<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/NCT03302585</url>
  </required_header>
  <id_info>
    <org_study_id>REB17-0922</org_study_id>
    <nct_id>NCT03302585</nct_id>
  </id_info>
  <brief_title>High-Dose Vitamin D Induction in Optic Neuritis</brief_title>
  <acronym>VitaDON2</acronym>
  <official_title>A Phase II Trial of High-Dose Vitamin D Induction in Optic Neuritis (VitaDON 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</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>
      This is a phase II randomized double-blind placebo/standard of care trial to determine if&#xD;
      rapidly inducing vitamin D sufficiency in patients with acute optic neuritis results in less&#xD;
      damage/greater recovery at 12 months as measured by optical coherence tomography, visual&#xD;
      evoked potentials, visual acuity and radiological measures. Our hypothesis, based on earlier&#xD;
      observational studies, is that acute optic neuritis in the context of vitamin D sufficiency&#xD;
      results in better visual outcomes compared to those that are not sufficient acutely,&#xD;
      regardless of such interventions as steroid therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present trial is based on the observation that vitamin D sufficiency appears to provide&#xD;
      some degree of neuroprotection and/or repair in the context of an acute optic neuritis when&#xD;
      followed over several months using optical coherence tomography measures. Based on these&#xD;
      findings, this randomized double-blinded placebo/standard of care controlled trial has been&#xD;
      designed to to see if rapidly inducing vitamin D sufficiency (defined in this trial as a&#xD;
      serum 25(OH)D value =&gt; 80 nmol/L) results in relatively less reduction in neuroaxonal injury&#xD;
      and/or improved recovery chronically (at month 12) versus those patients who do not achieve&#xD;
      vitamin D sufficiency in the acute optic neuritis period. of Vitamin D. In this trial, 66&#xD;
      patients in total will be randomized to either &quot;high-dose vitamin D induction&quot; treatment&#xD;
      group or the &quot;placebo/followed by standard of care vitamin D&quot; group and followed over 12&#xD;
      months.The primary measure of neuroaxonal integrity in this trial is optical coherence&#xD;
      tomography outcomes including ganglion cell layer thickness, retinal nerve fiber layer&#xD;
      thickness and macular volume. Other vision metrics and magnetic resonance imaging (MRI)&#xD;
      measures will provide secondary outcome indicators of this as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 23, 2017</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2022</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>A double-blind randomized placebo/standard therapy phase II trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Masked randomization and allocation, only data safety monitor will know allocation if adverse event requires unblinding</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Inter-eye (IED) ganglion cell layer thickness (GCL)</measure>
    <time_frame>month 12</time_frame>
    <description>The difference between the unaffected and affected eye GCL thickness between treatment and placebo group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients with GCL IED &lt;= 8 microns</measure>
    <time_frame>12 months</time_frame>
    <description>The proportion of patients with unaffected and affected eye GCL thickness of &lt; = 8 microns between groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mean GCL in affected eye over time</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>Rate of change in mean GCL thickness in affected eye over study between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean GCL in affected eye over time</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>Rate of change in mean GCL thickness in affected eye over study by 25(OH)D level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean GCL IED between eyes over time</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>Rate of change in mean GCL IED thickness in affected eye over study between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean GCL IED between eyes over time</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>Rate of change in mean GCL IED thickness in affected eye over study by 25(OH)D level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean retinal nerve fiber layer (RNFL) in affected eye over time</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>Rate of change in mean RNFL thickness in affected eye over study between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean RNFL in affected eye over time</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>Rate of change in mean RNFL thickness in affected eye over study by 25(OH)D level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean RNFL IED between eyes over time</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>Rate of change in mean RNFL and GCL thickness in affected eye over study between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean RNFL IED between eyes over time</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>Rate of change in mean RNFL and GCL thickness in affected eye over study by 25(OH)D level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean RNFL thickness</measure>
