Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000217202
Ethics application status
Approved
Date submitted
29/01/2018
Date registered
9/02/2018
Date last updated
9/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin D dosing study in Intensive Care Unit patients
Scientific title
A Randomized Study of the effect of a Single Dose of Intramuscular Cholecalciferol on vitamin D levels in Critically Ill Adults
Secondary ID [1] 293901 0
none
Universal Trial Number (UTN)
U1111-1208-6692
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Inflammatory Response Syndrome 306380 0
vitamin D deficiency 306381 0
Condition category
Condition code
Inflammatory and Immune System 305467 305467 0 0
Other inflammatory or immune system disorders
Metabolic and Endocrine 305468 305468 0 0
Other endocrine disorders
Metabolic and Endocrine 305534 305534 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Deep intramuscular injection of cholecalciferol (Vicotrat ®)-150,000IU or 300,000IU as a single dose will be administered by a registered nurse. Blood will be sampled from existing arterial or central lines at the same time as blood is sampled as part of routine clinical management.
Intervention code [1] 300174 0
Treatment: Drugs
Comparator / control treatment
Patients receiving the dose of 150,000IU cholecalciferol
Control group
Dose comparison

Outcomes
Primary outcome [1] 304607 0
serum levels of 25-hydroxy-vitamin D,
Timepoint [1] 304607 0
day 1, 3, 7, 14 (or ICU discharge if earlier). Primary time point day 7.
Primary outcome [2] 304663 0
1,25 dihydroxy vitamin D- serum assay
Timepoint [2] 304663 0
day 1, 3, 7, 14 (or ICU discharge if earlier). Primary time point day 7.
Primary outcome [3] 304664 0
PTH- serum assay
Timepoint [3] 304664 0
day 1, 3, 7, 14 (or ICU discharge if earlier). Primary time point day 7.
Secondary outcome [1] 342529 0
serum assay of C Reactive Protein,
Timepoint [1] 342529 0
day 1, 3, 7, 14 (or at ICU discharge if earlier)
Secondary outcome [2] 342717 0
serum assay of Interleukin 6
Timepoint [2] 342717 0
day 1, 3, 7, 14 (or ICU discharge if earlier). Primary time point day 7.
Secondary outcome [3] 342718 0
serum assay of Cathelicidin
Timepoint [3] 342718 0
day 1, 3, 7, 14 (or ICU discharge if earlier). Primary time point day 7.
Secondary outcome [4] 342719 0
ionised calcium serum assay (to look for toxicity)
Timepoint [4] 342719 0
day 1, 3, 7, 14 (or ICU discharge if earlier). Primary time point day 7.

Eligibility
Key inclusion criteria
Age >16 years
Expected length of stay in ICU>48 hours
Any of 3 SIRS criteria within the last 24 hours. The SIRS criteria include –
a. Temperature <36 or >38 degrees Celsius
b. Heart rate >90 bpm
c. Respiratory rate >20/min or PaCO2<32mmHg
d. White Blood Cell count >12,000 or <4,000/mm3 or >10% bands.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Hypercalcaemia (ionized calcium>1.3mmol/L)
Conditions associated with pathological 1 alpha-hydroxylase activity such as sarcoidosis, lymphoma and multiple myeloma.
Chronic Kidney Disease with eGFR<30ml/min
Severe coagulopathy (Platelets <30,000/cubic mm or INR>3) contraindicating intramuscular injection.
Death is likely in the next 24 hours or active treatment not deemed appropriate.

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)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Stata 13.1 (StataCorp, College Station, TX) and Prism 6 (GraphPad Software, La Jolla, CA). Comparisons between randomized arms will be made using a chi-square or Fisher exact test for categorical covariates, and a paired t test or Wilcoxon rank-sum test for continuous covari- ates, where appropriate. Formal comparisons of change in vitamin D sufficiency from baseline will be made with McNemar test. Changes in vitamin D, laboratory parameters, and inflammatory cytokines from baseline will be compared using mixed-effects random intercept model and used available data. Pearson correlation coefficients will be used to assess the linear correlation between 25OHD and cytokines at baseline. Spearman rank correlation coefficient will be used to assess the direction and relationship of change of 25-hydroxy D and cytokines from baseline to subsequent study days. p value of less than
or equal to 0.05 will be considered statistically significant

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/05/2013
Date of last participant enrolment
Anticipated
Actual
28/04/2014
Date of last data collection
Anticipated
Actual
11/05/2014
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9902 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 18709 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 298523 0
Charities/Societies/Foundations
Name [1] 298523 0
Intensive Care Foundation
Country [1] 298523 0
Australia
Funding source category [2] 298531 0
Charities/Societies/Foundations
Name [2] 298531 0
St Vincents Clinic Foundation
Country [2] 298531 0
Australia
Primary sponsor type
Individual
Name
Dr Priya Nair
Address
St Vincents Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 297671 0
Hospital
Name [1] 297671 0
St Vincents Hospital Sydney
Address [1] 297671 0
390 Victoria Street
Darlinghurst
NSW 2010
Country [1] 297671 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299501 0
St Vincents Hospital Human Research Ethics Committee
Ethics committee address [1] 299501 0
Ethics committee country [1] 299501 0
Australia
Date submitted for ethics approval [1] 299501 0
03/12/2012
Approval date [1] 299501 0
28/12/2012
Ethics approval number [1] 299501 0
HREC/12/SVH/322

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2402 2402 0 0
/AnzctrAttachments/374394-CCMED-D-15-00131.pdf (Publication)

Contacts
Principal investigator
Name 80634 0
Dr Priya Nair
Address 80634 0
Intensive Care Unit
St Vincents Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country 80634 0
Australia
Phone 80634 0
+61 2 83823611
Fax 80634 0
Email 80634 0
[email protected]
Contact person for public queries
Name 80635 0
Priya Nair
Address 80635 0
Intensive Care Unit
St Vincents Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country 80635 0
Australia
Phone 80635 0
+61 2 83823611
Fax 80635 0
Email 80635 0
[email protected]
Contact person for scientific queries
Name 80636 0
Priya Nair
Address 80636 0
Intensive Care Unit
St Vincents Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country 80636 0
Australia
Phone 80636 0
+61 2 83823611
Fax 80636 0
Email 80636 0
[email protected]

No information has been provided regarding IPD availability


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
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