Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000815066
Ethics application status
Approved
Date submitted
22/09/2010
Date registered
29/09/2010
Date last updated
29/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of vitamin D on cardiovascular outcomes in patients with chronic kidney disease
Scientific title
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
Secondary ID [1] 252736 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic kidney disease 258234 0
cardiovascular disease 258235 0
mineral metabolism 258236 0
Condition category
Condition code
Renal and Urogenital 258415 258415 0 0
Kidney disease
Cardiovascular 258425 258425 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257253 0
Treatment: Drugs
Comparator / control treatment
Control group is patients receiving standard care, comparison is between control group and the two interventions groups. Standard care involves best practice management of chronic kidney disease. This involves the active management fo cardiovascular risk factors, mineral paramaters such as phosphate and parathyroid hormone (PTH) and ensuring optimal glycemic control where appropriate.
Control group
Active

Outcomes
Primary outcome [1] 259263 0
Progression and incidence of coronary artery calcification in patients with stage 3b and 4 chronic kidney disease over 18 months. This will occur at baseline, 9 months and 18 months. We will use a non-contrast, electrocardiograph-gated, 320-slice computer tomography (CT) to assess the coronary arteries.
Timepoint [1] 259263 0
Patients will be assessed at baseline and 9 and 18 months following randomisation.
Secondary outcome [1] 265661 0
Assess the impact of calcitriol and vitami D3 therapy on progression of markers of chronic kidney disease mineral bone disorder (CKD-MBD) in particualr parathryroid hormone, fibroblast growth factor 23 (FGF-23). This will be assessed with serum biomarkers; phosphate, FGF-23 and PTH as well as bone mineral density measurements obtained from the computed tomography (CT) reconstructions.
Timepoint [1] 265661 0
These will occur three times during the study period; at baseline, 9 and 18 months following randomisation.
Secondary outcome [2] 265662 0
To assess the effect of calcitriol and vitamin D3 supplementation on arterial compliance as measured by pulse wave velocity
Timepoint [2] 265662 0
This will occur 3 times during the study period; at baseline, 9 and 18 months following randomisation.
Secondary outcome [3] 265663 0
To assess the effect of vitamin D3 and calcitriol on the degree of proteinuria. This will be assessed through a 24-hour urine collection assessing the protein excretion over 24 hours.
Timepoint [3] 265663 0
This will occur three times during the study period: at baseline, 9 and 18 months following randomisation.

Eligibility
Key inclusion criteria
Age greater than 18 years
Evidence of abnormal parathyroid hormone secretion
chronic kidney disease stage 3b and 4
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
serum calcium greater than 2.60
serum phosphate greater than 2.40
presence of atrial fibrillation
pregnancy
current calcitriol therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be enrolled after initial identification and discussion in outpatient clinics. After randomisation patients will be allocated to of two interventions, or ongoing standard care. The recruiting person will not be aware as to which arm the patients has been randomised to. The medications will be dispensed by pharmacy, however as there is no placebo arm and patients are not blinded there is no allocation concealment procedures. The only people blinded to the treatment will be the radiologists.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients will be randomised to one of three groups, two intervention and one control. There is no placebo arm. The investigators (radiology) will be blinded to treatment and 25-OH vitamin D levels.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3282 0
3168

Funding & Sponsors
Funding source category [1] 257696 0
Hospital
Name [1] 257696 0
Southern Health
Country [1] 257696 0
Australia
Primary sponsor type
Hospital
Name
Southern Health
Address
Monash Medical Centre, Clayton
246 Clayton Road
Clayton 3168
Victoria
Country
Australia
Secondary sponsor category [1] 256912 0
None
Name [1] 256912 0
Address [1] 256912 0
Country [1] 256912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259729 0
Southern Health
Ethics committee address [1] 259729 0
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 259729 0
Australia
Date submitted for ethics approval [1] 259729 0
Approval date [1] 259729 0
26/08/2010
Ethics approval number [1] 259729 0
Application no: 10228B

Summary
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.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 31676 0
Address 31676 0
Country 31676 0
Phone 31676 0
Fax 31676 0
Email 31676 0
Contact person for public queries
Name 14923 0
Dr Matthew Damsiewicz
Address 14923 0
Department of Nephrology
Monash Medical Centre
246 Clayton Road
Clayton 3168
Victoria
Country 14923 0
Australia
Phone 14923 0
+61 3 9594 6666
Fax 14923 0
Email 14923 0
Matthew.Damasiewicz@monash.edu
Contact person for scientific queries
Name 5851 0
Matthew Damasiewicz
Address 5851 0
Department of Nephrology
Monash Medical Centre
246 Clayton Road
Clayton 3168
Victoria
Country 5851 0
Australia
Phone 5851 0
+61 3 9594 6666
Fax 5851 0
Email 5851 0
Matthew.Damasiewicz@monash.edu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.