| CTRI Number |
CTRI/2021/04/032530 [Registered on: 05/04/2021] Trial Registered Prospectively |
| Last Modified On: |
01/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Vitamin D Supplementation in Rheumatoid Arthritis |
|
Scientific Title of Study
|
A Prospective Randomized, single centre, two arm open label trial to evaluate the efficacy of daily and weekly high dose vitamin D (Cholecalciferol) in Rheumatoid Arthritis patients – A Pilot Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arindam Nandy Roy |
| Designation |
Consultant Rheumatologist |
| Affiliation |
Yashoda Hospitals |
| Address |
Room No 184 , Op-10 , 1st Floor, Yashoda Hospitals,Behind Hari Hara Kala Bhavan, S.D.Road
Hyderabad
TELANGANA
500003
India |
| Phone |
9849279830 |
| Fax |
|
| Email |
doctor.arindam@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arindam Nandy Roy |
| Designation |
Consultant Rheumatologist |
| Affiliation |
Yashoda Hospitals |
| Address |
Room No 184 , Op-10 , 1st Floor, Yashoda Hospitals,Behind Hari Hara Kala Bhavan, S.D.Road
TELANGANA
500003
India |
| Phone |
9849279830 |
| Fax |
|
| Email |
doctor.arindam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arindam Nandy Roy |
| Designation |
Consultant Rheumatologist |
| Affiliation |
Yashoda Hospitals |
| Address |
Room No 184 , Op-10 , 1st Floor, Yashoda Hospitals,Behind Hari Hara Kala Bhavan, S.D.Road
TELANGANA
500003
India |
| Phone |
9849279830 |
| Fax |
|
| Email |
doctor.arindam@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Yashoda Hospitals,Behind Hari Hara Kala Bhavan,S.D Road,Secunderabad-500003
Telangana,INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Arindam Nandy Roy |
| Address |
Room No 184 , OP-10,1st Floor
Yashoda Hospitals, Behind Hari Hara Kala Bhavan, S.D Road,Secunderabad-500003
Telangana |
| Type of Sponsor |
Other [Dr Arindam Nandy Roy] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arindam Nandy Roy |
Yashoda Hospitals |
Room No 184,Op -10,Department of Rheumatology, Behind Hari Hara Kala Bhavan, S.D Road
Hyderabad
TELANGANA |
9849279830
doctor.arindam@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe - Yashoda Academy of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cholecalciferol |
60000 IU Weekly Once for 10 Weeks- Group A and
60000 IU daily Once for 10 days- Group B |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Are between the age of 18 to 60.
2. Subjects of either gender with documented Vitamin D deficiency (Serum 25(OH) D level of <20 ng/ml (<50 nmol/L).
3. Are clinically diagnosed with RA (according to ACR 2010 criteria) (7).
4. Have active disease defined by Simplified Disease Activity Index (SDAI) >3.3(8).
|
|
| ExclusionCriteria |
| Details |
1. Hypersensitivity to cholecalciferol (Vitamin D).
2. Pregnant and lactating women.
3. History of renal or any metabolic disease.
4. Subjects having arthritis other than Rheumatoid.
5. Any illness that could impair their ability to comply with the study, or are enrolled in another study.
6. Subjects willing to stop calcium/Multivitamin supplements at the time of consent.
7. Plan to start with biological agents.
8. Mental illness impairing ability to comply with study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary aim of the study is to compare the effect of oral high dose vitamin D 60000 IU taken daily for 10 days to weekly 60000 IU dose for 10 weeks in attaining optimal level at 3 months in Vitamin D deficient (Serum 25(OH) D level of 20 ng/ml (50 nmol/L) patients of Rheumatoid Arthritis.
|
At Day 0 i.e Baseline and
At Day 90 i.e End of Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see effect of vitamin D supplementation on disease severity as assessed by Simplified Disease Activity Index (SDAI). |
90 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/04/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Indian Journal of Rheumatology |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rheumatoid
arthritis (RA) is an autoimmune disorder in which unchecked immune and inflammatory
responses cause articular pain and eventually cartilage degradation and bone
destruction . Disease develops when there is an imbalance in the cytokine
network, either from excess production of pro-inflammatory cytokines or from
inadequate natural anti-inflammatory mechanism.Vitamin
D is a fat-soluble vitamin that is now known to play an important role in a
variety of biologic functions including immune regulation, proliferation,
differentiation, apoptosis, and angiogenesis, in addition to being the main
hormone regulating calcium phosphate homeostasis and mineral bone metabolism. It appears that vitamin D
deficiency is highly prevalent in patients with RA, and that vitamin D
deficiency may be linked to disease severity in RA [5,6]. Till date no study
has evaluated the differential treatment regimens of Vitamin D in RA patients. Baseline: Visit 1 Day 0 (when recruited and just prior to start of medicine): Demographic data, Co morbidities, tobacco use,
alcohol consumption, disease duration, RF factor and Anti CCP, disease standard
medications (Methotrexate,
Hydroxychlroquine, Sulphasalazine, Leflunomide and steroids),along with
lab parameters (Calcium and Vitamin D).
In addition, Complete blood count, Biochemical parameters (Liver and Kidney
function tests) results will be evaluated as routine practice. Blood samples as a part of regular follow up will be collected by
clinical technicians working in Yashoda Hospitals, Secunderabad.
End
of Study: Visit 2 Day 90: Lab
parameters: Vitamin D, Calcium, Complete
blood count, Biochemical parameters (liver and kidney function tests) results
will be evaluated. The physician will confirm if the
subject is taking the study medicine correctly, review any new medications the
subject has taken since the last visit that alters vitamin D levels and will
ask about adverse events that may have occurred.
|