    <time_frame>baseline</time_frame>
    <description>Mean RNFL thickness at baseline and months between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean RNFL thickness</measure>
    <time_frame>1 month</time_frame>
    <description>Mean RNFL thickness at month 1 between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean RNFL thickness</measure>
    <time_frame>6 months</time_frame>
    <description>Mean RNFL thickness at month 6 between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean RNFL thickness</measure>
    <time_frame>12 months</time_frame>
    <description>Mean RNFL thickness at month 12 between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean GCL thickness</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>Mean GCL thickness at baseline between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean GCL thickness</measure>
    <time_frame>1 month</time_frame>
    <description>Mean GCL thickness at month 1 between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean GCL thickness</measure>
    <time_frame>6 months</time_frame>
    <description>Mean GCL thickness at month 6 between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean GCL thickness</measure>
    <time_frame>12 months</time_frame>
    <description>Mean GCL thickness at month 12 between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-eye RNFL thickness</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>The difference between the unaffected and affected eye RNFL thickness at baseline between treatment and placebo groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-eye RNFL thickness</measure>
    <time_frame>1 months</time_frame>
    <description>The difference between the unaffected and affected eye RNFL thickness at month 1 between treatment and placebo groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-eye RNFL thickness</measure>
    <time_frame>6 months</time_frame>
    <description>The difference between the unaffected and affected eye RNFL thickness at month 6 between treatment and placebo groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-eye RNFL thickness</measure>
    <time_frame>12 months</time_frame>
    <description>The difference between the unaffected and affected eye RNFL thickness at month 12 between treatment and placebo groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-eye GCL thickness</measure>
    <time_frame>baseline</time_frame>
    <description>The difference between the unaffected and affected eye GCL thickness at baseline between treatment and placebo groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-eye GCL thickness</measure>
    <time_frame>1 month</time_frame>
    <description>The difference between the unaffected and affected eye GCL thickness at month 1 between treatment and placebo groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-eye GCL thickness</measure>
    <time_frame>6 months</time_frame>
    <description>The difference between the unaffected and affected eye GCL thickness at month 6 between treatment and placebo groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-eye GCL thickness</measure>
    <time_frame>12 months</time_frame>
    <description>The difference between the unaffected and affected eye RNFL thickness between treatment and placebo groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean macular volume (MV)</measure>
    <time_frame>baseline</time_frame>
    <description>Mean MV at baseline between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean macular volume (MV)</measure>
    <time_frame>1 month</time_frame>
    <description>Mean MV at month 1 between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean macular volume (MV)</measure>
    <time_frame>6 months</time_frame>
    <description>Mean MV at month 6 between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean macular volume (MV)</measure>
    <time_frame>12 months</time_frame>
    <description>Mean MV at month 12 between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean multifocal VEP (MfVEP) latency</measure>
    <time_frame>1 month</time_frame>
    <description>Mean MfVEP at month 1 between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change high and low contrast visual acuity (LogMAR)</measure>
    <time_frame>12 months</time_frame>
    <description>Mean high and low contrast visual acuity (LogMAR) between groups at from baseline to month 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between baseline mean multifocal VEP latency and month-12 GCL, GCL inter-eye difference, RNFL and inter-eye RNFL difference between treatment and placebo groups</measure>
    <time_frame>12 months</time_frame>
    <description>Correlation coefficient calculation between mean multifocal VEP latency at baseline and mean GCL, GCL inter-eye difference and RNFL and inter-eye RNFL difference at month 12 between treatment and placebo groups</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Conversion to clinically definite MS (CDMS)</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of patients with clinically isolated syndromes (CIS) who convert to CDMS between groups</description>
  </other_outcome>
  <other_outcome>
    <measure>New T2 brain lesions on MRI</measure>
    <time_frame>12 months</time_frame>
    <description>Mean number of new T2 lesions over study between groups</description>
  </other_outcome>
  <other_outcome>
    <measure>New contrast enhancing brain lesions on MRI</measure>
