<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/NCT01696526</url>
  </required_header>
  <id_info>
    <org_study_id>BMBF 0315668</org_study_id>
    <nct_id>NCT01696526</nct_id>
  </id_info>
  <brief_title>Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish</brief_title>
  <official_title>Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ulrike Lehmann</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 the bioavailability of conventional and vitamin D&#xD;
      fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: Human volunteers will receive conventional fish or vitamin D fortified fish for&#xD;
      a period of 4 weeks. At baseline and after 4 weeks, 25(OH)D3 will be measured in serum as the&#xD;
      main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH&#xD;
      concentration in serum.&#xD;
&#xD;
      Groups/Cohorts Assigned Interventions&#xD;
&#xD;
        1. Placebo group receiving conventional fish&#xD;
&#xD;
        2. intervention group receiving vitamin D fortified fish&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of 25-hydroxvitamin D</measure>
    <time_frame>after 4 weeks of consumption</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>vitamin D fortified fish</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Human volunteers receiving vitamin D fortified fish, 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional fish</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>consumption of conventional fish , 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>vitamin D fortified fish</intervention_name>
    <description>fish containing vitamin D3</description>
    <arm_group_label>vitamin D fortified fish</arm_group_label>
    <other_name>intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional fish</intervention_name>
    <description>fish containing low concentrations of vitamin D3</description>
    <arm_group_label>conventional fish</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  supplementation of vitamin d and calcium&#xD;
&#xD;
          -  hypercalcemia&#xD;
&#xD;
          -  hypercalciuria&#xD;
&#xD;
          -  chronical illness (diabetes, kidney diseases, cardiovascular diseases)&#xD;
&#xD;
          -  serum-creatinine above 115 mmol/l&#xD;
&#xD;
          -  pregnancy or breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriele I. Stangl, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Institut für Agrar- und Ernährungswissenschaften</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naturwissenschaftliche Fakultät</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>December 2012</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>December 19, 2012</last_update_submitted>
  <last_update_submitted_qc>December 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Martin-Luther-Universität Halle-Wittenberg</investigator_affiliation>
    <investigator_full_name>Ulrike Lehmann</investigator_full_name>
    <investigator_title>Scientist</investigator_title>
  </responsible_party>
  <keyword>vitamin D</keyword>
  <keyword>bioeffiency</keyword>
  <keyword>vitamin d fortified fish</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>
  </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/NCT01696526
org study id: BMBF 0315668
nct id: NCT01696526
lead sponsor: 
has dmc: Yes
The aim of this study is to investigate the bioavailability of conventional and vitamin D
      fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3.
Study design: Human volunteers will receive conventional fish or vitamin D fortified fish for
      a period of 4 weeks. At baseline and after 4 weeks, 25(OH)D3 will be measured in serum as the
      main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH
      concentration in serum.

      Groups/Cohorts Assigned Interventions

        1. Placebo group receiving conventional fish

        2. intervention group receiving vitamin D fortified fish
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: change of 25-hydroxvitamin D
time frame: after 4 weeks of consumption
arm group label: vitamin D fortified fish
arm group type: Experimental
description: Human volunteers receiving vitamin D fortified fish, 4 weeks
arm group label: conventional fish
arm group type: Placebo Comparator
description: consumption of conventional fish , 4 weeks
intervention type: Other
intervention name: vitamin D fortified fish
description: fish containing vitamin D3
arm group label: vitamin D fortified fish
other name: intervention
intervention type: Other
intervention name: conventional fish
description: fish containing low concentrations of vitamin D3
arm group label: conventional fish
other name: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gabriele I. Stangl, Prof.
role: Study Director
affiliation: Institut für Agrar- und Ernährungswissenschaften
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Martin-Luther-Universität Halle-Wittenberg
investigator full name: Ulrike Lehmann
investigator title: Scientist
mesh term: Vitamin D Deficiency
mesh term: Vitamin D