<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/NCT04404751</url>
  </required_header>
  <id_info>
    <org_study_id>Salt_HGHRC#01</org_study_id>
    <nct_id>NCT04404751</nct_id>
  </id_info>
  <brief_title>Quadruple Fortified Salt Clinical Trial</brief_title>
  <official_title>Effectiveness of Quadruple Fortified Salt in Improving Hemoglobin Levels Among Anemic Women of Reproductive Age (18-49 Years) in Rural Low Resource Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haydom Lutheran Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tanzania Food and Drugs Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Haydom Lutheran Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anaemia is the world leading cause of disability and is responsible for about more than&#xD;
      115,000 maternal deaths and 591,000 perinatal deaths per year, of which 3/4 occur in Africa&#xD;
      and Asia. Despite the fact that there are several causes of anemia, the most important causes&#xD;
      are due to micronutrients deficiency, namely iron, Folic acid and Vitamin B12. Low intakes of&#xD;
      these micronutrients consequently affect a woman's health, pregnancy outcome and the&#xD;
      nutritional status of breast-fed children. With these in mind we wish to test the&#xD;
      effectiveness of salt fortified with these four micronutrients (Iodine, Iron, Folic acid and&#xD;
      vitamin B12) in raising the Hemoglobin levels among the non-pregnant and non-lactating women&#xD;
      of reproductive age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anaemia is the low level of Haemoglobin based on the location. As per WHO a woman is termed&#xD;
      anaemic if has HB &lt;11g/dl but in high attitude is =&lt;13g/dl&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Haemoglobin level</measure>
    <time_frame>10 months of consuming fortified salt</time_frame>
    <description>After 10months use of quadruple fortified salt we expect the HB to rise by at least 50% as compared to those who used iodised salt</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Iron store replenishment</measure>
    <time_frame>10months of intervention</time_frame>
    <description>The quadruple fortified salt is expected to replenish the iron store 100% after 10 months use of QFS</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">174</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Iodised salt with Iron, Folic acid and Vitamin B12</intervention_name>
    <description>Fortified salt with either Iron and Iodine only or Fortified salt with Iodine, iron, Folic acid and Vitamin B12 compared with standard Iodized salt</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
    <other_name>Iodised salt with Iron</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult with relative low haemoglobin (Hb level 8g/dl to 13g/dl)&#xD;
&#xD;
          -  Able to eat food cooked with salt&#xD;
&#xD;
          -  Able to give consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planning to become pregnant within the study period,&#xD;
&#xD;
          -  chronically ill,&#xD;
&#xD;
          -  have haematological diseases during study time,&#xD;
&#xD;
          -  restricted to use salt in food&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Haydom Lutheran Hospital</name>
      <address>
        <city>Manyara</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 3, 2019</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>February 21, 2021</last_update_submitted>
  <last_update_submitted_qc>February 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2021</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>Folic Acid</mesh_term>
    <mesh_term>Vitamin B 12</mesh_term>
    <mesh_term>Hydroxocobalamin</mesh_term>
    <mesh_term>Iron</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/NCT04404751
org study id: Salt_HGHRC#01
nct id: NCT04404751
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Anaemia is the world leading cause of disability and is responsible for about more than
      115,000 maternal deaths and 591,000 perinatal deaths per year, of which 3/4 occur in Africa
      and Asia. Despite the fact that there are several causes of anemia, the most important causes
      are due to micronutrients deficiency, namely iron, Folic acid and Vitamin B12. Low intakes of
      these micronutrients consequently affect a woman's health, pregnancy outcome and the
      nutritional status of breast-fed children. With these in mind we wish to test the
      effectiveness of salt fortified with these four micronutrients (Iodine, Iron, Folic acid and
      vitamin B12) in raising the Hemoglobin levels among the non-pregnant and non-lactating women
      of reproductive age.
Anaemia is the low level of Haemoglobin based on the location. As per WHO a woman is termed
      anaemic if has HB <11g/dl but in high attitude is =<13g/dl
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Haemoglobin level
time frame: 10 months of consuming fortified salt
description: After 10months use of quadruple fortified salt we expect the HB to rise by at least 50% as compared to those who used iodised salt
measure: Iron store replenishment
time frame: 10months of intervention
description: The quadruple fortified salt is expected to replenish the iron store 100% after 10 months use of QFS
arm group label: Arm 1
arm group type: Active Comparator
arm group label: Arm 2
arm group type: Active Comparator
arm group label: Arm 3
arm group type: Sham Comparator
intervention type: Combination Product
intervention name: Iodised salt with Iron, Folic acid and Vitamin B12
description: Fortified salt with either Iron and Iodine only or Fortified salt with Iodine, iron, Folic acid and Vitamin B12 compared with standard Iodized salt
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
other name: Iodised salt with Iron
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: No
facility: 
country: Tanzania
responsible party type: Sponsor
mesh term: Folic Acid
mesh term: Vitamin B 12
mesh term: Hydroxocobalamin
mesh term: Iron