<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/NCT01708005</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A00453-40</org_study_id>
    <nct_id>NCT01708005</nct_id>
  </id_info>
  <brief_title>DIetary Supplements, Executive funcTions and Vitamin D (DIET-D)</brief_title>
  <acronym>DIET-D</acronym>
  <official_title>DIetary Supplements, Executive funcTions and Vitamin D (DIET-D): a Double-blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NUTRISANTE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effect after 12 weeks of the oral intake of&#xD;
      Lecitone®Se + 200UI/day of D3 vitamin with the effect of a placebo on changes in cognitive&#xD;
      performance in Trial Making Test score part B (this test evaluate executive functions of&#xD;
      mental flexibility) in older adults with Mild Cognitive Impairment (MCI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current treatments for Alzheimer's disease (AD) are symptomatic and can only temporarily slow&#xD;
      down AD without altering its natural evolution. The development of new therapies has&#xD;
      primarily focused on preventing the progression of AD. This therapeutic strategy involves&#xD;
      being interested in patients with an early stage of AD such as a mild cognitive impairment&#xD;
      (MCI). We hypothesized that the combination of Lecitone®Se with 200 IU/day of vitamin D can&#xD;
      slow or even improve cognitive decline, particularly executive functions.&#xD;
&#xD;
      The primary objective of this trial is to compare the effect after 12 weeks of the oral&#xD;
      intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in performance&#xD;
      obtained in the TMT B in the older adults with a MCI.&#xD;
&#xD;
      The secondary objectives of the study are as follows:&#xD;
&#xD;
        -  To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with&#xD;
           the effect of a placebo on changes in executive performance in patients with a MCI.&#xD;
&#xD;
        -  To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with&#xD;
           the effect of a placebo on changes in variability of stride time in patients with a MCI.&#xD;
&#xD;
        -  To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with&#xD;
           the effect of a placebo and a delay phase of supplementation on changes in executive&#xD;
           performance in patients with a MCI.&#xD;
&#xD;
        -  To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with&#xD;
           the effect of a placebo and a delay phase of supplementation on changes in variability&#xD;
           of stride time in patients with a MCI.&#xD;
&#xD;
        -  To determine the compliance and tolerance of the oral intake of Lecitone®Se-Vitamin D3&#xD;
           in patients with a MCI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2014</primary_completion_date>
  <phase>Phase 2/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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in executive performance</measure>
    <time_frame>This outcome is assessed at baseline, 12 and 24 weeks after inclusion.</time_frame>
    <description>Executive performance is measured with Trial Making Test part B (TMT B)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in other executive scores</measure>
    <time_frame>This outcome is assessed at baseline, 12 and 24 weeks after inclusion.</time_frame>
    <description>Test parts A and B, Stoop test, Processing Speed Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in posture</measure>
    <time_frame>This outcome is assessed at baseline, 12 and 24 weeks after inclusion.</time_frame>
    <description>Time Up &amp; Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between-group comparison of compliance to treatment</measure>
    <time_frame>This outcome is assessed at baseline, 12 and 24 weeks after inclusion.</time_frame>
    <description>This outcome is assessed together with the serum concentrations of 25OHD and calcium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in gait</measure>
    <time_frame>This outcome is assessed at baseline, 12 and 24 weeks after inclusion</time_frame>
    <description>Time Up &amp; Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between-group comparison of tolerance</measure>
    <time_frame>This outcome is assessed at baseline, 12 and 24 weeks after inclusion</time_frame>
    <description>This outcome is assessed with the serum concentrations of 25OHD and calcium</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>80 participants start the oral intake of Lecitone®Se-Vitamin D3 the day after inclusion and during 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>80 participants in this arm start the oral intake of placebo the day after inclusion and during 12 weeks.&#xD;
Then, they start the oral intake of Lecitone®Se-Vitamin D3 12 weeks after inclusion until the 24th week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lecitone®Se-Vitamin D3</intervention_name>
    <description>Lecitone®Se-Vitamin D3 is a dietary supplement combining the active ingredients in Lecitone®Se and 100 IU of vitamin D3. This dietary supplement comes in capsule form.&#xD;
Participants take 2 capsules of Lecitone®Se -Vitamin D3 per day. The dose of vitamin D supplementation will not be adjusted except in case of an adverse event such as hypercalcemia. In this case, vitamin D supplementation is stopped and the participant is released prematurely from the study.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The comparator is represented by placebo capsules of identical appearance (same size, same color and same smell) that Lecitone®Se-Vitamin D3 capsules.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 60 years&#xD;
&#xD;
          -  Memory complaints&#xD;
&#xD;
          -  No dementia (DSM-IV, NINCDS-ADRDA negative)&#xD;
&#xD;
          -  No depression (Geriatric Depression score ≤ 5/15)&#xD;
&#xD;
          -  Ability to walk a distance of 15 meters unaided&#xD;
&#xD;
          -  Diagnosis of MCI&#xD;
&#xD;
          -  To have hypovitaminosis D (i.e. serum 25-hydroxyvitamin D [25OHD]concentration ≤&#xD;
             30ng/mL)&#xD;
&#xD;
          -  To have no hypercalcemia (defined as serum calcium concentration ≥ 2,65mmol/L)&#xD;
&#xD;
          -  To have given and signed an informed consent to participate in the trial&#xD;
&#xD;
          -  To be affiliated to French Social Security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Others cognitive disorders (untreated thyroid dysfunction, chronic ongoing ethylism,&#xD;
             history of syphilis, stroke, severe depressive symptomatology (Geriatric Depression&#xD;
             score &gt; 5/15), existence of dementia according to DSM-IV and NINCDS-ADRDA criteria at&#xD;
             the time of inclusion)&#xD;
&#xD;
          -  Vitamin D supplementation during inclusion&#xD;
&#xD;
          -  Contraindications to vitamin D&#xD;
&#xD;
          -  Unstable medical condition&#xD;
&#xD;
          -  Enrollment in another simultaneous clinical trial&#xD;
&#xD;
          -  Civil defense measures underway&#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>Olivier Beauchet, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Angers University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 15, 2012</last_update_submitted>
  <last_update_submitted_qc>October 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mild Cognitive Impairment</keyword>
  <keyword>Vitamin D</keyword>
  <keyword>Cholecalciferol</keyword>
  <keyword>Lecitone®Se-Vitamin D3</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>
    <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/NCT01708005
org study id: 2012-A00453-40
nct id: NCT01708005
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to compare the effect after 12 weeks of the oral intake of
      Lecitone®Se + 200UI/day of D3 vitamin with the effect of a placebo on changes in cognitive
      performance in Trial Making Test score part B (this test evaluate executive functions of
      mental flexibility) in older adults with Mild Cognitive Impairment (MCI).
Current treatments for Alzheimer's disease (AD) are symptomatic and can only temporarily slow
      down AD without altering its natural evolution. The development of new therapies has
      primarily focused on preventing the progression of AD. This therapeutic strategy involves
      being interested in patients with an early stage of AD such as a mild cognitive impairment
      (MCI). We hypothesized that the combination of Lecitone®Se with 200 IU/day of vitamin D can
      slow or even improve cognitive decline, particularly executive functions.

