<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/NCT02185222</url>
  </required_header>
  <id_info>
    <org_study_id>SERC12-TC / D-COG</org_study_id>
    <secondary_id>2013-005110-36</secondary_id>
    <nct_id>NCT02185222</nct_id>
  </id_info>
  <brief_title>Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint</brief_title>
  <acronym>D-COG</acronym>
  <official_title>Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As recommended allowance of oral vitamine D are unable to ensure the recommended serum&#xD;
      concentration of vitamine D, the purpose of this study is to show that a dose of vitamin D3&#xD;
      higher than the recommended allowance may slow the cognitive decline of patients with a&#xD;
      memory complaint.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2014</start_date>
  <completion_date type="Actual">October 10, 2018</completion_date>
  <primary_completion_date type="Actual">October 10, 2018</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline memory functions measured by the score of the total recall test from Free and Cued Selective Recall Reminding Test (Rappel Libre / Rappel Indicé 16 items : RL/RI 16) at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
    <description>The score of the total recall test from Free and Cued Selective Recall Reminding Test (RL/RI 16) is recommended by a European Task Force consensus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline global efficiency measured by the Mc Nair scale at one year and at two years</measure>
    <time_frame>Baseline (inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of anaemia evaluated by red blood cells count</measure>
    <time_frame>Baseline (pre-inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of plasma calcium and albumin concentration</measure>
    <time_frame>Baseline (pre-inclusion), 45 days, one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of urinary calcium and creatinine concentration</measure>
    <time_frame>45 days, one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All adverse events</measure>
    <time_frame>Up to two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance</measure>
    <time_frame>Baseline (pre-inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline global efficiency measured by the Mini Mental State Examination at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline global efficiency measured by the Montreal Cognitive Assessment at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline instrumental activity of daily living measured by 8 items at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline language measured by the &quot;test de denomination orale d'images&quot; (DO-80) at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48)</measure>
    <time_frame>Baseline at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline executive functions measured by the stroop test at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline executive functions measured by the verbal fluency at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline executive functions measured by the Trail Making Test part B at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline attention and speed processing measured by the Trail Making Test part A at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline attention and speed processing measured by the Digit symbol test at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline visuospatial study measured by the Rey figure (copy) at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline praxis at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
    <description>Production of symbolic gesture, imitation utilization gesture, non sense gesture imitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline depressive symptoms measured by the Montgomery and Asberg Depression Rating Scale at one year and at two years</measure>
    <time_frame>Baseline (at inclusion), one year and two years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Memory Disorders</condition>
  <condition>Age-Related Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Cholecalciferol 100 000 UI (Unité Internationale)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral solution in single-dose : 100 000 UI per month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral solution in single-dose per month</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol 100 000 UI</intervention_name>
    <description>Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years</description>
    <arm_group_label>Cholecalciferol 100 000 UI (Unité Internationale)</arm_group_label>
    <other_name>Uvedose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Pre-Inclusion Criteria :&#xD;
&#xD;
          -  Patients aged 60 years or older,&#xD;
&#xD;
          -  Who report to a memory centre with symptoms of memory complaint,&#xD;
&#xD;
          -  Having a Mini-Mental State Examination (MMSE) score strictly &gt; the 5th percentile for&#xD;
             sociocultural level of the patient (GRECO standards for elderly patients),&#xD;
&#xD;
          -  Having visual, hearing abilities (authorized equipment) and an oral or written&#xD;
             expression sufficient for the suitable realization of the tests,&#xD;
&#xD;
          -  Who accept participation in the study and are able to sign the informed consent of the&#xD;
             - Affiliated to the French social security system.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Insufficient 25 OH D serum level : 25 OH D &lt; 50 nmol/L (20 ng/ml),&#xD;
&#xD;
          -  Normal corrected plasma calcium concentration,&#xD;
&#xD;
          -  Normal kidney function (cockcroft &gt; 30 mL/mn)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alzheimer's disease or other dementia,&#xD;
&#xD;
          -  Parkinson's disease treated,&#xD;
&#xD;
          -  Epilepsy treated,&#xD;
&#xD;
          -  Huntington's disease,&#xD;
&#xD;
          -  Brain tumor,&#xD;
&#xD;
          -  History of a progressive disease which may have consequences for the central nervous&#xD;
             system (blood pressure, higher or equal to 180/100 mmHg, chronic pulmonary disease&#xD;
             with hypoxia; cerebrovascular accident of less than 3 months, cranial traumatism with&#xD;
             persistent neurologic deficit, subdural hematoma, brain surgery),&#xD;
&#xD;
          -  Antecedent of alcoholism or chronic drug-addiction with an obvious or documented&#xD;
             consequence on cognition,&#xD;
&#xD;
          -  Severe depression : score Montgomery Asberg Depression Rating Scale (MADRS) &gt; 18,&#xD;
&#xD;
          -  Psychotropic drug therapy (at the discretion of the clinician),&#xD;
&#xD;
          -  Hypercalcaemia or treatment for a hypercalcaemia,&#xD;
&#xD;
          -  Known hypersensitivity to the vitamin D,&#xD;
&#xD;
          -  Granulomatous disease,&#xD;
&#xD;
          -  Treatment of vit D at doses higher than the current recommendations,&#xD;
&#xD;
          -  History of calcium urinary lithiasis of less than 1 year,&#xD;
