<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/NCT02212223</url>
  </required_header>
  <id_info>
    <org_study_id>Helsinki U</org_study_id>
    <nct_id>NCT02212223</nct_id>
  </id_info>
  <brief_title>Marwo-D Research -Need for Vitamin D in Different Population Groups</brief_title>
  <acronym>ODIN</acronym>
  <official_title>Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Helsinki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College Cork</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Technical University of Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Finnish Institute for Health and Welfare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Helsinki</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Insufficient intake of vitamin D is a public health problem, affecting about 40% of the&#xD;
      Finnish population in the winter. Vitamin D has a wide range of health effects: in addition&#xD;
      to its effect on bone, it is known to affect inflammatory response among other things. The&#xD;
      sources of vitamin D are the synthesis in the skin as well as diet and dietary supplements.&#xD;
      In Finland and in Northern Europe vitamin D is formed in the skin only from March to October.&#xD;
      This alone is not sufficient to cover the need for year-round, because vitamin D storage is&#xD;
      used in a few months. During the winter months the only sources of vitamin D are diet and&#xD;
      vitamin preparations. Current vitamin D recommendations are usually based on studies in white&#xD;
      population. However, there can be a difference in the need of vitamin D and in vitamin D&#xD;
      metabolism between different population groups. More research evidence is needed from the&#xD;
      northern countries. The aim of this study is to evaluate the vitamin D need in Somali&#xD;
      immigrant population and in original Finnish population. The hypothesis is that the Somalis&#xD;
      need more vitamin D to exceed the serum 25(OH)D concentration of 50 nmol/L than the original&#xD;
      Finnish population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum 25-hydroxyvitamin D (25(OH)D) concentrations</measure>
    <time_frame>Change from baseline in serum 25(OH)D concentration at 3 and 6 months</time_frame>
    <description>The effect of ethnicity on the serum 25(OH)D concentration response to vitamin D supplementation will be investigated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum calcium concentration</measure>
    <time_frame>Change from baseline in serum calcium concentration at 3 and 6 months</time_frame>
    <description>Markers of calcium metabolism, which are affected by vitamin D, will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum parathyroid hormone (PTH) concentration</measure>
    <time_frame>Change from baseline in serum PTH concentration at 3 and 6 months</time_frame>
    <description>Markers of calcium metabolism, which are affected by vitamin D, will be measured</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Polymorphisms in genes involved in the transport and metabolism of vitamin D</measure>
    <time_frame>Baseline</time_frame>
    <description>Genomic DNA will be isolated and single nucleotide polymorphisms (SNPs) for key genes involved in vitamin D transport and metabolism will be measured to investigate the ethnic variation in the genes.</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Serum 25-hydroxyvitamin D Concentrations (25OHD)</condition>
  <arm_group>
    <arm_group_label>Group 1: Somali immigrant group, 10 µg (400 IU) vitamin D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects belonging to Somali immigrant population are given a daily supplement containing 10 µg (400 IU) vitamin D3 to take for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Somali immigrant group, 20 µg (800 IU) vitamin D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects belonging to Somali immigrant population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: Somali immigrant group, 0 µg vitamin D3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects belonging to Somali immigrant population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: Original Finnish group, 10 µg (400 IU) vitamin D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects belonging to original Finnish population are given a daily supplement containing 10 µg (400 IU) vitamin D3 to take for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5: Original Finnish group, 20 µg (800 IU) vitamin D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects belonging to original Finnish population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 6: Original Finnish group, 0 µg vitamin D3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects belonging to original Finnish population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <arm_group_label>Group 1: Somali immigrant group, 10 µg (400 IU) vitamin D3</arm_group_label>
    <arm_group_label>Group 2: Somali immigrant group, 20 µg (800 IU) vitamin D3</arm_group_label>
    <arm_group_label>Group 4: Original Finnish group, 10 µg (400 IU) vitamin D3</arm_group_label>
    <arm_group_label>Group 5: Original Finnish group, 20 µg (800 IU) vitamin D3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  woman between 21-66 years of age&#xD;
&#xD;
          -  belongs to original Finnish population or to Somali immigrant population&#xD;
&#xD;
          -  healthy (= no disease requiring medication)&#xD;
&#xD;
          -  lives in the metropolitan area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or breastfeeding&#xD;
&#xD;
          -  has traveled to a sunny destination or destination near the equator during the&#xD;
             previous month&#xD;
&#xD;
          -  plans to travel to a sunny destination or destination near the equator in the next 6&#xD;
             months&#xD;
&#xD;
          -  has used a tanning bed during the previous month&#xD;
&#xD;
          -  plans to use a tanning bed in the next 6 months&#xD;
&#xD;
          -  the subject's blood 25-hydroxy-vitamin D level (25 (OH) D), exceeds 100 nmol / L or is&#xD;
             less than 30 nmol / L at baseline in the screening phase.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>66 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christel Lamberg-Allardt, Professor</last_name>
    <role>Study Director</role>
    <affiliation>University of Helsinki</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Food and Environmental Sciences, University of Helsinki</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>July 12, 2015</last_update_submitted>
  <last_update_submitted_qc>July 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Helsinki</investigator_affiliation>
    <investigator_full_name>Christel Lamberg-Allardt</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <keyword>Serum 25-hydroxyvitamin D (25OHD)</keyword>
  <keyword>Dietary supplement</keyword>
  <keyword>Ethnicity</keyword>
  <keyword>Immigrant</keyword>
  <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/NCT02212223
org study id: Helsinki U
nct id: NCT02212223
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Insufficient intake of vitamin D is a public health problem, affecting about 40% of the
      Finnish population in the winter. Vitamin D has a wide range of health effects: in addition
      to its effect on bone, it is known to affect inflammatory response among other things. The
      sources of vitamin D are the synthesis in the skin as well as diet and dietary supplements.
