A randomized placebo-controlled trial to assess efficacy of Vitamin-D supplementation in non-cystic fibrosis bronchiectasis patients - Not applicable

ICMR0 sites0 target enrollmentStarted: TBDLast updated: November 13, 2023

Trial Snapshot

No summary available.

•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

•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 < 4 weeks.

Sponsor

ICMR