<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/NCT03258970</url>
  </required_header>
  <id_info>
    <org_study_id>2</org_study_id>
    <nct_id>NCT03258970</nct_id>
  </id_info>
  <brief_title>No Association Between Vitamin C and E Supplementation, Frailty, and Grip Strength Over Five Years: The CoLaus Study</brief_title>
  <acronym>CoLaus</acronym>
  <official_title>No Association Between Vitamin C and E Supplementation, Frailty, and Grip Strength Over Five Years: The CoLaus Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</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>
      To assess the cross-sectional and 5-year prospective association between self-reported&#xD;
      vitamin C+E dietary supplementation and markers of grip strength and frailty in&#xD;
      community-dwelling Swiss adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants were drawn from the Colaus study, a prospective study designed to evaluate the&#xD;
      prevalence of cardiovascular risk factors (CVRFs) and identify genetic determinants of these&#xD;
      risk factors in an adult Swiss population. Details of the sampling procedure have been&#xD;
      previously published (22) and can be located online (http://www.colaus.ch).&#xD;
&#xD;
      Recruitment for the baseline Colaus study began in June 2003 and ended in May 2006, enrolling&#xD;
      6733 participants. The first follow-up was performed between April 2009 and September 2012,&#xD;
      5.5 years on average after the collection of baseline data. The information collected was&#xD;
      similar to that in the baseline examination but included questions regarding food consumption&#xD;
      and physical activity for the first time. The second follow-up was performed between May 2014&#xD;
      and July 2016, 10.7 years on average after the collection of baseline data and applied&#xD;
      similar methods to those in the first follow-up. For this study, data from the first and the&#xD;
      second follow-ups were used.&#xD;
&#xD;
      All participants were examined in the morning after a fast of at least 8 hours. They were&#xD;
      surveyed about their personal and family history of cardiovascular disease, CVRFs, and&#xD;
      cardiovascular treatment. They also specified all prescribed and nonprescribed drugs used in&#xD;
      the last 4 weeks, including dietary and vitamin supplements.&#xD;
&#xD;
      Vitamin supplement use Vitamin supplement use and dietary intake were evaluated using a&#xD;
      self-administered, semi-quantitative food frequency questionnaire (FFQ). This FFQ includes 3&#xD;
      questions regarding the intake of vitamin C, vitamin E, and multivitamins and was previously&#xD;
      validated in the nearby Geneva population (23, 24). In short, this questionnaire computes the&#xD;
      previous 4 weeks' dietary intake and comprises 97 distinct food items that account for more&#xD;
      than 90% of intake of calories, proteins, fat, carbohydrates, alcohol, cholesterol, vitamin&#xD;
      D, and retinol and 85% of fibre, carotene, and iron. There does not yet exist an FFQ in&#xD;
      Switzerland that can assess dietary intake for an entire year (25). Thus, this FFQ provides&#xD;
      the most accurate dietary assessment available. The FFQs were completed by participants prior&#xD;
      to their visits so the questionnaires could be reviewed by trained investigators in person.&#xD;
&#xD;
      Vitamin C+E users were defined as those who reported consumption of at least 0.5/day of&#xD;
      either vitamin C or vitamin E supplements on the FFQ. As there are few single-vitamin&#xD;
      supplements available in Switzerland and many MVM can contain either vitamin C or vitamin E&#xD;
      or both, the investigators also considered MVM for sensitivity analysis. As many participants&#xD;
      failed to provide the exact brand name of the MVM, it was not possible to calculate the exact&#xD;
      intake of vitamin C or vitamin E (5). Vitamin D and/or calcium supplements were coded&#xD;
      separately and were not included in the MVM category since most vitamin D and/or calcium&#xD;
      supplements were prescribed for management of osteoporosis in women.&#xD;
&#xD;
      Other covariates Subjects were considered smokers if they smoked at the time of the&#xD;
      interview; former smokers were defined as smokers who had quit smoking no matter how long&#xD;
      before their interview; never smokers were defined as those who had never smoked. Educational&#xD;
      level was categorized as low (primary), middle (apprenticeship or high school), and high&#xD;
      (university) for highest completed level of education. Physical activity was assessed with a&#xD;
      self-reported questionnaire previously validated in a population living in Geneva (28). This&#xD;
      questionnaire considers the category and duration of 70 different forms of (non)professional&#xD;
      activities and sports from the previous 7 days. Sedentary status was defined as expending&#xD;
