<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/NCT02243800</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0205</org_study_id>
    <nct_id>NCT02243800</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency</brief_title>
  <acronym>SCORPION</acronym>
  <official_title>Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CRINEX Laboratory</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BP 337 - 3 rue de Gentilly</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>92541 MONTROUGE Cedex FRANCE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      Vitamin D plays a key role in the regulation of calcium metabolism and bone physiology and&#xD;
      also presents immunomodulatory effects. In contrast to healthy individuals, macrophages and&#xD;
      synoviocytes synovium of patients with rheumatoid arthritis (RA) have receptors for vitamin&#xD;
      D. In vitro, 1,25 Vitamin D inhibits T cell proliferation and cytokine synthesis and&#xD;
      decreases pro-inflammatory process. There is an inverse relationship, at least in some&#xD;
      epidemiological studies, between the circulating levels of 25OH vitamin D and the occurrence&#xD;
      and / or activity of RA. The hypothesis of our study is that natural vitamin D&#xD;
      supplementation in patients with RA and a vitamin D deficiency (vitamin D &lt;30 ng / mL)&#xD;
      improves functional disability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an interventional, multicenter (13 rheumatology units) randomized, double-blinded&#xD;
      study against placebo, lasting 24 weeks. The main objective is to demonstrate that treatment&#xD;
      with cholecalciferol improves functional disability (HAQ) in patients with RA not in&#xD;
      remission (DAS28 VS&gt; 2.6 and the investigator does not think to change the treatment in the 3&#xD;
      months after enrolment) and vitamin D deficiency (vitamin D &lt;30 ng / ml). Secondary&#xD;
      objectives will be to examine whether there is a decrease in disease activity (tender joint&#xD;
      count, swollen joint count, VAS, EVA activity, ESR, CRP, EULAR criteria, ACR), a decrease in&#xD;
      fatigue (FACIT EVA - fatigue), improved quality of life (SF36, EMIR, PASS, MOS) and the&#xD;
      impact of RA (RAID).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2011</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in functional disability measured by the HAQ between the treated group and the placebo group.</measure>
    <time_frame>at day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The EULAR response criteria</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACR response criteria</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of tender joints</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of swollen joints</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS pain</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EVA activity</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parameters of inflammation</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthenia collected by VAS and FACIT - tiredness</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The impact of RA activity (RAID)</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (SF-36, EMIR, MOS, PASS)</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">164</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>cholecalciferol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One group will receive the study treatment: cholecalciferol One group will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One group will receive the study treatment: cholecalciferol One group will receive placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cholecalciferol versus placebo</intervention_name>
    <arm_group_label>cholecalciferol</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients with RA (ACR 1987) not in remission (DAS28&gt; 2.6) in whom no change in treatment&#xD;
        is considered by the investigator for at least 3 months, DMARD stable RA for at least 3&#xD;
        months and lack of infiltration in the last 2 months&#xD;
&#xD;
        - Serum 25-OH vitamin D &lt;30 ng / ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Arthritis resulting in class IV functional disability (according to the ACR criteria)&#xD;
&#xD;
          -  Hypercalcemia (serum calcium&gt; 2.6 mmol/L) and/or known hypercalciuria (calcium&#xD;
             excretion&gt; 4 mg / kg / day), history of renal colic, thiazideic therapy.&#xD;
&#xD;
          -  Known hypersensitivity to vitamin D&#xD;
&#xD;
          -  Patient refused to sign the consent form, pregnant or nursing women, patients minor,&#xD;
             major patients under protection of the Act&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin SOUBRIER</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>04 73 75 11 95</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>04 73 75 11 95</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>July 28, 2016</last_update_submitted>
  <last_update_submitted_qc>July 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <keyword>Rheumatoid arthritis</keyword>
  <keyword>Cholecalciferol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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>Cholecalciferol</mesh_term>
    <mesh_term>Vitamin D</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/NCT02243800
org study id: CHU-0205
nct id: NCT02243800
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
Vitamin D plays a key role in the regulation of calcium metabolism and bone physiology and
      also presents immunomodulatory effects. In contrast to healthy individuals, macrophages and
      synoviocytes synovium of patients with rheumatoid arthritis (RA) have receptors for vitamin
      D. In vitro, 1,25 Vitamin D inhibits T cell proliferation and cytokine synthesis and
      decreases pro-inflammatory process. There is an inverse relationship, at least in some
      epidemiological studies, between the circulating levels of 25OH vitamin D and the occurrence
      and / or activity of RA. The hypothesis of our study is that natural vitamin D
      supplementation in patients with RA and a vitamin D deficiency (vitamin D <30 ng / mL)
      improves functional disability.
This is an interventional, multicenter (13 rheumatology units) randomized, double-blinded
      study against placebo, lasting 24 weeks. The main objective is to demonstrate that treatment
      with cholecalciferol improves functional disability (HAQ) in patients with RA not in
      remission (DAS28 VS> 2.6 and the investigator does not think to change the treatment in the 3
      months after enrolment) and vitamin D deficiency (vitamin D <30 ng / ml). Secondary
      objectives will be to examine whether there is a decrease in disease activity (tender joint
      count, swollen joint count, VAS, EVA activity, ESR, CRP, EULAR criteria, ACR), a decrease in
      fatigue (FACIT EVA - fatigue), improved quality of life (SF36, EMIR, PASS, MOS) and the
      impact of RA (RAID).
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: The change in functional disability measured by the HAQ between the treated group and the placebo group.
time frame: at day 1
measure: The EULAR response criteria
time frame: at day 1
measure: ACR response criteria
time frame: at day 1
measure: The number of tender joints
time frame: at day 1
measure: The number of swollen joints
time frame: at day 1
measure: VAS pain
time frame: at day 1
measure: EVA activity
time frame: at day 1
measure: Parameters of inflammation
time frame: at day 1
measure: Asthenia collected by VAS and FACIT - tiredness
time frame: at day 1
measure: The impact of RA activity (RAID)
time frame: at day 1
measure: Quality of life (SF-36, EMIR, MOS, PASS)
time frame: at day 1
arm group label: cholecalciferol
arm group type: Experimental
description: One group will receive the study treatment: cholecalciferol One group will receive placebo
arm group label: placebo
arm group type: Placebo Comparator
description: One group will receive the study treatment: cholecalciferol One group will receive placebo
intervention type: Other
intervention name: cholecalciferol versus placebo
arm group label: cholecalciferol
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin SOUBRIER
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 04 73 75 11 95
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Vitamin D Deficiency
mesh term: Cholecalciferol
mesh term: Vitamin D