<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/NCT01718925</url>
  </required_header>
  <id_info>
    <org_study_id>3256</org_study_id>
    <nct_id>NCT01718925</nct_id>
  </id_info>
  <brief_title>25-hydroxyvitamin D and Fatigue: The VITALITY Study</brief_title>
  <official_title>Vitamin D, Fatigue and Patient Reported Outcome (PRO) in Chronic Somatic and Functional Disorders.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ostfold Hospital Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alesund Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sykehuset Telemark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sykehuset Innlandet HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ostfold University College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ostfold Hospital Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The burden of chronic disease is continuing to rise. Even though patients may be in remission&#xD;
      or have quiescent disease, several studies have confirmed that symptoms, such as e.g.,&#xD;
      fatigue, is troublesome.&#xD;
&#xD;
      The primary aim of this study is to investigate whether or not there might be an association&#xD;
      between levels of vitamin D and the subjective experience of fatigue in conditions, such as&#xD;
      inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel&#xD;
      syndrome.&#xD;
&#xD;
      Secondary aims is to study both the co-occurence and influence of pain, depression and&#xD;
      anxiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The burden of chronic disease is continuing to rise. Even though patients may be in remission&#xD;
      or have quiescent disease, several studies have confirmed that symptoms, such as e.g.,&#xD;
      fatigue, is troublesome.Previous studies have confirmed that vitamin D deficiency is&#xD;
      associated with both Crohn's disease and Rheumatoid Arthritis. Since Vitamin D is associated&#xD;
      with both onset of chronic disease and energy, we aim in this study to assess its impact on&#xD;
      fatigue in various chronic diseases.&#xD;
&#xD;
      The primary aim of this study is to investigate whether or not there might be an association&#xD;
      between levels of vitamin D and the subjective experience of fatigue in conditions, such as&#xD;
      inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel&#xD;
      syndrome.&#xD;
&#xD;
      Secondary aims is to study both the co-occurence and influence of pain, depression and&#xD;
      anxiety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>2 years</time_frame>
    <description>Fatigue and the impact of vitamin d levels</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">614</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <condition>Inflammatory Bowel Disease</condition>
  <condition>Diabetes</condition>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Inflammatory Bowel Disease</arm_group_label>
    <description>Ulcerative Colitis and Crohns's disease patients will be recruited from sqeduled outpatient follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Irritable Bowel Syndrome</arm_group_label>
    <description>Irritable Bowel patients will be recruited from sqeduled outpatient follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rheumatoid Arthritis</arm_group_label>
    <description>Rheumatoid Arthritis patients will be recruited from sqeduled outpatient follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diabetes Mellitus</arm_group_label>
    <description>Diabetes mellitus patients will be recruited from sqeduled outpatient follow-up</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with an established diagnose of IBD, DIA, IBS or RA is eligible for inclusion in&#xD;
        this study. Patients must be over 18 years of age. Disease activity will be measured using&#xD;
        the SCCAI for ulcerative colitis, SCDAI for Crohn's disease, DAS-28 for rheumatoid&#xD;
        arthritis. In Dia and IBD objective activity measures, such as calprotectin in stools and&#xD;
        HbA1C, will be collected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent,&#xD;
&#xD;
          -  over 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dementia,&#xD;
&#xD;
          -  cognitive disorders,&#xD;
&#xD;
          -  not able to comply with the study procedures,&#xD;
&#xD;
          -  on active vitamin D treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars-Petter Jelsness-Jørgensen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ostfold Hospital Trust</affiliation>
  </overall_official>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 14, 2015</last_update_submitted>
  <last_update_submitted_qc>October 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
  </condition_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/NCT01718925
org study id: 3256
nct id: NCT01718925
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The burden of chronic disease is continuing to rise. Even though patients may be in remission
      or have quiescent disease, several studies have confirmed that symptoms, such as e.g.,
      fatigue, is troublesome.

      The primary aim of this study is to investigate whether or not there might be an association
      between levels of vitamin D and the subjective experience of fatigue in conditions, such as
      inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel
      syndrome.

      Secondary aims is to study both the co-occurence and influence of pain, depression and
      anxiety.
The burden of chronic disease is continuing to rise. Even though patients may be in remission
      or have quiescent disease, several studies have confirmed that symptoms, such as e.g.,
      fatigue, is troublesome.Previous studies have confirmed that vitamin D deficiency is
      associated with both Crohn's disease and Rheumatoid Arthritis. Since Vitamin D is associated
      with both onset of chronic disease and energy, we aim in this study to assess its impact on
      fatigue in various chronic diseases.

      The primary aim of this study is to investigate whether or not there might be an association
      between levels of vitamin D and the subjective experience of fatigue in conditions, such as
      inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel
      syndrome.

      Secondary aims is to study both the co-occurence and influence of pain, depression and
      anxiety.
observational model: Cohort
time perspective: Cross-Sectional
measure: Fatigue
time frame: 2 years
description: Fatigue and the impact of vitamin d levels
arm group label: Inflammatory Bowel Disease
description: Ulcerative Colitis and Crohns's disease patients will be recruited from sqeduled outpatient follow-up
arm group label: Irritable Bowel Syndrome
description: Irritable Bowel patients will be recruited from sqeduled outpatient follow-up
arm group label: Rheumatoid Arthritis
description: Rheumatoid Arthritis patients will be recruited from sqeduled outpatient follow-up
arm group label: Diabetes Mellitus
description: Diabetes mellitus patients will be recruited from sqeduled outpatient follow-up
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lars-Petter Jelsness-Jørgensen, PhD
role: Principal Investigator
affiliation: Ostfold Hospital Trust
responsible party type: Sponsor
mesh term: Inflammatory Bowel Diseases
mesh term: Irritable Bowel Syndrome