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Clinical Trials/NCT01247311
NCT01247311
Completed
Not Applicable

The Impact of Vitamin D Supplementation on Vascular Stiffness and Blood Pressure in Chronic Kidney Disease Patients

University of British Columbia1 site in 1 country129 target enrollmentNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Disease (CKD)
Sponsor
University of British Columbia
Enrollment
129
Locations
1
Primary Endpoint
Help both physicians and dietitians decide whether vitamin D therapy is beneficial to patients with kidney disease
Status
Completed
Last Updated
8 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
August 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Help both physicians and dietitians decide whether vitamin D therapy is beneficial to patients with kidney disease

Time Frame: 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).

Study Sites (1)

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