Trial | NCT01544101  Report issue

Official Title

A Nutritional Intervention for Arthritis

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    32
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.
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 Started
Sep 30
2011
Primary Completion
Oct 31
2012
Study Completion
Oct 31
2012
Last Update
Oct 19
2012
Estimate

Other Vegan Diet

Vegan diet, which is devoid of animal products and minimal in fat

Dietary Supplement dietary supplement omega3 fatty acids aand vitamins

mixture of omega3 fatty acids aand vitamins

Vegan Diet Experimental

Supplement Placebo Comparator

Criteria 

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
No Results Posted