Rheumatoid ArthritisPhase 1NCT00461448
A Pilot Study of Potassium Supplementation for Adult Patients With Rheumatoid Arthritis
A Phase 1 study testing Potassium supplement in people with Rheumatoid Arthritis, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
Trial 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 stimulated cortisol secretion levels. Serum cortisol levels are decreased in RA patients who are taking prednisolone. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Potassium supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesIran
- Study dates
- Feb 2007to Apr 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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])
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Division of Rheumatoloy, Sina Teaching Hospital, Tabriz Medical Sciences University
Tabriz, East Azerbaidjan
Sheikh-ol-Raees Ultra Specialized Clinic
Tabriz, East Azerbaidjan
About this study
Official title: Pilot Study of Potassium Supplementation in the Treatment of Rheumatoid Arthritis: a 4-Week, Randomized, Double-Blind, Placebo-Controlled Trial
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.
Read more
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".
Read the 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 tests and procedures:
Medical history and physical examination. Measurements of weight and height. Blood sample collections for clinical and research purposes. Quality of life questionnaires.
We therefore examined the hypothesis that examines effect of an orally administrated grape juice enriched (GJE) with 6000 mg potassium (as KCl) compared with that of a placebo grape juice (PGJ) on serum indices (cortisol, ACTH, aldosterone, creatinine, pH, Na, K), urinalysis (urea, uric acid, K, Na, creatinine, pH), GFR corrected by body surface area, ESR, CRP, RF, pain, quality of life, and disease activity in a case-controlled double-blind protocol in patients with RA with an established low dietary potassium intake to further investigate endogenous cortisol secretion and consequent possible relief.
Clinical (like Disease Activity, Pain) variables, along with the Quality of Life, and Biochemical Indices will be compared in two groups of patients after 28 days of oral GJE and PJE administration.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Potassium supplement
- Keywords
- Potassium supplement, Rheumatoid Arthritis, Pain, Disease Activity
- Medical subject headings
- Arthritis, Rheumatoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium supplementDietary supplement
Patients were randomly allocated to receive either an EGJ containing 234.5 mmol microcrystalline KCl a total of 6000 mg of K in 2 EGJ, but split into 2 intakes daily) or PGJ for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 Potassium supplement | Active comparator | Patients received an Enriched Grape Juice containing 234.5 mmol microcrystalline KCl (a total of 6000 mg of K in 2 EGJ, but split into 2 intakes daily) Receives: Dietary Supplement: Potassium supplement |
| 2 Grape Juice | Placebo comparator | Patients received same amount of grape juice for 28 days. Receives: Dietary Supplement: Potassium supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's dietary and supplement potassium intake (combined technique: food frequency questionnaire, 24 hour food-recall, food record), serum potassium
Measured: within the 28 days (plus or minus 2 days)
Disease Activity Score (DAS28, 28-joint count) at d 0, 28
Measured: within the first 28 days (plus or minus 2 days)
Patient's global assessment of disease activity (0 to 10 cm visual analog scale: 0, symptom free; 10, very severe) at d 0, 28
Measured: within the first 28 days (plus or minus 2 days)
Patient's visual analogue scale (VAS) for pain at d 0, 28
Measured: within the first 28 days (plus or minus 2 days)
Duration of morning stiffness (in minutes) at d 0, 28
Measured: within the first 28 days (plus or minus 2 days)
Joint pain intensity, on a visual analogue scale (VAS) for pain (0 = no pain to 100mm =severe pain) at d 0, 28
Measured: within the first 28 days (plus or minus 2 days)
Onset of fatigue (in minutes) after walking at d 0, 28
Measured: within the first 28 days (plus or minus 2 days)
Ritchie's articular index for pain joints at d 0, 28
Measured: within the first 28 days (plus or minus 2 days)
Right and left grip strength (in mmHg) measured with a sphygmomanometer cuff inflated to 20 mmHg at d 0, 28
Measured: within the first 28 days (plus or minus 2 days)
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
Measured: within the first 28 days (plus or minus 2 days)
Secondary outcomes (1)
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
Measured: within the first 28 days (plus or minus 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startFeb 2007
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Reza Rastmanesh, Ph.D., Study chair, National Nutrition and Food Sciences Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461448
- Sponsor's protocol ID
- NNFTRI-B2484
- Status last verified
- Feb 2009
- First submitted
- 17 Apr 2007
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weber CE. Copper response to rheumatoid arthritis. Med Hypotheses. 1984 Dec;15(4):333-48. doi: 10.1016/0306-9877(84)90150-6.
PubMed 6152006Weber CE. Corticosteroid regulation of electrolytes. J Theor Biol. 1983 Oct 7;104(3):443-9. doi: 10.1016/0022-5193(83)90116-9.
PubMed 6656267Weber CE. A proposal for an experiment of potassium on rheumatoid arthritis. Clin Exp Rheumatol. 1983 Apr-Jun;1(2):184-6. No abstract available.