    <time_frame>12 months</time_frame>
    <description>Mean number of new contrast enhancing lesions over study between groups</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory novel MRI outcomes - diffusion tensor imaging (DTI)</measure>
    <time_frame>12 months</time_frame>
    <description>Changes in optic nerve, tract and radiations DTI between groups over study</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory novel MRI outcomes - texture</measure>
    <time_frame>12 months</time_frame>
    <description>Changes in optic nerve, tract and radiations texture between groups over study</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory novel MRI outcomes - cross-sectional area</measure>
    <time_frame>12 months</time_frame>
    <description>Changes in optic nerve, tract and radiations cross-sectional area between groups over study</description>
  </other_outcome>
  <other_outcome>
    <measure>Thalamic volume on MRI</measure>
    <time_frame>12 months</time_frame>
    <description>Mean thalamic volume over study between groups</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Optic Neuritis</condition>
  <arm_group>
    <arm_group_label>High-Dose Vitamin D Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive:&#xD;
-5 days of high-dose oral vitamin D3 (50,000 IU daily x 5), followed by 85 days of moderate dose oral vitamin D3 (10,000 IU daily x 85 days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo/Standard Vitamin D3 Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in this arm will receive Placebo/Standard of Care Vitamin D3:&#xD;
-5 days of placebo, followed by 85 days of standard of care dose of oral vitamin D3 (4,000 IU daily x 85 days)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>50,000 IU/d of oral vitamin D3 x 5 days followed by 10,000 IU/d of oral vitamin D3 x 85 days</description>
    <arm_group_label>High-Dose Vitamin D Treatment Group</arm_group_label>
    <other_name>Vitamin D - CHOLECALCIFEROL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo/Standard of Care Vitamin D3</intervention_name>
    <description>50,000 IU/d of oral vitamin D3 x 5 days followed by 40,000 IU/d of oral vitamin D3 x 85 days</description>
    <arm_group_label>Placebo/Standard Vitamin D3 Group</arm_group_label>
    <other_name>Vitamin D - CHOLECALCIFEROL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Canadian residents&#xD;
&#xD;
          -  Patients must be between age 18 and 45 years&#xD;
&#xD;
          -  Patients must have a diagnosis of either a CIS or RRMS (according to McDonald&#xD;
             criteria)&#xD;
&#xD;
          -  Patients must have an EDSS of 5.5 or less&#xD;
&#xD;
          -  Patients must demonstrate features of a first typical optic neuritis within 21 days of&#xD;
             recruitment (or must initiate treatment by day 30)&#xD;
&#xD;
          -  Patients must have a baseline 25(OH)D &lt; 80 nmol/L regardless of vitamin D3&#xD;
             supplementation&#xD;
&#xD;
          -  Patients must have no contraindications to high-dose vitamin D supplementation&#xD;
&#xD;
          -  Female patients must consent to use a reliable form of contraception (oral&#xD;
             contraceptive pill, intrauterine device, barrier methods, abstinence) for the duration&#xD;
             of the active treatment phase (first 90 days of where study drug provided) of the&#xD;
             trial&#xD;
&#xD;
          -  Patients must provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had a previous optic neuritis&#xD;
&#xD;
          -  Patients with evidence of a non-inflammatory cause of optic neuropathy&#xD;
&#xD;
          -  Patients with evidence of neuromyelitis optica spectrum disorder or &quot;NMOSD&quot; (i.e.&#xD;
             bilateral optic neuritis, MRI evidence of longitudinally enhancing lesions involving&#xD;
             the optic nerves (involving three or more segments of the optic nerve), and/or&#xD;
             involving the optic chiasm, and optic tracts&#xD;
&#xD;
          -  Patients with a 25(OH)D &gt; 80 nmol/L&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jodie Burton, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martha Rojas Zavala</last_name>
    <phone>403 944-4244</phone>
    <email>Martha.RojasZavala@albertahealthservices.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Foothills Medical Centre, University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Jodie Burton MD, MSc, FRCPC</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Optic Neuritis</keyword>
  <keyword>Vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuritis</mesh_term>
    <mesh_term>Optic Neuritis</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/NCT03302585
org study id: REB17-0922
nct id: NCT03302585
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a phase II randomized double-blind placebo/standard of care trial to determine if
      rapidly inducing vitamin D sufficiency in patients with acute optic neuritis results in less
      damage/greater recovery at 12 months as measured by optical coherence tomography, visual
      evoked potentials, visual acuity and radiological measures. Our hypothesis, based on earlier
      observational studies, is that acute optic neuritis in the context of vitamin D sufficiency
      results in better visual outcomes compared to those that are not sufficient acutely,
      regardless of such interventions as steroid therapy.
