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CTRI Number  CTRI/2025/02/080622 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
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 Pigment epithelium deerived factor and vascular endothelial growth factor in Diabetic Retinopathy patients  
Scientific Title of Study   Effect of vitamin D supplementation on serum levels of pigment epithelium derived factors and vascular endothelium growth factors 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  Prof SIMI ZAKAURRAB 
Designation  Professor 
Affiliation  AMUIO, JNMCH, AMU, Aligarh 
Address  AMUIO, Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  8439105927  
Fax    
Email  s_zrab@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Prof SIMI ZAKAURRAB 
Designation  Professor 
Affiliation  AMUIO, JNMCH, AMU, Aligarh 
Address  AMUIO, Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  8439105927  
Fax    
Email  s_zrab@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Prof SIMI ZAKAURRAB 
Designation  Professor 
Affiliation  AMUIO, JNMCH, AMU, Aligarh 
Address  AMUIO, Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  8439105927  
Fax    
Email  s_zrab@yahoo.co.in  
 
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 Ophthalmology JNMC, AMU 
Address  Room no 1 Department of ophythalmology, JNMC, AMU Aligarh 202001 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saima Nasrin  Jawaharlal Nehru medical college and Hospital   Institute of Ophthalmology, JNMC, AMU, Aligarh Aligarh UTTAR PRADESH
Aligarh
UTTAR PRADESH 		 8439105927

drsaimanasrin@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  
Status 
Not Applicable 
 
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
iv. patients who have recieved injection antiVEGF for past 3 months
v. patients who have recieved laser in retina for past 1 month 
 
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 vascular endothelial growth factor and pigment epithelial derived growth factor after vitamin D supplementation   12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
serum levels of vascular endothelial growth factor and pigment epithelial derived growth factor 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)= "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)   28/02/2025 
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 is a Randomized triple blinded parallel group study to determine the effect of Vitamin D3 supplementation on the serum levels of vascular endothelial growth factor and pigment epithelial derived factor in patients of Diabetic retinopathy for a period of 12 weeks in 120 patients that will be conducted at one center in India. the primary outcomes measures will be serum levels of vascular endothelial growth factor and pigment epithelial derived factor after vitamin D supplementation. the secondary outcomes will be serum levels of methylglyoxal in various grades of diabetic retinopathy.  
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