Not Yet RecruitingPhase 4ACTRN12610000815066

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


Sponsor

Southern Health

Enrollment

120 participants

Start Date

Nov 1, 2010

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study examines whether vitamin D supplements can improve heart and blood vessel health in people with moderate to severe chronic kidney disease. It is for adults over 18 who have chronic kidney disease (stage 3b or 4) and abnormal parathyroid hormone levels.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Australia

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ACTRN12610000815066