| CTRI Number |
CTRI/2024/07/070810 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Weekly Vitamin Treatment Affects Thinking in Kidney Patients on Dialysis"
|
|
Scientific Title of Study
|
Weekly intravenous thiamine supplementation in chronic kidney disease and Maintenance Haemo Dialysis and effect on cognition: a randomized control study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishnadas N C |
| Designation |
Senior consultant, NeurologyDepartment, Meitra Hospital |
| Affiliation |
Meitra Hospital |
| Address |
Room number 168 Neurology Department Meitra Hospital Karaparamba Kunduparamba Mini Bypass Rd Edakkad Calicut
Kozhikode
KERALA
673005
India |
| Phone |
9446842142 |
| Fax |
|
| Email |
swetha.p@meitra.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishnadas N C |
| Designation |
Senior consultant, NeurologyDepartment, Meitra Hospital |
| Affiliation |
Meitra Hospital |
| Address |
Room number 168 Neurology Department Meitra Hospital Karaparamba Kunduparamba Mini Bypass Rd Edakkad Calicut
Kozhikode
KERALA
673005
India |
| Phone |
9446842142 |
| Fax |
|
| Email |
swetha.p@meitra.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishnadas N C |
| Designation |
Senior consultant, NeurologyDepartment, Meitra Hospital |
| Affiliation |
Meitra Hospital |
| Address |
Room number 168 Neurology Department Meitra Hospital Karaparamba Kunduparamba Mini Bypass Rd Edakkad Calicut
Kozhikode
KERALA
673005
India |
| Phone |
9446842142 |
| Fax |
|
| Email |
swetha.p@meitra.com |
|
|
Source of Monetary or Material Support
|
| Meitra Hospital
Building No. 38/2208-B Karaparamba – Kunduparamba, Mini Bypass Rd, Edakkad, Kerala 673005, India |
|
|
Primary Sponsor
|
| Name |
Meitra Hospital |
| Address |
Building No. 38/2208-B Karaparamba – Kunduparamba, Mini Bypass Rd, Edakkad, Kerala 673005 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Krishnadas NC |
Meitra Hospital |
Room number 168 Neurology Department Karaparamba Kunduparamba Mini Bypass Rd Edakkad Calicut
Kozhikode
KERALA |
9446842142
swetha.p@meitra.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Meitra Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chronic Kidney Disease(CKD) patients |
Chronic Kidney Disease patients above 18 years who are undergoing Maintenance Haemo Dialysis. Study duration is 24 weeks.100mg Thiamine is giving weekly once intravenously. |
| Intervention |
thiamine supplementation in chronic kidney disease (CKD) patients |
Chronic Kidney Disease patients above 18 years who are undergoing Maintenance Haemo Dialysis . Study duration is 24 weeks. 100mg Thiamine is giving weekly once intravenously. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients above 18 years
2.On MHD for CKD for more than three months
3.Patients who agree to give consent for the study
|
|
| ExclusionCriteria |
| Details |
1.Patients with diagnosed dementia like
Alzheimer’s.
2.Patients with malignancy.
3.Patients who are unable to cooperate and
complete study.
4.Patients allergic to thiamine.
5. Patients who are already on thiamine
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary endpoint is the cognitive assessment with MOCA at the end of 24 weeks |
The primary endpoint is the cognitive assessment with MOCA at the end of 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The number of hospital admission days in the treatment and control groups at 24 weeks.
2.Survival comparison between the treatment and control groups at 24 weeks of follow-up.
3.The Quality of life in both groups at baseline and after 24 weeks
|
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to assess whether weekly intravenous thiamine injections in chronic kidney disease (CKD) patients undergoing hemodialysis (MHD) can enhance cognition, reduce the risk of delirium, lower hospital admissions, and improve quality of life. The trial is a prospective, randomized, single-center study involving two groups: one receiving thiamine injections after dialysis and a control group without the injection. The study tracks cognitive function, delirium occurrences, hospital admissions, and quality of life over 24 weeks, using cognitive assessment tools, delirium scoring, WHOQOL-BREF, and hospital admission records as endpoints. Various data, including demographics, medical history, dialysis specifics, and laboratory results, will be collected and analyzed to evaluate the impact of thiamine injections on these parameters in CKD patients undergoing MHD. |