<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/NCT02192229</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1150-5248</org_study_id>
    <nct_id>NCT02192229</nct_id>
  </id_info>
  <brief_title>Efficacy of the Dose Regimen of Oral Vitamin D 50,000 IU in the Treatment of Vitamin D Deficiency</brief_title>
  <official_title>Safety and Efficacy Evaluation of the Dose Regimen of Vitamin D 50,000 IU(Biodal) Tablet Supplementation in the Treatment of Population With Vitamin D Deficiency.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hayat Pharmaceutical Co. PLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hayat Pharmaceutical Co. PLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abstract:&#xD;
&#xD;
      The main objective of the proposed study is to examine the Safety and Efficacy Evaluation of&#xD;
      the Dose Regimen of Vitamin D 50,000 IU (Biodal) tablet supplementation in the treatment of&#xD;
      population with vitamin D deficiency.&#xD;
&#xD;
      A randomized, double-blind placebo, Parallel design comparing vitamin D with Placebo will be&#xD;
      conducted on 60 Healthy males and females with vitamin D deficiency, age from 18 to 49 years&#xD;
      who attend the rehabilitation clinics at Jordan University Hospital .Participants who met the&#xD;
      inclusion criteria will be asked to sign an informed witnessed consent form. Results obtained&#xD;
      are expected to assess the safety and efficacy of the dose regimen used in this study as per&#xD;
      Biodal SmPC. This study will also contribute to the global body of knowledge in this field.&#xD;
      The major findings generated from this study could open certain avenues for further research&#xD;
      through the association of the status of vitamin D in serum .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design will be a prospective randomized double blind parallel design comparing&#xD;
      Vitamin D with Placebo. This study will be conducted in Jordan University Hospital (JUH). The&#xD;
      participants will be Healthy males and females with vitamin D deficiency (18 to 49 years&#xD;
      old). All eligible males and females who agree to participate in the study will sign an&#xD;
      informed witnessed consent form at the beginning of the study. The expected duration of&#xD;
      participants participation will be around 120 days and the number of visits for each&#xD;
      participant will be 6 visits divided as follows; the first visit will be before 7 days of the&#xD;
      initiation of the trial (screening period), the second on day zero of the treatment period,&#xD;
      the third on day 30, the fourth on day 60, the fifth on day 90 and the sixth or the last&#xD;
      visit will be on day 104 (after 14 days of the last treatment). Therefore the treatment&#xD;
      period will be 90 days and the post treatment follow up period will be 14 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the effectiveness of the dose regimen considered in this study as the product SmPC which will be measured through the assessment of serum 25 (OH)D along the trial period.</measure>
    <time_frame>14 weeks</time_frame>
    <description>To assess the dose regimen effectiveness used in this study as per Biodal SmPC.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessing the level of (Urine analysis, Hematology ,Kidney Function Test,Liver Function Test, Virology, chemistry, 25(OH)D, Ca, Mg, Phosphate, Parathyroid hormone, Alkaline Phosphatase ) and reporting any adverse events through the trial period.</measure>
    <time_frame>14 weeks</time_frame>
    <description>Evaluation of the safety of the dose regimen of vitamin D3 supplementation which will be measured by assessing the level of laboratory tests which including (Urine analysis Hematology Kidney function tests, Liver function test, Virology, Clinical chemistry, 25(OH)D, Ca, Mg, PO4, PTH , Alkaline Phosphatase and pregnancy test for married females), Physical examinations ,ECG examination, vital signs, and reporting any adverse events through the trial period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention group will be supplemented with 50.000 IU vitamin D3 every week for 12 consecutive weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo group will receive placebo Tablet which will be manufactured in a pharmaceutical factory to be identical to vitamin D3 Tablet in color, shape, size, and packaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>50.000 IU vitamin D3 (Biodal 50,000 IU)</intervention_name>
    <arm_group_label>intervention group</arm_group_label>
    <other_name>Biodal 50,000 IU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (to mimic Biodal 50,000 IU)</intervention_name>
    <description>Placebo Tablet will be manufactured in a pharmaceutical factory to be identical to vitamin D3 Tablet in color, shape, size, and packaging</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Subject is willing and able to give voluntary informed consent for participation in&#xD;
             the study.&#xD;
&#xD;
          -  Ethnic group (Caucasian).&#xD;
&#xD;
          -  Healthy males or females aged between 18 and 49 years old.&#xD;
&#xD;
          -  Normal weight (BMI 18.5-25kg/m2).&#xD;
&#xD;
          -  Physical examination being assessed and accepted by the attending physician.&#xD;
&#xD;
          -  Systolic blood pressure within the normal range (90-140) mmHg.&#xD;
&#xD;
          -  Diastolic blood pressure within the normal range (60-90) mmHg.&#xD;
&#xD;
          -  Heart rate within the normal range (60-100 beats/min).&#xD;
&#xD;
          -  Oral body temperature within the normal range (35.9 - 37.6 Cº).&#xD;
&#xD;
          -  Diagnosed with vitamin D deficiency with 25-OH Vitamin D level &lt; 20ng/ml.&#xD;
&#xD;
          -  All laboratory tests which including : Urine analysis, Hematology (Hb, Packed Cell&#xD;
             Volume, Red Blood Cell, Mean Corpuscular Hemoglobin , Mean Corpuscular Hemoglobin&#xD;
             Concentration , Mea Corpuscular Volume, Leukocytes, Lymphocytes, Eosinophils,&#xD;
             Basophils, Monocytes, Neutrophils, Platelet count), Kidney function tests, Liver&#xD;
             function test, Virology, Clinical chemistry, Ca, Mg, PO4, PTH , Alkaline Phosphatase&#xD;
             and pregnancy test for married females ,results within the normal reference range.&#xD;
&#xD;
          -  Able and willing to comply with all study requirements.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        The subject may not enter the study if ANY of the following apply:&#xD;
