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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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000815066
Acronym
NIL
Enrollment
120
Registered
2010-09-29
Start date
2010-11-01
Completion date
Unknown
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

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.

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.

Sponsors

Southern Health
Lead SponsorHospital

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age greater than 18 years Evidence of abnormal parathyroid hormone secretion chronic kidney disease stage 3b and 4

Exclusion criteria

serum calcium greater than 2.60 serum phosphate greater than 2.40 presence of atrial fibrillation pregnancy current calcitriol therapy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026