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CTRI Number  CTRI/2023/11/059393 [Registered on: 01/11/2023] Trial Registered Prospectively
Last Modified On: 31/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A randomized placebo-controlled trial of Vitamin-D supplementation in bronchiectasis 
Scientific Title of Study   A randomized placebo-controlled trial to assess efficacy of Vitamin-D supplementation in non-cystic fibrosis bronchiectasis patients 
Trial Acronym  Not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Animesh Ray 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Room 3070 A Teaching block Department of Medicine AIIMS, New Delhi

South West
DELHI
110029
India 
Phone  9560093190  
Fax    
Email  doctoranimeshray@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Animesh Ray 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Room 3070 A Teaching block Department of Medicine AIIMS, New Delhi

South West
DELHI
110029
India 
Phone  9560093190  
Fax    
Email  doctoranimeshray@gmail.com  
 
Details of Contact Person
Public Query  
Name  Animesh Ray 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Room 3070 A Teaching block Department of Medicine AIIMS, New Delhi

South West
DELHI
110029
India 
Phone  9560093190  
Fax    
Email  doctoranimeshray@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research. V. Ramalingaswami Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029 
 
Primary Sponsor  
Name  ICMR 
Address  ndian Council of Medical Research. V. Ramalingaswami Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Animesh Ray  All India Institute of Medical Sciences (AIIMS) New Delhi  Ward C2, D2 , Medicine OPD,Chest Clinic under department of Medicine, AIIMS New Delhi-110029
South West
DELHI 		 9560093190

doctoranimeshray@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J479||Bronchiectasis, uncomplicated,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral placebo (multivitamin capsule)   e.g A to Z multivitamin capsules Oral placebo (multivitamin capsule) once a week for 12 weeks 
Intervention  vitamin D3   vitamin D3 60K capsules, Uprise D3, ALKEM laboratories Oral vitamin D3 60K once a week for 12 weeks 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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 levels 		 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 Outcome  
Outcome  TimePoints 
The difference in composition of the sputum microbiome

 		 at the end of 3 and 6 months 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [doctoranimeshray@gmail.com].

  6. For how long will this data be available start date provided 01-11-2023 and end date provided 31-10-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Rationale:  Bronchiectasis is a chronic inflammatory condition affecting the airways leading to chronic cough with sputum. The management strategy of bronchiectasis (non-CF) usually involves airway clearance therapy, treatment of exacerbations, long-term macrolide therapy and rehabilitation. However, the underlying inflammation is not addressed by any approved drug. Exacerbations of bronchiectasis mark events leading to significant morbidity and mortality. Novelty: Vitamin D has shown to be beneficial in certain inflammatory airway disorders but have not been formally evaluated in non-CF bronchiectasis. If found beneficial, it would be the first drug with anti-inflammatory activity to be used in bronchiectasis.

Objectives: The primary objective is to evaluate the effect of vitamin D on decreasing pulmonary exacerbations at 6 months. The secondary objectives are to evaluate the effect of vitamin D on symptom control, quality of life, serum inflammatory markers and sputum microbiome at 1, 3 and 6 months.

Methods: In this placebo-controlled triple blinded randomized controlled trial, 130 patients (65 in each group) would be randomized to either vitamin D or placebo (along with usual care). Consenting patients without recent infection and fulfilling the inclusion/exclusion criteria would be enrolled in this study. The different outcomes (exacerbations, symptoms, inflammatory markers, and sputum microbiome) would be assessed at different time points by appropriate tools. Serum neutrophil elastase and cathelicidin would be measured as inflammatory markers.

Expected outcome: It is expected that vitamin D would lead to significantly decreased exacerbations, systemic and inflammation and favorable changes in sputum microbiome over the follow-up period.

 
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