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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion 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: 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03417648
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Physicians Committee for Responsible Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Neal D Barnard
Principal Investigator Affiliation Physicians Committee for Responsible Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington, District of Columbia

Status

Recruiting

Address

Physicians Committee for Responsible Medicine

Washington, District of Columbia, 20016

Site Contact

Jihad Alwarith

[email protected]

202-527-7363