<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/NCT03754998</url>
  </required_header>
  <id_info>
    <org_study_id>WSong</org_study_id>
    <nct_id>NCT03754998</nct_id>
  </id_info>
  <brief_title>Community Interventions to Improve Iron and Iodine Status in Mother and Child Dyads in Northern Ghana</brief_title>
  <official_title>Community Interventions to Improve Iron and Iodine Status in Mother and Child Dyads in Northern Ghana</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michigan State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Michigan State University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND Ghana has reduced food insecurity prevalence by 49.2% in two decades. However,&#xD;
      prevalence of malnutrition especially stunting (in &lt;children5yr) has not matched the changes&#xD;
      in food security levels. Of several key nutritional factors that lead to stunting,&#xD;
      nutritional status of such trace minerals as iodine, iron and zinc has not been studied.&#xD;
      Nutritional inadequacy of these trace minerals may be detected by estimation of dietary&#xD;
      intake, and time-consuming and costly biochemical measurements of respective biomarkers.&#xD;
      Since there is no means to estimate dietary intake of the trace minerals in Ghana, due to&#xD;
      incomplete food composition data of the nutrients, identifying validated non-invasive,&#xD;
      dietary approaches to predict the biomarker status of these trace minerals are critical in&#xD;
      counteracting the challenges surrounding the persistent stunting due to micronutrient&#xD;
      deficiencies in Ghana. Additionally, exploring alternative approaches to providing access to&#xD;
      foods rich in trace minerals at household level is crucial.&#xD;
&#xD;
      STUDY AIMS AND HYPOTHESIS The ultimate goal of this research is to increase knowledge base on&#xD;
      improving trace mineral status in mother-child (6-23 mo) dyads through a sustainable&#xD;
      community-based interventions in northern Ghana. Investigators will begin with iron and&#xD;
      iodine that impair mothers and young children's growth and cognitive development most with&#xD;
      three aims: 1) to develop dietary screening tools that are validated by biomarkers for early&#xD;
      detection of deficiencies, 2) to determine efficacy (dose responses) of feeding indigenous&#xD;
      nutrient-rich meals in preventing deficiencies and improving iron and iodine status, and 3)&#xD;
      to demonstrate sustainable and scalable improvement of food systems through a container&#xD;
      gardening project for iron-rich Hibiscus sabdarifa for consumption and income by empowering&#xD;
      women during the dry/lean season in northern Ghana.&#xD;
&#xD;
      • Aims 1: To develop dietary screening tools that are validated by biomarkers for early&#xD;
      detection of deficiencies among children 6-23 months and their mothers H1.1: Dietary&#xD;
      diversity score can predict iron deficiency among children 6-23 months and their mothers.&#xD;
&#xD;
      H1.2: Dietary diversity score can predict iodine status deficiency among children 6-23 months&#xD;
      and their mothers.&#xD;
&#xD;
        -  Aims 2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron and iodine&#xD;
           status of dyads H2.1: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron&#xD;
           status of dyads H2.2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves&#xD;
           iodine status of dyads&#xD;
&#xD;
        -  Aims 3: to demonstrate that container gardening can provide sustainable and scalable&#xD;
           improvement of food systems for iron-rich Hibiscus sabdarifa for consumption and income&#xD;
           during the dry/lean season in northern Ghana H3.1: Container gardening can provide&#xD;
           adequate amounts of vegetables for mother and child dyad during the dry season H3.2:&#xD;
           Container gardening can provide adequate income to purchase iodized salt and Amani for&#xD;
           mother and child dyad during the dry season&#xD;
&#xD;
      SIGNIFICANCE This project addresses the gap in our knowledge and practices pertaining to&#xD;
      serious and persisting trace mineral deficiencies that result in stunting and cognitive&#xD;
      impairment in northern Ghana. Early detection of iron and iodine deficiencies with validated&#xD;
      non-invasive dietary screening tools (aim 1), effective indigenous nutrient-rich meal-based&#xD;
      programs (aim 2) and sustainable/scalable and women-led community-based food-system changing&#xD;
      agricultural project (aim 3) are expected to be the most creative approach to counteract iron&#xD;
      and iodine deficiencies in northern Ghana. This project will utilize science and education to&#xD;
      change practices, environments and policies to reduce the prevalence of trace mineral&#xD;
      deficiencies at the local, regional, national and global levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2017</start_date>
  <completion_date type="Actual">September 29, 2017</completion_date>
