| CTRI Number |
CTRI/2021/08/036020 [Registered on: 27/08/2021] Trial Registered Prospectively |
| Last Modified On: |
14/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Antioxidents Vitamin Supplements] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Vitamin E as an add on with standard therapy and its effect on patients with chronic kidney disease on renal dialysis |
|
Scientific Title of Study
|
Evaluation of Vitamin E as an add on with standard therapy and its effect on plasma Pentraxin-3 in patients with chronic kidney disease on renal dialysis A Randomized control Clinical Trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T M Vijayakumar |
| Designation |
Associate Professor |
| Affiliation |
SRM College of Pharmacy, SRMIST |
| Address |
Department of Pharmacy Practice,
SRM College of Pharmacy, SRMIST, Kattankulathur, Chengalpattu Dist
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003400350 |
| Fax |
|
| Email |
vijayakt3@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreedhar |
| Designation |
Associate professor |
| Affiliation |
SRM Medical College Hospital and Research Centre, SRMIST, |
| Address |
Department of Nephrology, SRM Medical College Hospital and Research Centre, SRMIST,
Kattankulathur, Chengalpattu Dist
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9444012894 |
| Fax |
|
| Email |
sreedhas@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Jagadeesan M |
| Designation |
Research Scholar |
| Affiliation |
SRM College of Pharmacy, SRMIST |
| Address |
Department of Pharmacy Practice,
SRM College of Pharmacy, SRMIST, Kattankulathur, Chengalpattu Dist
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7449277556 |
| Fax |
|
| Email |
jagapharmd2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical college Hospital and Research Centre, SRM Institute of Scince and Technology |
|
|
Primary Sponsor
|
| Name |
SRM Institute of Scince and Technology |
| Address |
Kattankulathur, Chengalpattu Dist, Tamil Nadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jagadeesan M |
SRM Medical College Hospital and Research Centre |
5th floor, Dialysis Unit, Department of Nephrology
Kancheepuram
TAMIL NADU |
7449277556
jagapharmd2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard or usual therapy for patient on hemodialysis with hypertension |
Tab. Amlodipine 5mg BD
Tab. Carvedilol 6.25 mg OD
Inj. Iron sucrose 100mg I.V- 15 days once
Inj. Epoetin Alfa 4000 units S.C – Weekly once
Tab. Folic acid 5mg OD
Cap. Vitamin B Complex- OD
total duration of therapy is 12 weeks |
| Intervention |
Vitamin-E |
capsule Vitamin -E 600mg per day, per oral, post dialysis will be added for 12 weeks along with thier standard therapy |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender, suffering from chronic kidney disease on hemodialysis at least for 3 months and age of 40 years to 70 years.
CKD patients on haemodialysis who were able to understand and agree for informed written informed consent for the participation in this study.
CKD patients on haemodialysis with Diabetes mellitus and hypertension as co-morbidities.
|
|
| ExclusionCriteria |
| Details |
CKD patients on haemodialysis who were disable or immobile.
CKD patients on haemodialysis with associated chronic liver disease (CLD), congestive heart failure (CHF), HIV, Active tuberculosis.
CKD patients on haemodialysis with immunosuppressive therapy and clinical signs of ongoing infection.
CKD patients with haemodialysis not on antioxidant therapy for last 3-6 months.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome of this study will help us to understand the significance of measuring serum PTX-3 levels among CKD patients on dialysis.
The present investigation will also reveal the risk of morbidity and mortality among two groups.
The outcome will also determine whether the extent of tissue injury (marked by the serum concentration of PTX-3) has any significant change between two groups. |
At baseline, 4 weeks, 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impact of Anti-oxidents in CKD patients on dialysis will be determined by serum pentroxin-3 level |
At baseline, 4 weeks, 8 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "152"
Final Enrollment numbers achieved (India)="152" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2021 |
| Date of Study Completion (India) |
23/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Chronic kidney disease (CKD) is associated with increased cardiovascular morbidity and mortality even in the early stages of the disease patients on hemodialysis have limited life expectancy due to multiple co-morbidities and complications due to internal injury and inflammation. Many studies have proven that serum/plasma pentraxin 3 is the sensitive biomarker for internal injury and inflammation than the hsCRP. In dialysis patients, oxidative stress and inflammation are associated with the development of CVD. The pro-inflammatory/anti-inflammatory phenotype is disturbed on the pro-inflammatory side in CKD patients. The oxygen-free radicals are central to the pathology of many degenerative diseases, including those of the kidney. Enhanced oxygen radical generation and/or a compromized antioxidant defence system results in chronic oxidative stress which significantly worsens many conditions includes cardiovascular diseases. Preservation of glomerular membrane integrity is crucial to renal function and biological membranes are protected from oxidative deterioration by the lipophilic antioxidant vitamin E, principally in the form of a-tocopherol. Vitamin E has potent antiinflammatory and anticoagulant properties. Additionally, it can prevent apoptosis due to oxidative stress. Therefore this study aimed to investigate the antioxidants as an add on with usual/regular therapy and its effect on plasma Pentraxin-3 in CKD patients with renal dialysis |