<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/NCT03807791</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL18_0392</org_study_id>
    <nct_id>NCT03807791</nct_id>
  </id_info>
  <brief_title>Study of Prevalence and Risk Factors of Hypovitaminosis C in Long Term Care Unit</brief_title>
  <acronym>Vitamin C</acronym>
  <official_title>Study of Prevalence and Risk Factors of Hypovitaminosis C in Long Term Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical finding of skin rashes which appear after a vitamin C deficiency in Long Term&#xD;
      Care Unit leads us to believe that the institutional diet could predispose to this kind of&#xD;
      deficiency. Vitamin C has a key role into the struggle against oxidant stress and is involved&#xD;
      into the connective tissue formation of the skin and the vascular endothelium. Vitamin C&#xD;
      deficiency affects currently 15 to 25% of the elderly over 65 years old reaching 15% women&#xD;
      and 20% men after 65 according to Johnston and Al. It concerns mainly the people in&#xD;
      precarious situations (persons without fixed homes, ethyl-smoking persons) and elderly over&#xD;
      65 years. Hypovitaminosis C, defined by plasma level between 5 mg/L and 15 mg/L (28.41 to&#xD;
      85.23 µmol/L), is currently undiagnosed, especially with people with a risk of food&#xD;
      deficiency and its prevalence increases with age. The treatment consists of a daily oral&#xD;
      supplementation of 1 gram of vitamin C/d for 15 days. A minimum intake of 10 mg/D of vitamin&#xD;
      C is required to prevent scurvy and maintain a total pool of 350 mg. A diet modification by a&#xD;
      systematic intake of 2 glasses of fresh orange juice and/or the consumption of raw fruits and&#xD;
      vegetables would prevent the appearance of scurvy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">June 14, 2019</completion_date>
  <primary_completion_date type="Actual">June 14, 2019</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vitamin C plasma level</measure>
    <time_frame>Between day 0 and day 7.</time_frame>
    <description>) Collection of the consent&#xD;
) At the same time as other analysis for current cares a blood sample taken by a nurse of our unit to determine plasma levels of vitamin C.&#xD;
) Registration of risk factors of vitamin C deficiency. .&#xD;
) Doing a clinical exam within 7 days after the blood sample.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Supposed risk factors of hypovitaminosis C</measure>
    <time_frame>Day 0</time_frame>
    <description>The supposed risk factors are represent by general risk factors, Anthropometric parameters, Nutritional risk factors, Risk factors because of Unit of Long Term Care, Pathologies associated, Clinical signs associated with vitamin C deficiency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cutaneous symptoms</measure>
    <time_frame>Day 0</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Vitamin C Deficiency</condition>
  <condition>Scurvy</condition>
  <arm_group>
    <arm_group_label>Patient living in the Unit of Long Term Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient living in the Unit of Long Term Care without any limit time</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>A blood sample will be taken by the nurse of our unit within a week after their consent. It consists as a simple blood sample and it will be taken during the normal analysis planed by the chief of the service in order to avoid to collect two different samples.&#xD;
The measurement method will use equipment from the Lyon Sud hospital laboratory. The samples need a pre-treatment in the 3 hours after taking the blood to avoid the oxidation of vitamin C and a result lower than expected.</description>
    <arm_group_label>Patient living in the Unit of Long Term Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female over 65 years old&#xD;
&#xD;
          -  living in the Unit of Long Term Care without any limit time.&#xD;
&#xD;
          -  with a system of social insurance&#xD;
&#xD;
          -  Who gave its consent by his own , or with help of his representant or his tutor or&#xD;
             curator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  rejection of the blood sample&#xD;
&#xD;
          -  patient feeding with articial nutritional feeding (stomach tube feeding)&#xD;
&#xD;
          -  person close to death, who is not able to feed himself and / or with life-threatening&#xD;
             in short time.&#xD;
&#xD;
          -  Patient with personal history of vitamin C deficiency.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Unité de soins Longue Durée, Hôpital Pierre Garraud (Hospices Civils de Lyon)</name>
      <address>
        <city>Lyon</city>
        <zip>69005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>August 29, 2019</last_update_submitted>
  <last_update_submitted_qc>August 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vitamine C deficiency</keyword>
  <keyword>skin rash</keyword>
  <keyword>scurvy</keyword>
  <keyword>food texture</keyword>
  <keyword>geriatric institution</keyword>
  <keyword>Unit Of Long Term Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scurvy</mesh_term>
    <mesh_term>Avitaminosis</mesh_term>
    <mesh_term>Ascorbic Acid Deficiency</mesh_term>
  </condition_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/NCT03807791
org study id: 69HCL18_0392
nct id: NCT03807791
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The clinical finding of skin rashes which appear after a vitamin C deficiency in Long Term
      Care Unit leads us to believe that the institutional diet could predispose to this kind of
      deficiency. Vitamin C has a key role into the struggle against oxidant stress and is involved
      into the connective tissue formation of the skin and the vascular endothelium. Vitamin C
      deficiency affects currently 15 to 25% of the elderly over 65 years old reaching 15% women
      and 20% men after 65 according to Johnston and Al. It concerns mainly the people in
      precarious situations (persons without fixed homes, ethyl-smoking persons) and elderly over
      65 years. Hypovitaminosis C, defined by plasma level between 5 mg/L and 15 mg/L (28.41 to
      85.23 µmol/L), is currently undiagnosed, especially with people with a risk of food
      deficiency and its prevalence increases with age. The treatment consists of a daily oral
      supplementation of 1 gram of vitamin C/d for 15 days. A minimum intake of 10 mg/D of vitamin
      C is required to prevent scurvy and maintain a total pool of 350 mg. A diet modification by a
      systematic intake of 2 glasses of fresh orange juice and/or the consumption of raw fruits and
      vegetables would prevent the appearance of scurvy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Vitamin C plasma level
time frame: Between day 0 and day 7.
description: ) Collection of the consent
) At the same time as other analysis for current cares a blood sample taken by a nurse of our unit to determine plasma levels of vitamin C.
) Registration of risk factors of vitamin C deficiency. .
) Doing a clinical exam within 7 days after the blood sample.
measure: Supposed risk factors of hypovitaminosis C
time frame: Day 0
description: The supposed risk factors are represent by general risk factors, Anthropometric parameters, Nutritional risk factors, Risk factors because of Unit of Long Term Care, Pathologies associated, Clinical signs associated with vitamin C deficiency
measure: Cutaneous symptoms
time frame: Day 0
arm group label: Patient living in the Unit of Long Term Care
arm group type: Experimental
description: Patient living in the Unit of Long Term Care without any limit time
intervention type: Procedure
intervention name: Blood sample
description: A blood sample will be taken by the nurse of our unit within a week after their consent. It consists as a simple blood sample and it will be taken during the normal analysis planed by the chief of the service in order to avoid to collect two different samples.
The measurement method will use equipment from the Lyon Sud hospital laboratory. The samples need a pre-treatment in the 3 hours after taking the blood to avoid the oxidation of vitamin C and a result lower than expected.
arm group label: Patient living in the Unit of Long Term Care
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Scurvy
mesh term: Avitaminosis
mesh term: Ascorbic Acid Deficiency
sharing ipd: No