  <primary_completion_date type="Actual">September 8, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Quasi experimental</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Iron Deficiency (ID)</measure>
    <time_frame>12 weeks</time_frame>
    <description>ID measured using serum transferrin receptor (Stfr). Cut off for ID (women - stfr&gt;4.40ug/l, children - stfr&gt;2.85ug/l).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General Anemia</measure>
    <time_frame>12 weeks</time_frame>
    <description>General anemia measured using hemoglobin levels (Hb). Cut off for General anemia (women - Hb&lt;12g/dl, children - Hb&lt;11g/dl)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iron Deficiency Anemia (IDA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>IDA is measured by concurrent presence of general anemia (women - Hb&lt;12g/dl, children - Hb&lt;11g/dl) and ID (women-stfr&gt;4.40ug/l, children - stfr&gt;2.85ug/l).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iodine status of participants</measure>
    <time_frame>12 weeks</time_frame>
    <description>Iodine status will be measured by urinary iodine concentration (ug/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hibiscus Sabdariffa produced/harvested from container gardening</measure>
    <time_frame>15 weeks</time_frame>
    <description>Quantity of Hibiscus Sabdariffa leaves (kg) per container</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Income generated form container gardening</measure>
    <time_frame>15 weeks</time_frame>
    <description>Income (cedis) generated from cabbage produced per container</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">239</enrollment>
  <condition>Iron Deficiency (ID)</condition>
  <condition>General Anemia</condition>
  <condition>Iron Deficiency Anemia (IDA)</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participating dyads in intervention communities were invited to consume veo soup/meal (HSM) three times a week and provided weekly supply of iodized salt (450 g) for the household usage as well as being engaged in dry season container gardening. The veo soup/meal is a local Ghanaian soup/meal mainly made of Hibiscus Sabdarifa leaves. It is a soup when prepared a bit watery and consumed with 'tou zaafi' (millet or corn based cooked paste). It is also a meal when prepared thick and eaten by itself. The Hibiscus Sabdariffa leaves meal (HSM) used in the present study was made of 18 kg Hibiscus Sabdariffa leaves, 8 kg groundnut, 1.1 kg dawadawa (fermented African locust beans), 3 kg dried fish plus 0.045 kg iodized salt, cooked with about 23 L (23 kg) water to yield 52.5 kg HSM. In each community, groups of ten women took turns to share the cooking activities, washing of bowls, and making water available for cooking. No treatment provided in our control communities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention Group</intervention_name>
    <description>The participating dyads in intervention communities were invited to consume veo soup/meal (HSM) three times a week and provided weekly supply of iodized salt (450 g) for the household usage as well as being engaged in dry season container gardening. The veo soup/meal is a local Ghanaian soup/meal mainly made of Hibiscus Sabdarifa leaves. It is a soup when prepared a bit watery and consumed with 'tou zaafi' (millet or corn based cooked paste). It is also a meal when prepared thick and eaten by itself. The Hibiscus Sabdariffa leaves meal (HSM) used in the present study was made of 18 kg Hibiscus Sabdariffa leaves, 8 kg groundnut, 1.1 kg dawadawa (fermented African locust beans), 3 kg dried fish plus 0.045 kg iodized salt, cooked with about 23 L (23 kg) water to yield 52.5 kg HSM. In each community, groups of ten women took turns to share the cooking activities, washing of bowls, and making water available for cooking. No treatment provided in our control communities.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be a woman (15-49 y) and having a child (6 - 23 months)&#xD;
&#xD;
          -  Live in research settings for the entire research duration (May 2016 - September 2017)&#xD;
&#xD;
          -  Live in selected communities in the Kassena Nankana West and Builsa North Districts of&#xD;
             the Upper East Region of Ghana&#xD;
&#xD;
          -  Selected districts should be among the top five food insecure districts&#xD;
&#xD;
          -  Households in selected communities should have access to water throughout the dry&#xD;
             season without shortages&#xD;
&#xD;
          -  Selected communities should have sizeable number of children (6 - 23 months old) for a&#xD;
             good sampling frame&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Not meeting the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clement Professor Won Song</last_name>
    <role>Study Chair</role>
    <affiliation>Michigan State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Clement Kubuga</last_name>
    <role>Principal Investigator</role>
