Vitamin D and the Health of Blood Vessels in Kidney Disease
NCT01247311
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Vitamin D and the Health of Blood Vessels in Kidney Disease | |||
Official Title ICMJE | The Impact of Vitamin D Supplementation on Vascular Stiffness and Blood Pressure in Chronic Kidney Disease Patients | |||
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). | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Chronic Kidney Disease (CKD) | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 129 | |||
Original Estimated Enrollment ICMJE | 125 | |||
Actual Study Completion Date ICMJE | August 2014 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01247311 | |||
Other Study ID Numbers ICMJE | H10-01689 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of British Columbia | |||
Study Sponsor ICMJE | University of British Columbia | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of British Columbia | |||
Verification Date | June 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |