Health Condition 1: J479- Bronchiectasis, uncomplicated
Conditions
Interventions
Intervention1: vitamin D3: vitamin D3 60K capsules, Uprise D3, ALKEM laboratories
Oral vitamin D3 60K once a week for 12 weeks
Control Intervention1: Oral placebo (multivitamin capsule): e.g A to Z mu
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients between age 14-85 years 2. Diagnosis of non-cystic fibrosis bronchiectasis (NCFB) confirmed by standard criteria (a & b fulfilled and no cystic fibrosis). 3. Are current sputum inducers with a history of chronic expectoration and able to produce sputum sampling. 4. Have mucopurulent or mucoid expectoration at baseline as assessed by sputum color chart (Murray 2009). 5. Must be willing to come for follow-up as per study protocol
Exclusion criteria
Exclusion criteria: 1. Have a primary diagnosis of asthma and COPD as judged by the investigator. 2. Are current smokers. 3. Receiving current treatment for non-tuberculous mycobacterial infection, ABPA or tuberculosis. 4. Have hypercalcemia at baseline. 5. Are not on a stable dose of inhaled corticosteroids for at least 4 week prior to enrolment. 6. Have been receiving vitamin-D ( >1000 U per week) for > 2 weeks prior to enrolment. 7. Patients having hypercalcemia (serum calcium > 10.5 mg/dl or ionized calcium levels > 5.4 mg/dl) 8. Cirrhosis with varices 9. Chronic renal dysfunction requiring dialysis 10. Hyperparathyroidism 11. History of allergy to Vitamin D3 or one of the excipients in the medications 12. Pregnancy and post-partum patients (till 42 days after delivery) 13. Disseminated malignancy, which is active 14. Patients already entered into any trial with intervention for bronchiectasis 15. Have any acute infections (including respiratory infections) that required antibiotic treatment within 4 weeks before Screening or within 12 weeks before Screening if the antibiotic prescription is a macrolide 16. Has been on azole therapy for chronic pulmonary aspergillosis for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pulmonary exacerbation-free course 2. QOL by BHQ Degreee of symptom control as assessed by Visual analogue scale Change in Pulmonary function (FEV1) 3. Serum neutrophil elastase and cathelicidin levelsTimepoint: 1. At the end of 6 months 2.at the end of 1, 3 and 6 months 3. at the end of 1, 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in composition of the sputum microbiome Timepoint: at the end of 3 and 6 months | — |
Countries
India
Contacts
Public ContactAnimesh Ray
All India Institute of Medical Sciences New Delhi
Outcome results
None listed