PubMed 6398157Rastmanesh 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):722-31. doi: 10.1016/j.jpain.2008.03.006. Epub 2008 May 12.
PubMed 18468955Rastmanesh 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. No abstract available.
PubMed 18986773
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Potassium Supplementation in the Treatment of Rheumatoid Arthritis: a 4-Week, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00461448
- Acronym / sponsor ID
- NNFTRI-B2484
- Conditions
- Rheumatoid Arthritis
- Keywords
- Potassium supplement, Rheumatoid Arthritis, Pain, Disease Activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
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 tests and procedures:
Medical history and physical examination. Measurements of weight and height. Blood sample collections for clinical and research purposes. Quality of life questionnaires.
We therefore examined the hypothesis that examines effect of an orally administrated grape juice enriched (GJE) with 6000 mg potassium (as KCl) compared with that of a placebo grape juice (PGJ) on serum indices (cortisol, ACTH, aldosterone, creatinine, pH, Na, K), urinalysis (urea, uric acid, K, Na, creatinine, pH), GFR corrected by body surface area, ESR, CRP, RF, pain, quality of life, and disease activity in a case-controlled double-blind protocol in patients with RA with an established low dietary potassium intake to further investigate endogenous cortisol secretion and consequent possible relief.
Clinical (like Disease Activity, Pain) variables, along with the Quality of Life, and Biochemical Indices will be compared in two groups of patients after 28 days of oral GJE and PJE administration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Potassium supplement | Active comparator | Dietary Supplement: Potassium supplementPatients received an Enriched Grape Juice containing 234.5 mmol microcrystalline KCl (a total of 6000 mg of K in 2 EGJ, but split into 2 intakes daily) |
| 2 Grape Juice | Placebo comparator | Dietary Supplement: Potassium supplementPatients received same amount of grape juice for 28 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium supplementPatients were randomly allocated to receive either an EGJ containing 234.5 mmol microcrystalline KCl a total of 6000 mg of K in 2 EGJ, but split into 2 intakes daily) or PGJ for 28 days. | Dietary supplement | 1 Potassium supplement, 2 Grape Juice |
Primary outcome
Patient's dietary and supplement potassium intake (combined technique: food frequency questionnaire, 24 hour food-recall, food record), serum potassium
Time frame: within the 28 days (plus or minus 2 days)
Disease Activity Score (DAS28, 28-joint count) at d 0, 28
Time frame: within the first 28 days (plus or minus 2 days)
Patient's global assessment of disease activity (0 to 10 cm visual analog scale: 0, symptom free; 10, very severe) at d 0, 28
Time frame: within the first 28 days (plus or minus 2 days)
Patient's visual analogue scale (VAS) for pain at d 0, 28
Time frame: within the first 28 days (plus or minus 2 days)
Duration of morning stiffness (in minutes) at d 0, 28
Time frame: within the first 28 days (plus or minus 2 days)
Joint pain intensity, on a visual analogue scale (VAS) for pain (0 = no pain to 100mm =severe pain) at d 0, 28
Time frame: within the first 28 days (plus or minus 2 days)
Onset of fatigue (in minutes) after walking at d 0, 28
Time frame: within the first 28 days (plus or minus 2 days)
Ritchie's articular index for pain joints at d 0, 28
Time frame: within the first 28 days (plus or minus 2 days)
Right and left grip strength (in mmHg) measured with a sphygmomanometer cuff inflated to 20 mmHg at d 0, 28
Time frame: within the first 28 days (plus or minus 2 days)
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
Time frame: within the first 28 days (plus or minus 2 days)
1 secondary outcome
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
Time frame: within the first 28 days (plus or minus 2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
- Background: PubMed 6152006Weber CE. Copper response to rheumatoid arthritis. Med Hypotheses. 1984 Dec;15(4):333-48. doi: 10.1016/0306-9877(84)90150-6.
- Background: PubMed 6656267Weber CE. Corticosteroid regulation of electrolytes. J Theor Biol. 1983 Oct 7;104(3):443-9. doi: 10.1016/0022-5193(83)90116-9.
- Background: PubMed 6398157Weber CE. A proposal for an experiment of potassium on rheumatoid arthritis. Clin Exp Rheumatol. 1983 Apr-Jun;1(2):184-6. No abstract available.
- Results publication: PubMed 18468955Rastmanesh 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):722-31. doi: 10.1016/j.jpain.2008.03.006. Epub 2008 May 12.
- Results publication: PubMed 18986773Rastmanesh 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. No abstract available.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Rastmanesh, Ph.D. study chair
National Nutrition and Food Sciences Technology Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Potassium supplement in people with Rheumatoid Arthritis, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's dietary and supplement potassium intake (combined technique: food frequency questionnaire, 24 hour food-recall, food record), serum potassium (time frame: within the 28 days (plus or minus 2 days)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00461448, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2009.