin (µg/L)
time frame: 1 day
description: Thyroglobulin will be measured in all population groups
measure: Breast milk iodine concentration (µg/L)
time frame: 1 day
description: Breast milk iodine concentration will be measured in lactating women.
measure: Thyroid function (TSH, T4)
time frame: 1 day
description: Thyroid function (TSH, T4) will be measured where relevant.
measure: Urinary sodium excretion (mg/day)
time frame: 1 day
description: Urinary sodium excretion will be assessed in school age children and women of reproductive age. Participants will be assessed only once. However, for urinary sodium excretion 30% of the study participants will be assessed in spot samples collected on two different days, spread over an expected average of 5 days
arm group label: Women of reproductive age
description: Age: 18-44 years
arm group label: Pregnant women
description: Age: 18-44 years
arm group label: Lactating women
description: Age: 18-44 years
arm group label: Young infants
description: Age: younger than 6 months
arm group label: Toddlers
description: Age: between 6 and 24 months
arm group label: School-aged children
description: Age: 6-12 years
Urine, dried blood spots, breast milk
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Weeks
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Andersson, PhD
role: Principal Investigator
affiliation: ETH Zurich
facility: 
facility: 
facility: 
facility: 
country: China
country: Croatia
country: Philippines
country: Switzerland
country: Ghana
responsible party type: Principal Investigator
investigator affiliation: Swiss Federal Institute of Technology
investigator full name: Maria Andersson
investigator title: PhD
sharing ipd: No