| CTRI Number |
CTRI/2025/12/098994 [Registered on: 12/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Supplementation of Vitamin C, Vitamin D3 and Zinc among Pulmonary tuberculosis patients at Puducherry |
|
Scientific Title of Study
|
Effectiveness of supplementing Vitamin C, Vitamin D3 and Zinc among Pulmonary tuberculosis Adult patients at Puducherry - A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhivya SR |
| Designation |
Post graduate |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Aarupadai Veedu Medical College & Hospital,
Kirumambakkam
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9840255579 |
| Fax |
|
| Email |
dhivya.rajasekaran@avmc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sivaraj R |
| Designation |
Professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Aarupadai Veedu Medical College & hospital;
Kirumambakkam
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9965646888 |
| Fax |
|
| Email |
sivaraj.rengaraj@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhivya SR |
| Designation |
Post graduate |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Aarupadai Veedu Medical College & hospital,
Kirumambakkam
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9840255579 |
| Fax |
|
| Email |
dhivya.rajasekaran@avmc.edu.in |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College & hospital
Kirumambakkam, Puducherry
Pin - 607403 |
|
|
Primary Sponsor
|
| Name |
Dhivya SR |
| Address |
No.100/, Raman street, Royapuram, Chennai 600013 |
| Type of Sponsor |
Other [Self funding] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhivya SR |
Aarupadai Veedu Medical College & Hospital |
Kirumambakkam, Pondicherry - 607403
Department of Pharmacology
Pondicherry
PONDICHERRY |
9840255579
dhivya.rajasekaran@avmc.edu.in |
| Dr Dhivya SR |
Government Hospital for Chest Disease, Puducherry |
No.6, Montorsier street, MG road area, Puducherry- 605001
Department of Respiratory Medicine
Pondicherry
PONDICHERRY |
9840255579
dhivya.rajasekaran@avmc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Government Chest Committee |
Approved |
| Institutional Human Ethical Committee |
Approved |
| Institutional Human Ethical Committee |
Approved |
| NOC |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CDZ - PTB |
1. T.Vitamin C 500mg OD x 60days (oral)
2. T.Vitamin D3 60K IU x 2months (weekly once) oral
3. T.Zinc 50mg OD x 60days (oral)
4. FDC - Vitamin C 500mg + Vitamin D3 2000 IU + Zinc 40mg OD x 60days (oral)
|
| Comparator Agent |
Control PTB |
ATT regimen as per WHO guidelines |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Sputum positive adults with drug sensitive tuberculosis above 18 years
|
|
| ExclusionCriteria |
| Details |
Pregnancy, lactating mothers and those with known allergies or contraindication to study supplements |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cure rate by sputum confirmation |
After 2 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in inflammatory markers ( TNF - alpha & IL-6 ) |
After 2 months of treatment |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
23/12/2025 |
| 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 study mainly focuses to assess the treatment outcome of Pulmonary Tuberculosis by categorizing the study participants into 2 groups. A total of 200 study participants will be randomized and adults diagnosed with drug sensitive pulmonary Tuberculosis will be randomly assigned to receive to receive either standard ATT ( control group ) or standard ATT plus oral supplements with Vitamin C, D3 and Zinc ( interventional group). Thus this study evaluates the effect of Vitamin C, D3 and Zinc supplementation on treatment outcome among adults with drug sensitive pulmonary Tuberculosis. |