<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/NCT03257215</url>
  </required_header>
  <id_info>
    <org_study_id>HREC 36237</org_study_id>
    <nct_id>NCT03257215</nct_id>
  </id_info>
  <brief_title>Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? The D-Vex Pilot Study</brief_title>
  <acronym>D-Vex</acronym>
  <official_title>A Phase IV, Double-blind, Randomised, Placebo-controlled Trial to Assess the Efficacy and Safety of Stoss Versus Daily Dose Oral Vitamin D Compared to Placebo for the Treatment of Atopic Dermatitis in Pre-school Aged Children- a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Murdoch Childrens Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Murdoch Childrens Research Institute</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vitamin D is known to have a regulatory influence on both the immune system and skin barrier&#xD;
      function. Studies in paediatric populations have found an inverse association of vitamin D&#xD;
      levels and with both prevalence and severity of atopic dermatitis (AD). Trials of vitamin D&#xD;
      as a treatment for AD are limited in number and size. There has never been a&#xD;
      placebo-controlled randomised controlled trial of stoss high dose versus daily standard dose&#xD;
      for the treatment of AD. Further, no trials have explored the presence of vitamin D pathway&#xD;
      genes and response to treatment of AD. This pilot study will be used as a reference to&#xD;
      determine outcomes and feasibility for undertaking a larger and more in depth definitive&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Recruitment very slow &amp; funding difficult - exacerbated by COVID-19 pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in SCORAD</measure>
    <time_frame>Change from baseline at 3 months</time_frame>
    <description>Atopic dermatitis severity score (SCORAD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vitamin D levels</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>vitamin D level in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin D polymorphisms</measure>
    <time_frame>Baseline</time_frame>
    <description>Presence of defined vitamin D polymorphisms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunoglobulin E (IgE) (serum)</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on Parameters of bone metabolism (serum)</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Calcium, Phosphate, Parathyroid hormone, Alkaline Phosphatase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on Parameters of bone metabolism (urine)</measure>
    <time_frame>Baseline, 1 month and 3 months</time_frame>
    <description>Calcium:Creatinine (urine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (family)</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Standardised questionnaire: Family Dermatology Life Quality Index (FDLQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (child)</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Standardised questionnaire: Child Dermatology Life Quality Index (CDLQI) if &gt;= 4 years of age OR Infant Dermatology Quality of Life (IDQOL) if &lt;4 years of age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to study medications</measure>
    <time_frame>Throughout the study period, , an average of 3 months</time_frame>
    <description>Vitamin D stoss/daily and placebo stoss/daily</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Throughout the study period, an average of 3 months</time_frame>
    <description>Serious adverse events and serious adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCORAD</measure>
    <time_frame>At 3 months</time_frame>
    <description>Atopic dermatitis severity score (SCORAD)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Stoss vitamin D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stoss vitamin D at Day 1 and daily placebo for 90 days (Day 1 to 90)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Daily vitamin D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stoss placebo at Day 1 and daily vitamin D for 90 days (Day 1 to 90)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Stoss placebo at Day 1 and daily placebo for 90 days (Day 1 to 90)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Stoss vitamin D</intervention_name>
    <description>A single 1.5 mL dose containing 150,000 IU cholecalciferol (100,000 IU/mL) administered on Day 1 (Solution in Olive Oil B.P. )</description>
    <arm_group_label>Stoss vitamin D</arm_group_label>
    <other_name>Stoss cholecalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daily vitamin D</intervention_name>
    <description>Daily 0.2 mL dose containing 1000 IU cholecalciferol administered from Day 1 to 90</description>
    <arm_group_label>Daily vitamin D</arm_group_label>
    <other_name>Daily cholecalciferol (OsteVit D Liquid®)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Stoss placebo</intervention_name>
    <description>A single 1.5 mL dose administered on Day 1</description>
    <arm_group_label>Daily vitamin D</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Oral Stoss Placebo (Olive Oil B.P.)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daily placebo</intervention_name>
    <description>A once daily 0.2 mL dose administered from Day 1 to 90</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Stoss vitamin D</arm_group_label>
    <other_name>Oral Daily Placebo (to match OsteVit D Liquid®)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  moderate to severe atopic dermatitis with a SCORAD ≥ 20 at baseline.&#xD;
&#xD;
          -  aged between 1 ≤ 12 years of age at the time of randomisation.&#xD;
&#xD;
          -  regularly ingest the recommended dietary intake (RDI) of calcium and plan to do so for&#xD;
             the next 3 months&#xD;
&#xD;
