Status:
COMPLETED
A Pilot Study of Potassium Supplementation for Adult Patients With Rheumatoid Arthritis
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
This study examines the hypothesis if patients with rheumatoid arthritis evaluate, or rate, symptom improvements after potassium supplementation (as KCl). Participants will undergo the following test...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00461448
Start Date
February 1 2007
End Date
April 1 2007
Last Update
February 6 2009
Active Locations (2)
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1
Division of Rheumatoloy, Sina Teaching Hospital, Tabriz Medical Sciences University
Tabriz, East Azerbaidjan, Iran
2
Sheikh-ol-Raees Ultra Specialized Clinic
Tabriz, East Azerbaidjan, Iran