      The primary objective of this trial is to compare the effect after 12 weeks of the oral
      intake of Lecitone®Se-Vitamin D3 with the effect of a placebo on changes in performance
      obtained in the TMT B in the older adults with a MCI.

      The secondary objectives of the study are as follows:

        -  To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with
           the effect of a placebo on changes in executive performance in patients with a MCI.

        -  To compare the effect after 12 weeks of the oral intake of Lecitone®Se-Vitamin D3 with
           the effect of a placebo on changes in variability of stride time in patients with a MCI.

        -  To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with
           the effect of a placebo and a delay phase of supplementation on changes in executive
           performance in patients with a MCI.

        -  To compare the effect after 24 weeks of the oral intake of Lecitone®Se-Vitamin D3 with
           the effect of a placebo and a delay phase of supplementation on changes in variability
           of stride time in patients with a MCI.

        -  To determine the compliance and tolerance of the oral intake of Lecitone®Se-Vitamin D3
           in patients with a MCI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in executive performance
time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
description: Executive performance is measured with Trial Making Test part B (TMT B)
measure: Change in other executive scores
time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
description: Test parts A and B, Stoop test, Processing Speed Index
measure: Change in posture
time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
description: Time Up & Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking
measure: Between-group comparison of compliance to treatment
time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion.
description: This outcome is assessed together with the serum concentrations of 25OHD and calcium
measure: Change in gait
time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
description: Time Up & Go, Five Time Sit-to-Stand and spatio-temporal analysis of walking
measure: Between-group comparison of tolerance
time frame: This outcome is assessed at baseline, 12 and 24 weeks after inclusion
description: This outcome is assessed with the serum concentrations of 25OHD and calcium
arm group label: Intervention
arm group type: Active Comparator
description: 80 participants start the oral intake of Lecitone®Se-Vitamin D3 the day after inclusion and during 24 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: 80 participants in this arm start the oral intake of placebo the day after inclusion and during 12 weeks.
Then, they start the oral intake of Lecitone®Se-Vitamin D3 12 weeks after inclusion until the 24th week.
intervention type: Drug
intervention name: Lecitone®Se-Vitamin D3
description: Lecitone®Se-Vitamin D3 is a dietary supplement combining the active ingredients in Lecitone®Se and 100 IU of vitamin D3. This dietary supplement comes in capsule form.
Participants take 2 capsules of Lecitone®Se -Vitamin D3 per day. The dose of vitamin D supplementation will not be adjusted except in case of an adverse event such as hypercalcemia. In this case, vitamin D supplementation is stopped and the participant is released prematurely from the study.
arm group label: Intervention
intervention type: Drug
intervention name: Placebo
description: The comparator is represented by placebo capsules of identical appearance (same size, same color and same smell) that Lecitone®Se-Vitamin D3 capsules.
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier Beauchet, MD,PhD
role: Principal Investigator
affiliation: Angers University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
mesh term: Vitamin D
mesh term: Cholecalciferol