Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001221842
Ethics application status
Approved
Date submitted
14/11/2012
Date registered
19/11/2012
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Double Blind Placebo Controlled Study to Determine the Effects of Vitamin D supplementation on Platelet and Vascular function in patients with Vitamin D insufficiency and known Coronary artery or peripheral vascular disease
Scientific title
Randomised Double Blind Placebo Controlled Study to Determine the Effects of Vitamin D supplementation on Platelet and Vascular function in patients with Vitamin D insufficiency and known Coronary artery or peripheral vascular disease
Secondary ID [1] 281548 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 287817 0
peripheral vascular disease 287824 0
Condition category
Condition code
Cardiovascular 288165 288165 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin D3 (Cholecalciferol) 2000IU once daily for twelve (12) weeks- oral capsule
Intervention code [1] 286062 0
Treatment: Drugs
Comparator / control treatment
Placebo, Microcellulose capsule
Control group
Placebo

Outcomes
Primary outcome [1] 288369 0
Follow up of both groups after 12 weeks with repeat testing of platelet function via citrated blood collection and tested by Platelet Aggregometry method.
Timepoint [1] 288369 0
12 weeks after randomisation
Primary outcome [2] 288374 0
Endothelial function test assessed by venous occlusion plethysmography and edoPat.
Timepoint [2] 288374 0
12 Weeks after randomisation
Secondary outcome [1] 299983 0
Arterial Stiffness test assessed by venous occlusion plethysmography and edoPat.
Timepoint [1] 299983 0
12 Weeks after randomisation

Eligibility
Key inclusion criteria
Measured Vitamin D level 25-50 nanomol/L
Not on Vitamin D replacement therapy for previous 3 months
Known history of CAD or PVD
Currently taking Aspirin as single anti-platelet therapy
Other appropriate arterial disease risk factor reduction therapy
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 40yrs or > 85yrs
Measured Vitamin D level < 25nmol/L
History of osteoporosis or low-impact fractures
Current or planned prenancy
Severe renal impairment (eGFR < 30)
Current or previous hypercalcemia
Known secondary cause of vitamin D insufficiency (eg. malabsorptive states)
Presence of an active malignancy
Liver cirrhosis
Planned coronary artery or peripheral vascular intervention within next 6 months
Current oral anticoagulation therapy (eg. Warfarin, Dabigatran)
Clopidogrel or anti-epileptic therapy at any stage of the trial periodo Any known hypersensitivity to Vitamin D (cholecalciferol)

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)
All patients admitted to the Cardiology services at the Alfred Hospital are screened for eligibility.
Allocation is by sealed opaque envelopes generated randomly by clinical trails section in Alfred Hospital pharmacy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation by pharmacy using a randomisation table embedded in Microsoft excel (computerised sequence generationa).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2013
Actual
1/05/2013
Date of last participant enrolment
Anticipated
15/12/2013
Actual
1/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286327 0
Government body
Name [1] 286327 0
Supported by NHMRC program grant
Country [1] 286327 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Commercial Road
Prahran Vic 3181
Country
Australia
Secondary sponsor category [1] 285116 0
None
Name [1] 285116 0
Address [1] 285116 0
Country [1] 285116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288402 0
Alfred Research and Ethics Commitee
Ethics committee address [1] 288402 0
Ethics committee country [1] 288402 0
Date submitted for ethics approval [1] 288402 0
22/10/2012
Approval date [1] 288402 0
11/12/2012
Ethics approval number [1] 288402 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34957 0
Dr James Shaw
Address 34957 0
Heart Centre Alfred Hospital Commercial Road Prahran Vic 3181
Country 34957 0
Australia
Phone 34957 0
+61 3 9076 3263
Fax 34957 0
Email 34957 0
j.shaw@alfred.org.au
Contact person for public queries
Name 18204 0
Dr Phillip Ngu
Address 18204 0
Heart Centre
Alfred Hospital
Commercial Road
Prahran Vic 3181
Country 18204 0
Australia
Phone 18204 0
+61 3 90762461
Fax 18204 0
Email 18204 0
Phillip.j.ngu@gmail.com
Contact person for scientific queries
Name 9132 0
Dr Phillip Ngu
Address 9132 0
Heart Centre
Alfred Hospital
Commercial Road
Prahran Vic 3181
Country 9132 0
Australia
Phone 9132 0
+61 3 90762461
Fax 9132 0
Email 9132 0
Phillip.j.ngu@gmail.com

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.