| CTRI Number |
CTRI/2024/06/069692 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| 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 find out vitamin D effect on hormones cortisol, estrogen and testosterone and its impact on primary open angle glaucoma |
|
Scientific Title of Study
|
Effect of vitamin D supplementation on serum levels of cortisol, estrogen and testosterone in patients of primary 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. Simi Zaka-ur-Rab |
| Designation |
Professor |
| Affiliation |
Institute of Ophthalmology,Jawaharlal Nehru Medical College and hospital, Aligarh Muslim University |
| Address |
Room No 1,
Department (Institute) of Ophthalmology,
Jawaharlal Nehru Medical College and hospital,
Aligarh Muslim University,
Aligarh
202001
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8921343401 |
| Fax |
|
| Email |
kavithapradeep1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Simi Zaka-ur-Rab |
| Designation |
Professor |
| Affiliation |
Institute of Ophthalmology,JNMCH,AMU |
| Address |
Institute of Ophthalmology
Jawaharlal Nehru Medical College and Hospital,
Aligarh Muslim University-Aligarh-202001
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9837003911 |
| Fax |
|
| Email |
s_zrab@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavitha G Pradeep |
| Designation |
Junior Resident |
| Affiliation |
Institute of Ophthalmology,JNMCH,AMU |
| Address |
Room No 1,
Division A
Department (Institute) of Ophthalmology,
Jawaharlal Nehru Medical College and hospital,
Aligarh Muslim University,
Aligarh
202001
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8921343401 |
| Fax |
|
| Email |
kavithapradeep1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department (Institute) of Ophthalmology,
Jawaharlal Nehru Medical College and hospital,
Aligarh Muslim University,
Aligarh
202001 |
|
|
Primary Sponsor
|
| Name |
Department Institute of Ophthalmology |
| Address |
Room No 1,
Department (Institute) of Ophthalmology,
Jawaharlal Nehru Medical College and hospital,
Aligarh Muslim University,
Aligarh
202001
AMU-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 |
| Dr Kavitha G Pradeep |
Jawaharlal Nehru Medical College and Hospital |
Room No 1
Division A
Institute of Ophthalmology
Jawaharlal Nehru Medical College and Hospital
Aligarh Muslim University
Aligarh 202001
Aligarh
UTTAR PRADESH |
9497577207
kavithapradeep1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Placebo |
dose:60000 IU
frequency: Once a week
route of administration: oral
total duration: 12 weeks |
| Intervention |
Vitamin D3 |
dose:60000 IU
frequency: Once a week
route of administration: oral
total duration: 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Primary open angle glaucoma |
|
| ExclusionCriteria |
| Details |
1. Patients receiving vit D and calcium supplements
2. Patients taking any other medication that could change vit D metabolism such as Phenytoin or Rifampin
3. Patients taking any medication that could change cortisol metabolism such as steroids, ketoconazole or mitotane.
4. Patients taking Hormone Replacement Therapy
5. Patients with very low and sufficient vit D 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 |
1. To study the effect of vit D supplementation on serum cortisol levels in patients of POAG
2. To study the effect of vit D supplementation on serum estrogen levels in patients of POAG
3. To study the effect of vit D supplementation on serum testosterone levels in patients of POAG |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the effect of vit D supplementation on control of intraocular pressure in patients of POAG
2. To compare the levels of serum cortisol in diabetic and non-diabetic patients of POAG
3. To compare the levels of serum estrogen in diabetic and non-diabetic patients of POAG
4. To compare the levels of serum testosterone in diabetic and non-diabetic patients of POAG |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/07/2024 |
| Date of Study Completion (India) |
10/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/07/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
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 prospective, randomized, double blinded, and parallel group study aimed at investigating the effect of Vitamin D supplementation on serum levels of cortisol, estrogen, and testosterone in patients of primary open angle glaucoma (POAG). It will be conducted in the Institute of Ophthalmology JNMCH, AMU, Aligarh, India. The intervention/study group will be administered 60,000 IU of Vitamin D3, once weekly, for a period of 12 weeks. At the end of supplementation serum levels of hormones and effect on IOP on study and control groups will be analysed. The primary objective is to study the effect of Vitamin D supplementation on the serum levels of cortisol, estrogen and testosterone in patients of POAG. The secondary objectives are to study the effect of Vitamin D supplementation on control of intraocular pressure and to compare the levels of serum cortisol, estrogen, testosterone between diabetic and non-diabetic patients of POAG.
|