<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/NCT01711905</url>
  </required_header>
  <id_info>
    <org_study_id>0315668</org_study_id>
    <nct_id>NCT01711905</nct_id>
  </id_info>
  <brief_title>Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers</brief_title>
  <official_title>Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers - a Randomized Trail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Martin-Luther-Universität Halle-Wittenberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Federal Ministry of Education and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Martin-Luther-Universität Halle-Wittenberg</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day&#xD;
      for 12 weeks can be used to normalize vitamin d-Status&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is the objective of this study to investigate whether a supplementation with Vitamin D3&#xD;
      can be used to normalize insufficient vitamin d status and reduce atherosclerotic risk&#xD;
      factors such as hypertension, inflammation and hyperlipidemia. The research question is&#xD;
      whether Vitamin D3 reduces the level of systemic inflammation and whether Vitamin D3 has an&#xD;
      effect on blood lipids.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>25-hydroxyvitamin D3</measure>
    <time_frame>after 12 weeks of supplementation</time_frame>
    <description>major outcome variable is the increase of 25-hydroxyvitamin D3 in the treatment group in comparison with the placebo group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>atherosclerotic risk factors</measure>
    <time_frame>after 12 weeks of supplementation</time_frame>
    <description>It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 can reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammation</measure>
    <time_frame>after 12 weeks of supplementation</time_frame>
    <description>It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce inflammation as an atherosclerotic risk factor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hyperlipidemia</measure>
    <time_frame>after 12 weeks of supplementation</time_frame>
    <description>It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce hyperlipidemia as an atherosclerotic risk factor</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Deficiency of Vitamin D3</condition>
  <arm_group>
    <arm_group_label>Vitamin D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cholecalciferol 20 µg per day for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Placebo for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>daily dosage of 20 µg Vitamin D3 for 12 weeks</description>
    <arm_group_label>Vitamin D3</arm_group_label>
    <other_name>cholecalciferol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers&#xD;
&#xD;
          -  age between 18 and 70 years&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of antihypertensive medication&#xD;
&#xD;
          -  use of vitamin d or calcium supplements&#xD;
&#xD;
          -  known renal, inflammatory or malignant diseases&#xD;
&#xD;
          -  hypercalcemia or hypercalciuria&#xD;
&#xD;
          -  participation in other clinical studies&#xD;
&#xD;
          -  use of tanning booths during the study&#xD;
&#xD;
          -  pregnancy or lactating period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriele I Stangl, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Institut für Agrar- und Ernährungswissenschaften</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naturwissenschaftliche Fakultät III</name>
      <address>
        <city>Halle/Saale</city>
        <state>Sachsen-Anhalt</state>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>April 19, 2013</last_update_submitted>
  <last_update_submitted_qc>April 19, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 22, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Martin-Luther-Universität Halle-Wittenberg</investigator_affiliation>
    <investigator_full_name>Ulrike Lehmann</investigator_full_name>
    <investigator_title>Principal Investigator</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>Cholecalciferol</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/NCT01711905
org study id: 0315668
nct id: NCT01711905
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day
      for 12 weeks can be used to normalize vitamin d-Status
It is the objective of this study to investigate whether a supplementation with Vitamin D3
      can be used to normalize insufficient vitamin d status and reduce atherosclerotic risk
      factors such as hypertension, inflammation and hyperlipidemia. The research question is
      whether Vitamin D3 reduces the level of systemic inflammation and whether Vitamin D3 has an
      effect on blood lipids.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: 25-hydroxyvitamin D3
time frame: after 12 weeks of supplementation
description: major outcome variable is the increase of 25-hydroxyvitamin D3 in the treatment group in comparison with the placebo group
measure: atherosclerotic risk factors
time frame: after 12 weeks of supplementation
description: It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 can reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.
measure: inflammation
time frame: after 12 weeks of supplementation
description: It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce inflammation as an atherosclerotic risk factor
measure: hyperlipidemia
time frame: after 12 weeks of supplementation
description: It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce hyperlipidemia as an atherosclerotic risk factor
arm group label: Vitamin D3
arm group type: Experimental
description: cholecalciferol 20 µg per day for 12 weeks
arm group label: Placebo
arm group type: No Intervention
description: Placebo for 12 weeks
intervention type: Dietary Supplement
intervention name: Vitamin D3
description: daily dosage of 20 µg Vitamin D3 for 12 weeks
arm group label: Vitamin D3
other name: cholecalciferol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gabriele I Stangl, Prof. Dr.
role: Study Director
affiliation: Institut für Agrar- und Ernährungswissenschaften
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Martin-Luther-Universität Halle-Wittenberg
investigator full name: Ulrike Lehmann
investigator title: Principal Investigator
mesh term: Vitamin D
mesh term: Cholecalciferol