- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01544101
A Nutritional Intervention for Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20016
- Physicians Committee for Responsible Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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: Vegan Diet
|
Vegan diet, which is devoid of animal products and minimal in fat
|
Placebo Comparator: Supplement
|
mixture of omega3 fatty acids aand vitamins
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Score
Time Frame: Baseline and 4 months
|
will be measured by visual analog scale
|
Baseline and 4 months
|
Disease Activity score
Time Frame: Baseline and 4 months
|
measured by number of painful, swollen and tender joints
|
Baseline and 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: Baseline and 4 months
|
measured by a modified health assessment questionnaire
|
Baseline and 4 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Neal Barnard, MD, Physicians Committee for Responsible Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WCCR-ARTH1
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.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
Clinical Trials on Vegan Diet
-
University of TorontoCanadian Institutes of Health Research (CIHR); Canadian Diabetes Association; The Physicians' Services Incorporated Foundation and other collaboratorsUnknown
-
University of South CarolinaCompleted
-
Wageningen UniversityRijnstate Hospital; Gelderse Vallei HospitalNot yet recruitingOsteo Arthritis Knee | Protein Synthesis
-
Stanford UniversityCompletedInflammation | Glucose Intolerance | Microbiome | Lipid Metabolism | Weight Change, Body | Immune FunctionUnited States
-
Rush University Medical CenterCompletedNutrition Disorders | Risk Reduction | Cardiovascular MorbidityUnited States
-
Physicians Committee for Responsible MedicineRecruiting
-
David Grant U.S. Air Force Medical CenterActive, not recruitingCardiometabolic Risk FactorsUnited States
-
Physicians Committee for Responsible MedicineSibley Memorial HospitalCompleted
-
NYU Langone HealthCompletedCoronary Artery Disease | InflammationUnited States
-
Physicians Committee for Responsible MedicineCompletedType 2 Diabetes