<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/NCT04400747</url>
  </required_header>
  <id_info>
    <org_study_id>PMRIST</org_study_id>
    <nct_id>NCT04400747</nct_id>
  </id_info>
  <brief_title>Oral Colecalciferol Treatment in Spinal Cord Lesion</brief_title>
  <official_title>The Effects of Single High-dose or Daily Low Dosage Oral Colecalciferol Treatment on Muscle Strength, Muscle Thickness and Independence in Spinal Cord Lesion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low vitamin D is frequently seen in patients with spinal cord injury (SCI) in acute and&#xD;
      chronic periods. Among its causes are insufficient sun exposure, limited oral intake,&#xD;
      obesity, the effect of the drugs used on the absorption of vitamin D, kidney and liver&#xD;
      diseases. If we consider patients with spinal cord injuries in Turkey, it is difficult to get&#xD;
      involved in the society, low exposure to the sun, lack of necessary health controls and&#xD;
      immobility brings extra risk factors for the low vitamin D compared to the general&#xD;
      population. Despite Turkey Endocrinology and Metabolism Endocrine Society and the&#xD;
      International Endocrine Association clinical practice guidelines do not provide specific&#xD;
      recommendations about vitamin D, for individuals with spinal cord injuries. Individuals with&#xD;
      SCI are at high risk for low vitamin D. Vitamin D levels need to be checked and replaced.&#xD;
      Vitamin D doses, application methods and dose intervals used in Physical Therapy and&#xD;
      Rehabilitation clinics are different. The aim of our study is to perform the necessary&#xD;
      vitamin D replacement for individuals with SCI who have vitamin D deficiency in different&#xD;
      dose intervals and to compare the effects of muscle strength, muscle thickness and functional&#xD;
      independence with the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Paraplegic patients who admitt to our Physical Therapy and Rehabilitation Clinic, will be&#xD;
      included in the rehabilitation program. Sixty spinal cord injured patients with serum 25 (OH)&#xD;
      D3 levels less than 20 ng / ml will be included in the study. One of the treatment groups&#xD;
      will receive 6,000 IU of vitamin D daily, and the other group 50,000 IU of vitamin D per week&#xD;
      for eight weeks. Patients with high calcium (Ca) values in blood tests, patients with kidney&#xD;
      stones and urinary stones in urinary ultrasonography (USG) to be performed routinely, as well&#xD;
      as patients who refuse to use vitamin D supplements will include in the control group. Spinal&#xD;
      cord independence measure (SCIM version 3) will be filled in at the beginning and at the end&#xD;
      of 8 weeks to all participants. Jamar Dynamometer will be measured for upper extremity muscle&#xD;
      strength, and biceps brachii and triceps muscle thicknesses will be measured by&#xD;
      ultrasonography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">January 4, 2021</completion_date>
  <primary_completion_date type="Actual">January 4, 2021</primary_completion_date>
  <phase>N/A</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>Sixty patients with spinal cord injury with serum 25 (OH) D3 levels less than 20 ng / ml will be included in the study. One of the treatment groups will receive 6,000 IU of vitamin D daily, and the other group 50000 IU of vitamin D per week for 8 weeks. 20 Patients who don't receive vitamin D will be included in the control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hand grip strength</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measurement of both hands grip strength by Jamar dynamometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spinal cord İndependence Measurement (SCIM version 3)</measure>
    <time_frame>8 weeks</time_frame>
    <description>The SCIM has been developed to address three specific areas of function in patients with spinal cord injuries (SCI). It looks at self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and a patient's mobility abilities (bed and transfers and indoors/outdoors).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle thickness</measure>
    <time_frame>8 weeks</time_frame>
    <description>Both sides biceps brachii and triceps muscle thicknesses will be measured by ultrasonography.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>weekly treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty patients with spinal cord injury with serum 25 (OH) D3 level less than 20 ng / ml will receive 50,000 IU of vitamin D weekly for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>daily treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty patients with spinal cord injury with serum 25 (OH) D3 level less than 20 ng / ml will receive 6,000 IU of vitamin D daily for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>20 patients with high calcium (Ca) values in blood tests, patients with kidney and urinary stones, as well as patients who refuse to use vitamin D supplements will be included in the control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>one group will take weekly oral 50000 IU Vitamin D3, other group will take daily oral 6000 IU Vitamin D3.</description>
