The effect of vitamin D on cardiovascular outcomes in patients with chronic kidney disease
Randomised controlled trial to assess the effect of vitamin D3 and 1,25-hydroxy vitamin D supplementation on vascular calcification and arterial stiffness in patients with chronic kidney disease
Southern Health
120 participants
Nov 1, 2010
Interventional
Conditions
Summary
Chronic kidney disease (CKD) affects approximately 10-15% of the population in developed countries. Cardiovascular disease (CVD) is the greatest risk faced by CKD patients compared to the general population, with an increased mortality that parallels the decline in renal function. Traditional strategies to reduce the risk of CVD, such as lipid lowering and blood pressure control, have had limited impact in the CKD population. This is likely because much of the excess risk of CVD has been attributed to non-traditional risk factors such as anaemia, inflammation and accelerated vascular calcification (VC) and arterial stiffness, related to abnormal phosphate and calcium metabolism in this population. Vitamin D deficiency has been linked to vascular calcification in epidemiological studies. Our aim is to assess as to whether vitamin D supplementation can delay or decrease the progression and incidence of vascular calcification in this population. At this stage there have been no clinical trials assessing the impact of vitamin D therapy on improving CV outcomes or altering the natural progression of surrogate CV markers such as VC and arterial stiffness in the CKD population.
Eligibility
Plain Language Summary
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Interventions
Administration of vitamin D3 and 1,25-hydroxy (OH) vitamin D (calcitriol) Calcitriol will be administered at a dose of 0.25 mcg daily, vitamin D3 will be administered at a dose of 1000 IU a day. Both will be administered orally, for a period fo 12 months following randomisation.
Locations(1)
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ACTRN12610000815066