<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/NCT01700881</url>
  </required_header>
  <id_info>
    <org_study_id>WCCR-ARTH-2</org_study_id>
    <nct_id>NCT01700881</nct_id>
  </id_info>
  <brief_title>A Nutrition Intervention for Arthritis -2</brief_title>
  <acronym>WCCR-ARTH2</acronym>
  <official_title>A Nutrition Intervention for Arthritis-2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Physicians Committee for Responsible Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Physicians Committee for Responsible Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a&#xD;
      low-fat, vegan diet improves pain and other subjective symptoms more effectively than a&#xD;
      control supplement or a placebo. The principal measure is pain as measured by Visual Analog&#xD;
      Scale (VAS) and disease activity as measured by number of painful swollen and tender joints,&#xD;
      respectively. The study duration is 36 weeks.&#xD;
&#xD;
      This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified&#xD;
      as triggers improves mood, using the Center for Epidemiologic Studies Depression&#xD;
      Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional&#xD;
      supplements can help reduce pain and also reduce the need for pain medications for some&#xD;
      people. The investigators will ask about 100 people to participate. All of them will get a&#xD;
      low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a&#xD;
      placebo), although some will get the diet first, and others will get the supplement first.&#xD;
      This order in which they will get the diet and the supplement will be determined randomly,&#xD;
      that is, by chance (like the toss of a coin). The principal measure is pain as measured by&#xD;
      Visual Analog Scale (VAS) and disease activity as measured by number of painful swollen and&#xD;
      tender joints, respectively. The Beck Depression Inventory II (BDI-II)will be used to measure&#xD;
      changes in mood. The study duration is 36 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 1, 2012</start_date>
  <completion_date type="Actual">November 1, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Score</measure>
    <time_frame>Change in pain score from Baseline at 4 months</time_frame>
    <description>will be measured by visual analog scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Activity score</measure>
    <time_frame>Change in disease activity score from Baseline at 4 months</time_frame>
    <description>measured by number of painful, swollen and tender joints</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in mood</measure>
    <time_frame>Change in mood from Baseline at 4 months</time_frame>
    <description>measured by the Beck Depression Inventory II (BDI-II).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in depression</measure>
    <time_frame>Change in depression from Baseline at 4 months</time_frame>
    <description>measured by Epidemiologic Studies Depression Scale-Revised (CESD-R).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life regarding pain</measure>
    <time_frame>Change in quality of life from Baseline at 4 months</time_frame>
    <description>Measured by a modified health assessment questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Plant-based diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The diet group will be asked to follow a low-fat, vegan diet for 16 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supplement</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The supplement group will follow an unrestricted diet, but will be given a pill containing a small, clinically insignificant amount of omega- 3 oils and vitamin E, which will serve as a placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Plant-based diet</intervention_name>
    <description>Weekly instructions will be given to the participants in the intervention group about following vegan diet.</description>
    <arm_group_label>Plant-based diet</arm_group_label>
    <other_name>Vegan diet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supplement</intervention_name>
    <description>Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E</description>
    <arm_group_label>Supplement</arm_group_label>
    <other_name>Vitamin E</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A diagnosis of rheumatoid arthritis based on 2010 ACR / EULAR Rheumatoid Arthritis&#xD;
        Classification Criteria. Classification as &quot;definite RA&quot; is based on:&#xD;
&#xD;
          -  the confirmed presence of synovitis in at least 1 joint&#xD;
&#xD;
          -  absence of an alternative diagnosis that better explains the synovitis&#xD;
&#xD;
          -  and achievement of a total score of 6 or greater (of a possible 10): 24 Joint&#xD;
             involvement, designating the metacarpophalangeal joints, proximal interphalangeal&#xD;
             joints, the interphalangeal joint of the thumb, second through third&#xD;
             metatarsophalangeal joint and wrist as small joints, and elbows, hip joints and knees&#xD;
             as large joints:&#xD;
&#xD;
               1. Involvement of 1 large joint gives 0 points&#xD;
&#xD;
               2. Involvement of 2-10 large joints gives 1 point&#xD;
&#xD;
               3. Involvement of 1-3 small joints (with or without involvement of large joints)&#xD;
                  gives 2 points&#xD;
&#xD;
               4. Involvement of 4-10 small joints (with or without involvement of large joints)&#xD;
                  gives 3 points&#xD;
&#xD;
               5. Involvement of more than 10 joints (with involvement of at least 1 small joint)&#xD;
                  gives 5 points&#xD;
&#xD;
          -  Serological parameters - including the rheumatoid factor as well as anti-citrullinated&#xD;
             protein antibody (ACPA):&#xD;
&#xD;
