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CTRI Number  CTRI/2025/07/089992 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Study on whether giving Vitamin D helps speed up recovery in patients with Drug-Sensitive Tuberculosis treated at public hospital in Western India. 
Scientific Title of Study   Effect of vitamin D supplementation on tuberculosis treatment outcome among Newly Registered Drug-Sensitive Tuberculosis (DSTB) patients at public health facilities of Western India. 
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 Dularikunwarba Zala 
Designation  1st year PG resident, department of community medicine 
Affiliation  GMERS medical college, Gotri.  
Address  Department of community medicine, 1st floor, GMERS medical college, Old TB campus, Gotri road, Gotri, Vadodara, Gujarat- 390021

Vadodara
GUJARAT
390021
India 
Phone  9978657007  
Fax    
Email  pritishakti1969@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kedar Mehta  
Designation  Associate professor, department of community medicine 
Affiliation  GMERS medical college, Gotri. 
Address  Department of community medicine, 1st floor, GMERS medical college, Old TB campus, Gotri road, Gotri, Vadodara, Gujarat- 390021

Vadodara
GUJARAT
390021
India 
Phone  9879036835  
Fax    
Email  kedar_mehta20@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Kedar Mehta  
Designation  Associate professor, department of community medicine 
Affiliation  GMERS medical college, Gotri. 
Address  Department of community medicine, 1st floor, GMERS medical college, Old TB campus, Gotri road, Gotri, Vadodara, Gujarat- 390021

Vadodara
GUJARAT
390021
India 
Phone  9879036835  
Fax    
Email  kedar_mehta20@yahoo.co.in  
 
Source of Monetary or Material Support  
GMERS medical college and hospital, Old TB campus, Gotri road, Gotri, Vadodara, Gujarat, India. Pin code- 390021 
 
Primary Sponsor  
Name  Dr Dularikunwarba Zala 
Address  GMERS medical college, Old TB campus, Gotri road, Gotri, Vadodara, Gujarat- 390021 
Type of Sponsor  Other [self funded] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Kedar Mehta  GMERS medical college, Old TB campus, Gotri road, Gotri, Vadodara, Gujarat- 390021 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kedar Mehta  GMERS medical college and hospital, Gotri, Vadodara  Department of community medicine, 1st floor, GMERS medical college, Old TB campus, Gotri road, Gotri, Vadodara, Gujarat- 390021
Vadodara
GUJARAT 		 9879036835

kedar_mehta20@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
International Human Ethics Committee, GMERS medical college and hospital, Gotri, Vadodara.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard anti-tuberculosis therapy (DOTS) alone as per NTEP guidelines.  Standard DOTS therapy- Daily oral fixed-dose combination (FDC) of first-line anti-TB drugs — Isoniazid- 75mg (H), Rifampicin- 150 mg (R), Ethambutol- 275mg (E), and Pyrazinamide- 400mg (Z) — given according to patient body weight. Treatment will be divided into two phases- Intensive Phase (IP)- First 2 months, with daily oral FDC containing HRZE. Continuation Phase (CP)- Following 4 months, with daily oral FDC containing HRE. FDC dose is based on body weight as per NTEP guidelines- 25–34 kg- 2 tablets per day. 35–49 kg- 3 tablets per day. 50–64 kg- 4 tablets per day. more than 65 kg- 5 tablets per day. Route- Oral. Frequency- Daily- 7 days per week. Total duration of DOTS therapy- 6 months. From October 2025 to December 2025. 
Intervention  Vitamin D3 (Cholecalciferol) supplementation in addition to standard anti-tuberculosis therapy (DOTS) as per NTEP guidelines.  Vitamin D3- Dose- 60,000 IU. Frequency- once a week. Route of administration- oral. Total duration of intervention- 8 weeks. Standard DOTS therapy- Daily oral fixed-dose combination (FDC) of first-line anti-TB drugs — Isoniazid- 75mg (H), Rifampicin- 150 mg (R), Ethambutol- 275mg (E), and Pyrazinamide- 400mg (Z) — given according to patient body weight. Treatment will be divided into two phases- Intensive Phase (IP)- First 2 months, with daily oral FDC containing HRZE. Continuation Phase (CP)- Following 4 months, with daily oral FDC containing HRE. FDC dose is based on body weight as per NTEP guidelines- 25–34 kg- 2 tablets per day. 35–49 kg- 3 tablets per day. 50–64 kg- 4 tablets per day. more than 65 kg- 5 tablets per day. Route- Oral. Frequency- Daily- 7 days per week. Total duration of DOTS therapy- 6 months. From January 2026 to March 2026.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Newly diagnosed drug-sensitive tuberculosis (DSTB) patients, pulmonary or extra-pulmonary, aged 18 years and above, willing to participate and provide written informed consent. 
 
ExclusionCriteria 
Details  Patients will be excluded if they have drug-resistant tuberculosis (MDR/XDR), are HIV-positive, have chronic kidney disease evidenced by elevated serum creatinine levels or have significant chronic liver disease. Patients will also be excluded if they have known hypercalcemia, a history of vitamin D toxicity, granulomatous diseases such as sarcoidosis, primary hyperparathyroidism, or malignancies associated with hypercalcemia (e.g., lymphoma, multiple myeloma). Individuals currently taking vitamin D supplements, those on digitalis (digoxin) therapy, pregnant or lactating women, and patients with a known hypersensitivity to vitamin D preparations will also be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Higher sputum smear conversion rates and improved overall treatment success rate.
 		 Sputum smear microscopy will be performed at- 2 months and at 6 months, to assess conversion from smear-positive to smear-negative status.
 
 
Secondary Outcome  
Outcome  TimePoints 
Greater weight gain, improvement in other clinical symptoms, monitoring & recording of any adverse events.  Outcome parameters will be assessed at baseline prior to treatment initiation, at 4 weeks, 8 weeks & monthly thereafter at 12, 16, 20 & 24 weeks, including at the point of treatment completion at 6 months.

 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   01/10/2025 
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="0"
Months="9"
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   Tuberculosis is still a significant public health issue in India. Vitamin D is recognized for its ability to maintain the body’s immune system and potentially help manage tuberculosis infection by boosting the body’s natural protection. The impact of oral vitamin D supplementation provided in addition to regular anti-tuberculosis treatment among newly diagnosed drug-sensitive TB patients in public health centre in Western India will be assessed in this study. These patients will be divided into two groups: one group will receive vitamin D supplements along with conventional treatment, and the second group will receive conventional treatment alone. The expected outcomes will be sputum smear conversion at two and six months, overall success of treatment, weight gain, improvement in clinical findings. Any side effects or adverse events will also be observed and documented. The research will track each patient for a maximum of six months to compare findings and present evidence on whether vitamin D can serve as an effective additional strategy in standard TB care. 
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