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
- Conditions
- Coronary artery diseaseperipheral vascular diseaseCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12612001221842
- Lead Sponsor
- Alfred Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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
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 periodoAny known hypersensitivity to Vitamin D (cholecalciferol)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Follow up of both groups after 12 weeks with repeat testing of platelet function via citrated blood collection and tested by Platelet Aggregometry method.[12 weeks after randomisation];Endothelial function test assessed by venous occlusion plethysmography and edoPat.[12 Weeks after randomisation]
- Secondary Outcome Measures
Name Time Method Arterial Stiffness test assessed by venous occlusion plethysmography and edoPat.[12 Weeks after randomisation]