<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/NCT01732328</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE 0002.0361.000-09</org_study_id>
    <secondary_id>CNPq</secondary_id>
    <nct_id>NCT01732328</nct_id>
  </id_info>
  <brief_title>Effect of Calcium Plus Vitamin D Supplementation on Adolescent Mother and Infant Bone Health</brief_title>
  <official_title>Calcium Plus Vitamin D Supplementation During Pregnancy of Adolescent Mothers: Effects on Maternal and Infant Bone Mass, Calcium and Bone Metabolism and Breast Milk Composition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio de Janeiro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rio de Janeiro State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Federal do Rio de Janeiro</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pregnancy and lactation are periods of high calcium requirement. Inadequate maternal calcium&#xD;
      intake and vitamin D insufficiency may adversely affect fetal and neonatal growth and&#xD;
      maternal bone mass particularly in adolescent mothers. The investigators propose to evaluate&#xD;
      the influence of calcium plus vitamin D supplementation during pregnancy on bone mass of&#xD;
      lactating adolescent mothers with habitually low calcium and vitamin D, on fetal growth and&#xD;
      neonate bone mass. Mothers are randomly assigned to receive daily calcium (600 mg) plus&#xD;
      vitamin D3 (200 IU) supplement or placebo from mid gestation until parturition. Fetal growth&#xD;
      parameters are assessed by standard ultrasound techniques at mid and late gestation. Maternal&#xD;
      bone mass is assessed by dual energy x-ray absorptiometry (DXA) at 2 and 5 months postpartum&#xD;
      and 6 months after weaning. Infant bone mass is assessed by DXA at 2 months postpartum.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2009</start_date>
  <completion_date type="Anticipated">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in maternal bone mass changes postpartum between supplemented and placebo groups</measure>
    <time_frame>2, 5 and 12 months postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in fetal growth and infant bone mass between supplemented and placebo groups</measure>
    <time_frame>2nd and 3rd trimester gestation and 2 mo postpartum</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in changes of bone and calcium related hormones and vitamin D status between supplemented and placebo groups</measure>
    <time_frame>2nd and 3rd trimester of pregnancy and 2, 5, 12 mo postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in human breast milk composition (nutrients and hormones) between supplemented and placebo groups</measure>
    <time_frame>2 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in maternal bone status according to vitamin D receptor (VDR) polymorphisms</measure>
    <time_frame>2, 5 and 12 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in infant body composition between supplemented and placebo groups</measure>
    <time_frame>2 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in changes of maternal body composition postpartum between supplemented and placebo groups</measure>
    <time_frame>2, 5 and 12 months postpartum</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Lactation Bone Loss</condition>
  <condition>Infant Bone Growth</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Inactive pill (microcrystalline cellulose and corn starch) taken daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcium plus vitamin D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>600mg of calcium and 200 international units (IU) vitamin D taken daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Calcium plus vitamin D</intervention_name>
    <arm_group_label>Calcium plus vitamin D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  13-19 y old&#xD;
&#xD;
          -  between 23 and 29 wk of gestation&#xD;
&#xD;
          -  primiparous&#xD;
&#xD;
          -  carrying single fetus&#xD;
&#xD;
          -  intending to exclusively or predominantly breastfeed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic health problems&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  users of nutritional supplements, except iron supplements provided during standard&#xD;
             prenatal care&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Flavia F Bezerra, DSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade do Estado do Rio de Janeiro, Brazil</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carmen M Donangelo, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidade Federal do Rio de Janeiro, Brazil</affiliation>
  </overall_official>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>November 21, 2012</last_update_submitted>
  <last_update_submitted_qc>November 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rio de Janeiro State University</investigator_affiliation>
    <investigator_full_name>Flavia Fioruci Bezerra</investigator_full_name>
    <investigator_title>DSc</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</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/NCT01732328
org study id: CAAE 0002.0361.000-09
secondary id: CNPq
nct id: NCT01732328
lead sponsor: 
collaborator: 
has dmc: No
Pregnancy and lactation are periods of high calcium requirement. Inadequate maternal calcium
      intake and vitamin D insufficiency may adversely affect fetal and neonatal growth and
      maternal bone mass particularly in adolescent mothers. The investigators propose to evaluate
      the influence of calcium plus vitamin D supplementation during pregnancy on bone mass of
      lactating adolescent mothers with habitually low calcium and vitamin D, on fetal growth and
      neonate bone mass. Mothers are randomly assigned to receive daily calcium (600 mg) plus
      vitamin D3 (200 IU) supplement or placebo from mid gestation until parturition. Fetal growth
      parameters are assessed by standard ultrasound techniques at mid and late gestation. Maternal
      bone mass is assessed by dual energy x-ray absorptiometry (DXA) at 2 and 5 months postpartum
      and 6 months after weaning. Infant bone mass is assessed by DXA at 2 months postpartum.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Differences in maternal bone mass changes postpartum between supplemented and placebo groups
time frame: 2, 5 and 12 months postpartum
measure: Differences in fetal growth and infant bone mass between supplemented and placebo groups
time frame: 2nd and 3rd trimester gestation and 2 mo postpartum
measure: Differences in changes of bone and calcium related hormones and vitamin D status between supplemented and placebo groups
time frame: 2nd and 3rd trimester of pregnancy and 2, 5, 12 mo postpartum
measure: Differences in human breast milk composition (nutrients and hormones) between supplemented and placebo groups
time frame: 2 months postpartum
measure: Differences in maternal bone status according to vitamin D receptor (VDR) polymorphisms
time frame: 2, 5 and 12 months postpartum
measure: Differences in infant body composition between supplemented and placebo groups
time frame: 2 months postpartum
measure: Differences in changes of maternal body composition postpartum between supplemented and placebo groups
time frame: 2, 5 and 12 months postpartum
arm group label: placebo
arm group type: Placebo Comparator
description: Inactive pill (microcrystalline cellulose and corn starch) taken daily
arm group label: Calcium plus vitamin D
arm group type: Active Comparator
description: 600mg of calcium and 200 international units (IU) vitamin D taken daily
intervention type: Dietary Supplement
intervention name: Calcium plus vitamin D
arm group label: Calcium plus vitamin D
criteria: 
gender: Female
minimum age: 13 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Flavia F Bezerra, DSc
role: Principal Investigator
affiliation: Universidade do Estado do Rio de Janeiro, Brazil
last name: Carmen M Donangelo, PhD
role: Study Director
affiliation: Universidade Federal do Rio de Janeiro, Brazil
responsible party type: Principal Investigator
investigator affiliation: Rio de Janeiro State University
investigator full name: Flavia Fioruci Bezerra
investigator title: DSc
mesh term: Vitamin D
mesh term: Calcium