<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/NCT01676636</url>
  </required_header>
  <id_info>
    <org_study_id>1000032744</org_study_id>
    <nct_id>NCT01676636</nct_id>
  </id_info>
  <brief_title>Delivery Vehicles for Prenatal Calcium Supplementation</brief_title>
  <official_title>Preference, Acceptability, and Palatability of Alternative Delivery Vehicles for Prenatal Calcium Supplementation Among Pregnant Women in Bangladesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Sprinkles Global Health Initiative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SickKids-led research team is currently developing a prenatal micronutrient powder that&#xD;
      will contain calcium, iron, and folic acid with different absorption characteristics. Once&#xD;
      the powder is developed, it can be incorporated into various oral delivery vehicles. The&#xD;
      overall effectiveness of a micronutrient program is highly dependent on the acceptance and&#xD;
      regular consumption of supplements (i.e., adherence) by the targeted users. This is a study&#xD;
      of the preference, acceptability, and palatability of 4 alternative delivery vehicles for the&#xD;
      innovative prenatal multiple micronutrient supplement: traditional tablets, oral&#xD;
      disintegrating tablets, unflavoured powder with a suspension agent, and flavoured powder with&#xD;
      a suspension agent. This study will be conducted in Dhaka, Bangladesh. This study&#xD;
      hypothesizes that that the formulation of the delivery vehicle will impact preference,&#xD;
      acceptability, and palatability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of Consumption of the Calcium Vehicle</measure>
    <time_frame>Change from Baseline in Consumption of the Calcium Vehicle at day 22</time_frame>
    <description>Consumption of the delivery vehicles will be measured during the once-weekly interactions with the research assistants in two ways: (1) by self-report from study participants; and (2) by counting the number of missing doses from those provided in the weekly supply.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>Day 1, Day 9, Day 16, Day 22</time_frame>
    <description>Measured by colour, preparation, administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of Use</measure>
    <time_frame>Day 1, Day 9, Day 16, Day 22</time_frame>
    <description>Measured by size and ease of swallowing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patibility</measure>
    <time_frame>Day 1, Day 9, Day 16, Day 22</time_frame>
    <description>Measured by taste, texture, aftertaste, and odour.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">149</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Pregnant Women</arm_group_label>
    <description>Women who are 13 to 30 weeks pregnant. Each participant will take all 4 different calcium vehicles and decide which one they prefer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Traditional Tablet</intervention_name>
    <description>The traditional tablets will be swallowed with liquid. Each tablet will contain 500 mg of calcium (as calcium carbonate), thus participants will be asked to take 3 per day.. Participants will be asked to take the tablets with a liquid of their choosing with a meal. Traditional tablets will function as a control in this study, as they represent what is widely available on the market in Bangladesh.</description>
    <arm_group_label>Pregnant Women</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chewable tablets</intervention_name>
    <description>Chewable tablets are chewed in the absence of additional water. Each chewable tablet will contain 300 mg of calcium (as calcium carbonate), thus participants will be asked to take 5 per day. Participants will be asked to consume the chewable tablets with a meal.</description>
    <arm_group_label>Pregnant Women</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Unflavoured Powder</intervention_name>
    <description>The unflavoured powder with suspension agent will be tasteless and consumed by either adding it to a semi-solid food or drink of one's choosing. Appropriate foods for mixing with the powder will be at the discretion of the participants. This vehicle was selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy. A similar product is Sprinkles, a multiple micronutrient powder developed at SickKids by Dr. Zlotkin.</description>
    <arm_group_label>Pregnant Women</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flavoured Powder</intervention_name>
    <description>The flavoured powder with suspension agent will be consumed by adding it to clean water with a meal. This vehicle was also selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy. Similar products include oral rehydration salts or artificial juice flavour crystals.</description>
    <arm_group_label>Pregnant Women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women who are between 13 and 30 weeks pregnant. Participants will be recruited from&#xD;
        Shimantik .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women ages 18 to &lt; 40 years&#xD;
&#xD;
          -  Gestational age of 13-30 completed weeks, estimated based on the recalled first day of&#xD;
             the last menstrual period (LMP)&#xD;
&#xD;
