- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03580681
A Nutrition Intervention for Arthritis -4 (WCCR-ARTH4)
A Nutrition Intervention for Arthritis-4
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
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Washington, District of Columbia, United States, 20016
- Physicians Committee for Responsible Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Plant-based diet
The diet group will be asked to follow a low-fat, vegan diet for 16 weeks
|
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
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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.
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Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Score
Time Frame: Change in pain score from Baseline at 4 months
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will be measured by visual analog scale from 0%, indicating no pain, to 100%, indicating pain as bad as it could possibly be
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Change in pain score from Baseline at 4 months
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Disease Activity score
Time Frame: Change in disease activity score from Baseline at 4 months
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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.
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Change in disease activity score from Baseline at 4 months
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Improvement in mood
Time Frame: Change in mood from Baseline at 4 months
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measured by the Beck Depression Inventory II (BDI-II), with scores ranging from 0 indicating minimal depression to 63, indicating severe depression.
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Change in mood from Baseline at 4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life of Mood
Time Frame: Change in quality of life from Baseline at 4 months
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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.
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Change in quality of life from Baseline at 4 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Neal D Barnard, Physicians Committee for Responsible Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Vitamin E
Other Study ID Numbers
- WCCR-ARTH-4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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