      In Finland and in Northern Europe vitamin D is formed in the skin only from March to October.
      This alone is not sufficient to cover the need for year-round, because vitamin D storage is
      used in a few months. During the winter months the only sources of vitamin D are diet and
      vitamin preparations. Current vitamin D recommendations are usually based on studies in white
      population. However, there can be a difference in the need of vitamin D and in vitamin D
      metabolism between different population groups. More research evidence is needed from the
      northern countries. The aim of this study is to evaluate the vitamin D need in Somali
      immigrant population and in original Finnish population. The hypothesis is that the Somalis
      need more vitamin D to exceed the serum 25(OH)D concentration of 50 nmol/L than the original
      Finnish population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Serum 25-hydroxyvitamin D (25(OH)D) concentrations
time frame: Change from baseline in serum 25(OH)D concentration at 3 and 6 months
description: The effect of ethnicity on the serum 25(OH)D concentration response to vitamin D supplementation will be investigated.
measure: Serum calcium concentration
time frame: Change from baseline in serum calcium concentration at 3 and 6 months
description: Markers of calcium metabolism, which are affected by vitamin D, will be measured
measure: Serum parathyroid hormone (PTH) concentration
time frame: Change from baseline in serum PTH concentration at 3 and 6 months
description: Markers of calcium metabolism, which are affected by vitamin D, will be measured
measure: Polymorphisms in genes involved in the transport and metabolism of vitamin D
time frame: Baseline
description: Genomic DNA will be isolated and single nucleotide polymorphisms (SNPs) for key genes involved in vitamin D transport and metabolism will be measured to investigate the ethnic variation in the genes.
arm group label: Group 1: Somali immigrant group, 10 µg (400 IU) vitamin D3
arm group type: Experimental
description: Subjects belonging to Somali immigrant population are given a daily supplement containing 10 µg (400 IU) vitamin D3 to take for 6 months
arm group label: Group 2: Somali immigrant group, 20 µg (800 IU) vitamin D3
arm group type: Experimental
description: Subjects belonging to Somali immigrant population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months
arm group label: Group 3: Somali immigrant group, 0 µg vitamin D3
arm group type: Placebo Comparator
description: Subjects belonging to Somali immigrant population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months
arm group label: Group 4: Original Finnish group, 10 µg (400 IU) vitamin D3
arm group type: Experimental
description: Subjects belonging to original Finnish population are given a daily supplement containing 10 µg (400 IU) vitamin D3 to take for 6 months.
arm group label: Group 5: Original Finnish group, 20 µg (800 IU) vitamin D3
arm group type: Experimental
description: Subjects belonging to original Finnish population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months.
arm group label: Group 6: Original Finnish group, 0 µg vitamin D3
arm group type: Placebo Comparator
description: Subjects belonging to original Finnish population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months.
intervention type: Dietary Supplement
intervention name: Vitamin D3
arm group label: Group 1: Somali immigrant group, 10 µg (400 IU) vitamin D3
arm group label: Group 2: Somali immigrant group, 20 µg (800 IU) vitamin D3
arm group label: Group 4: Original Finnish group, 10 µg (400 IU) vitamin D3
arm group label: Group 5: Original Finnish group, 20 µg (800 IU) vitamin D3
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 66 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christel Lamberg-Allardt, Professor
role: Study Director
affiliation: University of Helsinki
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: University of Helsinki
investigator full name: Christel Lamberg-Allardt
investigator title: Associate Professor
mesh term: Vitamin D
mesh term: Cholecalciferol