Rheumatoid ArthritisNCT01544101
A Nutritional Intervention for Arthritis
A study testing Vegan Diet and dietary supplement omega3 fatty acids aand vitamins in people with Rheumatoid Arthritis, run by Physicians Committee for Responsible Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Vegan Diet and dietary supplement omega3 fatty acids aand vitamins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- < 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, 20016
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Vegan Diet, dietary supplement omega3 fatty acids aand vitamins
- Keywords
- Rheumatoid Arthritis, Diet, Vegetarian, Diet, Fat-Restricted, Pain
- Medical subject headings
- Arthritis, Rheumatoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegan DietOther
Vegan diet, which is devoid of animal products and minimal in fat
dietary supplement omega3 fatty acids aand vitaminsDietary supplement
mixture of omega3 fatty acids aand vitamins
| Study group | Role | What they receive |
|---|---|---|
| Vegan Diet | Experimental | Not described Receives: Other: Vegan Diet |
| Supplement | Placebo comparator | Not described Receives: Dietary Supplement: dietary supplement omega3 fatty acids aand vitamins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
will be measured by visual analog scale
Measured: Baseline and 4 months
Disease Activity score
measured by number of painful, swollen and tender joints
Measured: Baseline and 4 months
Secondary outcomes (1)
Quality of Life
measured by a modified health assessment questionnaire
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physicians Committee for Responsible Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neal Barnard, MD, Principal investigator, Physicians Committee for Responsible Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544101
- Sponsor's protocol ID
- WCCR-ARTH1
- Status last verified
- Oct 2012
- First submitted
- 27 Feb 2012
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barnard ND, Levin S, Crosby L, Flores R, Holubkov R, Kahleova H. A Randomized, Crossover Trial of a Nutritional Intervention for Rheumatoid Arthritis. Am J Lifestyle Med. 2022 Apr 3;19(2):266-275. doi: 10.1177/15598276221081819. eCollection 2025 Feb.
PubMed 39981557
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutritional Intervention for Arthritis
- ClinicalTrials.gov ID
- NCT01544101
- Acronym / sponsor ID
- WCCR-ARTH1
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Diet, Vegetarian, Diet, Fat-Restricted, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Physicians Committee for Responsible MedicineUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan Diet | Experimental | Other: Vegan Diet |
| Supplement | Placebo comparator | Dietary Supplement: dietary supplement omega3 fatty acids aand vitamins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- Serological parameters - including the rheumatoid factor as well as anti-citrullinated protein antibody (ACPA):
- Continuing or recurring pain (i.e., joint pain daily, unless on pain medication).
Key exclusion criteria (11 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegan DietVegan diet, which is devoid of animal products and minimal in fat | Other | Vegan Diet |
| dietary supplement omega3 fatty acids aand vitaminsmixture of omega3 fatty acids aand vitamins | Dietary supplement | Supplement |
Primary outcome
Pain Score
Time frame: Baseline and 4 months
will be measured by visual analog scale
Disease Activity score
Time frame: Baseline and 4 months
measured by number of painful, swollen and tender joints
1 secondary outcome
Quality of Life
Time frame: Baseline and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
- Derived from this study: PubMed 39981557Barnard ND, Levin S, Crosby L, Flores R, Holubkov R, Kahleova H. A Randomized, Crossover Trial of a Nutritional Intervention for Rheumatoid Arthritis. Am J Lifestyle Med. 2022 Apr 3;19(2):266-275. doi: 10.1177/15598276221081819. eCollection 2025 Feb.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Barnard, MD principal investigator
Physicians Committee for Responsible Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegan Diet and dietary supplement omega3 fatty acids aand vitamins in people with Rheumatoid Arthritis, run by Physicians Committee for Responsible Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: Baseline and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01544101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2012.