&#xD;
          -  Nonsteroidal antiinflammatory drug (NSAID) chronic treatment,&#xD;
&#xD;
          -  Severe medical or surgical affection of less than 3 months,&#xD;
&#xD;
          -  Unstable health, severe hepatic or renal deficiency,&#xD;
&#xD;
          -  Deprivation of liberty, under judicial protection,&#xD;
&#xD;
          -  Institutionalization (EHPAD),&#xD;
&#xD;
          -  Illiteracy,&#xD;
&#xD;
          -  Participation in another biomedical research. A diagnosis of MCI (Mild Cognitive&#xD;
             Impairment) of less than 6 months is not a criterion of non-inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fanny HENNEKINE, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU TOURS - Hôpital Bretonneau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH BLOIS</name>
      <address>
        <city>Blois</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU BREST - Hôpital de la Cavale Blanche</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI ELBEUF Louviers Val-de-Reuil</name>
      <address>
        <city>Elbeuf</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU NANTES - Hôpital Bellier</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU NANTES - Hôpital Laënnec</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chr Orleans</name>
      <address>
        <city>Orléans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU POITIERS - Hôpital de la Milétrie</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU RENNES - Hôpital Hôtel Dieu</name>
      <address>
        <city>Rennes</city>
        <zip>35064</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU ROUEN - Hôpital Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU TOURS - Hôpital Bretonneau</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <keyword>Cholecalciferol</keyword>
  <keyword>25-hydroxyvitamin D</keyword>
  <keyword>Memory complaint</keyword>
  <keyword>Subjective memory complaint</keyword>
  <keyword>Mild cognitive impairment</keyword>
  <keyword>Preventive therapy</keyword>
  <keyword>Cognitive disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Memory Disorders</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>Cholecalciferol</mesh_term>
    <mesh_term>Vitamin D</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/NCT02185222
org study id: SERC12-TC / D-COG
secondary id: 2013-005110-36
nct id: NCT02185222
lead sponsor: 
has dmc: Yes
As recommended allowance of oral vitamine D are unable to ensure the recommended serum
      concentration of vitamine D, the purpose of this study is to show that a dose of vitamin D3
      higher than the recommended allowance may slow the cognitive decline of patients with a
      memory complaint.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Changes from baseline memory functions measured by the score of the total recall test from Free and Cued Selective Recall Reminding Test (Rappel Libre / Rappel Indicé 16 items : RL/RI 16) at one year and at two years
time frame: Baseline (at inclusion), one year and two years
description: The score of the total recall test from Free and Cued Selective Recall Reminding Test (RL/RI 16) is recommended by a European Task Force consensus.
measure: Changes from baseline global efficiency measured by the Mc Nair scale at one year and at two years
time frame: Baseline (inclusion), one year and two years
measure: Evolution of anaemia evaluated by red blood cells count
time frame: Baseline (pre-inclusion), one year and two years
measure: Evolution of plasma calcium and albumin concentration
time frame: Baseline (pre-inclusion), 45 days, one year and two years
measure: Evolution of urinary calcium and creatinine concentration
time frame: 45 days, one year and two years
measure: All adverse events
time frame: Up to two years
measure: Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance
time frame: Baseline (pre-inclusion), one year and two years
measure: Changes from baseline global efficiency measured by the Mini Mental State Examination at one year and at two years
time frame: Baseline (at inclusion), one year and two years
measure: Changes from baseline global efficiency measured by the Montreal Cognitive Assessment at one year and at two years
time frame: Baseline (at inclusion), one year and two years
measure: Changes from baseline instrumental activity of daily living measured by 8 items at one year and at two years
time frame: Baseline (at inclusion), one year and two years
measure: Changes from baseline language measured by the "test de denomination orale d'images" (DO-80) at one year and at two years
time frame: Baseline (at inclusion), one year and two years
measure: Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48)
time frame: Baseline at inclusion
measure: Changes from baseline executive functions measured by the stroop test at one year and at two years
time frame: Baseline (at inclusion), one year and two years
measure: Changes from baseline executive functions measured by the verbal fluency at one year and at two years
time frame: Baseline (at inclusion), one year and two years
measure: Changes from baseline executive functions measured by the Trail Making Test part B at one year and at two years
time frame: Baseline (at inclusion), one year and two years
measure: Changes from baseline attention and speed processing measured by the Trail Making Test part A at one year and at two years
time frame: Baseline (at inclusion), one year and two years
measure: Changes from baseline attention and speed processing measured by the Digit symbol test at one year and at two years
time frame: Baseline (at inclusion), one year and two years
measure: Changes from baseline visuospatial study measured by the Rey figure (copy) at one year and at two years
time frame: Baseline (at inclusion), one year and two years
measure: Changes from baseline praxis at one year and at two years
time frame: Baseline (at inclusion), one year and two years
description: Production of symbolic gesture, imitation utilization gesture, non sense gesture imitation
measure: Changes from baseline depressive symptoms measured by the Montgomery and Asberg Depression Rating Scale at one year and at two years
time frame: Baseline (at inclusion), one year and two years
arm group label: Cholecalciferol 100 000 UI (Unité Internationale)
arm group type: Experimental
description: Oral solution in single-dose : 100 000 UI per month
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral solution in single-dose per month
intervention type: Drug
intervention name: Cholecalciferol 100 000 UI
description: Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
arm group label: Cholecalciferol 100 000 UI (Unité Internationale)
other name: Uvedose
intervention type: Drug
intervention name: Placebo
description: Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Fanny HENNEKINE, PH
role: Principal Investigator
affiliation: CHRU TOURS - Hôpital Bretonneau
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Memory Disorders
mesh term: Cognitive Dysfunction
mesh term: Cholecalciferol
mesh term: Vitamin D