<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/NCT03272126</url>
  </required_header>
  <id_info>
    <org_study_id>TromsøEndo-2017-1</org_study_id>
    <nct_id>NCT03272126</nct_id>
  </id_info>
  <brief_title>Importance of Dosing Regimen for the Effect of Vitamin D Supplementation</brief_title>
  <official_title>Importance of Dosing Regimen for the Effect of Vitamin D Supplementation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tromso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Tromso</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>
      Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the&#xD;
      body. Lack of vitamin D is associated with cardio-vascular disease (CVD), type 2 diabetes,&#xD;
      cancer, infectious and immunological diseases, as well as risk factors for these diseases.&#xD;
      However, intervention studies with vitamin D have been inconclusive regarding diseases and&#xD;
      risk factors. This could be due to inclusion of subjects already vitamin D sufficient, and&#xD;
      short and underpowered studies. In addition, there are indications that the dosing regimens&#xD;
      may be important, so that daily doses with vitamin D are more efficient than intermittent&#xD;
      doses, which so far have been generally used. This could be related to the concentration of&#xD;
      circulating and thereby intracellular vitamin D concentrations, which probably is dependent&#xD;
      on daily vitamin D doses. This will be tested in the present study where 60 subjects will be&#xD;
      randomized to vitamin D 160 000 once, vitamin D 4000 IU/day, or placebo for four weeks. The&#xD;
      primary endpoints will be effects on serum hepcidin and plasma cathelicidin after 4 weeks,&#xD;
      with effects on serum PTH, RNA expression and microRNA in peripheral blood, telomerase&#xD;
      activity in peripheral blood mononuclear cells and the ration between serum 1,25(OH)2D and&#xD;
      24,25(OH)2D as secondary endpoints.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hepcidin change</measure>
    <time_frame>4 weeks</time_frame>
    <description>Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum hepcidin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in serum PTH after 1 month</measure>
    <time_frame>4 weeks</time_frame>
    <description>Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum PTH, cathelicidin, RNA expression and micro RNA in peripheral blood, telomerase activity and the ratio between 1,25(OH)2D and 24,25(OH)2D, after 1 month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in micro RNA Expression after 1 month</measure>
    <time_frame>4 weeks</time_frame>
    <description>Difference between vitamin D given as a bolus 160 000IU vs 4000 IU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in serum cathelicidin after 1 month</measure>
    <time_frame>4 weeks</time_frame>
    <description>Difference between vitamin D given as a bolus 160 000IU vs 4000 IU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in RNA Expression after 1 month</measure>
    <time_frame>4 weeks</time_frame>
    <description>Difference between vitamin D given as a bolus 160 000IU vs 4000 IU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in telomerase Activity after 1 month</measure>
    <time_frame>4 weeks</time_frame>
    <description>Difference between vitamin D given as a bolus 160 000IU vs 4000 IU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in ratio between 1,24(OH)2D and 24,24(OH)2D after 1 month</measure>
    <time_frame>4 weeks</time_frame>
    <description>Difference between vitamin D given as a bolus 160 000IU vs 4000 IU</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Hypovitaminosis D</condition>
  <arm_group>
    <arm_group_label>vitamin D bolus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vitamin D 160 000 IU given as bolus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vitamin D daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vitamin D 4000 IU daily for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>identical looking as vitamin d</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>vitamin D given as bolus versus daily dosing</description>
    <arm_group_label>vitamin D bolus</arm_group_label>
    <arm_group_label>vitamin D daily</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>identical looking as vitamin D</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:- Males and females 20 - 70 years&#xD;
&#xD;
          -  20 kg/m2 &gt; BMI &lt; 35 kg/m2&#xD;
&#xD;
          -  systolic BP &lt; 175 mmHg, diastolic BP &lt; 105 mmHg&#xD;
&#xD;
          -  Serum 25(OH)D level &lt; 50 nmol/L. Serum 25(OH)D &lt; 50 nmol/L is considered as vitamin D&#xD;
             deficiency, and accordingly, effects of vitamin D supplementation will be easier to&#xD;
             detect than if the included subjects were vitamin D sufficient.&#xD;
&#xD;
          -  Hgb, SR, CRP, creatinine &lt; 130 umol/L in males, &lt; 120 umol/L in females, calcium, FT4&#xD;
             and TSH within the normal reference range; ASAT &lt; 90 mU/L ALAT &lt; 140 U/L, HbA1c &lt; 6.6&#xD;
