<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/NCT02238704</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #: 1205003071</org_study_id>
    <secondary_id>P414/01/2013</secondary_id>
    <nct_id>NCT02238704</nct_id>
  </id_info>
  <brief_title>Cornell University-Micronutrient Initiative Calcium Supplementation Study</brief_title>
  <acronym>MICA</acronym>
  <official_title>A Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kenya Ministry of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Nairobi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Micronutrient Initiative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The World Health Organization (WHO) now recommends prenatal calcium supplementation for&#xD;
      prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to&#xD;
      compare the effect of two dosing strategies on the amount of supplement ingested by pregnant&#xD;
      women and adherence to related recommendations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a non-inferiority trial that compares the effect of a dosing strategy involving&#xD;
      lower overall dose and fewer administrations per day to the current WHO recommendation. The&#xD;
      comparator arm, Regimen B, prescribes 3 doses per day (consistent with current WHO standard)&#xD;
      and was found to be burdensome in qualitative studies. The experimental arm, Regimen A,&#xD;
      prescribes 2 doses per day and has been associated with greater satisfaction. On face value&#xD;
      Regimen A should result in 33% less amount of supplement ingested than Regimen B. However, we&#xD;
      hypothesize that the difference in amount ingested, when rolled out in routine practice will&#xD;
      be MUCH LESS than that BECAUSE THE LOWER DOSE REGIMEN RESULTS IN HIGHER LEVELS OF ADHERENCE.&#xD;
      We hypothesize that THE DIFFERENCE IN AMOUNT CONSUMED WILL BE NEGLIGIBLE OR will not exceed&#xD;
      15%. Hence, we hypothesize that Regimen A is not inferior to Regimen B in terms of total&#xD;
      amount of supplement ingested (within a 15% margin of inferiority).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of calcium supplement ingested</measure>
    <time_frame>8 weeks after ANC consultation, during which recruitment into the study occurred</time_frame>
    <description>This is the actual number of supplements ingested expressed as a percentage of the number of supplements expected to be ingested since the ANC consultation if 100% adherent to the current WHO recommendation.&#xD;
[Total number of calcium supplements consumed/(Number of days since last ANC consultation X 3)] X 100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to related recommendations</measure>
    <time_frame>8 weeks after ANC consultation, during which recruitment into the study occurred</time_frame>
    <description>Adherence to other features of the WHO recommendation (taking supplements with food).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation</measure>
    <time_frame>8 weeks after ANC consultation, during which recruitment into the study occurred</time_frame>
    <description>Motivation scores extracted from the survey instrument administered at follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>8 weeks after ANC consultation, during which recruitment into the study occurred</time_frame>
    <description>Self-efficacy scores extracted from the survey instrument administered at follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction</measure>
    <time_frame>8 weeks after ANC consultation, during which recruitment into the study occurred</time_frame>
    <description>Satisfaction scores extracted from the survey instrument administered at follow up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1032</enrollment>
  <condition>Preeclampsia</condition>
  <arm_group>
    <arm_group_label>Regimen A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>500mg elemental calcium (as CaCO3) + 200 microgram Vit D per administration, administered 2 times a day, at least 2hours apart with one administration of 60mg elemental iron (as FeSO4) at any time of the day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>500mg elemental calcium (as CaCO3) + 200 microgram Vit D per administration, administered 3 times a day, at least 2hours apart with one administration of 60mg elemental iron (as FeSO4) at any time of the day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Regimen A calcium and iron/folic acid</intervention_name>
    <description>Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women</description>
    <arm_group_label>Regimen A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Regimen B calcium and iron/folic acid</intervention_name>
    <description>Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women</description>
    <arm_group_label>Regimen B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Attendance at ANC clinic in a primary care facility in Kakamega north&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gestational age &lt; 16 weeks,&#xD;
&#xD;
          -  Gestational age &gt; 30 weeks,&#xD;
&#xD;
          -  Dietary or medicinal consumption of adequate calcium (according to the screening&#xD;
             survey),&#xD;
&#xD;
          -  Intention to leave study community before 8weeks from date of interview&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine Dickin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chebwayi Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chegulo Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chevoso Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chimoi dispensary</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chombeli Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imbiakhalo Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kimangeti Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kuvasali Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malava district hospital</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manda Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miting'ongo Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mugai Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Namagara Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shamberere Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shihome Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shivanga Health centre</name>
      <address>
        <city>Kakamega</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>July 26, 2016</last_update_submitted>
  <last_update_submitted_qc>July 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adherence</keyword>
  <keyword>Calcium supplementation</keyword>
  <keyword>Prevention of preeclampsia</keyword>
  <keyword>Adherence to calcium supplementation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Iron</mesh_term>
    <mesh_term>Folic Acid</mesh_term>
    <mesh_term>Vitamin B Complex</mesh_term>
    <mesh_term>Calcium</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/NCT02238704
org study id: IRB #: 1205003071
secondary id: P414/01/2013
nct id: NCT02238704
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The World Health Organization (WHO) now recommends prenatal calcium supplementation for
      prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to
      compare the effect of two dosing strategies on the amount of supplement ingested by pregnant
      women and adherence to related recommendations.
