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

Rheumatoid Arthritis Clinical Trial

Official title:

A Nutrition Intervention for Arthritis-4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03580681
• Other study ID #: WCCR-ARTH-4
• Status: Completed
• Phase: N/A
• Start date: August 22, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2021
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Plant-based diet
Weekly instructions will be given to the participants in the intervention group about following vegan diet.

Dietary Supplement:
• Supplement
Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E

Locations

Country	Name	City	State
United States	Physicians Committee for Responsible Medicine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in pain score from Baseline at 4 months
Primary	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.	Change in disease activity score from Baseline at 4 months
Primary	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.	Change in mood from Baseline at 4 months
Secondary	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.	Change in quality of life from Baseline at 4 months