<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/NCT02210884</url>
  </required_header>
  <id_info>
    <org_study_id>HE1357</org_study_id>
    <nct_id>NCT02210884</nct_id>
  </id_info>
  <brief_title>Maternal Vit D Supplements &amp; Infant and Maternal Biomarkers &amp; Outcomes in Southern Ethiopia</brief_title>
  <official_title>Effects of Maternal Vitamin D Supplementation on Markers of Vitamin D Status and Related Infant and Maternal Outcomes in Southern Ethiopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oklahoma State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oklahoma State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Synthesis of vitamin D in the skin through the action of sunlight is a major source of&#xD;
      vitamin D in parts of the world where foods are not fortified with the vitamin. Skin&#xD;
      pigmentation (color), dress habits and season are some of the factors that limit sun exposure&#xD;
      and affect vitamin D synthesis in the skin. Maternal vitamin D status is especially important&#xD;
      to meet infant needs when newborns are not supplemented with vitamin D. In Ethiopia, vitamin&#xD;
      D status of lactating women and infants and breast milk vitamin D concentration have never&#xD;
      been assessed. The purpose of this study is to assess changes in maternal and infant markers&#xD;
      of vitamin D status before and after vitamin D supplementation of the lactating mothers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin D is a vitamin that regulates calcium and phosphorous homeostasis and ensures proper&#xD;
      mineralization of bone. Lactating women and infants are considered to be at risk of vitamin D&#xD;
      deficiency due to increased needs for vitamin D and calcium. Stores of vitamin D acquired in&#xD;
      utero and breast milk are the main sources of vitamin D for infants. Maternal vitamin D&#xD;
      deficiency, exclusive breastfeeding, skin pigmentation and limited sun exposure are commonly&#xD;
      seen in infants with rickets. However, the UV exposure, dress habits, traditional practices&#xD;
      and other risk factors to vitamin D deficiency in Ethiopia have not been explored. This study&#xD;
      aims to fill this research gap.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 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>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma 25(OH)D concentrations of lactating women</measure>
    <time_frame>3 months after enrollment</time_frame>
    <description>Maternal plasma 25(OH) will be assessed at baseline and after three months of weekly supplementation with 15,000 IU vitamin D or placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma 25(OH)D concentrations of lactating women</measure>
    <time_frame>6 months after enrollment</time_frame>
    <description>Maternal plasma 25(OH)D concentrations will be measured at 6 months after weekly supplementation with 15,000 IU vitamin D3 or placebo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma 25(OH)D concentrations of lactating women</measure>
    <time_frame>1 year</time_frame>
    <description>Maternal 25 (OH)D concentrations will be measured at 1 year after weekly supplementation with 15,000 IU of vitamin D or placebo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma 25(OH) vitamin D of infants at 6 months of age</measure>
    <time_frame>6 months</time_frame>
    <description>Plasma 25(OH) vitamin D of 6-month-old infants whose mothers received weekly doses of 15,000 IU vitamin D or placebo from time of enrollment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma 25(OH) vitamin D of 1-year-old infants</measure>
    <time_frame>1 year</time_frame>
    <description>Plasma 25(OH) vitamin D of 1-year-old infants whose mothers received weekly doses of 15,000 IU vitamin D or placebo from time of enrollment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breast milk concentration of vitamin D</measure>
    <time_frame>3 months</time_frame>
    <description>Breast milk concentration of vitamin D will be measured three months after enrollment in lactating women who have received 15,000 IU Vitamin D weekly or placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breast milk concentration of vitamin D</measure>
    <time_frame>6 months</time_frame>
    <description>Breast milk concentration of vitamin D will be measured six months after enrollment in lactating women who have received 15,000 IU Vitamin D weekly or placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breast milk concentration of vitamin D</measure>
    <time_frame>1 year</time_frame>
    <description>Breast milk concentration of vitamin D will be measured twelve months after enrollment in lactating women who have received 15,000 IU Vitamin D weekly or placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Assessment of Infants for Rickets</measure>
    <time_frame>3 months</time_frame>
    <description>Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Assessment of Infants for Rickets</measure>
    <time_frame>6 months</time_frame>
    <description>Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Assessment of Infants for Rickets</measure>
    <time_frame>12 months</time_frame>
    <description>Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infant motor developmental milestones</measure>
    <time_frame>Weekly for one year</time_frame>
    <description>Progress toward standardized infant motor developmental milestones will be assessed weekly in infants whose mothers received 15,000 IU of vitamin D or placebo from time of study enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant acute respirtory tract infections</measure>
    <time_frame>Weekly for one year</time_frame>
    <description>Incidence of infant acute respiratory tract infections will be assessed weekly in infants whose mothers received 15,000 IU of vitamin D or placebo from time of study enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant anthropometry</measure>
    <time_frame>Quarterly for one year</time_frame>
    <description>Weight and length of infants will be assessed quarterly in infants whose mothers received 15,000 IU of vitamin D or placebo from time of study enrollment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Vitamin D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly oral dose of 15,000 IU of Vitamin D3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule containing no vitamin D</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>Weekly oral supplementation with 15,000 IU vitamin D</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Vitamin D</arm_group_label>
    <other_name>Vitamin D3</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Available for enrollment within 2 weeks of delivery&#xD;
&#xD;
          -  Residing in the study area in Ethiopia&#xD;
&#xD;
          -  Apparently healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Self-reported chronic or acute disease condition&#xD;
&#xD;
          -  Not breastfeeding&#xD;
&#xD;
          -  Twin births&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara J Stoecker, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Oklahoma State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hawassa University</name>
      <address>
        <city>Hawassa</city>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ethiopia</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vitamin D supplementation</keyword>
  <keyword>Lactation</keyword>
  <keyword>25 hydroxyvitamin D</keyword>
  <keyword>Breast feeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</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/NCT02210884
org study id: HE1357
nct id: NCT02210884
lead sponsor: 
has dmc: Yes
Synthesis of vitamin D in the skin through the action of sunlight is a major source of
      vitamin D in parts of the world where foods are not fortified with the vitamin. Skin
      pigmentation (color), dress habits and season are some of the factors that limit sun exposure
      and affect vitamin D synthesis in the skin. Maternal vitamin D status is especially important
      to meet infant needs when newborns are not supplemented with vitamin D. In Ethiopia, vitamin
      D status of lactating women and infants and breast milk vitamin D concentration have never
      been assessed. The purpose of this study is to assess changes in maternal and infant markers
      of vitamin D status before and after vitamin D supplementation of the lactating mothers.
