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A Nutrition Intervention for Arthritis -2 (WCCR-ARTH2)

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ClinicalTrials.gov Identifier: NCT01700881
Recruitment Status : Active, not recruiting
First Posted : October 4, 2012
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine

Tracking Information
First Submitted Date  ICMJE October 1, 2012
First Posted Date  ICMJE October 4, 2012
Last Update Posted Date March 3, 2020
Study Start Date  ICMJE October 2012
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
  • Pain Score [ Time Frame: Change in pain score from Baseline at 4 months ]
    will be measured by visual analog scale
  • Disease Activity score [ Time Frame: Change in disease activity score from Baseline at 4 months ]
    measured by number of painful, swollen and tender joints
  • Improvement in mood [ Time Frame: Change in mood from Baseline at 4 months ]
    measured by the Beck Depression Inventory II (BDI-II).
  • Improvement in depression [ Time Frame: Change in depression from Baseline at 4 months ]
    measured by Epidemiologic Studies Depression Scale-Revised (CESD-R).
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
  • Pain Score [ Time Frame: Change from Baseline at 4 months ]
    will be measured by visual analog scale
  • Disease Activity score [ Time Frame: Change from Baseline at 4 months ]
    measured by number of painful, swollen and tender joints
  • Improvement in mood [ Time Frame: Change from Baseline at 4 months ]
    measured by the Beck Depression Inventory II (BDI-II).
  • Improvement in mood [ Time Frame: Change from Baseline at 4 months ]
    measured by Epidemiologic Studies Depression Scale-Revised (CESD-R).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
Quality of Life regarding pain [ Time Frame: Change in quality of life from Baseline at 4 months ]
Measured by a modified health assessment questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
Quality of Life [ Time Frame: Change from Baseline at 4 months ]
Measured by a modified health assessment questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Nutrition Intervention for Arthritis -2
Official Title  ICMJE A Nutrition Intervention for Arthritis-2
Brief Summary

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).

Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Other: Plant-based diet
    Weekly instructions will be given to the participants in the intervention group about following vegan diet.
    Other Name: Vegan diet
  • Other: Supplement
    Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E
    Other Name: Vitamin E
Study Arms  ICMJE
  • Experimental: Plant-based diet
    The diet group will be asked to follow a low-fat, vegan diet for 16 weeks
    Intervention: Other: Plant-based diet
  • Placebo Comparator: Supplement
    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: Other: Supplement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 2, 2014)
6
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2012)
32
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

A diagnosis of rheumatoid arthritis based on 2010 ACR / EULAR Rheumatoid Arthritis Classification Criteria. Classification as "definite RA" is based on:

  • the confirmed presence of synovitis in at least 1 joint
  • absence of an alternative diagnosis that better explains the synovitis
  • and achievement of a total score of 6 or greater (of a possible 10): 24 Joint involvement, designating the metacarpophalangeal joints, proximal interphalangeal joints, the interphalangeal joint of the thumb, second through third metatarsophalangeal joint and wrist as small joints, and elbows, hip joints and knees as large joints:

    1. Involvement of 1 large joint gives 0 points
    2. Involvement of 2-10 large joints gives 1 point
    3. Involvement of 1-3 small joints (with or without involvement of large joints) gives 2 points
    4. Involvement of 4-10 small joints (with or without involvement of large joints) gives 3 points
    5. Involvement of more than 10 joints (with involvement of at least 1 small joint) gives 5 points
  • Serological parameters - including the rheumatoid factor as well as anti-citrullinated protein antibody (ACPA):

    1. Negative RF and negative ACPA gives 0 points
    2. Low-positive RF or low-positive ACPA gives 2 points
    3. High-positive RF or high-positive ACPA gives 3 points Acute phase reactants: 1 point for elevated erythrocyte sedimentation rate (ESR) or elevated C-reactive protein (CRP) value Duration of arthritis: 1 point for symptoms lasting six weeks or longer
  • Continuing or recurring pain (i.e., joint pain daily, unless on pain medication).
  • Age at least 18 years
  • Ability and willingness to participate in all components of the study
  • Willingness to be assigned to either the diet group or supplement group
  • Pain medications unchanged within last 6 weeks.

Exclusion Criteria:

  • < 18 years of age
  • Rheumatoid arthritis for more than 6 years
  • Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
  • Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
  • Pregnancy
  • Unstable medical or psychiatric illness
  • Likely to be disruptive in group sessions (as determined by research staff)
  • Already following a low-fat, vegan diet
  • Lack of English fluency
  • Inability to maintain current medication regimen
  • Inability or unwillingness to participate in all components of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01700881
Other Study ID Numbers  ICMJE WCCR-ARTH-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Physicians Committee for Responsible Medicine
Study Sponsor  ICMJE Physicians Committee for Responsible Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neal D Barnard, MD Physicians Committee for Responsible Medicine
PRS Account Physicians Committee for Responsible Medicine
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP