Rheumatoid Arthritis Clinical Trial
Official title:
Pilot Study of Potassium Supplementation in the Treatment of Rheumatoid Arthritis: a 4-Week, Randomized, Double-Blind, Placebo-Controlled Trial
Verified date | February 2009 |
Source | hahid Beheshti University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ministry of Health |
Study type | Interventional |
Rheumatoid arthritis is the paradigmatic immune-mediated inflammatory arthropathy. With
respect to rheumatoid arthritis (RA), patients have been described as having inappropriately
low spontaneous and stimulated cortisol secretion levels. Serum cortisol levels are
decreased in RA patients who are taking prednisolone. Also, in patients RA, of longer
duration, glucocorticoid receptor (GR) down-regulation has been reported without any change
in cortisol levels. There is a reduced capacity for local reactivation of cortisone to
cortisol in RA synovial cells. It is noteworthy that since synthetic glucocorticoids also
use same reactivation shuttle (the cortisol-cortisone shuttle), the results also apply to
therapeutic glucocorticoids.
Glucocorticoids are widely used to treat chronic inflammatory conditions including
rheumatoid arthritis. Prednisolone has a greater effect than non-steroidal,
anti-inflammatory drugs on joint tenderness and pain, whereas the difference in grip
strength was not significant. There are no qualitative differences between the effects of
endogenous cortisol and exogenously applied synthetic glucocorticoids, since all effects are
transmitted via the same receptor. Cortisol, on the other hand, plays a major role in normal
potassium homeostasis.
Recent studies have highlighted a role for diet, with suggestions that diets high in
caffeine, low in antioxidants and high in red meat may contribute to an increased risk for
the development of rheumatoid arthritis. Higher intakes of complex carbohydrates, dietary
fiber, magnesium, folic acid, vitamin C and E, carotenoids and other phytochemicals have
been shown to offer distinct advantages compared to diets containing meat and other foods of
animal origin. The relation of a potassium deficiency to RA is much less well documented.
The first person to definitively link potassium with arthritis was DeCoti Marsh. LaCelle,
Morgan & Atwater found that the cells of 50 arthritic patients were 30 to 50% lower than
healthy people.
Our current clinical trial (clinical trial no NCT00399282) shows that most of patients with
RA do not have enough potassium intake. This condition may contribute to a subclinical lower
serum cortisol, although there is possibility that cortisol serum levels might be unchanged
due to a sufficient "cortisol homeostasis" and "potassium homeostasis".
Status | Completed |
Enrollment | 36 |
Est. completion date | April 2007 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Age 18 years or older - Diagnosis of RA, as defined by fulfilling at least four of seven American College of Rheumatology (ACR) criteria - Onset of arthritis after the age of 16 years - Positive for rheumatoid factor (RF) - Active RA, as defined by at least four swollen joints, at least four tender joints, and either an erythrocyte sedimentation rate (ESR) of greater than 30 mm/hr OR C-reactive protein level greater than 1.0 mg/dl (normal less than 0.4) - Willing to follow the study protocol - Willing to intake PGJ or EGJ - On a salt-restricted diet Exclusion Criteria: - Abnormal kidney (including kidney stones in the 5 years prior to study entry or creatinine clearance less than 50 ml/min/1.73 m2 of body surface area) or liver disease - Currently taking medications that might affect potassium - Intra-articular injections within 4 weeks prior to study entry - Current peptic ulcer disease - History of alcohol or substance abuse - Active infection, or chronic or persistent infection that might worsen with immunosuppressive treatment (e.g., HIV, hepatitis B virus, hepatitis C virus, tuberculosis [TB]) - Known coronary artery disease or significant cardiac arrhythmias or severe congestive heart failure (New York Heart Association [NYHA] classes III or IV) - Definitive diagnosis of another autoimmune rheumatologic disease (e.g., systemic lupus erythematosus [SLE], scleroderma, primary Sjogren's syndrome, primary vasculitis) - History of cancer. Participants with previous resected basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ Grade I cervical cancer within 5 years prior to study entry are not excluded. - Any condition or treatment (including biologic therapies) that, in the opinion of the investigator, may place the participant at unacceptable risk during the study - Pregnancy - Vegetarian - Use of estrogen replacement therapy - Current use of diuretics, beta-blockers, anabolic drugs (steroids or other), angiotensin converting enzyme (ACE) inhibitors, or angiotensin receptor blockers (ARBs), etc, or any drug (s) other than drugs indicated for the purpose of RA therapy which is (are) known to effect serum potassium levels - Hyperparathyroidism - Untreated thyroid disease - Significant immune disorder - Adrenal insufficiency, primary aldosteronism, or Bartter's syndrome - Diabetes mellitus |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Division of Rheumatoloy, Sina Teaching Hospital, Tabriz Medical Sciences University | Tabriz | East Azerbaidjan |
Iran, Islamic Republic of | Sheikh-ol-Raees Ultra Specialized Clinic | Tabriz | East Azerbaidjan |
Lead Sponsor | Collaborator |
---|---|
hahid Beheshti University of Medical Sciences |
Iran, Islamic Republic of,
Rastmanesh R, Abargouei AS, Shadman Z, Ebrahimi AA, Weber CE. A pilot study of potassium supplementation in the treatment of hypokalemic patients with rheumatoid arthritis: a randomized, double-blinded, placebo-controlled trial. J Pain. 2008 Aug;9(8):722- — View Citation
Rastmanesh R. Psoriasis and vegetarian diets: a role for cortisol and potassium? Med Hypotheses. 2009 Mar;72(3):368. doi: 10.1016/j.mehy.2008.09.031. Epub 2008 Nov 4. — View Citation
Weber CE. A proposal for an experiment of potassium on rheumatoid arthritis. Clin Exp Rheumatol. 1983 Apr-Jun;1(2):184-6. — View Citation
Weber CE. Copper response to rheumatoid arthritis. Med Hypotheses. 1984 Dec;15(4):333-48. — View Citation
Weber CE. Corticosteroid regulation of electrolytes. J Theor Biol. 1983 Oct 7;104(3):443-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient's dietary and supplement potassium intake (combined technique: food frequency questionnaire, 24 hour food-recall, food record), serum potassium | within the 28 days (plus or minus 2 days) | Yes | |
Primary | Disease Activity Score (DAS28, 28-joint count) at d 0, 28 | within the first 28 days (plus or minus 2 days) | No | |
Primary | Patient's global assessment of disease activity (0 to 10 cm visual analog scale: 0, symptom free; 10, very severe) at d 0, 28 | within the first 28 days (plus or minus 2 days) | No | |
Primary | Patient's visual analogue scale (VAS) for pain at d 0, 28 | within the first 28 days (plus or minus 2 days) | No | |
Primary | Duration of morning stiffness (in minutes) at d 0, 28 | within the first 28 days (plus or minus 2 days) | No | |
Primary | Joint pain intensity, on a visual analogue scale (VAS) for pain (0 = no pain to 100mm =severe pain) at d 0, 28 | within the first 28 days (plus or minus 2 days) | No | |
Primary | Onset of fatigue (in minutes) after walking at d 0, 28 | within the first 28 days (plus or minus 2 days) | No | |
Primary | Ritchie's articular index for pain joints at d 0, 28 | within the first 28 days (plus or minus 2 days) | No | |
Primary | Right and left grip strength (in mmHg) measured with a sphygmomanometer cuff inflated to 20 mmHg at d 0, 28 | within the first 28 days (plus or minus 2 days) | No | |
Primary | Classification of functional status in RA according to revised criteria of the American College of Rheumatology at Patient's global assessment of disease activity (0 to 10 cm visual analog scale: 0, symptom free; 10, very severe) at d 0, 28 | within the first 28 days (plus or minus 2 days) | No | |
Secondary | Serum cortisol, NA, K, ACTH, aldosterone, creatinine, urea, uric acid, pH; urinalysis (urea, uric acid, Na, K, pH, creatinine), CRP, RF, and ESR at d 0, 28 | within the first 28 days (plus or minus 2 days) | Yes |
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