| CTRI Number |
CTRI/2025/06/089903 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
28/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Multiple Vitamin A and Zinc therapy cycle in Adult Patients Suffering from Vitamin A Deficiency Related Bitots spot |
|
Scientific Title of Study
|
Effects of multiple cycle of vitamin-A[ 2 lakhs IU] along with oral zinc [50mg] supplementation on adult Bitots spots disappearance - A comparative study visiting Tertiary Care Hospital, AIIMS Deoghar.” |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujit Das |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Deoghar |
| Address |
Department of ophthalmology, AIIMS, Deoghar, Jharkhand
Deoghar
JHARKHAND
814152
India |
| Phone |
8527583337 |
| Fax |
|
| Email |
imdrsujitdas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujit Das |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Deoghar |
| Address |
Department of ophthalmology, AIIMS, Deoghar, Jharkhand
Deoghar
JHARKHAND
814152
India |
| Phone |
8527583337 |
| Fax |
|
| Email |
imdrsujitdas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujit Das |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Deoghar |
| Address |
Department of ophthalmology, AIIMS, Deoghar, Jharkhand
Deoghar
JHARKHAND
814152
India |
| Phone |
8527583337 |
| Fax |
|
| Email |
imdrsujitdas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sujit Das |
| Address |
AIIMS Deoghar Jharkhand, department of ophthalmology |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sujit Das |
AIIMS, Deoghar |
Department of ophthalmology, AIIMS, Deoghar, Jharkhand
Deoghar
JHARKHAND |
08527583337
imdrsujitdas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Deoghar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male or Female without any acute or chronic illness, especially cardiovascular illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral Vitamin A and Topical artificial tear |
Multiple (minimum 3, maximum 6, depends on disappearance of Bitots spot) cycles of Oral vitamin A (once cycle consists of Dose: Day 1, Day 3, and Day 15, 2 lakhs IU in each day) with 3 weeks interval along with Topical artificial tear (Carboxymethyl cellulose) on eye 1 drop 4 times a day to continue till completion of Oral vitamin A therapy |
| Intervention |
Oral Vitamin A, Oral Zinc, and Topical artificial tear |
Multiple (minimum 3, maximum 6, depends on disappearance of Bitots spot) cycles of Oral vitamin A (once cycle consists of Dose: Day 1, Day 3, and Day 15, 2 lakhs IU in each day) with 3 weeks interval along with Oral Zinc (50 mg twice daily after food) for 3 months and Topical artificial tear (Carboxymethyl cellulose) on eye 1 drop 4 times a day to continue till completion of Oral vitamin A therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients presented with Bitot’s spot will be included in the study |
|
| ExclusionCriteria |
| Details |
Patient with malnutrition, liver disease, cardiac disease, gastrointestinal disease and chronic alcoholic will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The aim of the study is to see the total disappearance of Bitot’s spot with multiple cycle of vitamin-A [2lakhs IU] supplementation with no recurrence |
Baeline, 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/07/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
- What additional supporting information will be shared?
- Who will be able to view these files?
- For what types of analyses will this data be available?
- By what mechanism will data be made available?
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information -
|
|
Brief Summary
|
This comparative interventional study will beconducted at the tertiary care center, AIIMS Deoghar, to evaluate the effects of multiple cycles of high-dose vitamin A and oral zinc supplementation on the disappearance of Bitot’s spots in adults. Patients presenting with clinically diagnosed Bitot’s spots will be recruited after obtaining informed consent. Eligible participants will be randomly assigned to two treatment arms. The control group received the conventional therapy comprising vitamin A supplementation at a dose of 2 lakh IU on day 1, day 3, and day 15, along with topical lubricating eye drops. The intervention group received repeated cycles of the same dose of vitamin A (2 lakh IU, on day 1, day 3, and day 15) every three weeks, for a maximum of six cycles, in addition to daily oral zinc supplementation (50 mg twice daily for 3 monts) and lubricating drops. Clinical assessment for Bitot’s spot resolution and any adverse effects will be performed at each follow-up visit. The primary outcome was the rate of disappearance of Bitot’s spots, and secondary outcomes included time to resolution and recurrence rates. |