      more than 90% of daily energy expenditures in activities less intense than moderate- and&#xD;
      high-intensity (defined by expending at least 4 times one's basal metabolic rate) (29, 30).&#xD;
&#xD;
      Body weight and height were measured while participants stood without shoes in light indoor&#xD;
      attire. Body weight was measured in kilograms to the nearest 100 g using a Seca® scale&#xD;
      (Hamburg, Germany) that was frequently calibrated. Height was measured to the nearest 5 mm&#xD;
      using a Seca® (Hamburg, Germany) height gauge. Body composition was examined with electrical&#xD;
      bioelectrical impedance using the Bodystat 1500 analyzer (Isle of Man, UK) that has been&#xD;
      previously validated (31).&#xD;
&#xD;
      Other dietary (non-vitamin) supplements were obtained from the drug questionnaire given to&#xD;
      all participants and include substances such as shark cartilage, cod liver oil, or plant&#xD;
      extracts not registered as phytotherapy in the Swiss drug compendium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">August 10, 2017</completion_date>
  <primary_completion_date type="Actual">August 10, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Grip strength</measure>
    <time_frame>Between April 2009 and September 2012, and 5.5 years afterwards</time_frame>
    <description>Grip strength was assessed using the Baseline® Hydraulic Hand Dynamometer (Fabrication Enterprises Inc, Elmsford, NY, USA) with the subject seated, shoulders adducted and neutrally rotated, elbow flexed at 90°, forearm in neutral position, and wrist between 0 and 30° of dorsiflexion per American Society of Hand Therapists's guidelines (26). Three measurements were performed successively with the subject's right hand, and the highest value (expressed in kg), along with the participant's dominant hand choice, was recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Low grip strength</measure>
    <time_frame>Between April 2009 and September 2012, and 5.5 years afterwards</time_frame>
    <description>Grip strength was categorized as low (defined as frail in this study) or normal according to the Fried criteria, which also considers sex and body mass index (BMI).</description>
  </secondary_outcome>
  <enrollment type="Actual">2711</enrollment>
  <condition>Frail Elderly Syndrome</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational cohort study</intervention_name>
    <description>taking vitamin supplements</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine, blood and DNA samples available, but not used in this study&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All inhabitants of Lausanne city, Switzerland, aged 35 to 75 at the time of the Baseline&#xD;
        study (2003-2006)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria Participation in the first follow-up of the CoLaus study Exclusion&#xD;
        criteria for the cross-sectional study&#xD;
&#xD;
          1. missing grip strength;&#xD;
&#xD;
          2. missing covariates&#xD;
&#xD;
          3. missing or suspicious body fat values Further exclusion criteria for the prospective&#xD;
             analysis&#xD;
&#xD;
          4. did not complete the second follow-up&#xD;
&#xD;
          5. missing grip strength at the second follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Peter Vollenweider, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Vaudois</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gérard Waeber, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Vaudois</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Firmann M, Mayor V, Vidal PM, Bochud M, Pecoud A, Hayoz D, Paccaud F, Preisig M, Song KS, Yuan X, Danoff TM, Stirnadel HA, Waterworth D, Mooser V, Waeber G, Vollenweider P. The CoLaus study: a population-based study to investigate the epidemiology and genetic determinants of cardiovascular risk factors and metabolic syndrome. BMC Cardiovasc Disord. 2008 Mar 17;8:6. doi: 10.1186/1471-2261-8-6.</citation>
    <PMID>18366642</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>Pedro Marques-Vidal</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>vitamin supplement</keyword>
  <keyword>Vitamin C</keyword>
  <keyword>Vitamin E</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</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/NCT03258970
org study id: 2
nct id: NCT03258970
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the cross-sectional and 5-year prospective association between self-reported
      vitamin C+E dietary supplementation and markers of grip strength and frailty in
      community-dwelling Swiss adults.
Participants were drawn from the Colaus study, a prospective study designed to evaluate the
      prevalence of cardiovascular risk factors (CVRFs) and identify genetic determinants of these
      risk factors in an adult Swiss population. Details of the sampling procedure have been
      previously published (22) and can be located online (http://www.colaus.ch).

