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CTRI Number  CTRI/2021/11/037914 [Registered on: 10/11/2021] Trial Registered Prospectively
Last Modified On: 15/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to determine the effect of adjunct Vitamin D treatment in pulmonary tuberculosis patients with Vitamin D deficient. 
Scientific Title of Study   A prospective interventional randomized parallel group active controlled double blind clinical trial to determine the effect of adjunct Vitamin D treatment on DLC, ESR, serum ADA, serum CRP, Oxygen Saturation, and Body Weight in Vitamin D deficient pulmonary tuberculosis patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harish Chandra 
Designation  Post Graduate Junior Resident 
Affiliation  Uttar Pradesh University of Medical Sciences 
Address  Department of Biochemistry, Academic Block, UPUMS, Saifai, Etawah.
Saifai, Etawah, U.P.
Etawah
UTTAR PRADESH
206130
India 
Phone  7800185679  
Fax    
Email  hcmaurya17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Adil Rahman 
Designation  Additional Professor 
Affiliation  Uttar Pradesh University of Medical Sciences 
Address  Room no. 02, Department of Biochemistry, Academic Block, UPUMS, Saifai, Etawah.
Saifai, Etawah, U.P.
Etawah
UTTAR PRADESH
206130
India 
Phone  9410641429  
Fax    
Email  dradilrahman@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Harish Chandra 
Designation  Post Graduate Junior Resident 
Affiliation  Uttar Pradesh University of Medical Sciences 
Address  Department of Biochemistry, Academic Block, UPUMS, Saifai, Etawah.
Saifai, Etawah, U.P.
Etawah
UTTAR PRADESH
206130
India 
Phone  7800185679  
Fax    
Email  hcmaurya17@gmail.com  
 
Source of Monetary or Material Support  
Uttar Pradesh University of Medical Sciences, Saifai, Etawah 
 
Primary Sponsor  
Name  Dr Harish Chandra 
Address  Department of Biochemistry, Academic Block, UPUMS, Saifai, Etawah. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Indian Council of Medical Research  Ansari Nagar, New Delhi- 110029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harish Chandra  Uttar Pradesh University of Medical Sciences  Room Number 27, First Floor and Wards, Fourth Floor Department of Respiratory Medicine, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, 206130.
Etawah
UTTAR PRADESH 
7800185679

hcmaurya17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, UPUMS, Saifai, Etawah  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 
Intervention  Adjunct Vitamin D3 supplementation and standard ATT (anti-tubercular treatment).  Each individual of intervention group will receive standard ATT and 4 doses of 2.5 mg (100000 IU) of Vitamin D3, orally, within 7 days of starting ATT, at 2 week, 4 week and at 6 week of treatment.  
Comparator Agent  Standard ATT.  Each individual of control group will receive standard ATT without Vitamin D supplementation. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Newly diagnosed stable Pulmonary Tuberculosis patients with Vitamin D deficiency. 
 
ExclusionCriteria 
Details  With history and biochemical evidence :-
1. Patient with extra pulmonary tuberculosis and drug resistant tuberculosis like MDR-TB, XDR-TB etc.
2. Chronic pulmonary disease like COPD, bronchial asthma, bronchiectasis, pulmonary fibrosis, pulmonary silicosis, sarcoidosis and pulmonary lobectomy.
3. Chronic Liver disease, Aspartate transaminase or Alanine transaminase more than 120 IU per Litre or total serum bilirubin more than 40 micromol per Litre.
4. Chronic Kidney disease, Nephrolithiasis, serum creatinine more than 250 micromol per Litre.
5. Malignancy
6. HIV infection
7. Hyperparathyroidism
8. Thyrotoxicosis
9. Chronic cardiac disease like angina, congestive heart failure, myocardial infarction, arrhythmia etc.
10. Cytotoxic drugs or other immunosuppressant treatment in the month preceding enrollment.
11. Serum corrected calcium more than 2.65 mmol per Litre.
12. Pregnant or breastfeeding.
13. Diabetes Mellitus.
14. Use of drugs affecting Vitamin D metabolism - Anticonvulsants, Glucocorticoids, Calcium and Theophylline. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect of adjunct Vitamin D treatment on the DLC, ESR, serum ADA, and serum CRP.  AT 2 week, 4 week, 6 week and 8 week of treatment period. 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of adjunct Vitamin D treatment on Oxygen saturation (SpO2) and Body weight.  At 2 week, 4 week, 6 week, 8 week and 12 week of treatment period. 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2021 
Date of Study Completion (India) 05/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

 Tuberculosis (TB)is one of the top 10 causes of death worldwide and the leading cause of death from a single infectious agent (ranking above HIV/AIDS). In 2019, globally about 10 million people developed tuberculosis and 1.4 million died. About a quarter of the world’s population is infected with M. tuberculosis.  India is the highest TB burden country in the world having an estimated incidence of 26.9 lakh cases in 2019 (WHO).

 Hypovitaminosis D is associated with more severe clinical symptoms, a higher degree of sputum smear positivity and more extensive lesions in chest radiograph among pulmonary tuberculosis patients. Also, low serum Vitamin D level is a good predictor of prolonged clinical course (poor treatment outcome) in patients with active pulmonary TB.    

 Vitamin D is an immunomodulator agent. Vitamin D (1,25 (OH)2D) mediates antimicrobial activity via induction of reactive oxygen intermediates, reactive nitrogen intermediates, antimicrobial peptides (Cathelecidin) and Autophagy. Vitamin D regulate the Adaptive Immune System by inhibiting Lymphocyte proliferation and reducing production of pro-inflammatory cytokines to prevent excessive response. Thus, the ability of 1,25(OH)2D to promote antibacterial activity while simultaneously modulating T-cell function underlines the potential importance of Vitamin D in maintaining a balanced immune response to infection, while minimizing tissue damage within the host.     

Therefore to evaluate the effect of vitamin D supplementation on the outcome of pulmonary TB patient we assessed the effect of vitamin D supplementation on following variables DLC, ESR, serum ADA, serum CRP, oxygen saturation (SpO2) and body weight in vitamin D deficient newly diagnosed pulmonary TB patients. For this, we  conducted a prospective interventional randomized double blind parallel group active controlled clinical trial. After randomization, we allocated the study participants in two groups, the control group (received standard ATT without vitamin D3   supplementation) and intervention  group (received standard ATT with vitamin D3 supplementation). At the time of enrollment of participants we measured baseline characteristics including study variables. During follow-up measurement of all the study variables and monitoring of any adverse events was carried out. Statistical analysis of all data obtained from participants was analyzed using SPSS software.

 
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