| CTRI Number |
CTRI/2024/04/065762 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to show the effect Of Vitamin D Supplementation On Serum
Methylglyoxal in Diabetic Retinopathy patients |
|
Scientific Title of Study
|
Effect Of Vitamin D Supplementation On Serum Levels Of
Methylglyoxal In Patients Of Diabetic Retinopathy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simi Zaka-ur-Rab |
| Designation |
Professor |
| Affiliation |
Aligarh Muslim University |
| Address |
Room No 1, Department (Institute) of Ophthalmology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7993066959 |
| Fax |
|
| Email |
srilikhithasweety@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Simi Zaka-ur-Rab |
| Designation |
Professor |
| Affiliation |
Aligarh Muslim University |
| Address |
Room No 1, Department (Institute) of Ophthalmology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7993066959 |
| Fax |
|
| Email |
s_zrab@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Goli Sri Likhitha |
| Designation |
PG Resident |
| Affiliation |
Aligarh Muslim University |
| Address |
Room No 1, Department (Institute) of Ophthalmology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7993066959 |
| Fax |
|
| Email |
srilikhithasweety@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 1, Department (Institute) of Ophthalmology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh - 202001 |
|
|
Primary Sponsor
|
| Name |
Institute of the ophthalmology, JNMC, AMU |
| Address |
Jawaharlal Nehru Medical College, AMU, Aligarh, 202001 |
| 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 |
| Goli Sri Likhitha |
Jawaharlal Nehru medical college and Hospital |
Institute of Ophthalmology, JNMC, AMU, Aligarh
Aligarh
UTTAR PRADESH |
7993066959
srilikhithasweety@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Regd.) Under Central Drugs Standard Control Organisation(CDSCO) Ministry of Health & Family Welfare, Govt, of India) & (Under National Ethics Committee Registry for Biomedical and Health Research - NECRBHR DHR-ICMR, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E103||Type 1 diabetes mellitus with ophthalmic complications, (2) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
once in a week for 12 weeks |
| Intervention |
Vitamin D3 |
60000IU once in a week for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Non Proliferative and Proliferative Diabetic Retinopathy |
|
| ExclusionCriteria |
| Details |
i. Patients receiving vitamin D and calcium supplements.
ii. Patients taking any other medication that could change vitamin D metabolism, such as Rifampicin or Phenytoin.
iii. Patients with very low vitamin D / sufficient vitamin levels.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| serum levels of methylglyoxal after vitamin D supplementation |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| serum methylglyoxal in various grades of diabetic retinopathy |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "208"
Final Enrollment numbers achieved (India)="208" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/05/2024 |
| Date of Study Completion (India) |
14/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This is a Randomized double blinded parallel group study to determine the effect of Vitamin D3 supplementation on the serum levels of Methylglyoxal in patients of Diabetic retinopathy for a period of 12 weeks in 208 patients that will be conducted at one centre in India. the primary outcomes measured will be serum levels of methylglyoxal after vitamin D supplementation. the secondary outcomes will be serum levels of methylglyoxal in various grades of diabetic retinopathy. |