ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03417648
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine

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.

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).


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Plant-based diet Other: Supplement Not Applicable

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 Beck Depression Inventory II (BDI-II)will be used to measure changes in mood. The study duration is 36 weeks.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Nutrition Intervention for Arthritis-3
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018


Arm Intervention/treatment
Experimental: Plant-based diet
The diet group will be asked to follow a low-fat, vegan diet for 16 weeks
Other: Plant-based diet
Weekly instructions will be given to the participants in the intervention group about following vegan diet.

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.
Other: Supplement
unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E
Other Name: Vitamin E




Primary Outcome Measures :
  1. Pain Score [ Time Frame: Change in pain score from Baseline at 4 months ]
    will be measured by visual analog scale from 0%, indicating no pain, to 100%, indicating pain as bad as it could possibly be

  2. Disease Activity score [ Time Frame: Change in disease activity score from Baseline at 4 months ]
    measured by number of painful, swollen and tender joints

  3. Improvement in mood [ Time Frame: Change in mood from Baseline at 4 months ]
    measured by the Beck Depression Inventory II (BDI-II).


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Change in quality of life from Baseline at 4 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417648


Contacts
Contact: Jihad Alwarith 202-527-7363 jalwarith@pcrm.org

Locations
United States, District of Columbia
Physicians Committee for Responsible Medicine Recruiting
Washington, District of Columbia, United States, 20016
Contact: Jihad Alwarith    202-527-7363    jalwarith@pcrm.org   
Principal Investigator: Neal Barnard         
Sponsors and Collaborators
Physicians Committee for Responsible Medicine
Investigators
Principal Investigator: Neal D Barnard Physicians Committee for Responsible Medicine

Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT03417648     History of Changes
Other Study ID Numbers: WCCR-ARTH-3
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Physicians Committee for Responsible Medicine:
Rheumatoid Arthritis, Diet, Fat-Restricted, Diet, Vegetarian

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents