<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/NCT03037593</url>
  </required_header>
  <id_info>
    <org_study_id>1611M98781</org_study_id>
    <nct_id>NCT03037593</nct_id>
  </id_info>
  <brief_title>High Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women</brief_title>
  <official_title>A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Demonstrate dose-dependent relationship between vitamin D supplementation and rates of&#xD;
      gestational diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Determine the effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal&#xD;
      vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin&#xD;
      among pregnant women at high risk for gestational diabetes.&#xD;
&#xD;
      Explore the effect of increased vitamin D supplementation (4000 IU daily + prenatal vitamin),&#xD;
      compared to a standard prenatal vitamin, on glycemic control, need for oral hypoglycemic&#xD;
      agents and/or insulin, and delivery outcomes among the subset of women who develop&#xD;
      gestational diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Failure to recruit adequate patients&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <intervention_model_description>This will be a randomized single-center study with a target study group of 300 women. Women will be followed from enrollment through the remainder of their pregnancy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of gestational diabetes</measure>
    <time_frame>Baseline to Delivery of child</time_frame>
    <description>effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prescription for insulin or oral hypoglycemic agents</measure>
    <time_frame>Baseline to Delivery of child</time_frame>
    <description>Prescription for insulin or oral hypoglycemic agents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>Delivery of child</time_frame>
    <description>Natural or C-Section</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth weight</measure>
    <time_frame>Delivery of Child</time_frame>
    <description>Weight in Kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apgar score</measure>
    <time_frame>Birth of child to 5 minutes</time_frame>
    <description>&lt;7 at 5 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder Dystocia</measure>
    <time_frame>Birth of child</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4000 IU vitamin D3 +prenatal vitamin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>standard prenatal vitamin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>4000 IU vitamin D3</intervention_name>
    <description>vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>cholecalciferol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women who are currently pregnant and receiving prenatal care at the Women's Health&#xD;
             Specialists Clinic (University of Minnesota Physicians) from either MD/DO or CNM&#xD;
             providers&#xD;
&#xD;
          2. Subject established prenatal care no later than the completed 12th week of gestation&#xD;
             (12 6/7 weeks)&#xD;
&#xD;
          3. Subject possesses as least one of the following characteristics:&#xD;
&#xD;
               1. BMI greater than or equal to 30 kg/m2&#xD;
&#xD;
               2. History of gestational diabetes in a prior pregnancy&#xD;
&#xD;
               3. History of infant with birth weight of 4500g or greater&#xD;
&#xD;
          4. Subject is capable of giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age less than 18 years&#xD;
&#xD;
          2. Multiple gestation pregnancies (twins, triplets or greater multiples)&#xD;
&#xD;
          3. Vitamin D deficiency (defined as less than 20 ng/mL)&#xD;
&#xD;
          4. Preexisting diabetes mellitus defined as either:&#xD;
&#xD;
               1. pre-existing diagnosis prior to current pregnancy&#xD;
&#xD;
               2. failure of three-hour glucose tolerance test in first trimester of pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samantha Hoffman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Gestational Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</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>Cholecalciferol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03037593
org study id: 1611M98781
nct id: NCT03037593
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Demonstrate dose-dependent relationship between vitamin D supplementation and rates of
      gestational diabetes.
Determine the effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal
      vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin
      among pregnant women at high risk for gestational diabetes.

      Explore the effect of increased vitamin D supplementation (4000 IU daily + prenatal vitamin),
      compared to a standard prenatal vitamin, on glycemic control, need for oral hypoglycemic
      agents and/or insulin, and delivery outcomes among the subset of women who develop
      gestational diabetes.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: This will be a randomized single-center study with a target study group of 300 women. Women will be followed from enrollment through the remainder of their pregnancy
primary purpose: Treatment
masking: None (Open Label)
measure: incidence of gestational diabetes
time frame: Baseline to Delivery of child
description: effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes.
measure: Prescription for insulin or oral hypoglycemic agents
time frame: Baseline to Delivery of child
description: Prescription for insulin or oral hypoglycemic agents
measure: Mode of delivery
time frame: Delivery of child
description: Natural or C-Section
measure: Birth weight
time frame: Delivery of Child
description: Weight in Kg
measure: Apgar score
time frame: Birth of child to 5 minutes
description: <7 at 5 minutes
measure: Shoulder Dystocia
time frame: Birth of child
arm group label: Intervention
arm group type: Experimental
description: 4000 IU vitamin D3 +prenatal vitamin
arm group label: Control
arm group type: No Intervention
description: standard prenatal vitamin
intervention type: Drug
intervention name: 4000 IU vitamin D3
description: vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin
arm group label: Intervention
other name: cholecalciferol
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samantha Hoffman, MD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
mesh term: Vitamin D
mesh term: Cholecalciferol
sharing ipd: Undecided