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

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

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Other: Plant-based diet; Other: Supplement	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Nutrition Intervention for Arthritis-2
• Study Start Date: October 2012
• Estimated Primary Completion Date: November 2020
• Estimated Study Completion Date: November 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Plant-based diet; The diet group will be asked to follow a low-fat, vegan diet for 16 weeks	Other: Plant-based diet; Weekly instructions will be given to the participants in the intervention group about following vegan diet.; Other Name: Vegan 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.	Other: Supplement; Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E; Other Name: Vitamin E

Outcome Measures

Primary Outcome Measures :

1. Pain Score [ Time Frame: Change in pain score from Baseline at 4 months ]
   will be measured by visual analog scale
2. Disease Activity score [ Time Frame: Change in disease activity score from Baseline at 4 months ]
   measured by number of painful, swollen and tender joints
3. Improvement in mood [ Time Frame: Change in mood from Baseline at 4 months ]
   measured by the Beck Depression Inventory II (BDI-II).
4. Improvement in depression [ Time Frame: Change in depression from Baseline at 4 months ]
   measured by Epidemiologic Studies Depression Scale-Revised (CESD-R).

Secondary Outcome Measures :

1. Quality of Life regarding pain [ Time Frame: Change in quality of life from Baseline at 4 months ]
   Measured by a modified health assessment questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, District of Columbia

Physicians Committee for Responsible Medicine

Washington, District of Columbia, United States, 20016

Sponsors and Collaborators

Physicians Committee for Responsible Medicine

Investigators

• Principal Investigator: Neal D Barnard, MD; Physicians Committee for Responsible Medicine

More Information

• Responsible Party: Physicians Committee for Responsible Medicine
• ClinicalTrials.gov Identifier: NCT01700881
• Other Study ID Numbers: WCCR-ARTH-2
• First Posted: October 4, 2012
• Last Update Posted: March 3, 2020
• Last Verified: March 2020

Keywords provided by Physicians Committee for Responsible Medicine:

Rheumatoid Arthritis, Diet, Fat-Restricted, Diet, Vegetarian

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Vitamin E; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents