Vitamin D and the Health of Blood Vessels in Kidney Disease
NCT ID: NCT01247311
Last Updated: 2017-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
129 participants
INTERVENTIONAL
2010-11-30
2014-08-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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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
Vitamin D
0.5ug 1,25 vitamin D given orally 3xweek for six months
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
Vitamin D
5000 IU vitamin D given orally 3xweek for six months
3.
Placebo given orally 3xweek for six months
Dietary supplement
Placebo given orally 3xweek for six months
Interventions
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Dietary supplement
Placebo given orally 3xweek for six months
Vitamin D
5000 IU vitamin D given orally 3xweek for six months
Vitamin D
0.5ug 1,25 vitamin D given orally 3xweek for six months
Eligibility Criteria
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Inclusion Criteria
* treated with maximal conventional cardiovascular disease (CVD) risk reduction medications
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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The Kidney Foundation of Canada
OTHER
Pfizer
INDUSTRY
University of British Columbia
OTHER
Responsible Party
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Principal Investigators
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Adeera Levin, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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St Paul's Hospital & Vancouver General Hospital
Vancouver, British Columbia, Canada
Countries
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References
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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.
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.
Other Identifiers
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H10-01689
Identifier Type: -
Identifier Source: org_study_id
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