             %&#xD;
&#xD;
          -  The subjects must agree not to take any vitamin D supplementation, including cod liver&#xD;
             oil or &quot;mølje&quot;, use solarium or go on sunny vacation during the intervention period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects allergic to peanuts&#xD;
&#xD;
          -  subjects with primary hyperparathyroidism&#xD;
&#xD;
          -  granulomatous diseases (sarcoidosis, tuberculosis, Wegner's granulomatosis)&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  renal stones the last five years&#xD;
&#xD;
          -  subjects seriously ill (or with chronic disease) and unfit for participation in the&#xD;
             study (as judged by one of the study doctors)&#xD;
&#xD;
          -  subjects using vitamin D supplements exceeding 800 IU per day or active vitamin D&#xD;
             drugs (Rocaltrol or Etalpha)&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>rolf jorde, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UiT, Tromsø</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of North Norway</name>
      <address>
        <city>Tromsø</city>
        <zip>9038</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>June 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>May 23, 2018</last_update_submitted>
  <last_update_submitted_qc>May 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rickets</mesh_term>
    <mesh_term>Avitaminosis</mesh_term>
    <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>
  <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/NCT03272126
org study id: TromsøEndo-2017-1
nct id: NCT03272126
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the
      body. Lack of vitamin D is associated with cardio-vascular disease (CVD), type 2 diabetes,
      cancer, infectious and immunological diseases, as well as risk factors for these diseases.
      However, intervention studies with vitamin D have been inconclusive regarding diseases and
      risk factors. This could be due to inclusion of subjects already vitamin D sufficient, and
      short and underpowered studies. In addition, there are indications that the dosing regimens
      may be important, so that daily doses with vitamin D are more efficient than intermittent
      doses, which so far have been generally used. This could be related to the concentration of
      circulating and thereby intracellular vitamin D concentrations, which probably is dependent
      on daily vitamin D doses. This will be tested in the present study where 60 subjects will be
      randomized to vitamin D 160 000 once, vitamin D 4000 IU/day, or placebo for four weeks. The
      primary endpoints will be effects on serum hepcidin and plasma cathelicidin after 4 weeks,
      with effects on serum PTH, RNA expression and microRNA in peripheral blood, telomerase
      activity in peripheral blood mononuclear cells and the ration between serum 1,25(OH)2D and
      24,25(OH)2D as secondary endpoints.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Hepcidin change
time frame: 4 weeks
description: Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum hepcidin
measure: Difference in serum PTH after 1 month
time frame: 4 weeks
description: Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum PTH, cathelicidin, RNA expression and micro RNA in peripheral blood, telomerase activity and the ratio between 1,25(OH)2D and 24,25(OH)2D, after 1 month
measure: Difference in micro RNA Expression after 1 month
time frame: 4 weeks
description: Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
measure: Difference in serum cathelicidin after 1 month
time frame: 4 weeks
description: Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
measure: Difference in RNA Expression after 1 month
time frame: 4 weeks
description: Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
measure: Difference in telomerase Activity after 1 month
time frame: 4 weeks
description: Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
measure: Difference in ratio between 1,24(OH)2D and 24,24(OH)2D after 1 month
time frame: 4 weeks
description: Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
arm group label: vitamin D bolus
arm group type: Experimental
description: vitamin D 160 000 IU given as bolus
arm group label: vitamin D daily
arm group type: Experimental
description: vitamin D 4000 IU daily for 28 days
arm group label: placebo
arm group type: Placebo Comparator
description: identical looking as vitamin d
intervention type: Drug
intervention name: Vitamin D
description: vitamin D given as bolus versus daily dosing
arm group label: vitamin D bolus
arm group label: vitamin D daily
intervention type: Drug
intervention name: Placebo
description: identical looking as vitamin D
arm group label: placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: rolf jorde, MD PhD
role: Principal Investigator
affiliation: UiT, Tromsø
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Rickets
mesh term: Avitaminosis
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
sharing ipd: No