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CompletedNCT03580681Updated Jun 18, 2021

A Nutrition Intervention for Arthritis -4 (WCCR-ARTH4)

An interventional study of Plant-based diet and Supplement in Rheumatoid Arthritis, sponsored by Physicians Committee for Responsible Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-06-18.

Sponsored by Physicians Committee for Responsible Medicine · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid Arthritis
  • Diet
  • Fat-Restricted
  • Vegeterian
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 2 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Physicians Committee for Responsible Medicine is the lead sponsor of 32 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • \< 18 years of age
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Plant-based diet

    The diet group will be asked to follow a low-fat, vegan diet for 16 weeks

    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.

    Dietary Supplement: Supplement

Interventions

  • OtherPlant-based diet

    Weekly instructions will be given to the participants in the intervention group about following vegan diet.

  • Dietary supplementSupplement

    Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E

    Also known as: Vitamin E

06

What researchers measure

Primary outcomes

  1. Pain Score

    will be measured by visual analog scale from 0%, indicating no pain, to 100%, indicating pain as bad as it could possibly be

    Time frame: Change in pain score from Baseline at 4 months

  2. Disease Activity score

    measured by number of painful, swollen and tender joints from scores below 2.6, indicating disease remission, to more than 5.1, indicating severe disease activity.

    Time frame: Change in disease activity score from Baseline at 4 months

  3. Improvement in mood

    measured by the Beck Depression Inventory II (BDI-II), with scores ranging from 0 indicating minimal depression to 63, indicating severe depression.

    Time frame: Change in mood from Baseline at 4 months

Secondary outcomes

  1. Quality of Life of Mood

    measured by a Modified Health Assessment Questionnaire (MHAQ). The questionnaire measures the difficulty level of performing 8 different activities. A score of 0 = the activity can be performed without difficulty. A score of 3 = the activity cannot be performed. The MHAQ is calculated as the average of these scores in order to determine overall quality of life.

    Time frame: Change in quality of life from Baseline at 4 months

07

Study locations

1 site
  • Physicians Committee for Responsible Medicine
    Washington, District of Columbia 20016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03580681
Lead sponsor
Physicians Committee for Responsible Medicine
Responsible party
Sponsor
First posted
Jul 9, 2018
Start date
Aug 22, 2018
Primary completion
Jun 1, 2020
Completion
Jun 1, 2020
Last update
Jun 18, 2021

Study contacts

Neal D Barnard
principal investigator · Physicians Committee for Responsible Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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