<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/NCT03019120</url>
  </required_header>
  <id_info>
    <org_study_id>0103-16-LND</org_study_id>
    <nct_id>NCT03019120</nct_id>
  </id_info>
  <brief_title>Vitamin D Supplementation and Neurocognition</brief_title>
  <acronym>Dcog</acronym>
  <official_title>The Effect of Vitamin D Supplementation on Neurocognitive Function in Older Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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 study will evaluate the effect of vitamin D supplementation on the neurocognitive&#xD;
      function of older people with lower than normal levels of vitamin D at baseline&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Ageing is associated with an increased risk of cognitive decline. Vitamin D plays&#xD;
      an important role in many of the symptoms and conditions related to advanced age, including&#xD;
      impaired balance, falls and osteoporosis. Vitamin D also has a physiological effect on the&#xD;
      function of the central nervous system, and studies have suggested a relationship between&#xD;
      this vitamin and changes in cognitive function of older people. The investigators propose a&#xD;
      pilot study to evaluate the effect of vitamin D supplementation on the neurocognitive&#xD;
      function of older people.&#xD;
&#xD;
      Methods: A total of 30 subjects of both genders older than 65 years with levels of 25-OH&#xD;
      Vitamin D lower than 30 ng/ml on routine laboratory screening will be included in the study.&#xD;
      Exclusion criteria will include any unstable medical condition as determined by the treating&#xD;
      physician, a diagnosis of dementia, the use of supplements containing vitamin D in any dose,&#xD;
      significant visual or hearing impairment not corrected by spectacles or hearing aids, and a&#xD;
      level of literacy that limits the performance of computerized neurocognitive testing.&#xD;
      Following provision of written informed consent for inclusion in the study, subjects will&#xD;
      answer a questionnaire providing demographic details, undergo cognitive screening by use of&#xD;
      the MoCA test, and computerized cognitive assessment using the Neurotrax battery. All&#xD;
      subjects will undergo repeat testing for level of 25-OH Vitamin D, and where below-normal&#xD;
      levels are confirmed patients will receive a supplemental monthly oral dose of 60000 units&#xD;
      Vitamin D administered by a nurse for a period of 3 months. Levels of serum calcium will be&#xD;
      repeated monthly (end of month 1, 2, 3). At 3 months subjects will undergo repeat testing for&#xD;
      level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax&#xD;
      battery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Due to administrative reasons, it was not possible to enroll subjects.&#xD;
  </why_stopped>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">February 24, 2020</completion_date>
  <primary_completion_date type="Actual">February 24, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cognitive function as assessed by the Neurotrax computerized cognitive assessment battery</measure>
    <time_frame>3 months</time_frame>
    <description>The Neurotrax computerized cognitive assessment instrument measures the following domains: Memory, executive functions, attention, verbal functions and motor skills. This instrument was found to have high validity in identifying patients who suffer from cognitive decline in comparison to healthy patients in the elderly. There are many advantages to a computerized cognitive assessment tool. It allows a measurement of various cognitive domains as well as an accurate, detailed and objective measurements of patients. It is also very sensitive to cognitive changes occurring in a specific individual over time.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <condition>Neurocognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Active Comparator: Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vitamin D supplementation for subjects with below normal levels of this vitamin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>Subjects will undergo a cognitive evaluation using the Montreal Cognitive Assessment (MoCA) screening test and the Neurotrax computerized cognitive assessment battery.&#xD;
Subjects will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months.&#xD;
Levels of serum calcium will be repeated monthly (end of month 1, 2, 3).&#xD;
Subjects will undergo a repeat blood test to examine the level of vitamin D at the end of 3 months of follow-up.&#xD;
At 3-month follow-up subjects will be asked to complete the Neurotrax computerized cognitive assessment battery.</description>
    <arm_group_label>Active Comparator: Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 65 years and older.&#xD;
&#xD;
          -  Level of vitamin D (25-OH vitamin D) is less than 30 ng / ml.&#xD;
&#xD;
          -  Stable health status as assessed by the treating primary care physician.&#xD;
&#xD;
          -  Do not take supplements containing vitamin D.&#xD;
&#xD;
          -  Normal cognitive function as determined by MoCA Test screening and clinical assessment&#xD;
&#xD;
          -  Adequate literacy to enable the performance of cognitive assessment instruments&#xD;
&#xD;
          -  Provide informed consent as required by the Ethics Committee.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age younger than 65 years&#xD;
&#xD;
          -  Health status not stable as determined by the treating primary care physician&#xD;
&#xD;
          -  A diagnosis of dementia&#xD;
&#xD;
          -  Taking supplements containing Vitamin D&#xD;
&#xD;
          -  Significant visual or hearing impairment not corrected by spectacles or hearing aids&#xD;
&#xD;
          -  Impaired competency limiting the subject's ability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elad Rubin, M.A</last_name>
    <role>Study Director</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laniado Medical Center</name>
      <address>
        <city>Netanya</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Annweiler C, Allali G, Allain P, Bridenbaugh S, Schott AM, Kressig RW, Beauchet O. Vitamin D and cognitive performance in adults: a systematic review. Eur J Neurol. 2009 Oct;16(10):1083-9. doi: 10.1111/j.1468-1331.2009.02755.x. Epub 2009 Jul 29.</citation>
    <PMID>19659751</PMID>
  </reference>
  <reference>
    <citation>Buell JS, Dawson-Hughes B. Vitamin D and neurocognitive dysfunction: preventing &quot;D&quot;ecline? Mol Aspects Med. 2008 Dec;29(6):415-22. doi: 10.1016/j.mam.2008.05.001. Epub 2008 May 13.</citation>
    <PMID>18579197</PMID>
  </reference>
  <reference>
    <citation>Dwolatzky T, Whitehead V, Doniger GM, Simon ES, Schweiger A, Jaffe D, Chertkow H. Validity of a novel computerized cognitive battery for mild cognitive impairment. BMC Geriatr. 2003 Nov 2;3:4. doi: 10.1186/1471-2318-3-4.</citation>
    <PMID>14594456</PMID>
  </reference>
  <reference>
    <citation>Lifshitz M, Dwolatzky T, Press Y. Validation of the Hebrew version of the MoCA test as a screening instrument for the early detection of mild cognitive impairment in elderly individuals. J Geriatr Psychiatry Neurol. 2012 Sep;25(3):155-61. doi: 10.1177/0891988712457047.</citation>
    <PMID>23124009</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>Tzvi Dwolatzky</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</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/NCT03019120
org study id: 0103-16-LND
nct id: NCT03019120
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the effect of vitamin D supplementation on the neurocognitive
      function of older people with lower than normal levels of vitamin D at baseline
Background: Ageing is associated with an increased risk of cognitive decline. Vitamin D plays
      an important role in many of the symptoms and conditions related to advanced age, including
      impaired balance, falls and osteoporosis. Vitamin D also has a physiological effect on the
      function of the central nervous system, and studies have suggested a relationship between
      this vitamin and changes in cognitive function of older people. The investigators propose a
      pilot study to evaluate the effect of vitamin D supplementation on the neurocognitive
      function of older people.

