search
Back to results

A Nutritional Intervention for Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vegan Diet
dietary supplement omega3 fatty acids aand vitamins
Sponsored by
Physicians Committee for Responsible Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  1. A diagnosis of rheumatoid arthritis, as defined below.

    A diagnosis of rheumatoid arthritis is 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 of4-10 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
  2. Continuing or recurring pain (i.e., joint pain daily, unless on pain medication).
  3. Age at least 18 years
  4. Ability and willingness to participate in all components of the study
  5. Willingness to be assigned to either the diet group or supplement group
  6. Pain medications unchanged within last 6 weeks.

Exclusion Criteria:

  1. < 18 years of age
  2. Rheumatoid arthritis for more than 6 years
  3. 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
  4. Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
  5. Pregnancy
  6. Unstable medical or psychiatric illness
  7. Likely to be disruptive in group sessions (as determined by research staff)
  8. Already following a low-fat, vegan diet
  9. Lack of English fluency
  10. Inability to maintain current medication regimen
  11. 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

Vegan Diet

Supplement

Arm Description

Outcomes

Primary Outcome Measures

Pain Score
will be measured by visual analog scale
Disease Activity score
measured by number of painful, swollen and tender joints

Secondary Outcome Measures

Quality of Life
measured by a modified health assessment questionnaire

Full Information

First Posted
February 27, 2012
Last Updated
October 18, 2012
Sponsor
Physicians Committee for Responsible Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT01544101
Brief Title
A Nutritional Intervention for Arthritis
Official Title
A Nutritional Intervention for Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physicians Committee for Responsible Medicine

4. Oversight

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.
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 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, Vegetarian, Diet, Fat-Restricted, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vegan Diet
Arm Type
Experimental
Arm Title
Supplement
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Vegan Diet
Intervention Description
Vegan diet, which is devoid of animal products and minimal in fat
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary supplement omega3 fatty acids aand vitamins
Intervention Description
mixture of omega3 fatty acids aand vitamins
Primary Outcome Measure Information:
Title
Pain Score
Description
will be measured by visual analog scale
Time Frame
Baseline and 4 months
Title
Disease Activity score
Description
measured by number of painful, swollen and tender joints
Time Frame
Baseline and 4 months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
measured by a modified health assessment questionnaire
Time Frame
Baseline and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of rheumatoid arthritis, as defined below. A diagnosis of rheumatoid arthritis is 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 of4-10 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Barnard, MD
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

Learn more about this trial

A Nutritional Intervention for Arthritis

We'll reach out to this number within 24 hrs