    <affiliation>University for Development Studies - Ghana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Builsa North and Kessena Nankana West Districts</name>
      <address>
        <city>Bolgatanga</city>
        <state>Upper East Region</state>
        <zip>00233</zip>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 23, 2018</last_update_submitted>
  <last_update_submitted_qc>November 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Michigan State University</investigator_affiliation>
    <investigator_full_name>Won O. Song</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_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/NCT03754998
org study id: WSong
nct id: NCT03754998
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
BACKGROUND Ghana has reduced food insecurity prevalence by 49.2% in two decades. However,
      prevalence of malnutrition especially stunting (in <children5yr) has not matched the changes
      in food security levels. Of several key nutritional factors that lead to stunting,
      nutritional status of such trace minerals as iodine, iron and zinc has not been studied.
      Nutritional inadequacy of these trace minerals may be detected by estimation of dietary
      intake, and time-consuming and costly biochemical measurements of respective biomarkers.
      Since there is no means to estimate dietary intake of the trace minerals in Ghana, due to
      incomplete food composition data of the nutrients, identifying validated non-invasive,
      dietary approaches to predict the biomarker status of these trace minerals are critical in
      counteracting the challenges surrounding the persistent stunting due to micronutrient
      deficiencies in Ghana. Additionally, exploring alternative approaches to providing access to
      foods rich in trace minerals at household level is crucial.

      STUDY AIMS AND HYPOTHESIS The ultimate goal of this research is to increase knowledge base on
      improving trace mineral status in mother-child (6-23 mo) dyads through a sustainable
      community-based interventions in northern Ghana. Investigators will begin with iron and
      iodine that impair mothers and young children's growth and cognitive development most with
      three aims: 1) to develop dietary screening tools that are validated by biomarkers for early
      detection of deficiencies, 2) to determine efficacy (dose responses) of feeding indigenous
      nutrient-rich meals in preventing deficiencies and improving iron and iodine status, and 3)
      to demonstrate sustainable and scalable improvement of food systems through a container
      gardening project for iron-rich Hibiscus sabdarifa for consumption and income by empowering
      women during the dry/lean season in northern Ghana.

      • Aims 1: To develop dietary screening tools that are validated by biomarkers for early
      detection of deficiencies among children 6-23 months and their mothers H1.1: Dietary
      diversity score can predict iron deficiency among children 6-23 months and their mothers.

      H1.2: Dietary diversity score can predict iodine status deficiency among children 6-23 months
      and their mothers.

        -  Aims 2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron and iodine
           status of dyads H2.1: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron
           status of dyads H2.2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves
           iodine status of dyads

        -  Aims 3: to demonstrate that container gardening can provide sustainable and scalable
           improvement of food systems for iron-rich Hibiscus sabdarifa for consumption and income
           during the dry/lean season in northern Ghana H3.1: Container gardening can provide
           adequate amounts of vegetables for mother and child dyad during the dry season H3.2:
           Container gardening can provide adequate income to purchase iodized salt and Amani for
           mother and child dyad during the dry season

      SIGNIFICANCE This project addresses the gap in our knowledge and practices pertaining to
      serious and persisting trace mineral deficiencies that result in stunting and cognitive
      impairment in northern Ghana. Early detection of iron and iodine deficiencies with validated
      non-invasive dietary screening tools (aim 1), effective indigenous nutrient-rich meal-based
      programs (aim 2) and sustainable/scalable and women-led community-based food-system changing
      agricultural project (aim 3) are expected to be the most creative approach to counteract iron
      and iodine deficiencies in northern Ghana. This project will utilize science and education to
      change practices, environments and policies to reduce the prevalence of trace mineral
      deficiencies at the local, regional, national and global levels.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Quasi experimental
primary purpose: Prevention
masking: None (Open Label)
measure: Iron Deficiency (ID)
time frame: 12 weeks
description: ID measured using serum transferrin receptor (Stfr). Cut off for ID (women - stfr>4.40ug/l, children - stfr>2.85ug/l).
