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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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001221842
Enrollment
30
Registered
2012-11-19
Start date
2013-05-01
Completion date
2013-12-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to investigate the potentially beneficial effects of Vitamin D supplementation on platelet aggregation and endothelial function, in patients who have proven vitamin D insufficiency and a known history of either Coronary artery disease (CAD) or Peripheral Vascular Disease (PVD).

Interventions

Vitamin D3 (Cholecalciferol) 2000IU once daily for twelve (12) weeks- oral capsule

Sponsors

Alfred Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years
Healthy volunteers
No

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

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026