    <arm_group_label>daily treatment group</arm_group_label>
    <arm_group_label>weekly treatment group</arm_group_label>
    <other_name>cholecalciferol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18-60 years old&#xD;
&#xD;
          2. Thoracic level chronic spinal cord injury&#xD;
&#xD;
          3. A, B, C, D complete / incomplete patients according to ASIA classification&#xD;
&#xD;
          4. 25 (OH) D3 level in serum is &lt;20 ng / ml&#xD;
&#xD;
          5. Complete muscle strength in upper extremity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals with chronic liver, kidney, respiratory and parathyroid disease&#xD;
&#xD;
          2. Chronic constipation&#xD;
&#xD;
          3. Patients who have recently used vitamin D&#xD;
&#xD;
          4. Use of drugs that will affect vitamin D and Ca level (Thiazide group diuretics,&#xD;
             statins)&#xD;
&#xD;
          5. Acute inflammation (may show false low in vitamin D levels)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Demet Ferahman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul Physical Medicine Rehabilitation Training &amp; Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Physical Medicine Rehabilitation Training &amp; Research Hospital</name>
      <address>
        <city>İstanbul</city>
        <zip>34173</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Hummel K, Craven BC, Giangregorio L. Serum 25(OH)D, PTH and correlates of suboptimal 25(OH)D levels in persons with chronic spinal cord injury. Spinal Cord. 2012 Nov;50(11):812-6. doi: 10.1038/sc.2012.67. Epub 2012 Jun 19.</citation>
    <PMID>22710945</PMID>
  </reference>
  <reference>
    <citation>Bauman WA, Zhong YG, Schwartz E. Vitamin D deficiency in veterans with chronic spinal cord injury. Metabolism. 1995 Dec;44(12):1612-6. doi: 10.1016/0026-0495(95)90083-7.</citation>
    <PMID>8786732</PMID>
  </reference>
  <reference>
    <citation>Lamarche J, Mailhot G. Vitamin D and spinal cord injury: should we care? Spinal Cord. 2016 Dec;54(12):1060-1075. doi: 10.1038/sc.2016.131. Epub 2016 Sep 20.</citation>
    <PMID>27645263</PMID>
  </reference>
  <reference>
    <citation>Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6. Erratum In: J Clin Endocrinol Metab. 2011 Dec;96(12):3908.</citation>
    <PMID>21646368</PMID>
  </reference>
  <reference>
    <citation>Bauman WA, Morrison NG, Spungen AM. Vitamin D replacement therapy in persons with spinal cord injury. J Spinal Cord Med. 2005;28(3):203-7. doi: 10.1080/10790268.2005.11753813.</citation>
    <PMID>16048137</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 17, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Demet Ferahman</investigator_full_name>
    <investigator_title>Assistant doctor</investigator_title>
  </responsible_party>
  <keyword>25(OH)D</keyword>
  <keyword>hand grip strength</keyword>
  <keyword>Spinal cord injuries</keyword>
  <keyword>muscle thickness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</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>
  <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/NCT04400747
org study id: PMRIST
nct id: NCT04400747
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Low vitamin D is frequently seen in patients with spinal cord injury (SCI) in acute and
      chronic periods. Among its causes are insufficient sun exposure, limited oral intake,
      obesity, the effect of the drugs used on the absorption of vitamin D, kidney and liver
      diseases. If we consider patients with spinal cord injuries in Turkey, it is difficult to get
      involved in the society, low exposure to the sun, lack of necessary health controls and
      immobility brings extra risk factors for the low vitamin D compared to the general
      population. Despite Turkey Endocrinology and Metabolism Endocrine Society and the
      International Endocrine Association clinical practice guidelines do not provide specific
      recommendations about vitamin D, for individuals with spinal cord injuries. Individuals with
      SCI are at high risk for low vitamin D. Vitamin D levels need to be checked and replaced.
      Vitamin D doses, application methods and dose intervals used in Physical Therapy and
      Rehabilitation clinics are different. The aim of our study is to perform the necessary
      vitamin D replacement for individuals with SCI who have vitamin D deficiency in different
      dose intervals and to compare the effects of muscle strength, muscle thickness and functional
      independence with the control group.
