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CTRI Number  CTRI/2024/11/077220 [Registered on: 22/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the efficacy of Vitamin D as an adjunctive treatment along with Anti Tubercular Therapy on early sputum negativity in smear positive Pulmonary Tuberculosis 
Scientific Title of Study   Randomized controlled trial to study the efficacy of Vitamin D as an adjunctive treatment along with ATT on early sputum conversion in smear positive Pulmonary Tuberculosis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IEC/24/25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ayushi Singh 
Designation  DNB Trainee 
Affiliation  Punjab Institute of Medical Sciences 
Address  OPD no.9, First floor, Department of TB & Chest, Punjab Institute of Medical Sciences, Jalandhar, Punjab, 144006

Jalandhar
PUNJAB
144006
India 
Phone  9901594164  
Fax    
Email  ayushisngh412@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Soni 
Designation  Professor and Head 
Affiliation  Punjab Institute of Medical Sciences 
Address  OPD no.9, First Floor, Department of TB and Chest, Punjab Institute of Medical Sciences, Jalandhar, Punjab, 144006


PUNJAB
144006
India 
Phone  9872818687  
Fax    
Email  sandeepsoni079@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ayushi Singh 
Designation  DNB Trainee 
Affiliation  Punjab Institute of Medical Sciences 
Address  OPD no.9, First Floor, Department of TB and Chest, Punjab Institute of Medical Sciences, Jalandhar, Punjab, 144006

Jalandhar
PUNJAB
144006
India 
Phone  9901594164  
Fax    
Email  ayushisngh412@gmail.com  
 
Source of Monetary or Material Support  
STATE TB TASK FORCE PUNJAB, GMC PATIALA, 147001, India 
 
Primary Sponsor  
Name  State Task force Punjab  
Address  State Task Force Punjab, GMC Patiala, 147001 
Type of Sponsor  Other [State Task force, Punjab to promote the research which is useful for elimination of TB.] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ayushi Singh   Punjab Institute of Medical Sciences  OPD no 9, 1st floor, Department of TB and Chest, Punjab Institute of Medical Sciences, ITI college road, Model House, Jalandhar, Punjab, 144001
Jalandhar
PUNJAB 		 09901594164

ayushisngh412@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, punjab Institute of Medical Sciences  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  Conventional ATT alone  Conventional ATT alone is given  
Intervention  Therapeutic dose of Vitamin D along with ATT  Supplemented with oral doses of vitamin D3- 50,000 IU once a week for 8 weeks along with conventional Anti Tubercular Therapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Newly diagnosed microbiologically confirmed smear positive Pulmonary Tuberculosis with serum 25 hydroxy cholecalciferol levels less than 30 ng/ml 
 
ExclusionCriteria 
Details  1) Patient’s refusal
2) Pregnancy or lactation
3) Miliary TB
4) MDR TB
5) Old treated pulmonary TB
6) Hypersensitivity to Vitamin D supplements
7) A history of hypercalcemia, sarcoidosis, nephrolithiasis, hyperparathyroidism, seizures or cancer in the past.
8) Serum calcium above 10.5 mg/ml.
9) Current use of cytotoxic or immunosuppressive drug
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) To compare the rate of sputum conversion between vitamin D supplementation group and control group  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
2) To evaluate the safety & tolerability profile of therapeutic dose of vitamin D in TB patients  6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 2 
Date of First Enrollment (India)   30/11/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ayushisngh412@gmail.com].

  6. For how long will this data be available start date provided 30-11-2024 and end date provided 30-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - .
Brief Summary  

This study aims to evaluate “The efficacy of vitamin D as an adjunctive treatment along with ATT on early sputum conversion in smear positive pulmonary tuberculosis”. I am conducting this study under the guidance of Dr. Sandeep Soni, Professor & Head of department, Respiratory Medicine in Punjab Institute of Medical Sciences, Jalandhar, Punjab. This will be an open label randomized clinical study and there will be a minimum of 80 patients with smear positive Pulmonary Tuberculosis. They will be supplemented with oral doses of vitamin D3- 50,000 IU once a week for 8 weeks during the intensive phase and followed up every 14 days on day 0, 14, 28, 42, 56 with sputum smear examination, serum Vitamin D levels, Serum Calcium levels and clinical assessment. There is limited data on the efficacy of Vitamin D causing early sputum conversion in smear positive pulmonary tuberculosis and therefore this randomized clinical study aims to give evidence that would help in clinical practice and assist ongoing efforts at streamlining TB treatment.

This study addresses specific targets outlined in the END TB STRATEGY, such as decline in TB deaths, ending catastrophic costs for TB-affected households by 2035.

The study findings can contribute to achieving the milestones set by the End TB strategy, particularly in terms of reducing the burden of smear-positive pulmonary tuberculosis and improving treatment outcomes.

 
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