               1. Negative RF and negative ACPA gives 0 points&#xD;
&#xD;
               2. Low-positive RF or low-positive ACPA gives 2 points&#xD;
&#xD;
               3. High-positive RF or high-positive ACPA gives 3 points Acute phase reactants: 1&#xD;
                  point for elevated erythrocyte sedimentation rate (ESR) or elevated C-reactive&#xD;
                  protein (CRP) value Duration of arthritis: 1 point for symptoms lasting six weeks&#xD;
                  or longer&#xD;
&#xD;
          -  Continuing or recurring pain (i.e., joint pain daily, unless on pain medication).&#xD;
&#xD;
          -  Age at least 18 years&#xD;
&#xD;
          -  Ability and willingness to participate in all components of the study&#xD;
&#xD;
          -  Willingness to be assigned to either the diet group or supplement group&#xD;
&#xD;
          -  Pain medications unchanged within last 6 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  Rheumatoid arthritis for more than 6 years&#xD;
&#xD;
          -  Alcohol consumption of more than 2 drinks per day or the equivalent, episodic&#xD;
             increased drinking (e.g., more than 2 drinks per day on weekends), or a history of&#xD;
             alcohol abuse or dependency followed by any current use&#xD;
&#xD;
          -  Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is&#xD;
             not a criteria for exclusion)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Unstable medical or psychiatric illness&#xD;
&#xD;
          -  Likely to be disruptive in group sessions (as determined by research staff)&#xD;
&#xD;
          -  Already following a low-fat, vegan diet&#xD;
&#xD;
          -  Lack of English fluency&#xD;
&#xD;
          -  Inability to maintain current medication regimen&#xD;
&#xD;
          -  Inability or unwillingness to participate in all components of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neal D Barnard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physicians Committee for Responsible Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physicians Committee for Responsible Medicine</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>June 15, 2021</last_update_submitted>
  <last_update_submitted_qc>June 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid Arthritis, Diet, Fat-Restricted, Diet, Vegetarian</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin E</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/NCT01700881
org study id: WCCR-ARTH-2
nct id: NCT01700881
lead sponsor: 
has dmc: Yes
The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a
      low-fat, vegan diet improves pain and other subjective symptoms more effectively than a
      control supplement or a placebo. The principal measure is pain as measured by Visual Analog
      Scale (VAS) and disease activity as measured by number of painful swollen and tender joints,
      respectively. The study duration is 36 weeks.

      This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified
      as triggers improves mood, using the Center for Epidemiologic Studies Depression
      Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).
Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional
      supplements can help reduce pain and also reduce the need for pain medications for some
      people. The investigators will ask about 100 people to participate. All of them will get a
      low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a
      placebo), although some will get the diet first, and others will get the supplement first.
      This order in which they will get the diet and the supplement will be determined randomly,
      that is, by chance (like the toss of a coin). The principal measure is pain as measured by
      Visual Analog Scale (VAS) and disease activity as measured by number of painful swollen and
      tender joints, respectively. The Beck Depression Inventory II (BDI-II)will be used to measure
      changes in mood. The study duration is 36 weeks.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pain Score
time frame: Change in pain score from Baseline at 4 months
description: will be measured by visual analog scale
measure: Disease Activity score
time frame: Change in disease activity score from Baseline at 4 months
description: measured by number of painful, swollen and tender joints
measure: Improvement in mood
time frame: Change in mood from Baseline at 4 months
description: measured by the Beck Depression Inventory II (BDI-II).
measure: Improvement in depression
time frame: Change in depression from Baseline at 4 months
description: measured by Epidemiologic Studies Depression Scale-Revised (CESD-R).
measure: Quality of Life regarding pain
time frame: Change in quality of life from Baseline at 4 months
description: Measured by a modified health assessment questionnaire
arm group label: Plant-based diet
arm group type: Experimental
description: The diet group will be asked to follow a low-fat, vegan diet for 16 weeks
arm group label: Supplement
arm group type: Placebo Comparator
description: The supplement group will follow an unrestricted diet, but will be given a pill containing a small, clinically insignificant amount of omega- 3 oils and vitamin E, which will serve as a placebo.
intervention type: Other
intervention name: Plant-based diet
description: Weekly instructions will be given to the participants in the intervention group about following vegan diet.
arm group label: Plant-based diet
other name: Vegan diet
intervention type: Other
intervention name: Supplement
description: Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E
arm group label: Supplement
other name: Vitamin E
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Neal D Barnard, MD
role: Principal Investigator
affiliation: Physicians Committee for Responsible Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Vitamin E