<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/NCT03810261</url>
  </required_header>
  <id_info>
    <org_study_id>VITAD-01-2018 Part 2</org_study_id>
    <nct_id>NCT03810261</nct_id>
  </id_info>
  <brief_title>Challenges in Achieving Adequate Vitamin D Status in the Adult Population/ Part 2</brief_title>
  <acronym>VITAD/2</acronym>
  <official_title>Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nutrition Institute, Slovenia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VIST - Faculty of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Slovenian Research Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Valens Int. d.o.o., Slovenija</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nutrition Institute, Slovenia</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 efficiency of different vitamin D formulations in treating suboptimal vitamin D status in&#xD;
      adult population will be determined. It will provide insights into the influence of&#xD;
      formulation on vitamin D absorption.&#xD;
&#xD;
      A randomised controlled intervention trial will be conducted on at least 72 subjects (18-65&#xD;
      years) with suboptimal Vitamin D status. Subjects will be selected from a pool of subjects in&#xD;
      Part 1 of the study, after completion of winter sampling.&#xD;
&#xD;
      Study subjects will be randomised into four study groups (at least 18 subjects per study&#xD;
      group). Three different treatments will be compared with a control group, which will not&#xD;
      receive any supplemental Vitamin D. The three tested Vitamin D preparations in the treatment&#xD;
      groups will be (A) oil-based VALENS vitamin D; (B) water-based VALENS vitamin D; and (C)&#xD;
      Vitamin D capsules with starch-adsorbed vitamin D (powder). All these products are&#xD;
      commercially available. Prior to study, actual level of vitamin D will be determined using&#xD;
      appropriate analytical method. The treatment will be with 1000 IU Vitamin D per day, for two&#xD;
      months, in all three groups. Second serum vitamin D level will be determined on last day of&#xD;
      the treatment, and compared with pre-treatment vitamin D level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">April 2, 2019</completion_date>
  <primary_completion_date type="Actual">April 2, 2019</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in vitamin D serum concentration after 8 weeks of supplementation</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Oil-based vitamin D group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oil-based vitamin D, 1000 IU/day for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Water-based vitamin D group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Water-based vitamin D, 1000 IU/day for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D capsules group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receive no intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oil-based vitamin D</intervention_name>
    <description>Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks.</description>
    <arm_group_label>Oil-based vitamin D group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Water-based vitamin D</intervention_name>
    <description>Participants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks.</description>
    <arm_group_label>Water-based vitamin D group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D capsules</intervention_name>
    <description>Participants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks.</description>
    <arm_group_label>Vitamin D capsules group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  vitamin D suboptimal status&#xD;
&#xD;
          -  Signed Informed consent form (ICF),&#xD;
&#xD;
          -  Caucasian race&#xD;
&#xD;
          -  Age between 18 and 65 years at the time of the signature of Informed consent form&#xD;
             (ICF),&#xD;
&#xD;
          -  Willingness to avoid a consumption of any food supplements containing Vitamin D during&#xD;
             the study, except the ones prescribed by the study researchers, and to avoid use of&#xD;
             solarium or other artificial UVB sources&#xD;
&#xD;
          -  Willingness to follow all study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breastfeeding,&#xD;
&#xD;
          -  Known or suspected allergy to any ingredient of the tested products in Part 2,&#xD;
&#xD;
          -  Pronounced avoidance of sunshine (eg reporting of allergy to the sun)&#xD;
&#xD;
          -  Use of food supplements containing Vitamin D or fish oil or omega 3 fatty acids in&#xD;
             last three months prior to inclusion,&#xD;
&#xD;
          -  Special dietary habits used by a small part of the population (veganism, low-carb&#xD;
             high-fat (LCHF) diet, caloric restriction diet, note: vegetarians are not excluded)&#xD;
&#xD;
          -  Diets prescribed by the medical profession&#xD;
&#xD;
          -  Disorders of the kidneys, thyroid, digestive tract, osteoporosis and other bone&#xD;
             diseases, skin diseases&#xD;
&#xD;
          -  Other diseases and conditions that affect the absorption and synthesis of vitamin D&#xD;
&#xD;
          -  Exposure to stronger sunlight in the last three months prior to engaging in a survey&#xD;
             (travel to countries with stronger sunshine, use of solarium),&#xD;
&#xD;
          -  The consumption of margarine or plant substitutes for milk / milk products several&#xD;
             times a day, as these foods are most often enriched with vitamin D,&#xD;
&#xD;
          -  Visiting the solarium in the last three months before joining the survey,&#xD;
&#xD;
          -  Mental incapacity that precludes adequate understanding or cooperation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katja Žmitek, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Researcher</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nutrition Institute, Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <link>
    <url>https://www.mdpi.com/2072-6643/12/5/1268/htm</url>
    <description>Study results: Efficiency of Vitamin D Supplementation in Healthy Adults is Associated with Body Mass Index and Baseline Serum 25-Hydroxyvitamin D Level</description>
  </link>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>June 16, 2021</last_update_submitted>
  <last_update_submitted_qc>June 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</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/NCT03810261
org study id: VITAD-01-2018 Part 2
nct id: NCT03810261
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The efficiency of different vitamin D formulations in treating suboptimal vitamin D status in
      adult population will be determined. It will provide insights into the influence of
      formulation on vitamin D absorption.

      A randomised controlled intervention trial will be conducted on at least 72 subjects (18-65
      years) with suboptimal Vitamin D status. Subjects will be selected from a pool of subjects in
      Part 1 of the study, after completion of winter sampling.

      Study subjects will be randomised into four study groups (at least 18 subjects per study
      group). Three different treatments will be compared with a control group, which will not
      receive any supplemental Vitamin D. The three tested Vitamin D preparations in the treatment
      groups will be (A) oil-based VALENS vitamin D; (B) water-based VALENS vitamin D; and (C)
      Vitamin D capsules with starch-adsorbed vitamin D (powder). All these products are
      commercially available. Prior to study, actual level of vitamin D will be determined using
      appropriate analytical method. The treatment will be with 1000 IU Vitamin D per day, for two
      months, in all three groups. Second serum vitamin D level will be determined on last day of
      the treatment, and compared with pre-treatment vitamin D level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in vitamin D serum concentration after 8 weeks of supplementation
time frame: 8 weeks
arm group label: Oil-based vitamin D group
arm group type: Experimental
description: Oil-based vitamin D, 1000 IU/day for 8 weeks
arm group label: Water-based vitamin D group
arm group type: Experimental
description: Water-based vitamin D, 1000 IU/day for 8 weeks
arm group label: Vitamin D capsules group
arm group type: Experimental
description: Vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks
arm group label: Control group
arm group type: No Intervention
description: This group will receive no intervention.
intervention type: Dietary Supplement
intervention name: Oil-based vitamin D
description: Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks.
arm group label: Oil-based vitamin D group
intervention type: Dietary Supplement
intervention name: Water-based vitamin D
description: Participants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks.
arm group label: Water-based vitamin D group
intervention type: Dietary Supplement
intervention name: Vitamin D capsules
description: Participants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks.
arm group label: Vitamin D capsules group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Katja Žmitek, PhD
role: Principal Investigator
affiliation: Researcher
facility: 
country: Slovenia
url: https://www.mdpi.com/2072-6643/12/5/1268/htm
description: Study results: Efficiency of Vitamin D Supplementation in Healthy Adults is Associated with Body Mass Index and Baseline Serum 25-Hydroxyvitamin D Level
responsible party type: Sponsor
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
sharing ipd: No