The present trial is based on the observation that vitamin D sufficiency appears to provide
      some degree of neuroprotection and/or repair in the context of an acute optic neuritis when
      followed over several months using optical coherence tomography measures. Based on these
      findings, this randomized double-blinded placebo/standard of care controlled trial has been
      designed to to see if rapidly inducing vitamin D sufficiency (defined in this trial as a
      serum 25(OH)D value => 80 nmol/L) results in relatively less reduction in neuroaxonal injury
      and/or improved recovery chronically (at month 12) versus those patients who do not achieve
      vitamin D sufficiency in the acute optic neuritis period. of Vitamin D. In this trial, 66
      patients in total will be randomized to either "high-dose vitamin D induction" treatment
      group or the "placebo/followed by standard of care vitamin D" group and followed over 12
      months.The primary measure of neuroaxonal integrity in this trial is optical coherence
      tomography outcomes including ganglion cell layer thickness, retinal nerve fiber layer
      thickness and macular volume. Other vision metrics and magnetic resonance imaging (MRI)
      measures will provide secondary outcome indicators of this as well.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A double-blind randomized placebo/standard therapy phase II trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Masked randomization and allocation, only data safety monitor will know allocation if adverse event requires unblinding
measure: Inter-eye (IED) ganglion cell layer thickness (GCL)
time frame: month 12
description: The difference between the unaffected and affected eye GCL thickness between treatment and placebo group
measure: Proportion of patients with GCL IED <= 8 microns
time frame: 12 months
description: The proportion of patients with unaffected and affected eye GCL thickness of < = 8 microns between groups
measure: Change in mean GCL in affected eye over time
time frame: baseline to 12 months
description: Rate of change in mean GCL thickness in affected eye over study between groups
measure: Change in mean GCL in affected eye over time
time frame: baseline to 12 months
description: Rate of change in mean GCL thickness in affected eye over study by 25(OH)D level
measure: Change in mean GCL IED between eyes over time
time frame: baseline to 12 months
description: Rate of change in mean GCL IED thickness in affected eye over study between groups
measure: Change in mean GCL IED between eyes over time
time frame: baseline to 12 months
description: Rate of change in mean GCL IED thickness in affected eye over study by 25(OH)D level
measure: Change in mean retinal nerve fiber layer (RNFL) in affected eye over time
time frame: baseline to 12 months
description: Rate of change in mean RNFL thickness in affected eye over study between groups
measure: Change in mean RNFL in affected eye over time
time frame: baseline to 12 months
description: Rate of change in mean RNFL thickness in affected eye over study by 25(OH)D level
measure: Change in mean RNFL IED between eyes over time
time frame: baseline to 12 months
description: Rate of change in mean RNFL and GCL thickness in affected eye over study between groups
measure: Change in mean RNFL IED between eyes over time
time frame: baseline to 12 months
description: Rate of change in mean RNFL and GCL thickness in affected eye over study by 25(OH)D level
measure: Mean RNFL thickness
time frame: baseline
description: Mean RNFL thickness at baseline and months between groups
measure: Mean RNFL thickness
time frame: 1 month
description: Mean RNFL thickness at month 1 between groups
measure: Mean RNFL thickness
time frame: 6 months
description: Mean RNFL thickness at month 6 between groups
measure: Mean RNFL thickness
time frame: 12 months
description: Mean RNFL thickness at month 12 between groups
measure: Mean GCL thickness
time frame: baseline to 12 months
description: Mean GCL thickness at baseline between groups
measure: Mean GCL thickness
time frame: 1 month
description: Mean GCL thickness at month 1 between groups
measure: Mean GCL thickness
time frame: 6 months
description: Mean GCL thickness at month 6 between groups
measure: Mean GCL thickness
time frame: 12 months
description: Mean GCL thickness at month 12 between groups
measure: Inter-eye RNFL thickness
time frame: baseline to 12 months
description: The difference between the unaffected and affected eye RNFL thickness at baseline between treatment and placebo groups
measure: Inter-eye RNFL thickness
time frame: 1 months
description: The difference between the unaffected and affected eye RNFL thickness at month 1 between treatment and placebo groups
measure: Inter-eye RNFL thickness
time frame: 6 months
description: The difference between the unaffected and affected eye RNFL thickness at month 6 between treatment and placebo groups
measure: Inter-eye RNFL thickness
time frame: 12 months
description: The difference between the unaffected and affected eye RNFL thickness at month 12 between treatment and placebo groups
measure: Inter-eye GCL thickness
time frame: baseline
description: The difference between the unaffected and affected eye GCL thickness at baseline between treatment and placebo groups
measure: Inter-eye GCL thickness
time frame: 1 month
description: The difference between the unaffected and affected eye GCL thickness at month 1 between treatment and placebo groups
measure: Inter-eye GCL thickness
time frame: 6 months
description: The difference between the unaffected and affected eye GCL thickness at month 6 between treatment and placebo groups
measure: Inter-eye GCL thickness
time frame: 12 months
description: The difference between the unaffected and affected eye RNFL thickness between treatment and placebo groups
measure: Mean macular volume (MV)
time frame: baseline
description: Mean MV at baseline between groups
measure: Mean macular volume (MV)
time frame: 1 month
description: Mean MV at month 1 between groups
measure: Mean macular volume (MV)
time frame: 6 months
description: Mean MV at month 6 between groups
measure: Mean macular volume (MV)
time frame: 12 months
description: Mean MV at month 12 between groups
measure: Mean multifocal VEP (MfVEP) latency
time frame: 1 month
description: Mean MfVEP at month 1 between groups
measure: Mean change high and low contrast visual acuity (LogMAR)
time frame: 12 months
description: Mean high and low contrast visual acuity (LogMAR) between groups at from baseline to month 12
measure: Correlation between baseline mean multifocal VEP latency and month-12 GCL, GCL inter-eye difference, RNFL and inter-eye RNFL difference between treatment and placebo groups
time frame: 12 months
description: Correlation coefficient calculation between mean multifocal VEP latency at baseline and mean GCL, GCL inter-eye difference and RNFL and inter-eye RNFL difference at month 12 between treatment and placebo groups
measure: Conversion to clinically definite MS (CDMS)
time frame: 12 months
description: Proportion of patients with clinically isolated syndromes (CIS) who convert to CDMS between groups
measure: New T2 brain lesions on MRI
time frame: 12 months
description: Mean number of new T2 lesions over study between groups
measure: New contrast enhancing brain lesions on MRI
time frame: 12 months
description: Mean number of new contrast enhancing lesions over study between groups
measure: Exploratory novel MRI outcomes - diffusion tensor imaging (DTI)
time frame: 12 months
description: Changes in optic nerve, tract and radiations DTI between groups over study
measure: Exploratory novel MRI outcomes - texture
time frame: 12 months
description: Changes in optic nerve, tract and radiations texture between groups over study
measure: Exploratory novel MRI outcomes - cross-sectional area
time frame: 12 months
description: Changes in optic nerve, tract and radiations cross-sectional area between groups over study
measure: Thalamic volume on MRI
time frame: 12 months
description: Mean thalamic volume over study between groups
arm group label: High-Dose Vitamin D Treatment Group
arm group type: Experimental
description: Patients in this arm will receive:
-5 days of high-dose oral vitamin D3 (50,000 IU daily x 5), followed by 85 days of moderate dose oral vitamin D3 (10,000 IU daily x 85 days)
arm group label: Placebo/Standard Vitamin D3 Group
arm group type: Placebo Comparator
description: Patients in this arm will receive Placebo/Standard of Care Vitamin D3:
-5 days of placebo, followed by 85 days of standard of care dose of oral vitamin D3 (4,000 IU daily x 85 days)
intervention type: Drug
intervention name: Vitamin D3
description: 50,000 IU/d of oral vitamin D3 x 5 days followed by 10,000 IU/d of oral vitamin D3 x 85 days
arm group label: High-Dose Vitamin D Treatment Group
other name: Vitamin D - CHOLECALCIFEROL
intervention type: Drug
intervention name: Placebo/Standard of Care Vitamin D3
description: 50,000 IU/d of oral vitamin D3 x 5 days followed by 40,000 IU/d of oral vitamin D3 x 85 days
arm group label: Placebo/Standard Vitamin D3 Group
other name: Vitamin D - CHOLECALCIFEROL
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Jodie Burton, MD, MSc
role: Principal Investigator
affiliation: University of Calgary
last name: Martha Rojas Zavala
phone: 403 944-4244
email: Martha.RojasZavala@albertahealthservices.ca
facility: 
status: Recruiting
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Jodie Burton MD, MSc, FRCPC
investigator title: Assistant Professor
mesh term: Neuritis
mesh term: Optic Neuritis
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
sharing ipd: No