This study is a non-inferiority trial that compares the effect of a dosing strategy involving
      lower overall dose and fewer administrations per day to the current WHO recommendation. The
      comparator arm, Regimen B, prescribes 3 doses per day (consistent with current WHO standard)
      and was found to be burdensome in qualitative studies. The experimental arm, Regimen A,
      prescribes 2 doses per day and has been associated with greater satisfaction. On face value
      Regimen A should result in 33% less amount of supplement ingested than Regimen B. However, we
      hypothesize that the difference in amount ingested, when rolled out in routine practice will
      be MUCH LESS than that BECAUSE THE LOWER DOSE REGIMEN RESULTS IN HIGHER LEVELS OF ADHERENCE.
      We hypothesize that THE DIFFERENCE IN AMOUNT CONSUMED WILL BE NEGLIGIBLE OR will not exceed
      15%. Hence, we hypothesize that Regimen A is not inferior to Regimen B in terms of total
      amount of supplement ingested (within a 15% margin of inferiority).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Amount of calcium supplement ingested
time frame: 8 weeks after ANC consultation, during which recruitment into the study occurred
description: This is the actual number of supplements ingested expressed as a percentage of the number of supplements expected to be ingested since the ANC consultation if 100% adherent to the current WHO recommendation.
[Total number of calcium supplements consumed/(Number of days since last ANC consultation X 3)] X 100
measure: Adherence to related recommendations
time frame: 8 weeks after ANC consultation, during which recruitment into the study occurred
description: Adherence to other features of the WHO recommendation (taking supplements with food).
measure: Motivation
time frame: 8 weeks after ANC consultation, during which recruitment into the study occurred
description: Motivation scores extracted from the survey instrument administered at follow up.
measure: Self-efficacy
time frame: 8 weeks after ANC consultation, during which recruitment into the study occurred
description: Self-efficacy scores extracted from the survey instrument administered at follow up.
measure: Satisfaction
time frame: 8 weeks after ANC consultation, during which recruitment into the study occurred
description: Satisfaction scores extracted from the survey instrument administered at follow up.
arm group label: Regimen A
arm group type: Experimental
description: 500mg elemental calcium (as CaCO3) + 200 microgram Vit D per administration, administered 2 times a day, at least 2hours apart with one administration of 60mg elemental iron (as FeSO4) at any time of the day
arm group label: Regimen B
arm group type: Active Comparator
description: 500mg elemental calcium (as CaCO3) + 200 microgram Vit D per administration, administered 3 times a day, at least 2hours apart with one administration of 60mg elemental iron (as FeSO4) at any time of the day
intervention type: Dietary Supplement
intervention name: Regimen A calcium and iron/folic acid
description: Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women
arm group label: Regimen A
intervention type: Dietary Supplement
intervention name: Regimen B calcium and iron/folic acid
description: Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women
arm group label: Regimen B
criteria: 
gender: Female
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Katherine Dickin, PhD
role: Principal Investigator
affiliation: Cornell University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Kenya
responsible party type: Sponsor
mesh term: Pre-Eclampsia
mesh term: Calcium, Dietary
mesh term: Iron
mesh term: Folic Acid
mesh term: Vitamin B Complex
mesh term: Calcium