<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/NCT03819530</url>
  </required_header>
  <id_info>
    <org_study_id>20181056741</org_study_id>
    <nct_id>NCT03819530</nct_id>
  </id_info>
  <brief_title>Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study</brief_title>
  <acronym>CUPIP</acronym>
  <official_title>A Pilot Study of Micronutrient Supplementation for Child of Urban Poverty Iron Project in Selangor, Malaysia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</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 first 1,000 days of life are critical periods for brain development. Proper nutrition&#xD;
      lays the foundation for optimal growth, health, and neurodevelopment across the lifespan.&#xD;
      Poor nutrition in this vulnerable period has irreversible consequences, including stunting,&#xD;
      susceptibility to sickness, reduced school performance and productivity, and impaired&#xD;
      intellectual and social development. UNICEF reported in 2018 that among the low cost flat&#xD;
      residents in urban areas of the Klang Valley, 15% of children under 5 years old were stunted,&#xD;
      22% underweight, and 23% either overweight or obese.&#xD;
&#xD;
      Will a micronutrient supplementation program improve the growth and iron status of children&#xD;
      aged 6 months to 5 years staying in Lembah Subang? Children will be randomized into treatment&#xD;
      and control groups. Treatment groups will receive dietary micronutrient supplementation&#xD;
      packets. Measurements of height and weight and iron status will be taken at baseline and 4&#xD;
      months later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study in a single-centre, using a single-blind, two-parallel group,&#xD;
      randomized trial conducted amongst children aged 6 months to 5 years residing at PPR Lembah&#xD;
      Subang, located in the state of Selangor, Malaysia between October 2019 and February 2020 (4&#xD;
      months). The participants were randomly assigned in a 3:2 treatment-to-control allocation to&#xD;
      receive, in addition to the baseline deworming treatment, either daily micronutrient packets&#xD;
      for 4 months (intervention arm) or no micronutrient supplementation (control group). This&#xD;
      residency area comprises a local population with mixed ethnic makeup and poor socioeconomic&#xD;
      status (majority are B40).&#xD;
&#xD;
      We distributed flyers, posters, and leaflets with the help of the community mothers in PPR&#xD;
      communities to encourage participation. Registration, informed consent and anthropometric&#xD;
      measurements, dietary logs and blood drawn for iron status were taken prior to randomization.&#xD;
      All children received a baseline deworming treatment at this point.&#xD;
&#xD;
      The treatment group received baseline deworming medications, a 4-month supply of daily&#xD;
      micronutrient supplementation and a compliance monitoring log. The control group only&#xD;
      received similar baseline deworming medications without any daily micronutrient&#xD;
      supplementation. Only the research investigators and outcome assessors were masked to the&#xD;
      treatment status whilst the participants and interventionists research investigators were&#xD;
      aware of the assigned intervention.&#xD;
&#xD;
      Primary endpoints assessed in this study are changes in serum ferritin and hemoglobin levels&#xD;
      at 0 and 4 months after interventions. The secondary endpoints are changes in age-and-sex&#xD;
      standardized height and weight percentile scores at 0 and 4 months after micronutrient&#xD;
      supplementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2019</start_date>
  <completion_date type="Actual">March 15, 2020</completion_date>
  <primary_completion_date type="Actual">February 29, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Treatment group: receives baseline deworming medication and daily micronutrient supplementation for 4 months; Control group: receives baseline deworming medication only</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in serum ferritin level between baseline and after 4 months mineral supplementation</measure>
    <time_frame>First blood test upon enrollment, at 0 months. Second blood test at 4 months</time_frame>
    <description>Blood test for serum ferritin level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in reticulocyte hemoglobin level between baseline and after 4 months mineral supplementation</measure>
    <time_frame>First blood test upon enrollment, at 0 months. Second blood test at 4 months</time_frame>
    <description>Blood test for RET-He level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in C-reactive protein level between baseline and after 4 months mineral supplementation</measure>
    <time_frame>First blood test upon enrollment, at 0 months. Second blood test at 4 months</time_frame>
    <description>Blood test for C-reactive protein level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in height (cm)</measure>
    <time_frame>First height measurement upon enrollment at 0 months. Second height measurement at 6 months.</time_frame>
    <description>Height of child will be measured at baseline (0 months) and after 4 months mineral supplementation (or no supplementation for control group).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight (kg)</measure>
    <time_frame>First weight measurement upon enrollment at 0 months. Second weight measurement at 4 months.</time_frame>
    <description>Weight of child will be measured at baseline (0 months) and after 4 months mineral supplementation (or no supplementation for control group).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Iron-deficiency</condition>
  <condition>Iron Deficiency Anemia</condition>
  <condition>Micronutrient Deficiency</condition>
  <condition>Nutrient Deficiency</condition>
  <condition>Stunting</condition>
  <arm_group>
    <arm_group_label>Supplementation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives baseline deworming medication. Intervention: receive daily micronutrient supplementation packets- 4 month supply, to be taken every day. Blood iron and anthropometric measurements taken at 0 and 4 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Receives baseline deworming medication. Blood iron and anthropometric measurements taken at 0 and 4 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin and Mineral Powder</intervention_name>
    <description>Vitamin and mineral nutritional supplement. Each packet is 1g of powder, to be taken with food.</description>
    <arm_group_label>Supplementation Group</arm_group_label>
    <other_name>Multiple Micronutrient Powder</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 6 months to 5 years living in PPR Lembah Subang&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ex-premature babies and children with congenital abnormalities resulting in gross&#xD;
             impairment&#xD;
&#xD;
          -  Children whose caregiver did not consent to participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lucy Chai See Lum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Malaya, Faculty of Medic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Malaya Medical Center</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>Wilayah Persekutuan Kuala Lumpur</state>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>August 28, 2022</last_update_submitted>
  <last_update_submitted_qc>August 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Micronutrients</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not planning to share patient data.</ipd_description>
  </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/NCT03819530
org study id: 20181056741
nct id: NCT03819530
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The first 1,000 days of life are critical periods for brain development. Proper nutrition
      lays the foundation for optimal growth, health, and neurodevelopment across the lifespan.
      Poor nutrition in this vulnerable period has irreversible consequences, including stunting,
      susceptibility to sickness, reduced school performance and productivity, and impaired
      intellectual and social development. UNICEF reported in 2018 that among the low cost flat
      residents in urban areas of the Klang Valley, 15% of children under 5 years old were stunted,
      22% underweight, and 23% either overweight or obese.

