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
|
|
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. |