ANZCTR - Registration

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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]

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

vitamin D deficiency

Condition category

Condition code

Inflammatory and Immune System

Other inflammatory or immune system disorders

Metabolic and Endocrine

Other endocrine disorders

Metabolic and Endocrine

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]

Treatment: Drugs

Comparator / control treatment

Patients receiving the dose of 150,000IU cholecalciferol

Control group

Dose comparison

Outcomes

Primary outcome [1]

serum levels of 25-hydroxy-vitamin D,

Timepoint [1]

day 1, 3, 7, 14 (or ICU discharge if earlier). Primary time point day 7.

Primary outcome [2]

1,25 dihydroxy vitamin D- serum assay

Timepoint [2]

day 1, 3, 7, 14 (or ICU discharge if earlier). Primary time point day 7.

Primary outcome [3]

PTH- serum assay

Timepoint [3]

day 1, 3, 7, 14 (or ICU discharge if earlier). Primary time point day 7.

Secondary outcome [1]

serum assay of C Reactive Protein,

Timepoint [1]

day 1, 3, 7, 14 (or at ICU discharge if earlier)

Secondary outcome [2]

serum assay of Interleukin 6

Timepoint [2]

day 1, 3, 7, 14 (or ICU discharge if earlier). Primary time point day 7.

Secondary outcome [3]

serum assay of Cathelicidin

Timepoint [3]

day 1, 3, 7, 14 (or ICU discharge if earlier). Primary time point day 7.

Secondary outcome [4]

ionised calcium serum assay (to look for toxicity)

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment postcode(s) [1]

2010 - Darlinghurst

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Intensive Care Foundation

Address [1]

Level 2, 10 Ievers Terrace
Carlton, Victoria 3053, Australia

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

St Vincents Clinic Foundation

Address [2]

St Vincents Clinic
Victoria Street
Darlinghurst
NSW 2010

Country [2]

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]

Hospital

Name [1]

St Vincents Hospital Sydney

Address [1]

390 Victoria Street
Darlinghurst
NSW 2010

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincents Hospital Human Research Ethics Committee

Ethics committee address [1]

Victoria Street
Darlinghurst
NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/12/2012

Approval date [1]

28/12/2012

Ethics approval number [1]

HREC/12/SVH/322

Summary

Brief summary

Deficiency of vitamin D has been increasingly recognised as a significant public health problem, even in a sunny country like Australia. We and other groups have found that this deficiency is even more common and pronounced in critically ill patients in the Intensive Care Unit.(ICU)
There is now scientific evidence suggesting that vitamin D has widespread roles outside its traditionally recognised role in bone health. Its deficiency has been associated with cardiovascular disease, some cancers, autoimmune and inflammatory diseases, etc. We therefore propose that supplementing vitamin D in critically ill patients while they are in the ICU, particularly those showing signs of an inflammatory response, may improve their outcomes. This needs to be studied in depth within the context of a well-designed, large clinical trial. 
As a variety of doses are currently used in clinical practice, the appropriate dose that is required, particularly in patients who are critically ill, is not known. The design of such trials can only be achieved by obtaining extensive background information on safety and the effects of supplementation using different doses, which are in common use, to determine which dose to use in further trials of critically ill patients and what effects can be achieved with this. Such studies are not available currently. Fortunately, vitamin D is a medication that can be used safely in a wide range of doses and we plan to use 2 doses within this range.
In this study, 50 patients admitted to the ICU who meet certain criteria, suggesting that they have signs of the inflammatory response, will be randomly allocated to receive one of 2 single doses of vitamin D by intramuscular injection. We will collect a small quantity of blood for testing at baseline and on days 1,3,7 and 14 following the dose. We will measure vitamin D and metabolite levels and markers of inflammation in order to study whether target levels can be obtained with these doses and also what effect it has on the inflammatory response. We will monitor closely for any side effects, although these would be extremely unlikely in the doses that we propose to use. We will also collect information from the patients record on routinely collected clinical data and certain outome measures. All information collected and presented will be de-identified and all records will be securely maintained to ensure privacy.
This study will provide us with vital information that we require for the next stage of this project, which is the development of a large study in a number of ICUs to explore the effects of vitamin D supplementation on outcome in this patient group. If shown to be beneficial, this could be an intervention that has a widespread global impact, including in low and middle income countries, as vitamin D is a cheap, safe and easily available medication.

Trial website

Trial related presentations / publications

Nair P, Venkatesh B, Lee P, Kerr S, Hoechter DJ, Dimeski G, Grice J, Myburgh J, Center JR.
A Randomized Study of a Single Dose of Intramuscular Cholecalciferol in Critically Ill Adults.
Crit Care Med. 2015 Nov;43(11):2313-20

Public notes

Attachments [1]

/AnzctrAttachments/374394-CCMED-D-15-00131.pdf (Publication)

Contacts

Principal investigator

Name

Dr Priya Nair

Address

Intensive Care Unit
St Vincents Hospital
390 Victoria Street
Darlinghurst
NSW 2010

Country

Australia

Phone

+61 2 83823611

Fax

Priya.Nair@svha.org.au

Contact person for public queries

Name

Priya Nair

Address

Intensive Care Unit
St Vincents Hospital
390 Victoria Street
Darlinghurst
NSW 2010

Country

Australia

Phone

+61 2 83823611

Fax

Priya.Nair@svha.org.au

Contact person for scientific queries

Name

Priya Nair

Address

Intensive Care Unit
St Vincents Hospital
390 Victoria Street
Darlinghurst
NSW 2010

Country

Australia

Phone

+61 2 83823611

Fax

Priya.Nair@svha.org.au

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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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