      Will a micronutrient supplementation program improve the growth and iron status of children
      aged 6 months to 5 years staying in Lembah Subang? Children will be randomized into treatment
      and control groups. Treatment groups will receive dietary micronutrient supplementation
      packets. Measurements of height and weight and iron status will be taken at baseline and 4
      months later.
This is a pilot study in a single-centre, using a single-blind, two-parallel group,
      randomized trial conducted amongst children aged 6 months to 5 years residing at PPR Lembah
      Subang, located in the state of Selangor, Malaysia between October 2019 and February 2020 (4
      months). The participants were randomly assigned in a 3:2 treatment-to-control allocation to
      receive, in addition to the baseline deworming treatment, either daily micronutrient packets
      for 4 months (intervention arm) or no micronutrient supplementation (control group). This
      residency area comprises a local population with mixed ethnic makeup and poor socioeconomic
      status (majority are B40).

      We distributed flyers, posters, and leaflets with the help of the community mothers in PPR
      communities to encourage participation. Registration, informed consent and anthropometric
      measurements, dietary logs and blood drawn for iron status were taken prior to randomization.
      All children received a baseline deworming treatment at this point.

      The treatment group received baseline deworming medications, a 4-month supply of daily
      micronutrient supplementation and a compliance monitoring log. The control group only
      received similar baseline deworming medications without any daily micronutrient
      supplementation. Only the research investigators and outcome assessors were masked to the
      treatment status whilst the participants and interventionists research investigators were
      aware of the assigned intervention.

      Primary endpoints assessed in this study are changes in serum ferritin and hemoglobin levels
      at 0 and 4 months after interventions. The secondary endpoints are changes in age-and-sex
      standardized height and weight percentile scores at 0 and 4 months after micronutrient
      supplementation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Treatment group: receives baseline deworming medication and daily micronutrient supplementation for 4 months; Control group: receives baseline deworming medication only
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in serum ferritin level between baseline and after 4 months mineral supplementation
time frame: First blood test upon enrollment, at 0 months. Second blood test at 4 months
description: Blood test for serum ferritin level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group).
measure: Change in reticulocyte hemoglobin level between baseline and after 4 months mineral supplementation
time frame: First blood test upon enrollment, at 0 months. Second blood test at 4 months
description: Blood test for RET-He level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group).
measure: Change in C-reactive protein level between baseline and after 4 months mineral supplementation
time frame: First blood test upon enrollment, at 0 months. Second blood test at 4 months
description: Blood test for C-reactive protein level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group).
measure: Change in height (cm)
time frame: First height measurement upon enrollment at 0 months. Second height measurement at 6 months.
description: Height of child will be measured at baseline (0 months) and after 4 months mineral supplementation (or no supplementation for control group).
measure: Change in weight (kg)
time frame: First weight measurement upon enrollment at 0 months. Second weight measurement at 4 months.
description: Weight of child will be measured at baseline (0 months) and after 4 months mineral supplementation (or no supplementation for control group).
arm group label: Supplementation Group
arm group type: Experimental
description: Receives baseline deworming medication. Intervention: receive daily micronutrient supplementation packets- 4 month supply, to be taken every day. Blood iron and anthropometric measurements taken at 0 and 4 months.
arm group label: Control Group
arm group type: No Intervention
description: Receives baseline deworming medication. Blood iron and anthropometric measurements taken at 0 and 4 months.
intervention type: Dietary Supplement
intervention name: Vitamin and Mineral Powder
description: Vitamin and mineral nutritional supplement. Each packet is 1g of powder, to be taken with food.
arm group label: Supplementation Group
other name: Multiple Micronutrient Powder
criteria: 
gender: All
minimum age: 6 Months
maximum age: 5 Years
healthy volunteers: No
last name: Lucy Chai See Lum, MD
role: Principal Investigator
affiliation: University Malaya, Faculty of Medic
facility: 
country: Malaysia
responsible party type: Sponsor
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Micronutrients
sharing ipd: No
ipd description: Not planning to share patient data.