          -  Current residence in Dhaka at a fixed address&#xD;
&#xD;
          -  Plan to remain in Dhaka for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reported complications of current pregnancy&#xD;
&#xD;
          -  Complicated medical or obstetric history that may increase the risk of preterm birth&#xD;
             or prenatal complications, based on self-report&#xD;
&#xD;
          -  Moderate or severe anaemia (hemoglobin &lt; 90 g/L, accessed with Hemocue)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stanley Zlotkin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Roth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Center for Diarrheal Disease Research</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>April 14, 2021</last_update_submitted>
  <last_update_submitted_qc>April 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Stanley Zlotkin</investigator_full_name>
    <investigator_title>Chief, Global Child Health</investigator_title>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Calcium</keyword>
  <keyword>Supplements</keyword>
  <!-- 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/NCT01676636
org study id: 1000032744
nct id: NCT01676636
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The SickKids-led research team is currently developing a prenatal micronutrient powder that
      will contain calcium, iron, and folic acid with different absorption characteristics. Once
      the powder is developed, it can be incorporated into various oral delivery vehicles. The
      overall effectiveness of a micronutrient program is highly dependent on the acceptance and
      regular consumption of supplements (i.e., adherence) by the targeted users. This is a study
      of the preference, acceptability, and palatability of 4 alternative delivery vehicles for the
      innovative prenatal multiple micronutrient supplement: traditional tablets, oral
      disintegrating tablets, unflavoured powder with a suspension agent, and flavoured powder with
      a suspension agent. This study will be conducted in Dhaka, Bangladesh. This study
      hypothesizes that that the formulation of the delivery vehicle will impact preference,
      acceptability, and palatability.
observational model: Cohort
time perspective: Prospective
measure: Frequency of Consumption of the Calcium Vehicle
time frame: Change from Baseline in Consumption of the Calcium Vehicle at day 22
description: Consumption of the delivery vehicles will be measured during the once-weekly interactions with the research assistants in two ways: (1) by self-report from study participants; and (2) by counting the number of missing doses from those provided in the weekly supply.
measure: Acceptability
time frame: Day 1, Day 9, Day 16, Day 22
description: Measured by colour, preparation, administration.
measure: Ease of Use
time frame: Day 1, Day 9, Day 16, Day 22
description: Measured by size and ease of swallowing.
measure: Patibility
time frame: Day 1, Day 9, Day 16, Day 22
description: Measured by taste, texture, aftertaste, and odour.
arm group label: Pregnant Women
description: Women who are 13 to 30 weeks pregnant. Each participant will take all 4 different calcium vehicles and decide which one they prefer.
intervention type: Drug
intervention name: Traditional Tablet
description: The traditional tablets will be swallowed with liquid. Each tablet will contain 500 mg of calcium (as calcium carbonate), thus participants will be asked to take 3 per day.. Participants will be asked to take the tablets with a liquid of their choosing with a meal. Traditional tablets will function as a control in this study, as they represent what is widely available on the market in Bangladesh.
arm group label: Pregnant Women
intervention type: Drug
intervention name: Chewable tablets
description: Chewable tablets are chewed in the absence of additional water. Each chewable tablet will contain 300 mg of calcium (as calcium carbonate), thus participants will be asked to take 5 per day. Participants will be asked to consume the chewable tablets with a meal.
arm group label: Pregnant Women
intervention type: Drug
intervention name: Unflavoured Powder
description: The unflavoured powder with suspension agent will be tasteless and consumed by either adding it to a semi-solid food or drink of one's choosing. Appropriate foods for mixing with the powder will be at the discretion of the participants. This vehicle was selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy. A similar product is Sprinkles, a multiple micronutrient powder developed at SickKids by Dr. Zlotkin.
arm group label: Pregnant Women
intervention type: Drug
intervention name: Flavoured Powder
description: The flavoured powder with suspension agent will be consumed by adding it to clean water with a meal. This vehicle was also selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy. Similar products include oral rehydration salts or artificial juice flavour crystals.
arm group label: Pregnant Women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stanley Zlotkin, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
last name: Daniel Roth, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
facility: 
country: Bangladesh
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Stanley Zlotkin
investigator title: Chief, Global Child Health