&#xD;
          -  Female subjects who is pregnant, lactating or planning pregnancy during the course of&#xD;
             the study.&#xD;
&#xD;
          -  Ethnic group non Caucasian.&#xD;
&#xD;
          -  Males and Females aged &lt;18 or &gt;49 years old.&#xD;
&#xD;
          -  Underweight, overweight and obese Females and males&#xD;
&#xD;
          -  Males and Females diagnosed with diabetes, hypothyroidism, hyperthyroidism, liver&#xD;
             disease, renal dysfunction, cardiovascular diseases including hypertension,&#xD;
             androgen-secreting tumor, Cushing syndrome, congenital adrenal hyperplasia,&#xD;
             hyperprolactinemia, and/or virilism.&#xD;
&#xD;
          -  Known history or presence of food allergies or intolerance (e.g dairy products or&#xD;
             gluten containing food), or any known condition that could interfere with the&#xD;
             absorption, distribution, metabolism or execration of drugs.&#xD;
&#xD;
          -  History of drug or alcohol abuse, smoking of 10 cigarettes or more (or equivalent) per&#xD;
             day.&#xD;
&#xD;
          -  Subjects who took medications known to affect metabolic parameters, such as metformin&#xD;
             and corticosteroid drugs, vitamin D and calcium.&#xD;
&#xD;
          -  Participation in another clinical or bioequivalence study within 90 days prior to the&#xD;
             start of this study period.&#xD;
&#xD;
          -  Subjects with abnormal ECG.&#xD;
&#xD;
          -  Subjects with any abnormal laboratory results except 25 OH-Cholecalciferol level.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Talal Aburjai, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Jordan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ziad Hawamdeh, Prof</last_name>
    <phone>+962 799 060 814</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Jordan University Hospital</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>December 23, 2013</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</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>Cholecalciferol</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/NCT02192229
org study id: U1111-1150-5248
nct id: NCT02192229
lead sponsor: 
has dmc: Yes
Abstract:

      The main objective of the proposed study is to examine the Safety and Efficacy Evaluation of
      the Dose Regimen of Vitamin D 50,000 IU (Biodal) tablet supplementation in the treatment of
      population with vitamin D deficiency.

      A randomized, double-blind placebo, Parallel design comparing vitamin D with Placebo will be
      conducted on 60 Healthy males and females with vitamin D deficiency, age from 18 to 49 years
      who attend the rehabilitation clinics at Jordan University Hospital .Participants who met the
      inclusion criteria will be asked to sign an informed witnessed consent form. Results obtained
      are expected to assess the safety and efficacy of the dose regimen used in this study as per
      Biodal SmPC. This study will also contribute to the global body of knowledge in this field.
      The major findings generated from this study could open certain avenues for further research
      through the association of the status of vitamin D in serum .
The study design will be a prospective randomized double blind parallel design comparing
      Vitamin D with Placebo. This study will be conducted in Jordan University Hospital (JUH). The
      participants will be Healthy males and females with vitamin D deficiency (18 to 49 years
      old). All eligible males and females who agree to participate in the study will sign an
      informed witnessed consent form at the beginning of the study. The expected duration of
      participants participation will be around 120 days and the number of visits for each
      participant will be 6 visits divided as follows; the first visit will be before 7 days of the
      initiation of the trial (screening period), the second on day zero of the treatment period,
      the third on day 30, the fourth on day 60, the fifth on day 90 and the sixth or the last
      visit will be on day 104 (after 14 days of the last treatment). Therefore the treatment
      period will be 90 days and the post treatment follow up period will be 14 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Evaluation of the effectiveness of the dose regimen considered in this study as the product SmPC which will be measured through the assessment of serum 25 (OH)D along the trial period.
time frame: 14 weeks
description: To assess the dose regimen effectiveness used in this study as per Biodal SmPC.
measure: Assessing the level of (Urine analysis, Hematology ,Kidney Function Test,Liver Function Test, Virology, chemistry, 25(OH)D, Ca, Mg, Phosphate, Parathyroid hormone, Alkaline Phosphatase ) and reporting any adverse events through the trial period.
time frame: 14 weeks
description: Evaluation of the safety of the dose regimen of vitamin D3 supplementation which will be measured by assessing the level of laboratory tests which including (Urine analysis Hematology Kidney function tests, Liver function test, Virology, Clinical chemistry, 25(OH)D, Ca, Mg, PO4, PTH , Alkaline Phosphatase and pregnancy test for married females), Physical examinations ,ECG examination, vital signs, and reporting any adverse events through the trial period.
arm group label: intervention group
arm group type: Active Comparator
description: The intervention group will be supplemented with 50.000 IU vitamin D3 every week for 12 consecutive weeks
arm group label: Placebo group
arm group type: Placebo Comparator
description: The placebo group will receive placebo Tablet which will be manufactured in a pharmaceutical factory to be identical to vitamin D3 Tablet in color, shape, size, and packaging
intervention type: Drug
intervention name: 50.000 IU vitamin D3 (Biodal 50,000 IU)
arm group label: intervention group
other name: Biodal 50,000 IU
intervention type: Drug
intervention name: Placebo (to mimic Biodal 50,000 IU)
description: Placebo Tablet will be manufactured in a pharmaceutical factory to be identical to vitamin D3 Tablet in color, shape, size, and packaging
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Talal Aburjai, Ph.D.
role: Principal Investigator
affiliation: University of Jordan
last name: Ziad Hawamdeh, Prof
phone: +962 799 060 814
facility: 
country: Jordan
responsible party type: Sponsor
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Cholecalciferol