| CTRI Number |
CTRI/2024/08/072110 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of role of oral supplementation of Vitamin B12 and folate in Open Angle Glaucoma |
|
Scientific Title of Study
|
Evaluation of role of Vitamin B12 and folate in Open Angle Glaucoma |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof.Srishti Raj |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Ophthalmology
Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463503967 |
| Fax |
|
| Email |
srishtipgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Srishti Raj |
| Designation |
Professor |
| Affiliation |
Post Graduate institute of medical education and research |
| Address |
Department of Ophthalmology
Post Graduate institute of medical education and research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463503967 |
| Fax |
|
| Email |
srishtipgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Abha Gupta |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate institute of medical education and research |
| Address |
Department of Ophthalmology
Post Graduate institute of medical education and research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9464307493 |
| Fax |
|
| Email |
abhagupta943@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology
Post Graduate Institute of Medical Education and Research
Chandigarh , India
Pin - 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medicine Education and Research |
| Address |
Sector- 12
Chandigarh
Pin-160012 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrSrishti Raj |
Post Graduate Institute of Medicine Education and Research |
Room number - 117
Department of Ophthalmology
Advanced Eye Centre
Chandigarh
CHANDIGARH |
09463503967
srishtipgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NO DRUG |
No oral supplementation to the control group. |
| Intervention |
Tablet Vitamin B 12 and Tablet Folate |
The patients will receive tablet vitamin B 12 1000 mcg and tablet folic acid 5 mg once a day for six months. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Primary open angle glaucoma, normal tension glaucoma and pseudoexfolaituve glaucoma on medical management and give their consent for enrollment in trial. |
|
| ExclusionCriteria |
| Details |
Patient with age less than 40 years and more than 70 years with preexisting colour vision deficiency and best corrected visual acuity of less than 20/40 due to reasons other than glaucoma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be to analyze the progression of glaucoma after oral supplementation of Vitamin B 12 and folate. |
This will be done at the presentation and after 6 months of follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be to analyze the correlation between serum levels of Vitamin B 12 ad folate in glaucoma progression. |
This will be done at the presentation & after 6 months of follow up. |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
30/08/2024 |
| 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="6"
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 in a interventional randomized controlled prospective trial which aims to evaluate the neuroprotective role of Vitamin B 12 and Folate in glaucoma progression. |