| CTRI Number |
CTRI/2025/08/093021 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [vitamin D supplementation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vitamin D supplementation effect on inflammation in pulmonary tuberculosis patients |
|
Scientific Title of Study
|
To study clinical effects of vitamin D supplementation on AGE-RAGE anti-inflammatory pathway in pulmonary tuberculosis patients in tertiary care hospital |
| 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 Savita Devi |
| Designation |
Research Scientist-I |
| Affiliation |
Kalpana Chawla Govt. Medical College, Karnal |
| Address |
Room No 426, Multidisciplinary Research Unit, Location-I, Kalpana Chawla Govt. medical College, Karnal
Karnal
HARYANA
132001
India |
| Phone |
9518189146 |
| Fax |
|
| Email |
savitajohn4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Devi |
| Designation |
Research Scientist-I |
| Affiliation |
Kalpana Chawla Govt. Medical College, Karnal |
| Address |
Room No 426, Multidisciplinary Research Unit, Location-I, Kalpana Chawla Govt. Medical College, Karnal
Karnal
HARYANA
132001
India |
| Phone |
9518189146 |
| Fax |
|
| Email |
savitajohn4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita Devi |
| Designation |
Research Scientist-I |
| Affiliation |
Kalpana Chawla Govt. Medical College, Karnal |
| Address |
Room No 426, Multidisciplinary Research Unit, Location-I, Kalpana Chawla Govt. Medical College, Karnal
Karnal
HARYANA
132001
India |
| Phone |
9518189146 |
| Fax |
|
| Email |
savitajohn4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Health Research, Ministry of Health & Family Welfare, Red Cross Road,
New Delhi, India-110001 |
|
|
Primary Sponsor
|
| Name |
Department Of Health Research |
| Address |
Department Of Health Research, Ministry of Health & Family Welfare, Red Cross Road,
New Delhi, India-110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 Savita Devi |
Multidisciplinary Research Unit, Kalpana Chawla Govt. Medical College, Karnal |
Room No 426, Multidisciplinary Research Unit, Location-I,
Kalpana Chawla Govt. Medical College, Karnal
Karnal
HARYANA |
9518189146
savitajohn4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KCGMC, Karnal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
standard TB therapy as approved by WHO |
isoniazid, rifampicin, pyrazinamide and Ethambutol |
| Intervention |
Vitamin D supplementation |
Vit D at the weekly dose of 60000 IU will be given via oral administration (in form of tablets) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients belonging to both sex, i.e. male and females of 18 yrs and above age group
2. Patients willing to provide written informed consent
3. Patients diagnosed with TB (Sputum +, microbiologically diagnosed)
4. Patients with no other coronary heart disease and malignant tumors
5. Patients on first line therapy (sensitive patients)
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe organ diseases or liver dysfunctions
2. Patients who are not willing to provide written informed consent
3. Patients with mental illnesses
4. Patients with history of allergy to the study drugs
5. Patients with human immuno deficiency virus, upper respiratory tract infection, any infectious disease conditions which is asymptomatic, Hepatitis B and C
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Since vitamin D possess antibacterial effect, therefore, it may reduces the inflammatory AGE-RAGE pathway and eventually, TNF-alpha in TB patients |
The effect of supplementation will be observed in nearly 3 months or when patients will become sputum negative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
25/08/2025 |
| 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="2"
Months="0"
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
|
The primary aim of the study is to evaluate the inflammation controlling effect of Vitamin D supplementation due to the antibacterial effect along with standard therapy in pulmonary TB patients via the AGE-RAGE pathway. The vitamin D deficient patients will be recruited and will be divided in to two groups, standard therapy and vitamin D along with standard therapy. Baseline level detection of different inflammatory molecules in the pathway will be analysed in both groups. When patients will become sputum negative, again different inflammatory molecules in the pathway will be analysed in both groups. |