CTRI Number |
CTRI/2022/03/040726 [Registered on: 02/03/2022] Trial Registered Retrospectively |
Last Modified On: |
25/02/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Nutraceutical |
Study Design |
Other |
Public Title of Study
Modification(s)
|
The effect of potassium rich diet in Rheumatoid arthritis |
Scientific Title of Study
|
The effect of potassium augmentation on pain in patients of RA under supervised standard of care treatment |
Secondary IDs if Any
|
Secondary ID |
Registry |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
TOKTAM KIANIFARD |
Address |
Center for Rheumatic Diseases(CRD), Hermes Elegance, 1988 Convent street, Camp,Pune
Pune MAHARASHTRA 411001 India |
Phone |
07507083222 |
Fax |
|
Email |
toktam_kiani81@yahoo.com |
|
Details Contact Person Scientific Query
Modification(s)
|
Name |
ARVIND CHOPRA |
Address |
No11.Hermes Elegance 1988,Convent Street,Camp. Pune
Pune MAHARASHTRA 411001 India |
Phone |
02026344099 |
Fax |
91-20-26350084 |
Email |
crdp@vsnl.net |
|
Details Contact Person Public Query
Modification(s)
|
Name |
ARVIND CHOPRA |
Address |
No11.Hermes Elegance 1988,Convent Street,Camp. Pune
Pune MAHARASHTRA 411001 India |
Phone |
02026344099 |
Fax |
91-20-26350084 |
Email |
crdp@vsnl.net |
|
Source of Monetary or Material Support
|
Arthritis Reseach and Care Foundation-Center for Rheumatic Diseases(CRD),Pune |
|
Primary Sponsor
|
Name |
Dr ARVIND CHOPRA |
Address |
Center for Rheumatic Diseases, hermes Elegance, 1988, Convent street, Camp, Pune |
Type of Sponsor |
Other [Research institution and private clinic] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
TOKTAM KIANIFARD |
Center for Rheumatic Diseases |
Rheumatology Department, 11, Hermes Elegance,1988,convent street,Camp. Pune |
7028913929
toktam_kiani81@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
CRD Ethic Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
RHEUMATOID ARTHRITIS |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Active control arm |
The active control arm is routine diet being consumed by the patient . No dietary advice is given to this group.
Patients will continue the standard rheumatology care. |
Intervention |
Arm 1 |
Active intervention arm 1- K+ rich diet using natural source. This increases the daily oral K+ intake by 3.5-4.1 gm. In this arm, the dietary sources advised are in categories and each categories contains 2-3 recommendations of diet items ; cereal, pulses, fruits and vegetables are the categories and diet items are Ragi, Wheat, Bajra, Jowar, Tur dal,Mong dal, Chawli, Shevga vegetable, Brinjal,Karela, Banana,Musambi.
patients will continue standard Rheumatology care. |
Intervention |
Arm 2 |
Active intervention arm 2- this contains the K+ rich diet described in arm 1 and a K+ supplement. This supplement is made up of powder dietary items in standardized proportions mixed with standard oral rehydration salt (sold in the market as ORS to correct dehydration containing sodium chloride, potassium chloride, bicarbonate and glucose as per recommendation of Indian pharmacopeia and sold as over the counter.) The dietary items in the supplement are Chawli, moon dal, coriander seed and jeera seed. This diet based supplement will provide 4.1gm oral potassium daily in addition to the K+ rich diet .
The patients will continue the standard rheumatology care |
|
Inclusion Criteria
Modification(s)
|
Age From |
18.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
1. Patients diagnosed RA according to American College of Rheumatology 1987 classification criteria and the new ACR/EULAR 2010 criteria
2.RA disease duration ≥6 months
3.Pain VAS ≥ 4 cm (10 cm scale)
4.Requiring frequent pain relieving medication for over 2 weeks or moderately severe pain interfering with daily activities of at least 2 weeks duration
5.Patient receiving supervised standard of care treatment for RA for at least 12 weeks.
6.Able to understand the study and willing to give written informed consent
|
|
ExclusionCriteria |
Details |
1.Oral steroid equivalent prednisolone >10 mg daily and unstable consumption of 4 weeks prior to screening.
2.Male or female patients <18 years of age or >75 years of age
3.Patients with abnormal kidney function test as per standard laboratory criteria.
4.Serum K+ level˃5.5 mEq/L
5.Patients with Uncontrolled diabetes and hypertension
6.Patients on diuretics or any drug altering serum K+
7.Pregnant or breast feeding women
8.Patients who are incapacitated largely or wholly bedridden.
9.Patients on any herbal, homeopathic or ayurvedic medicine.
10Patients with history of heart failure or unstable angina.
11. History or presence of any medical or psychiatric condition.
12.Any other concern as per discretion of rheumatologist
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in maximum pain experienced during last 24 hours measured on Visual Analogue Scale |
Baseline and follow up end points at monthly interval up to study completion at 16 weeks (0,1 month, 2 months, 3 months and completion) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Joint Counts for pain/ swelling, Physician and patients global assessment, Health assessment questionnaire RA pain score, SF36(Physical and mental), ESR,CRP titer,DAS 28 (Disease Activity Score/EULAR), ACR index improvement(@0%,50%,70%) |
Baseline and follow up end points at monthly interval up to study completion at 16 weeks (0,1 month, 2 months, 3 months and completion) |
|
Target Sample Size
|
Total Sample Size="172" Sample Size from India="172" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
12/02/2014 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="0" Months="4" Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not yet submitted |
Brief Summary
Modification(s)
|
The aim of the study is to investigate the role of potassium (K+) in reducing pain in patients suffering from rheumatoid arthritis. The oral intake of K+ will be increased by using known dietary sources rich in K+ and easily available K+ supplement. Suitable consenting patients on supervised standard rheumatology care in community based referral clinic (CRD, Pune) will be randomized into one of the three arms- augmented dietary K+, augmented dietary K+ using dietary sources and K+ supplement and routine diet (active control). This will be a randomized single blind (investigator) parallel efficacy three arm active control study of 16 weeks duration carried out in a single center. The study sample sized was calculated based on the primary efficacy of reduction in pain on visual analogue scale with 80% power (Type II error) and significant p < 0.05 (Type I error). Secondary efficacy measures include reduction in clinical and laboratory measure of disease activity and improved functional and quality of life indices. Patients will be monitored for any adverse event and expected K+ related side effects. Patients will be monitored at four weekly intervals till study completion. Patients will be examined by rheumatologists and other trained study personnel. The protocol was approved by the ethics committee (CRD, Pune) and will adhere to guidelines on clinical trials issued by ICMR, GCP and ICH/WHO. The intervention by K+ rich diet and by K+ rich supplement will increase the daily oral K+ intake by 3.5-4.1 gm and 4.1 gm respectively. Patients randomized to intervention arms will be provide with personal discussion and special brochures in local language. 171 patients of RA have been enrolled in the study. The dietary survey in the pilot study
showed that dietary K+ was low (p<0.5)
in RA patients and more so in women (p<0.05). It further showed that the
rest of the RA diet was well matched with Indian standards of RDA and seemed
adequate in proteins, fats, minerals and vitamins. The Indian version of RAPS was determined
to have face and content validity with a fair-good correlation with several
measures of disease activity and quality of life; used in main study. Pain and efficacy measures improved
(P<0.05) by intervention; difference was NS by intent to treat analysis (mean
change pain VAS: A=-1.3 cm; B=2 cm; C= 1.2; p=0.17, ANOVA).But completer
analysis showed significant change (p=0.04)in mean pain VAS in Arm B(K+ supplement).B arm showed best response
(P<0.05) in proportion patients with at least 50% reduction and minimal
clinical important difference in pain VAS on completion from baseline. B arm also
showed maximum improvement (NS) in HAQ (Indian validated version) and SF 36
physical score. There was reduction (NS) in in mean DAS 28score (A:-1.4;B:-1.2;C:-0.9).
Only mild adverse events were reported (<8% patients by study arm). Routine
laboratory measures of hemogram, metabolic renal hepatic parameters remained
normal. None withdrew due to AE. Withdrawal rate was ~10% and mostly due to
logistic issues. On completion, B arm demonstrated a maximum serum cortisol
(AM) increase. K+ intervention arms showed reduction in systolic BP. Ongoing medication,
dietary factors and compliance, disease activity status may confound results. The
inverse association (r=-0.22) between dietary K+ and pain VAS was significant
(p<0.01), albeit modest. Disease
duration, serum K+, allocation to Diet K+ arm and body mass index were
significant predictors of pain relief
(pain VAS) in a robust logistic regression model. Conclusion: The diet of RA patients is
insufficient in K+ though of adequate
match to Indian standards. An Indian version of RAPS was found valid for
measuring pain. This pragmatic study showed a clinically important pain reduction,
though modest, over and above that obtained by standard care using dietary K+ augmentation. Other possible
benefits were reduced disease activity and improved BP (cardiovascular) status.
Overall, this seemed to be a gentle useful adjunct therapy in RA.
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