Pulmonary Tuberculosis and Vitamin D

• Status: Unknown status
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Tuberculosis and vitamin D deficiency are important public health problems in India. Before the advent of effective antitubercular therapy, patients with tuberculosis were advised treatment and rest at sanatorium where sunshine was available in plenty. There have been reports associating vitamin D deficiency with tuberculosis in terms of incidence and beneficial response following addition of vitamin D to antitubercular therapy. Sputum AFB conversion rate is higher in patients with tuberculosis supplemented with vitamin D. The present study would systematically assess role of adjunct vitamin D therapy (cholecalciferol) in patients with pulmonary tuberculosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indian Council of Medical Research
• Collaborator: Ministry of Science and Technology, India
• Treatments: Calcium Carbonate; Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. All patients of either sex with Newly diagnosed sputum positive pulmonary TB cases

2. Aged between 18 to 60 yrs

Exclusion Criteria:

1. Category II pulmonary TB and multi-drug resistant TB (MDR-TB) patients

2. Presence of secondary immunodeficiency states : HIV, organ transplantation, diabetes mellitus, malignancy, treatment with corticosteroids

3. Hepatitis B and C positivity

4. Patients with extrapulmonary TB and/or patients requiring surgical intervention

5. Currently receiving cytotoxic therapy, or have received it within the last 3 months

6. Pregnancy and lactation

7. Patients with a known seizure disorder

8. Patients with known symptomatic cardiac disease, such as arrhythmias or coronary artery disease

9. Patients with abnormal renal functions (serum creatinine more than 2 mg/dl; more than 2+ proteinuria)

10. Patients with abnormal hepatic functions (bilirubin = 1.5 mg/dl; AST, ALT, SAP > 1.5 times above upper limit

11. Patients with hematological abnormalities (WBC lesser than or equal to 3000/mm3; platelet count less than or equal to 100,000/mm3)

12. Seriously ill and moribund patients with complications : tachypnoea, chronic cor pulmonale, congestive cardiac failure, BMI<15, severe hypoalbuminemia

13. Patients unable to comply with the treatment regimen

14. Patients with history of alcohol or drug abuse