<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/NCT01678079</url>
  </required_header>
  <id_info>
    <org_study_id>1000033463</org_study_id>
    <nct_id>NCT01678079</nct_id>
  </id_info>
  <brief_title>Encapsulated Calcium Absorption in Pregnancy</brief_title>
  <acronym>ENCAP</acronym>
  <official_title>Bioavailability and Acceptability of Enteric-Coated Microencapsulated Calcium During Pregnancy: A Randomized Crossover Trial in Bangladesh (Encapsulated Calcium Absorption in Pregnancy)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saving Lives at Birth</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Grand Challenges Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Agency for International Development (USAID)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Government of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>World Bank</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>
      This study will enroll at least 60 pregnant women in a randomized cross-over study in Dhaka,&#xD;
      Bangladesh. Each participant will be randomized to one of 3 calcium doses: 500 mg, 1000 mg,&#xD;
      1500 mg elemental Ca per day. Each participant will undergo two calcium absorption tests, one&#xD;
      with a micronutrient supplement powder containing non-encapsulated (non-coated) calcium and&#xD;
      the other with a micronutrient supplement powder containing encapsulated calcium at the same&#xD;
      dose. The absorption tests will be separated by a 2-week washout period. Fractional calcium&#xD;
      absorption will be measured using the dual stable isotope method. For each test, the&#xD;
      formulation will be administered orally for 9 days; on the 10th day, a 44Ca- labeled stable&#xD;
      isotope will be given orally and a 42Ca-labeled stable isotope dose will be given&#xD;
      intravenously. Urine will be collected for 48 hours to measure calcium absorption.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fractional Calcium Absorption</measure>
    <time_frame>Fractional calcium absorption during day 10-11</time_frame>
    <description>The primary analysis will be a comparison of mean fractional absorption of the two calcium formulations (enteric-coated vs. non-coated). The secondary analysis will be a comparison of mean fractional absorption across different calcium doses (500, 1000, 1500 mg per day).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fractional Calcium Absorption</measure>
    <time_frame>Fractional calcium absorption during day 35-36</time_frame>
    <description>The primary analysis will be a comparison of mean fractional absorption of the two calcium formulations (enteric-coated vs. non-coated). The secondary analysis will be a comparison of mean fractional absorption across different calcium doses (500, 1000, 1500 mg per day).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Palatability and Acceptability</measure>
    <time_frame>Baseline, +10/11 days, +35/36 days</time_frame>
    <description>The palatability and acceptability of the microencapsulated and non-encapsulated calcium formulations will be surveyed to assess the following parameters using semi-quantitative measures (i.e. Organoleptic properties, such as taste, odour, texture and colour, and adherence to prescribed micronutrient regimen, and reasons for non-adherence)</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Micronutrient Powder, Enteric-coated Calcium (500 mg/day)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Encapsulated Calcium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Micronutrient Powder, Enteric-coated Calcium (1000 mg/day)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Encapsulated Calcium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Micronutrient Powder, Enteric-coated Calcium (1500 mg/day)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Encapsulated Calcium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Micronutrient Powder, Uncoated Calcium (500 mg/day)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Non-capsulated Calcium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Micronutrient Powder, Uncoated Calcium (1000 mg/day)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Non-capsulated Calcium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Micronutrient Powder, Uncoated Calcium (1500 mg/day)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Non-capsulated Calcium</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Encapsulated Calcium</intervention_name>
    <description>The intervention is a multi-micronutrient powder containing enteric-coated calcium carbonate, in addition to ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg).</description>
    <arm_group_label>Micronutrient Powder, Enteric-coated Calcium (1000 mg/day)</arm_group_label>
    <arm_group_label>Micronutrient Powder, Enteric-coated Calcium (1500 mg/day)</arm_group_label>
    <arm_group_label>Micronutrient Powder, Enteric-coated Calcium (500 mg/day)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Non-capsulated Calcium</intervention_name>
    <description>The comparator/control intervention is a micronutrient powder containing non-coated calcium (500, 1000 or 1500 mg elemental calcium from calcium carbonate), ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg). This product will be similar in Ca dose, appearance, taste and texture to the experimental formulation but will not include the enteric-coating.</description>
    <arm_group_label>Micronutrient Powder, Uncoated Calcium (1000 mg/day)</arm_group_label>
    <arm_group_label>Micronutrient Powder, Uncoated Calcium (1500 mg/day)</arm_group_label>
    <arm_group_label>Micronutrient Powder, Uncoated Calcium (500 mg/day)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18 to 30 years&#xD;
&#xD;
          -  Current residence in Dhaka at a fixed address&#xD;
&#xD;
          -  Plan to remain in Dhaka for at least 2 months from date of enrolment&#xD;
&#xD;
          -  Gestational age of 27 completed weeks ± 1 week, estimated based on the recalled first&#xD;
             day of the last menstrual period (LMP)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complicated medical or obstetric history, based on self-report or clinical assessment&#xD;
             by physician (e.g., cardiovascular disease, uterine hemorrhage, placenta previa,&#xD;
             threatened abortion, hypertension, preeclampsia, multiple gestation, diabetes, renal&#xD;
