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Trial registered on ANZCTR


Registration number
ACTRN12612001222831
Ethics application status
Approved
Date submitted
14/11/2012
Date registered
19/11/2012
Date last updated
22/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin D3 supplementation in adult patients with non-cystic fibrosis bronchiectasis - a feasibility study
Scientific title
Vitamin D3 supplementation in bronchiectasis - a feasibility study
Secondary ID [1] 281547 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 287816 0
Condition category
Condition code
Respiratory 288164 288164 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cholecalciferol 25,000iu single capsule oral dose
Intervention code [1] 286061 0
Prevention
Intervention code [2] 286067 0
Treatment: Other
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288368 0
To assess the range of 25(OH) D levels in adult patients with non-cystic fibrosis bronchiectasis and whether vitamin D3 supplementation increases 25(OH) D levels above 75 nmol/L.
Serum samples will be collected at baseline, week 13 and week 26 (end of study) for analysis
Timepoint [1] 288368 0
Baseline, week 13 and week 26
Secondary outcome [1] 299977 0
To estimate time to first exacerbation and exacerbation frequency after vitamin D3 supplementation.
Patients will be keeping daily diaries to record respiratory symptoms and concomitant medications will be reviewed and recorded at all visits from baseline to week 26
Timepoint [1] 299977 0
At baseline, week 13 and week 26
Secondary outcome [2] 299978 0
To assess whether vitamin D3 supplementation increases lung function.
Spirometry will be performed at all visits from baseline to week 26 for analysis.
Timepoint [2] 299978 0
At baseline, week 13 and week 26
Secondary outcome [3] 299979 0
To assess whether vitamin D3 supplementation improves health-related quality of life measures.

Participants are required to complete the Leicester Cough Questionnaires (LCQ) and CO-OP charts at baseline, week 13 and week 26.
Timepoint [3] 299979 0
At baseline, week 13 and week 26
Secondary outcome [4] 299980 0
To assess whether vitamin D3 supplementation improves chronic rhinosinusitis symptoms.
Nasal endoscopy will be performed at baseline and week 26, Sino-Nasal Outcome Test (SNOT-20) will be completed by participants at baseline, week 13 and week 26.
Timepoint [4] 299980 0
At baseline, week 13 and week 26
Secondary outcome [5] 299981 0
To assess whether vitamin D3 supplementation decreases airway inflammation.
Sputum samples will be collected at baseline and week 26 for analysis of sputum cell counts.
Timepoint [5] 299981 0
At baseline and week 26
Secondary outcome [6] 299982 0
To assess whether vitamin D3 supplementation reduces bacterial infection.
Patients will be keeping daily diaries to record respiratory symptoms and concomitant medications will be reviewed and recorded at all visits from baseline to week 26.
Timepoint [6] 299982 0
At baseline, week 13 and week 26

Eligibility
Key inclusion criteria
Patients with a diagnosis of bronchiectasis based on high resolution chest CT scan within the previous 2 years
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients taking Vitamin D3 supplement >600iu per day, patients with cystic fibrosis

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible participants who have signed a written informed consent will be allocated to treatment with Vit D3
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4682 0
New Zealand
State/province [1] 4682 0
Auckland

Funding & Sponsors
Funding source category [1] 286328 0
Government body
Name [1] 286328 0
Health Research Council
Address [1] 286328 0
PO Box 5541, Wellesley Street, Auckland, New Zealand 1141
Country [1] 286328 0
New Zealand
Primary sponsor type
Other
Name
Middlemore Clinical Trials
Address
Private Bag 93311
Otahuhu
Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 285117 0
None
Name [1] 285117 0
NA
Address [1] 285117 0
NA
Country [1] 285117 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288403 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 288403 0
Ministry of health, 1 The Terrace, PO Box 5013, Wellington 6011
Ethics committee country [1] 288403 0
New Zealand
Date submitted for ethics approval [1] 288403 0
13/09/2012
Approval date [1] 288403 0
31/10/2012
Ethics approval number [1] 288403 0
12/NTA/41

Summary
Brief summary
This study aims to assess the range of 25(OH) D levels in adult patients with non-cystic bronchiectasis and assess whether vitamin D3 supplementation increases 25(OH) D levels above 75 nmol/L
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 34956 0
Dr Dr Jim Bartley
Address 34956 0
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland
Country 34956 0
New Zealand
Phone 34956 0
+64 211485077
Fax 34956 0
Email 34956 0
j.bartley@middlemore.co.nz
Contact person for public queries
Name 18203 0
Mrs Catherine Howie
Address 18203 0
Middlemore Clinical Trials
100 Hospital Road
Papatoetoe
Auckland 2025
Country 18203 0
New Zealand
Phone 18203 0
+64 9 2760044 Ext 2017
Fax 18203 0
+64 9 276 3878
Email 18203 0
catherine.howie@mmclintrials.nz
Contact person for scientific queries
Name 9131 0
Dr Dr Jim Bartley
Address 9131 0
Middlemore Hospital
Hospital Road
Otahuhu
Auckland 1640
Country 9131 0
New Zealand
Phone 9131 0
+649 276 0000
Fax 9131 0
+64 9 2763878
Email 9131 0
Jim.Bartley@middlemore.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary