Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000516987
Ethics application status
Not yet submitted
Date submitted
13/05/2011
Date registered
18/05/2011
Date last updated
18/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin D status in heart surgery patients and effects on clinical outcomes
Scientific title
In elective cardiac surgery patients, what is the effect of vitamin D status on clinical ICU outcomes, and does a 6 week period of vitamin D supplementation post surgery increase serum vitamin D levels in those found to be deficient?
Secondary ID [1] 262165 0
Nil
Universal Trial Number (UTN)
U1111-1121-3689
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective cardiac surgery patients requiring either or both coronary artery bypass graft or valve repair or replacement 265852 0
Condition category
Condition code
Cardiovascular 266007 266007 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After initial screening before surgery, participants found to be deficient in vitamin D will be given oral supplements of 4000IU of vitamin D3 daily for 6 weeks after discharge from hospital.
Intervention code [1] 264578 0
Early detection / Screening
Intervention code [2] 264599 0
Treatment: Other
Intervention code [3] 264600 0
Diagnosis / Prognosis
Comparator / control treatment
Participants not found to be deficient in vitamin D will have medical information (length of ventilation time, length of ICU stay, APACHE scores) gathered as comparator.
Control group
Active

Outcomes
Primary outcome [1] 266749 0
To identify the prevalence of vitamin D deficiency and insufficiency in cardiac ICU patients presenting to the Alfred Hospital by serum analysis of 25-hydroxy-vitamin D levels
Timepoint [1] 266749 0
Immediately before cardiac surgery
Primary outcome [2] 266750 0
To identify whether vitamin D deficiency or insufficiency is associated with increased length of ventilation use and ICU stay
Timepoint [2] 266750 0
Immediately after cardiac surgery
Primary outcome [3] 266751 0
To identify whether vitamin D deficiency or insufficiency is associated with greater severity of illness as measured by the APACHE 3
Timepoint [3] 266751 0
In postoperative period, over length of hospital stay
Secondary outcome [1] 276306 0
Patients response to 6 weeks treatment with 4000 IU daily of vitamin D3 using a popular over-the-counter product by serum analysis of 25-hydroxy-vitamin D levels
Timepoint [1] 276306 0
6 weeks from hospital discharge after cardiac surgery

Eligibility
Key inclusion criteria
All elective cardiac surgery patients over 18 years admitted to the Alfred hospital during the study period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to give informed consent; patients taking supplements containing vitamin D or who have taken them within the last 3 months; patients who have undergone parathyroidectomy; patients with hypercalcaemia or hyperphosphataemia; patients taking medications known to affect vitamin D metabolism; patients with liver failure or nephrotic syndrome

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible, adult, elective cardiac surgery patients presenting to the preadmission clinic at The Alfred hospital in the study time period will be recruited
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 265075 0
Commercial sector/Industry
Name [1] 265075 0
Blackmores Ltd
Country [1] 265075 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
Commercial Rd
Prahran Vic 3181
Country
Australia
Secondary sponsor category [1] 264164 0
None
Name [1] 264164 0
Address [1] 264164 0
Country [1] 264164 0
Other collaborator category [1] 252001 0
University
Name [1] 252001 0
Monash University
Address [1] 252001 0
Department of Surgery
5th floor, Alfred Centre
90 Commercial Rd
Melbourne Vic 3004
Country [1] 252001 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 267055 0
Ethics committee address [1] 267055 0
Ethics committee country [1] 267055 0
Date submitted for ethics approval [1] 267055 0
23/05/2011
Approval date [1] 267055 0
Ethics approval number [1] 267055 0

Summary
Brief summary
Vitamin D deficiency and insufficiency has been detected in the general community and is likely to be present in cardiac intensive care unit patients. This may impact recovery from surgery and rehospitalisation risk.

The primary aim of this study is to identify the prevalence of vitamin D deficiency and insufficiency in cardiac ICU patients presenting to the Alfred Hospital.

Secondary aims are to identify whether vitamin D deficiency or insufficiency is associated with longer ICU stay, longer ventilation time and/or APACHE 3 scores showing deterioration. And also to ascertain whether supplementation with 4000IU of vitamin D daily restores serum levels to within normal range.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32606 0
Address 32606 0
Country 32606 0
Phone 32606 0
Fax 32606 0
Email 32606 0
Contact person for public queries
Name 15853 0
Ondine Spitzer
Address 15853 0
Dept of Surgery
5th floor, The Alfred Centre
99 Commercial Rd
Melbourne Vic 3004
Country 15853 0
Australia
Phone 15853 0
+61 3 99030838
Fax 15853 0
Email 15853 0
[email protected]
Contact person for scientific queries
Name 6781 0
Dr Lesley Braun
Address 6781 0
Dept of Surgery
5th floor, The Alfred Centre
99 Commercial Rd
Melbourne Vic 3004
Country 6781 0
Australia
Phone 6781 0
+61 3 99030326
Fax 6781 0
Email 6781 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
No additional documents have been identified.