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Vitamin D and the Health of Blood Vessels in Kidney Disease

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ClinicalTrials.gov Identifier: NCT01247311
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : June 15, 2017
Sponsor:
Collaborators:
The Kidney Foundation of Canada
Pfizer
Information provided by (Responsible Party):
University of British Columbia

Tracking Information
First Submitted Date  ICMJE November 12, 2010
First Posted Date  ICMJE November 24, 2010
Last Update Posted Date June 15, 2017
Study Start Date  ICMJE November 2010
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01247311 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Dietary Supplement: Dietary supplement
    Placebo given orally 3xweek for six months
  • Dietary Supplement: Vitamin D
    5000 IU vitamin D given orally 3xweek for six months
  • Dietary Supplement: Vitamin D
    0.5ug 1,25 vitamin D given orally 3xweek for six months
Study Arms  ICMJE
  • Active Comparator: 1.

    1,25 Vitamin D (0.50ug *3 per week)

    This is a prospective randomized double blind placebo controlled study of 125 stable CKD subjects examining the impact of vitamin D supplementation (1,25 vitamin D or 25 vitamin D formulations) compared to placebo on arterial stiffness and other parameters of vascular health

    Intervention: Dietary Supplement: Vitamin D
  • Active Comparator: 2.

    25 Vitamin D (5000IU * 3 per week)

    This is a prospective randomized double blind placebo controlled study of 125 stable CKD subjects examining the impact of vitamin D supplementation (1,25 vitamin D or 25 vitamin D formulations) compared to placebo on arterial stiffness and other parameters of vascular health

    Intervention: Dietary Supplement: Vitamin D
  • Placebo Comparator: 3.
    Placebo given orally 3xweek for six months
    Intervention: Dietary Supplement: Dietary supplement
Publications *

*   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
 (submitted: September 23, 2014)
129
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2010)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
  • The Kidney Foundation of Canada
  • Pfizer
Investigators  ICMJE
Principal Investigator: Adeera Levin, Dr. University of British Columbia
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