          -  have a legally acceptable representative capable of understanding the informed consent&#xD;
             document and providing consent on the participant's behalf.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of vitamin D supplementation, including a stoss dose of vitamin D in the previous&#xD;
             year, or daily supplementation in the past month&#xD;
&#xD;
          -  drink vitamin D fortified formula (all formulas) as the main milk intake&#xD;
&#xD;
          -  received oral steroids within the past 6 months&#xD;
&#xD;
          -  received oral immunosuppression in the past (cyclosporine, azathioprine, methotrexate)&#xD;
&#xD;
          -  received UV therapy in the past 12 months&#xD;
&#xD;
          -  have been fully formula fed within the past 6 months&#xD;
&#xD;
          -  ave renal or liver or gastrointestinal (e.g.: coeliac, inflammatory bowel disease)&#xD;
             disease&#xD;
&#xD;
          -  receiving thiazide-type diuretics or anticonvulsant therapy&#xD;
&#xD;
          -  have ever been diagnosed with Hypercalcaemia, Hypertension or Rickets&#xD;
&#xD;
          -  unable to provide consent without the aid of an interpreter&#xD;
&#xD;
          -  in the opinion of the Investigator, are unable to follow the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kirsten P Perrett, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Murdoch Children's Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Children's Hospital Melbourne</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</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>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</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>
  <!-- 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/NCT03257215
org study id: HREC 36237
nct id: NCT03257215
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Vitamin D is known to have a regulatory influence on both the immune system and skin barrier
      function. Studies in paediatric populations have found an inverse association of vitamin D
      levels and with both prevalence and severity of atopic dermatitis (AD). Trials of vitamin D
      as a treatment for AD are limited in number and size. There has never been a
      placebo-controlled randomised controlled trial of stoss high dose versus daily standard dose
      for the treatment of AD. Further, no trials have explored the presence of vitamin D pathway
      genes and response to treatment of AD. This pilot study will be used as a reference to
      determine outcomes and feasibility for undertaking a larger and more in depth definitive
      study.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in SCORAD
time frame: Change from baseline at 3 months
description: Atopic dermatitis severity score (SCORAD)
measure: Vitamin D levels
time frame: Baseline and 3 months
description: vitamin D level in serum
measure: Vitamin D polymorphisms
time frame: Baseline
description: Presence of defined vitamin D polymorphisms
measure: Immunoglobulin E (IgE) (serum)
time frame: Baseline and 3 months
description: Serum
measure: Effects on Parameters of bone metabolism (serum)
time frame: Baseline and 3 months
description: Calcium, Phosphate, Parathyroid hormone, Alkaline Phosphatase
measure: Effects on Parameters of bone metabolism (urine)
time frame: Baseline, 1 month and 3 months
description: Calcium:Creatinine (urine)
measure: Quality of life (family)
time frame: Baseline and 3 months
description: Standardised questionnaire: Family Dermatology Life Quality Index (FDLQI)
measure: Quality of life (child)
time frame: Baseline and 3 months
description: Standardised questionnaire: Child Dermatology Life Quality Index (CDLQI) if >= 4 years of age OR Infant Dermatology Quality of Life (IDQOL) if <4 years of age
measure: Compliance to study medications
time frame: Throughout the study period, , an average of 3 months
description: Vitamin D stoss/daily and placebo stoss/daily
measure: Adverse events
time frame: Throughout the study period, an average of 3 months
description: Serious adverse events and serious adverse events
measure: SCORAD
time frame: At 3 months
description: Atopic dermatitis severity score (SCORAD)
arm group label: Stoss vitamin D
arm group type: Active Comparator
description: Stoss vitamin D at Day 1 and daily placebo for 90 days (Day 1 to 90)
arm group label: Daily vitamin D
arm group type: Active Comparator
description: Stoss placebo at Day 1 and daily vitamin D for 90 days (Day 1 to 90)
arm group label: Placebo
arm group type: Placebo Comparator
description: Stoss placebo at Day 1 and daily placebo for 90 days (Day 1 to 90)
intervention type: Drug
intervention name: Stoss vitamin D
description: A single 1.5 mL dose containing 150,000 IU cholecalciferol (100,000 IU/mL) administered on Day 1 (Solution in Olive Oil B.P. )
arm group label: Stoss vitamin D
other name: Stoss cholecalciferol
intervention type: Drug
intervention name: Daily vitamin D
description: Daily 0.2 mL dose containing 1000 IU cholecalciferol administered from Day 1 to 90
arm group label: Daily vitamin D
other name: Daily cholecalciferol (OsteVit D Liquid®)
intervention type: Drug
intervention name: Stoss placebo
description: A single 1.5 mL dose administered on Day 1
arm group label: Daily vitamin D
arm group label: Placebo
other name: Oral Stoss Placebo (Olive Oil B.P.)
intervention type: Drug
intervention name: Daily placebo
description: A once daily 0.2 mL dose administered from Day 1 to 90
arm group label: Placebo
arm group label: Stoss vitamin D
other name: Oral Daily Placebo (to match OsteVit D Liquid®)
criteria: 
gender: All
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kirsten P Perrett, MBBS
role: Principal Investigator
affiliation: Murdoch Children's Research Institute
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins