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Vitamin D and the Health of Blood Vessels in Kidney Disease

Primary Purpose

Chronic Kidney Disease (CKD)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dietary supplement
Vitamin D
Vitamin D
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease (CKD) focused on measuring Vitamin D, pulse wave velocity

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Paul's Hospital & Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1.

2.

3.

Arm Description

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

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

Placebo given orally 3xweek for six months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 12, 2010
Last Updated
June 13, 2017
Sponsor
University of British Columbia
Collaborators
The Kidney Foundation of Canada, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01247311
Brief Title
Vitamin D and the Health of Blood Vessels in Kidney Disease
Official Title
The Impact of Vitamin D Supplementation on Vascular Stiffness and Blood Pressure in Chronic Kidney Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
The Kidney Foundation of Canada, Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease (CKD)
Keywords
Vitamin D, pulse wave velocity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.
Arm Type
Active Comparator
Arm Description
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
Arm Title
2.
Arm Type
Active Comparator
Arm Description
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
Arm Title
3.
Arm Type
Placebo Comparator
Arm Description
Placebo given orally 3xweek for six months
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary supplement
Intervention Description
Placebo given orally 3xweek for six months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
5000 IU vitamin D given orally 3xweek for six months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
0.5ug 1,25 vitamin D given orally 3xweek for six months
Primary Outcome Measure Information:
Title
Help both physicians and dietitians decide whether vitamin D therapy is beneficial to patients with kidney disease
Description
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).
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeera Levin, Dr.
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Paul's Hospital & Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25381032
Citation
Levin A, Perry T, De Zoysa P, Sigrist MK, Humphries K, Tang M, Djurdjev O. A randomized control trial to assess the impact of vitamin D supplementation compared to placebo on vascular stiffness in chronic kidney disease patients. BMC Cardiovasc Disord. 2014 Nov 7;14:156. doi: 10.1186/1471-2261-14-156.
Results Reference
background
PubMed Identifier
28550081
Citation
Levin A, Tang M, Perry T, Zalunardo N, Beaulieu M, Dubland JA, Zerr K, Djurdjev O. Randomized Controlled Trial for the Effect of Vitamin D Supplementation on Vascular Stiffness in CKD. Clin J Am Soc Nephrol. 2017 Sep 7;12(9):1447-1460. doi: 10.2215/CJN.10791016. Epub 2017 May 26.
Results Reference
result

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Vitamin D and the Health of Blood Vessels in Kidney Disease

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