Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000582752
Ethics application status
Approved
Date submitted
22/05/2013
Date registered
24/05/2013
Date last updated
20/11/2019
Date data sharing statement initially provided
20/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of adjunct high-dose vitamin D on community-acquired pneumonia in hospitalised adults - a randomised controlled trial
Scientific title
Effect of adjunct high-dose vitamin D on radiographic and clinical outcomes of community-acquired pneumonia in hospitalised adults - a double-blind, placebo-controlled, randomised controlled trial
Secondary ID [1] 282549 0
Nil
Universal Trial Number (UTN)
U1111-1140-2885
Trial acronym
VIDCAPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 289218 0
Condition category
Condition code
Infection 289553 289553 0 0
Other infectious diseases
Respiratory 289554 289554 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin D3, 200,000 IU as a single dose orally.
Administration will be directly observed.
Intervention code [1] 287217 0
Treatment: Drugs
Comparator / control treatment
Placebo, identical in appearance to the treatment, administered as a single oral dose.
Control group
Placebo

Outcomes
Primary outcome [1] 289643 0
The resolution of pulmonary inflammatory infiltrate on a follow-up chest X-ray.
Timepoint [1] 289643 0
6 weeks after taking study treatment.
Secondary outcome [1] 302928 0
Length of hospital stay.
Timepoint [1] 302928 0
At discharge from index hospital admission
Secondary outcome [2] 302929 0
In-hospital mortality.
Timepoint [2] 302929 0
At death or discharge from hospital.
Secondary outcome [3] 302930 0
Intensive care unit admission.
Timepoint [3] 302930 0
During index hospital admission.
Secondary outcome [4] 302931 0
Amount and duration of antimicrobial therapy.
Timepoint [4] 302931 0
During index hospitalisation.
Secondary outcome [5] 302932 0
Readmission to hospital.
Timepoint [5] 302932 0
After index hospitalisation until 6 week follow-up.
Secondary outcome [6] 302933 0
6-week and 12-month mortality.
Timepoint [6] 302933 0
6 weeks and 12 months after treatment/placebo administration..
Secondary outcome [7] 302934 0
Resolution of symptoms as assessed by questionnaire designed specifically for this study.
Timepoint [7] 302934 0
6 weeks after treatment/placebo administration.
Secondary outcome [8] 302935 0
Return to normal activity as assessed by questionnaire designed specifically for this study.
Timepoint [8] 302935 0
6 weeks after treatment/placebo administration.

Eligibility
Key inclusion criteria
(1) A confirmed radiological diagnosis of pneumonia, defined as: ‘New inflammatory infiltrate on a chest radiograph where patients have an acute illness with clinical features of pneumonia and radiographic pulmonary shadowing that is at least segmental or present in one lobe and is neither pre-existing or because of some other known cause.’
(2) <48 hours since admission to hospital
(3) Age >=18 years
(4) Ability to give informed consent
(5) Ability to orally consume the study medication
(6) Ability to attend a follow-up appointment at 6 weeks post-study treatment for a chest x-ray
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Pneumonia is not the principal reason for admission
(2) Pneumonia associated with bronchial obstruction, bronchiectasis, or known tuberculosis
(3) Use of vitamin D3 supplements other than as part of a multivitamin preparation where the daily intake would not exceed 400 IU.
(4) High plasma corrected calcium > 2.6 mmol/L (corrected for plasma albumin concentration)
(5) Use of immunosuppressants (e.g. doses of prednisone >10mg, methotrexate, azathioprine and cyclosporin)
(6) Any prior history of hypercalcaemia, nephrolithiasis or sarcoidosis
(7) Current kidney disorders requiring dialysis treatment or polycystic kidney disease
(8) Cirrhosis of the liver
(9) Already enrolled or planning to enrol in a research study that would conflict with full participation in the study or confound the observation or interpretation of the study findings (e.g. where vitamin D levels are tested and results are known by the participant; where the participant is required to take conflicting medications)
(10) Pregnancy or breast-feeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
24/06/2013
Actual
27/06/2013
Date of last participant enrolment
Anticipated
Actual
3/12/2015
Date of last data collection
Anticipated
Actual
5/12/2016
Sample size
Target
400
Accrual to date
Final
135
Recruitment outside Australia
Country [1] 5096 0
New Zealand
State/province [1] 5096 0

Funding & Sponsors
Funding source category [1] 287332 0
University
Name [1] 287332 0
University of Otago
Country [1] 287332 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
P.O. Box 4345
Christchurch 8140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 286079 0
Hospital
Name [1] 286079 0
Canterbury District Health Board
Address [1] 286079 0
P.O. Box 4710
Christchurch 8011
New Zealand
Country [1] 286079 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289306 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 289306 0
1 the Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 289306 0
New Zealand
Date submitted for ethics approval [1] 289306 0
03/05/2013
Approval date [1] 289306 0
21/05/2013
Ethics approval number [1] 289306 0
13/STH/41

Summary
Brief summary
The primary purpose of the study is to determine whether providing a single high dose of vitamin D using in conjunction with standard treatment (including antibiotics) improves outcomes in adults hospitalised with pneumonia. The main hypothesis is that outcomes will be improved in those taking vitamin D compared to those who are given a placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40262 0
Prof David Murdoch
Address 40262 0
Department of Pathology
University of Otago, Christchurch
P.O. Box 4345
Christchurch 8140
Country 40262 0
New Zealand
Phone 40262 0
+64 3 364 0590
Fax 40262 0
Email 40262 0
[email protected]
Contact person for public queries
Name 40263 0
David Murdoch
Address 40263 0
Department of Pathology
University of Otago, Christchurch
P.O. Box 4345
Christchurch 8140
Country 40263 0
New Zealand
Phone 40263 0
+64 3 364 0590
Fax 40263 0
Email 40263 0
[email protected]
Contact person for scientific queries
Name 40264 0
David Murdoch
Address 40264 0
Department of Pathology
University of Otago, Christchurch
P.O. Box 4345
Christchurch 8140
Country 40264 0
New Zealand
Phone 40264 0
+64 3 364 0590
Fax 40264 0
Email 40264 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data collected during the trial is available.
The data sets have sufficient data for re-analysis and also inclusion in future meta-analyses including all blood/biochemical measurements, chest x-ray findings, and some basic demographic details. However, the data sets have been amended to exclude any data that could lead to participant identification and are de-identified.
When will data be available (start and end dates)?
Data is immediately available following publication; no end date has been determined
Available to whom?
Data is available to researchers at reasonable request to Professor Murdoch and at his discretion.
We are required to maintain all records/data for a period of at least 10 years as part of our ethical approval. To protect participant privacy we have opted not to upload data onto a public data base but keep it under the control of Prof Murdoch who at his discretion can provide the data sets to researchers.
Available for what types of analyses?
Meta analyses
How or where can data be obtained?
De-identified data sets can be obtained from Prof Murdoch at reasonable request


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.