measure: General Anemia
time frame: 12 weeks
description: General anemia measured using hemoglobin levels (Hb). Cut off for General anemia (women - Hb<12g/dl, children - Hb<11g/dl)
measure: Iron Deficiency Anemia (IDA)
time frame: 12 weeks
description: IDA is measured by concurrent presence of general anemia (women - Hb<12g/dl, children - Hb<11g/dl) and ID (women-stfr>4.40ug/l, children - stfr>2.85ug/l).
measure: Iodine status of participants
time frame: 12 weeks
description: Iodine status will be measured by urinary iodine concentration (ug/l)
measure: Hibiscus Sabdariffa produced/harvested from container gardening
time frame: 15 weeks
description: Quantity of Hibiscus Sabdariffa leaves (kg) per container
measure: Income generated form container gardening
time frame: 15 weeks
description: Income (cedis) generated from cabbage produced per container
arm group label: Intervention Group
arm group type: Experimental
description: The participating dyads in intervention communities were invited to consume veo soup/meal (HSM) three times a week and provided weekly supply of iodized salt (450 g) for the household usage as well as being engaged in dry season container gardening. The veo soup/meal is a local Ghanaian soup/meal mainly made of Hibiscus Sabdarifa leaves. It is a soup when prepared a bit watery and consumed with 'tou zaafi' (millet or corn based cooked paste). It is also a meal when prepared thick and eaten by itself. The Hibiscus Sabdariffa leaves meal (HSM) used in the present study was made of 18 kg Hibiscus Sabdariffa leaves, 8 kg groundnut, 1.1 kg dawadawa (fermented African locust beans), 3 kg dried fish plus 0.045 kg iodized salt, cooked with about 23 L (23 kg) water to yield 52.5 kg HSM. In each community, groups of ten women took turns to share the cooking activities, washing of bowls, and making water available for cooking. No treatment provided in our control communities.
intervention type: Behavioral
intervention name: Intervention Group
description: The participating dyads in intervention communities were invited to consume veo soup/meal (HSM) three times a week and provided weekly supply of iodized salt (450 g) for the household usage as well as being engaged in dry season container gardening. The veo soup/meal is a local Ghanaian soup/meal mainly made of Hibiscus Sabdarifa leaves. It is a soup when prepared a bit watery and consumed with 'tou zaafi' (millet or corn based cooked paste). It is also a meal when prepared thick and eaten by itself. The Hibiscus Sabdariffa leaves meal (HSM) used in the present study was made of 18 kg Hibiscus Sabdariffa leaves, 8 kg groundnut, 1.1 kg dawadawa (fermented African locust beans), 3 kg dried fish plus 0.045 kg iodized salt, cooked with about 23 L (23 kg) water to yield 52.5 kg HSM. In each community, groups of ten women took turns to share the cooking activities, washing of bowls, and making water available for cooking. No treatment provided in our control communities.
arm group label: Intervention Group
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clement Professor Won Song
role: Study Chair
affiliation: Michigan State University
last name: Clement Kubuga
role: Principal Investigator
affiliation: University for Development Studies - Ghana
facility: 
country: Ghana
responsible party type: Principal Investigator
investigator affiliation: Michigan State University
investigator full name: Won O. Song
investigator title: Professor
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies