<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/NCT03035084</url>
  </required_header>
  <id_info>
    <org_study_id>RAC2161235</org_study_id>
    <nct_id>NCT03035084</nct_id>
  </id_info>
  <brief_title>Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena?</brief_title>
  <official_title>Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena? A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Faisal Specialist Hospital &amp; Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Faisal Specialist Hospital &amp; Research Center</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>
      Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3&#xD;
      level and therefore have proposed that D3 would be preferable in term of raising total&#xD;
      25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in&#xD;
      25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being&#xD;
      specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in&#xD;
      25(OH)D2 level.&#xD;
&#xD;
      The investigators plan to conduct a double-blind placebo-controlled trial to examine the&#xD;
      effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">November 20, 2017</completion_date>
  <primary_completion_date type="Actual">November 20, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1</measure>
    <time_frame>day 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2</measure>
    <time_frame>day 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1</measure>
    <time_frame>day 56</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2</measure>
    <time_frame>day 56</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level</measure>
    <time_frame>day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level</measure>
    <time_frame>day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group</measure>
    <time_frame>day 28</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <condition>25-Hydroxyvitamin D Concentration</condition>
  <arm_group>
    <arm_group_label>Group-2-D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group-2-Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group-1-D2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less= 65 nmol/l will be randomly assigned to vitamin D2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group-1-Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less =65 nmol/l will be randomly assigned to placebo oral capsule.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>Single oral dose of 50,000 IU of vitamin D3</description>
    <arm_group_label>Group-2-D3</arm_group_label>
    <other_name>cholecalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D2</intervention_name>
    <description>Single oral dose of 50,000 IU of vitamin D2</description>
    <arm_group_label>Group-1-D2</arm_group_label>
    <arm_group_label>Group-2-D3</arm_group_label>
    <arm_group_label>Group-2-Placebo</arm_group_label>
    <other_name>Ergocalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Placebo oral capsule</description>
    <arm_group_label>Group-1-Placebo</arm_group_label>
    <arm_group_label>Group-2-Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  non-pregnant adults (age ≥18 years)&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  total 25(OH)D level between 20 to 65 nmol/L.&#xD;
&#xD;
          -  living in Riyadh area&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  consumption of more than one serving of milk daily&#xD;
&#xD;
          -  taking vitamin D supplements&#xD;
&#xD;
          -  habitual weekly sun exposure of 10 hours or more&#xD;
&#xD;
          -  history of granulomatous, liver, or kidney disease&#xD;
&#xD;
          -  taking anticonvulsants, barbiturates, or steroids&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muhammad M Hammami, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Faisal Specialist Hospital &amp; Research Center (Riydah)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King Faisal Specialist Hospital &amp; Research Center</name>
      <address>
        <city>Riyadh</city>
        <state>Central</state>
        <zip>11211</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>August 9, 2018</last_update_submitted>
  <last_update_submitted_qc>August 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03035084
org study id: RAC2161235
nct id: NCT03035084
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3
      level and therefore have proposed that D3 would be preferable in term of raising total
      25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in
      25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being
      specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in
      25(OH)D2 level.

      The investigators plan to conduct a double-blind placebo-controlled trial to examine the
      effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
time frame: day 28
measure: ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
time frame: day 28
measure: ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
time frame: day 56
measure: ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
time frame: day 56
measure: Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level
time frame: day 28
measure: Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level
time frame: day 28
measure: Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group
time frame: day 28
arm group label: Group-2-D3
arm group type: Experimental
description: Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3
arm group label: Group-2-Placebo
arm group type: Placebo Comparator
description: Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule.
arm group label: Group-1-D2
arm group type: Experimental
description: Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less= 65 nmol/l will be randomly assigned to vitamin D2.
arm group label: Group-1-Placebo
arm group type: Placebo Comparator
description: Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less =65 nmol/l will be randomly assigned to placebo oral capsule.
intervention type: Drug
intervention name: Vitamin D3
description: Single oral dose of 50,000 IU of vitamin D3
arm group label: Group-2-D3
other name: cholecalciferol
intervention type: Drug
intervention name: Vitamin D2
description: Single oral dose of 50,000 IU of vitamin D2
arm group label: Group-1-D2
arm group label: Group-2-D3
arm group label: Group-2-Placebo
other name: Ergocalciferol
intervention type: Drug
intervention name: Placebo oral capsule
description: Placebo oral capsule
arm group label: Group-1-Placebo
arm group label: Group-2-Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Muhammad M Hammami, MD, PhD
role: Principal Investigator
affiliation: King Faisal Specialist Hospital & Research Center (Riydah)
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
sharing ipd: Undecided