      Methods: A total of 30 subjects of both genders older than 65 years with levels of 25-OH
      Vitamin D lower than 30 ng/ml on routine laboratory screening will be included in the study.
      Exclusion criteria will include any unstable medical condition as determined by the treating
      physician, a diagnosis of dementia, the use of supplements containing vitamin D in any dose,
      significant visual or hearing impairment not corrected by spectacles or hearing aids, and a
      level of literacy that limits the performance of computerized neurocognitive testing.
      Following provision of written informed consent for inclusion in the study, subjects will
      answer a questionnaire providing demographic details, undergo cognitive screening by use of
      the MoCA test, and computerized cognitive assessment using the Neurotrax battery. All
      subjects will undergo repeat testing for level of 25-OH Vitamin D, and where below-normal
      levels are confirmed patients will receive a supplemental monthly oral dose of 60000 units
      Vitamin D administered by a nurse for a period of 3 months. Levels of serum calcium will be
      repeated monthly (end of month 1, 2, 3). At 3 months subjects will undergo repeat testing for
      level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax
      battery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in cognitive function as assessed by the Neurotrax computerized cognitive assessment battery
time frame: 3 months
description: The Neurotrax computerized cognitive assessment instrument measures the following domains: Memory, executive functions, attention, verbal functions and motor skills. This instrument was found to have high validity in identifying patients who suffer from cognitive decline in comparison to healthy patients in the elderly. There are many advantages to a computerized cognitive assessment tool. It allows a measurement of various cognitive domains as well as an accurate, detailed and objective measurements of patients. It is also very sensitive to cognitive changes occurring in a specific individual over time.
arm group label: Active Comparator: Intervention group
arm group type: Experimental
description: Vitamin D supplementation for subjects with below normal levels of this vitamin.
intervention type: Drug
intervention name: Vitamin D
description: Subjects will undergo a cognitive evaluation using the Montreal Cognitive Assessment (MoCA) screening test and the Neurotrax computerized cognitive assessment battery.
Subjects will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months.
Levels of serum calcium will be repeated monthly (end of month 1, 2, 3).
Subjects will undergo a repeat blood test to examine the level of vitamin D at the end of 3 months of follow-up.
At 3-month follow-up subjects will be asked to complete the Neurotrax computerized cognitive assessment battery.
arm group label: Active Comparator: Intervention group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Elad Rubin, M.A
role: Study Director
affiliation: Rambam Health Care Campus
facility: 
country: Israel
citation: Annweiler C, Allali G, Allain P, Bridenbaugh S, Schott AM, Kressig RW, Beauchet O. Vitamin D and cognitive performance in adults: a systematic review. Eur J Neurol. 2009 Oct;16(10):1083-9. doi: 10.1111/j.1468-1331.2009.02755.x. Epub 2009 Jul 29.
PMID: 19659751
citation: Buell JS, Dawson-Hughes B. Vitamin D and neurocognitive dysfunction: preventing "D"ecline? Mol Aspects Med. 2008 Dec;29(6):415-22. doi: 10.1016/j.mam.2008.05.001. Epub 2008 May 13.
PMID: 18579197
citation: Dwolatzky T, Whitehead V, Doniger GM, Simon ES, Schweiger A, Jaffe D, Chertkow H. Validity of a novel computerized cognitive battery for mild cognitive impairment. BMC Geriatr. 2003 Nov 2;3:4. doi: 10.1186/1471-2318-3-4.
PMID: 14594456
citation: Lifshitz M, Dwolatzky T, Press Y. Validation of the Hebrew version of the MoCA test as a screening instrument for the early detection of mild cognitive impairment in elderly individuals. J Geriatr Psychiatry Neurol. 2012 Sep;25(3):155-61. doi: 10.1177/0891988712457047.
PMID: 23124009
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: Tzvi Dwolatzky
investigator title: Prof.
mesh term: Vitamin D Deficiency
mesh term: Cognitive Dysfunction
mesh term: Vitamin D
sharing ipd: No