Chronic Kidney Disease (CKD)
Conditions
Keywords
Vitamin D, pulse wave velocity
Brief summary
Individuals with kidney disease have a high risk of heart disease. This is not related to traditional risk factors, such as high blood pressure, high cholesterol or being overweight. A lack of vitamin D could be the reason why blood vessels become damaged and could explain the link between heart disease and kidney disease.
Detailed description
Most people living in Canada do not receive enough vitamin D from the sun or from the food they eat. When a person has kidney disease this is a particular problem as kidney disease stops what little vitamin D we do have being activated in the body. Low levels of activated vitamin D causes a domino effect with calcium and phosphate and all the hormones that control calcium and phosphate. Some people believe that this imbalance damages the blood vessels causing them to become stiff and inflexible (arterial stiffness) and this in turn could cause heart disease. In addition there are two different types of vitamin D that can be prescribed and it is currently not known whether there is any difference between the two types of vitamin D and the effect they have on the blood vessels. The purpose of this study is to investigate whether providing vitamin D as a medication can have a direct affect on the stiffness of the blood vessels. The findings of this study will help both physicians and dietitians decide whether Vitamin D therapy is beneficial to patients and should help decide which type of Vitamin D is best to give to people with chronic kidney disease (CKD).
Interventions
DIETARY_SUPPLEMENTDietary supplement
Placebo given orally 3xweek for six months
DIETARY_SUPPLEMENTVitamin D
5000 IU vitamin D given orally 3xweek for six months
Sponsors
The Kidney Foundation of Canada
Pfizer
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with an estimated glomerular filtration rate (eGFR) between 15 - 45 ml/min, and \<2ml/min change in glomerular filtration rate (GFR) over the past 6 months * treated with maximal conventional cardiovascular disease (CVD) risk reduction medications
Exclusion criteria
* patients with estimated glomerular filtration rate (eGFR) change of \>2.1 ml/min over the past 6 months * those who have terminal malignancies * those with planned transplant within 6 months, or who are likely to commence renal replacement therapy (dialysis) within the 6 months after enrolment * those with active infections or active inflammatory diseases (Systemic Lupus Erythematosus (SLE), vasculitis) * those who refuse to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Help both physicians and dietitians decide whether vitamin D therapy is beneficial to patients with kidney disease | 15 months | The specific measurements to establish the primary outcome measure include:a pulse wave velocity test which is a non-invasive test used to measure the elasticity of the blood vessels (randomized groups will be compared from baseline to 6 months); blood pressure measurements (randomized groups will be compared for rate of change in BP over 6 months); blood and urine collection (randomized groups will be compared for rate of change in proteinuria, fibroblast growth factor-23, serum parathyroid hormone, phosphate, calcium and C-reactive protein). |
Countries
Canada
Outcome results
None listed