Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461448
Status:
COMPLETED
Last Update Posted:
2009-02-06
First Post:
2007-04-17
Brief Title:
A Pilot Study of Potassium Supplementation for Adult Patients With Rheumatoid Arthritis
Sponsor:
Shahid Beheshti University of Medical Sciences
Organization:
Shahid Beheshti University of Medical Sciences
Study Overview
Official Title:
Pilot Study of Potassium Supplementation in the Treatment of Rheumatoid Arthritis a 4-Week Randomized Double-Blind Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None