Vitamin D is a vitamin that regulates calcium and phosphorous homeostasis and ensures proper
      mineralization of bone. Lactating women and infants are considered to be at risk of vitamin D
      deficiency due to increased needs for vitamin D and calcium. Stores of vitamin D acquired in
      utero and breast milk are the main sources of vitamin D for infants. Maternal vitamin D
      deficiency, exclusive breastfeeding, skin pigmentation and limited sun exposure are commonly
      seen in infants with rickets. However, the UV exposure, dress habits, traditional practices
      and other risk factors to vitamin D deficiency in Ethiopia have not been explored. This study
      aims to fill this research gap.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Plasma 25(OH)D concentrations of lactating women
time frame: 3 months after enrollment
description: Maternal plasma 25(OH) will be assessed at baseline and after three months of weekly supplementation with 15,000 IU vitamin D or placebo.
measure: Plasma 25(OH)D concentrations of lactating women
time frame: 6 months after enrollment
description: Maternal plasma 25(OH)D concentrations will be measured at 6 months after weekly supplementation with 15,000 IU vitamin D3 or placebo
measure: Plasma 25(OH)D concentrations of lactating women
time frame: 1 year
description: Maternal 25 (OH)D concentrations will be measured at 1 year after weekly supplementation with 15,000 IU of vitamin D or placebo
measure: Plasma 25(OH) vitamin D of infants at 6 months of age
time frame: 6 months
description: Plasma 25(OH) vitamin D of 6-month-old infants whose mothers received weekly doses of 15,000 IU vitamin D or placebo from time of enrollment
measure: Plasma 25(OH) vitamin D of 1-year-old infants
time frame: 1 year
description: Plasma 25(OH) vitamin D of 1-year-old infants whose mothers received weekly doses of 15,000 IU vitamin D or placebo from time of enrollment
measure: Breast milk concentration of vitamin D
time frame: 3 months
description: Breast milk concentration of vitamin D will be measured three months after enrollment in lactating women who have received 15,000 IU Vitamin D weekly or placebo.
measure: Breast milk concentration of vitamin D
time frame: 6 months
description: Breast milk concentration of vitamin D will be measured six months after enrollment in lactating women who have received 15,000 IU Vitamin D weekly or placebo.
measure: Breast milk concentration of vitamin D
time frame: 1 year
description: Breast milk concentration of vitamin D will be measured twelve months after enrollment in lactating women who have received 15,000 IU Vitamin D weekly or placebo.
measure: Clinical Assessment of Infants for Rickets
time frame: 3 months
description: Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets
measure: Clinical Assessment of Infants for Rickets
time frame: 6 months
description: Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets
measure: Clinical Assessment of Infants for Rickets
time frame: 12 months
description: Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets
measure: Infant motor developmental milestones
time frame: Weekly for one year
description: Progress toward standardized infant motor developmental milestones will be assessed weekly in infants whose mothers received 15,000 IU of vitamin D or placebo from time of study enrollment
measure: Infant acute respirtory tract infections
time frame: Weekly for one year
description: Incidence of infant acute respiratory tract infections will be assessed weekly in infants whose mothers received 15,000 IU of vitamin D or placebo from time of study enrollment
measure: Infant anthropometry
time frame: Quarterly for one year
description: Weight and length of infants will be assessed quarterly in infants whose mothers received 15,000 IU of vitamin D or placebo from time of study enrollment
arm group label: Vitamin D
arm group type: Experimental
description: Weekly oral dose of 15,000 IU of Vitamin D3
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule containing no vitamin D
intervention type: Dietary Supplement
intervention name: Vitamin D
description: Weekly oral supplementation with 15,000 IU vitamin D
arm group label: Placebo
arm group label: Vitamin D
other name: Vitamin D3
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Barbara J Stoecker, PhD
role: Study Director
affiliation: Oklahoma State University
facility: 
country: Ethiopia
responsible party type: Sponsor
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins