xml: <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/NCT06010121</url>
    </required_header>
    <id_info>
      <org_study_id>02-AP-VD</org_study_id>
      <nct_id>NCT06010121</nct_id>
    </id_info>
    <brief_title>Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3</brief_title>
    <official_title>Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AronPharma Sp. z o. o.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AronPharma Sp. z o. o.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study was to compare the profiles of 25-hydroxyvitamin D serum concentration&#xD;
        in healthy adults after 4 weeks of using vitamin D supplementation either in a liposomal or a&#xD;
        traditional formulation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be randomized, cross-over, participants will be randomly assigned to one of&#xD;
        the study groups: A) the group receiving vitamin D3 in traditional formulation B) the group&#xD;
        receiving vitamin D3 in liposomal formulation. The day before the start of supplementation&#xD;
        (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation, participants will&#xD;
        have their blood drawn. Then, after a wash-out period of 2 months, the groups will be&#xD;
        switched. Participants will again receive daily supplementation with vitamin D3 for 4 weeks.&#xD;
        Blood will be drawn before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2)&#xD;
        after the start of supplementation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 17, 2023</start_date>
    <completion_date type="Actual">June 6, 2023</completion_date>
    <primary_completion_date type="Actual">June 6, 2023</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>Crossover Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Level of 25-hydroxycholecalciferol</measure>
      <time_frame>Baseline, 2 weeks, 4 weeks</time_frame>
      <description>Comparison of the level of 25(OH)D3 achieved in the blood</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">27</enrollment>
    <condition>Bioavailability of Vitamin D</condition>
    <arm_group>
      <arm_group_label>Liposomal Vitamin D</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Daily oral dose of liposomal vitamin D for 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Traditional Vitamin D</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Daily oral dose of traditional vitamin D for 4 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Liposomal Vitamin D</intervention_name>
      <description>2000 IU of cholecalciferol in liposomal formulation</description>
      <arm_group_label>Liposomal Vitamin D</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Traditional Vitamin D</intervention_name>
      <description>2000 IU of cholecalciferol in traditional formulation</description>
      <arm_group_label>Traditional Vitamin D</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women and men, 18-60 years old.&#xD;
  &#xD;
            -  Signed informed consent.&#xD;
  &#xD;
            -  No injuries or hospitalizations within the last 3 months.&#xD;
  &#xD;
            -  No vitamin D supplementation for the 2 months prior to the study initiation.&#xD;
  &#xD;
            -  Refraining for the period of the clinical trial from consuming foods additionally&#xD;
               fortified with vitamin D and dietary supplements containing vitamin D&#xD;
  &#xD;
            -  Refraining for the period of the clinical trial from the use of cosmetic therapies&#xD;
               that use prolonged body illumination&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unwilling to give consent&#xD;
  &#xD;
            -  Injuries within the last 3 months&#xD;
  &#xD;
            -  Obesity, BMI above 30&#xD;
  &#xD;
            -  Bariatric surgery&#xD;
  &#xD;
            -  Cystic fibrosis, celiac disease, Crohn's disease&#xD;
  &#xD;
            -  Metabolic diseases&#xD;
  &#xD;
            -  Drugs reducing cholesterol absorption, thiazide diuretics, glucocorticosteroids,&#xD;
               anticonvulsants, calcium-containing preparations,&#xD;
  &#xD;
            -  Planned prolonged exposure to sunlight during the study period&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Gdański Uniwersytet Medyczny</name>
        <address>
          <city>Gdańsk</city>
          <zip>80-211</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Liposovit-D</keyword>
    <keyword>Vitamin D</keyword>
    <keyword>Cholecalciferol</keyword>
    <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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06010121
  org study id: 02-AP-VD
  nct id: NCT06010121
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study was to compare the profiles of 25-hydroxyvitamin D serum concentration
        in healthy adults after 4 weeks of using vitamin D supplementation either in a liposomal or a
        traditional formulation.
  The study will be randomized, cross-over, participants will be randomly assigned to one of
        the study groups: A) the group receiving vitamin D3 in traditional formulation B) the group
        receiving vitamin D3 in liposomal formulation. The day before the start of supplementation
        (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation, participants will
        have their blood drawn. Then, after a wash-out period of 2 months, the groups will be
        switched. Participants will again receive daily supplementation with vitamin D3 for 4 weeks.
        Blood will be drawn before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2)
        after the start of supplementation.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: Level of 25-hydroxycholecalciferol
  time frame: Baseline, 2 weeks, 4 weeks
  description: Comparison of the level of 25(OH)D3 achieved in the blood
  arm group label: Liposomal Vitamin D
  arm group type: Experimental
  description: Daily oral dose of liposomal vitamin D for 4 weeks
  arm group label: Traditional Vitamin D
  arm group type: Active Comparator
  description: Daily oral dose of traditional vitamin D for 4 weeks
  intervention type: Dietary Supplement
  intervention name: Liposomal Vitamin D
  description: 2000 IU of cholecalciferol in liposomal formulation
  arm group label: Liposomal Vitamin D
  intervention type: Dietary Supplement
  intervention name: Traditional Vitamin D
  description: 2000 IU of cholecalciferol in traditional formulation
  arm group label: Traditional Vitamin D
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  facility: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Vitamin D
  mesh term: Ergocalciferols
  mesh term: Cholecalciferol
  mesh term: Vitamins
  sharing ipd: No