A study to determine the effect of adjunct Vitamin D treatment in pulmonary tuberculosis patients with Vitamin D deficient.

Completed

Conditions: Tuberculosis of lung,

Registration Number: CTRI/2021/11/037914

Lead Sponsor: Dr Harish Chandra

Brief Summary: 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 worldâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 130

Inclusion Criteria

Newly diagnosed stable Pulmonary Tuberculosis patients with Vitamin D deficiency.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Uttar Pradesh University of Medical Sciences
🇮🇳
Etawah, UTTAR PRADESH, India
Uttar Pradesh University of Medical Sciences
🇮🇳Etawah, UTTAR PRADESH, India
Dr Harish Chandra
Principal investigator
7800185679
hcmaurya17@gmail.com