A Nutritional Intervention for Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:
NCT01544101
First received: February 27, 2012
Last updated: October 18, 2012
Last verified: October 2012
  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.


Condition Intervention
Rheumatoid Arthritis
Other: Vegan Diet
Dietary Supplement: dietary supplement omega3 fatty acids aand vitamins

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Nutritional Intervention for Arthritis

Resource links provided by NLM:


Further study details as provided by Physicians Committee for Responsible Medicine:

Primary Outcome Measures:
  • Pain Score [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    will be measured by visual analog scale

  • Disease Activity score [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    measured by number of painful, swollen and tender joints


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    measured by a modified health assessment questionnaire


Enrollment: 32
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vegan Diet Other: Vegan Diet
Vegan diet, which is devoid of animal products and minimal in fat
Placebo Comparator: Supplement Dietary Supplement: dietary supplement omega3 fatty acids aand vitamins
mixture of omega3 fatty acids aand vitamins

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Continuing or recurring pain (i.e., joint pain daily, unless on pain medication).
  3. Age at least 18 years
  4. Ability and willingness to participate in all components of the study
  5. Willingness to be assigned to either the diet group or supplement group
  6. Pain medications unchanged within last 6 weeks.

Exclusion Criteria:

  1. < 18 years of age
  2. Rheumatoid arthritis for more than 6 years
  3. 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
  4. Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
  5. Pregnancy
  6. Unstable medical or psychiatric illness
  7. Likely to be disruptive in group sessions (as determined by research staff)
  8. Already following a low-fat, vegan diet
  9. Lack of English fluency
  10. Inability to maintain current medication regimen
  11. Inability or unwillingness to participate in all components of the study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544101

Locations
United States, District of Columbia
Physicians Committee for Responsible Medicine
Washington, District of Columbia, United States, 20016
Sponsors and Collaborators
Physicians Committee for Responsible Medicine
Investigators
Principal Investigator: Neal Barnard, MD Physicians Committee for Responsible Medicine
  More Information

No publications provided

Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT01544101     History of Changes
Other Study ID Numbers: WCCR-ARTH1
Study First Received: February 27, 2012
Last Updated: October 18, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Food Habits
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Habits
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014