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A Nutrition Intervention for Arthritis -3 (WCCR-ARTH3)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Plant-based diet

Supplement

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Diet, Fat-Restricted, Diet, Vegetarian

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Physicians Committee for Responsible Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Plant-based diet

Supplement

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Disease Activity score

measured by number of painful, swollen and tender joints

Improvement in mood

measured by the Beck Depression Inventory II (BDI-II).

Secondary Outcome Measures

Quality of Life

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.

Full Information

NCT ID

NCT03417648

First Posted

January 25, 2018

Last Updated

March 1, 2019

Sponsor

Physicians Committee for Responsible Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03417648

Brief Title

A Nutrition Intervention for Arthritis -3 (WCCR-ARTH3)

Official Title

A Nutrition Intervention for Arthritis-3

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

March 8, 2018 (Actual)

Primary Completion Date

December 14, 2018 (Actual)

Study Completion Date

December 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Physicians Committee for Responsible Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Plant-based diet

Arm Type

Experimental

Arm Description

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

Arm Title

Supplement

Arm Type

Placebo Comparator

Arm 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(s)

Plant-based diet

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Supplement

Other Intervention Name(s)

Vitamin E

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain Score

Description

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

Title

Disease Activity score

Description

measured by number of painful, swollen and tender joints

Time Frame

Change in disease activity score from Baseline at 4 months

Title

Improvement in mood

Description

measured by the Beck Depression Inventory II (BDI-II).

Time Frame

Change in mood from Baseline at 4 months

Secondary Outcome Measure Information:

Title

Quality of Life

Description

Time Frame

Change in quality of life from Baseline at 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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: Involvement of 1 large joint gives 0 points Involvement of 2-10 large joints gives 1 point Involvement of 1-3 small joints (with or without involvement of large joints) gives 2 points Involvement of 4-10 small joints (with or without involvement of large joints) gives 3 points 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): Negative RF and negative ACPA gives 0 points Low-positive RF or low-positive ACPA gives 2 points 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neal D Barnard

Organizational Affiliation

Physicians Committee for Responsible Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Physicians Committee for Responsible Medicine

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

12. IPD Sharing Statement

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A Nutrition Intervention for Arthritis -3 (WCCR-ARTH3)

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