      Recruitment for the baseline Colaus study began in June 2003 and ended in May 2006, enrolling
      6733 participants. The first follow-up was performed between April 2009 and September 2012,
      5.5 years on average after the collection of baseline data. The information collected was
      similar to that in the baseline examination but included questions regarding food consumption
      and physical activity for the first time. The second follow-up was performed between May 2014
      and July 2016, 10.7 years on average after the collection of baseline data and applied
      similar methods to those in the first follow-up. For this study, data from the first and the
      second follow-ups were used.

      All participants were examined in the morning after a fast of at least 8 hours. They were
      surveyed about their personal and family history of cardiovascular disease, CVRFs, and
      cardiovascular treatment. They also specified all prescribed and nonprescribed drugs used in
      the last 4 weeks, including dietary and vitamin supplements.

      Vitamin supplement use Vitamin supplement use and dietary intake were evaluated using a
      self-administered, semi-quantitative food frequency questionnaire (FFQ). This FFQ includes 3
      questions regarding the intake of vitamin C, vitamin E, and multivitamins and was previously
      validated in the nearby Geneva population (23, 24). In short, this questionnaire computes the
      previous 4 weeks' dietary intake and comprises 97 distinct food items that account for more
      than 90% of intake of calories, proteins, fat, carbohydrates, alcohol, cholesterol, vitamin
      D, and retinol and 85% of fibre, carotene, and iron. There does not yet exist an FFQ in
      Switzerland that can assess dietary intake for an entire year (25). Thus, this FFQ provides
      the most accurate dietary assessment available. The FFQs were completed by participants prior
      to their visits so the questionnaires could be reviewed by trained investigators in person.

      Vitamin C+E users were defined as those who reported consumption of at least 0.5/day of
      either vitamin C or vitamin E supplements on the FFQ. As there are few single-vitamin
      supplements available in Switzerland and many MVM can contain either vitamin C or vitamin E
      or both, the investigators also considered MVM for sensitivity analysis. As many participants
      failed to provide the exact brand name of the MVM, it was not possible to calculate the exact
      intake of vitamin C or vitamin E (5). Vitamin D and/or calcium supplements were coded
      separately and were not included in the MVM category since most vitamin D and/or calcium
      supplements were prescribed for management of osteoporosis in women.

      Other covariates Subjects were considered smokers if they smoked at the time of the
      interview; former smokers were defined as smokers who had quit smoking no matter how long
      before their interview; never smokers were defined as those who had never smoked. Educational
      level was categorized as low (primary), middle (apprenticeship or high school), and high
      (university) for highest completed level of education. Physical activity was assessed with a
      self-reported questionnaire previously validated in a population living in Geneva (28). This
      questionnaire considers the category and duration of 70 different forms of (non)professional
      activities and sports from the previous 7 days. Sedentary status was defined as expending
      more than 90% of daily energy expenditures in activities less intense than moderate- and
      high-intensity (defined by expending at least 4 times one's basal metabolic rate) (29, 30).

      Body weight and height were measured while participants stood without shoes in light indoor
      attire. Body weight was measured in kilograms to the nearest 100 g using a Seca® scale
      (Hamburg, Germany) that was frequently calibrated. Height was measured to the nearest 5 mm
      using a Seca® (Hamburg, Germany) height gauge. Body composition was examined with electrical
      bioelectrical impedance using the Bodystat 1500 analyzer (Isle of Man, UK) that has been
      previously validated (31).

      Other dietary (non-vitamin) supplements were obtained from the drug questionnaire given to
      all participants and include substances such as shark cartilage, cod liver oil, or plant
      extracts not registered as phytotherapy in the Swiss drug compendium.
observational model: Cohort
time perspective: Prospective
measure: Grip strength
time frame: Between April 2009 and September 2012, and 5.5 years afterwards
description: Grip strength was assessed using the Baseline® Hydraulic Hand Dynamometer (Fabrication Enterprises Inc, Elmsford, NY, USA) with the subject seated, shoulders adducted and neutrally rotated, elbow flexed at 90°, forearm in neutral position, and wrist between 0 and 30° of dorsiflexion per American Society of Hand Therapists's guidelines (26). Three measurements were performed successively with the subject's right hand, and the highest value (expressed in kg), along with the participant's dominant hand choice, was recorded.
measure: Low grip strength
time frame: Between April 2009 and September 2012, and 5.5 years afterwards
description: Grip strength was categorized as low (defined as frail in this study) or normal according to the Fried criteria, which also considers sex and body mass index (BMI).
intervention type: Other
intervention name: Observational cohort study
description: taking vitamin supplements
Urine, blood and DNA samples available, but not used in this study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
last name: Peter Vollenweider, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Vaudois
last name: Gérard Waeber, MD, PhD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Vaudois
facility: 
country: Switzerland
citation: Firmann M, Mayor V, Vidal PM, Bochud M, Pecoud A, Hayoz D, Paccaud F, Preisig M, Song KS, Yuan X, Danoff TM, Stirnadel HA, Waterworth D, Mooser V, Waeber G, Vollenweider P. The CoLaus study: a population-based study to investigate the epidemiology and genetic determinants of cardiovascular risk factors and metabolic syndrome. BMC Cardiovasc Disord. 2008 Mar 17;8:6. doi: 10.1186/1471-2261-8-6.
PMID: 18366642
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: Pedro Marques-Vidal
investigator title: Associate professor
mesh term: Frailty
sharing ipd: No