Paraplegic patients who admitt to our Physical Therapy and Rehabilitation Clinic, will be
      included in the rehabilitation program. Sixty spinal cord injured patients with serum 25 (OH)
      D3 levels less than 20 ng / ml will be included in the study. One of the treatment groups
      will receive 6,000 IU of vitamin D daily, and the other group 50,000 IU of vitamin D per week
      for eight weeks. Patients with high calcium (Ca) values in blood tests, patients with kidney
      stones and urinary stones in urinary ultrasonography (USG) to be performed routinely, as well
      as patients who refuse to use vitamin D supplements will include in the control group. Spinal
      cord independence measure (SCIM version 3) will be filled in at the beginning and at the end
      of 8 weeks to all participants. Jamar Dynamometer will be measured for upper extremity muscle
      strength, and biceps brachii and triceps muscle thicknesses will be measured by
      ultrasonography.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Sixty patients with spinal cord injury with serum 25 (OH) D3 levels less than 20 ng / ml will be included in the study. One of the treatment groups will receive 6,000 IU of vitamin D daily, and the other group 50000 IU of vitamin D per week for 8 weeks. 20 Patients who don't receive vitamin D will be included in the control group.
primary purpose: Treatment
masking: None (Open Label)
measure: Hand grip strength
time frame: 8 weeks
description: Measurement of both hands grip strength by Jamar dynamometer
measure: Spinal cord İndependence Measurement (SCIM version 3)
time frame: 8 weeks
description: The SCIM has been developed to address three specific areas of function in patients with spinal cord injuries (SCI). It looks at self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and a patient's mobility abilities (bed and transfers and indoors/outdoors).
measure: Muscle thickness
time frame: 8 weeks
description: Both sides biceps brachii and triceps muscle thicknesses will be measured by ultrasonography.
arm group label: weekly treatment group
arm group type: Experimental
description: Twenty patients with spinal cord injury with serum 25 (OH) D3 level less than 20 ng / ml will receive 50,000 IU of vitamin D weekly for 8 weeks.
arm group label: daily treatment group
arm group type: Experimental
description: Twenty patients with spinal cord injury with serum 25 (OH) D3 level less than 20 ng / ml will receive 6,000 IU of vitamin D daily for 8 weeks.
arm group label: control group
arm group type: No Intervention
description: 20 patients with high calcium (Ca) values in blood tests, patients with kidney and urinary stones, as well as patients who refuse to use vitamin D supplements will be included in the control group
intervention type: Drug
intervention name: Vitamin D3
description: one group will take weekly oral 50000 IU Vitamin D3, other group will take daily oral 6000 IU Vitamin D3.
arm group label: daily treatment group
arm group label: weekly treatment group
other name: cholecalciferol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Demet Ferahman, MD
role: Principal Investigator
affiliation: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
facility: 
country: Turkey
citation: Hummel K, Craven BC, Giangregorio L. Serum 25(OH)D, PTH and correlates of suboptimal 25(OH)D levels in persons with chronic spinal cord injury. Spinal Cord. 2012 Nov;50(11):812-6. doi: 10.1038/sc.2012.67. Epub 2012 Jun 19.
PMID: 22710945
citation: Bauman WA, Zhong YG, Schwartz E. Vitamin D deficiency in veterans with chronic spinal cord injury. Metabolism. 1995 Dec;44(12):1612-6. doi: 10.1016/0026-0495(95)90083-7.
PMID: 8786732
citation: Lamarche J, Mailhot G. Vitamin D and spinal cord injury: should we care? Spinal Cord. 2016 Dec;54(12):1060-1075. doi: 10.1038/sc.2016.131. Epub 2016 Sep 20.
PMID: 27645263
citation: Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6. Erratum In: J Clin Endocrinol Metab. 2011 Dec;96(12):3908.
PMID: 21646368
citation: Bauman WA, Morrison NG, Spungen AM. Vitamin D replacement therapy in persons with spinal cord injury. J Spinal Cord Med. 2005;28(3):203-7. doi: 10.1080/10790268.2005.11753813.
PMID: 16048137
responsible party type: Principal Investigator
investigator affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
investigator full name: Demet Ferahman
investigator title: Assistant doctor
mesh term: Spinal Cord Injuries
mesh term: Vitamin D
mesh term: Cholecalciferol
sharing ipd: No