             disease)&#xD;
&#xD;
          -  Higher risk pregnancy based on one or more of the following clinical findings at time&#xD;
             of recruitment:&#xD;
&#xD;
               -  Severe anemia (hemoglobin &lt;70 g/L assessed by Hemocue)&#xD;
&#xD;
               -  Proteinuria (≥ 100 mg/dl based on urine dipstick)&#xD;
&#xD;
               -  Glycosuria (≥ 100 mg/dl based on urine dipstick)&#xD;
&#xD;
               -  Hypertension (systolic blood pressure, ≥140 mm Hg and/or diastolic blood pressure&#xD;
                  ≥90 mm Hg)&#xD;
&#xD;
          -  Reported use of dietary supplements that contain &gt;500 mg of calcium per day and/or&#xD;
             &gt;400 IU (10 mcg) of vitamin D per day&#xD;
&#xD;
          -  Reported use (chewing) of betel leaf, areca nut and lime (together referred to locally&#xD;
             as paan) during pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Roth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stanley Zlotkin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Johns Hopkins Bloomberg School of Public Health</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>November 17, 2014</last_update_submitted>
  <last_update_submitted_qc>November 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2014</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>Daniel Roth</investigator_full_name>
    <investigator_title>Staff Physician, Paediatric Medicine</investigator_title>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Micronutrient Powder</keyword>
  <keyword>Calcium</keyword>
  <keyword>Iron</keyword>
  <keyword>Bangladesh</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</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/NCT01678079
org study id: 1000033463
nct id: NCT01678079
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study will enroll at least 60 pregnant women in a randomized cross-over study in Dhaka,
      Bangladesh. Each participant will be randomized to one of 3 calcium doses: 500 mg, 1000 mg,
      1500 mg elemental Ca per day. Each participant will undergo two calcium absorption tests, one
      with a micronutrient supplement powder containing non-encapsulated (non-coated) calcium and
      the other with a micronutrient supplement powder containing encapsulated calcium at the same
      dose. The absorption tests will be separated by a 2-week washout period. Fractional calcium
      absorption will be measured using the dual stable isotope method. For each test, the
      formulation will be administered orally for 9 days; on the 10th day, a 44Ca- labeled stable
      isotope will be given orally and a 42Ca-labeled stable isotope dose will be given
      intravenously. Urine will be collected for 48 hours to measure calcium absorption.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fractional Calcium Absorption
time frame: Fractional calcium absorption during day 10-11
description: The primary analysis will be a comparison of mean fractional absorption of the two calcium formulations (enteric-coated vs. non-coated). The secondary analysis will be a comparison of mean fractional absorption across different calcium doses (500, 1000, 1500 mg per day).
measure: Fractional Calcium Absorption
time frame: Fractional calcium absorption during day 35-36
description: The primary analysis will be a comparison of mean fractional absorption of the two calcium formulations (enteric-coated vs. non-coated). The secondary analysis will be a comparison of mean fractional absorption across different calcium doses (500, 1000, 1500 mg per day).
measure: Palatability and Acceptability
time frame: Baseline, +10/11 days, +35/36 days
description: The palatability and acceptability of the microencapsulated and non-encapsulated calcium formulations will be surveyed to assess the following parameters using semi-quantitative measures (i.e. Organoleptic properties, such as taste, odour, texture and colour, and adherence to prescribed micronutrient regimen, and reasons for non-adherence)
arm group label: Micronutrient Powder, Enteric-coated Calcium (500 mg/day)
arm group type: Experimental
description: Encapsulated Calcium
arm group label: Micronutrient Powder, Enteric-coated Calcium (1000 mg/day)
arm group type: Experimental
description: Encapsulated Calcium
arm group label: Micronutrient Powder, Enteric-coated Calcium (1500 mg/day)
arm group type: Experimental
description: Encapsulated Calcium
arm group label: Micronutrient Powder, Uncoated Calcium (500 mg/day)
arm group type: Active Comparator
description: Non-capsulated Calcium
arm group label: Micronutrient Powder, Uncoated Calcium (1000 mg/day)
arm group type: Active Comparator
description: Non-capsulated Calcium
arm group label: Micronutrient Powder, Uncoated Calcium (1500 mg/day)
arm group type: Active Comparator
description: Non-capsulated Calcium
intervention type: Dietary Supplement
intervention name: Encapsulated Calcium
description: The intervention is a multi-micronutrient powder containing enteric-coated calcium carbonate, in addition to ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg).
arm group label: Micronutrient Powder, Enteric-coated Calcium (1000 mg/day)
arm group label: Micronutrient Powder, Enteric-coated Calcium (1500 mg/day)
arm group label: Micronutrient Powder, Enteric-coated Calcium (500 mg/day)
intervention type: Dietary Supplement
intervention name: Non-capsulated Calcium
description: The comparator/control intervention is a micronutrient powder containing non-coated calcium (500, 1000 or 1500 mg elemental calcium from calcium carbonate), ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg). This product will be similar in Ca dose, appearance, taste and texture to the experimental formulation but will not include the enteric-coating.
arm group label: Micronutrient Powder, Uncoated Calcium (1000 mg/day)
arm group label: Micronutrient Powder, Uncoated Calcium (1500 mg/day)
arm group label: Micronutrient Powder, Uncoated Calcium (500 mg/day)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Roth, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
last name: Stanley Zlotkin, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
facility: 
facility: 
facility: 
country: Bangladesh
country: Canada
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Daniel Roth
investigator title: Staff Physician, Paediatric Medicine
mesh term: Calcium, Dietary
mesh term: Calcium