Vitamin D and the Health of Blood Vessels in Kidney Disease

NCT ID: NCT01247311

Last Updated: 2017-06-15

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-08-31

Brief Summary

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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

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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).

Conditions

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Chronic Kidney Disease (CKD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

5000 IU vitamin D given orally 3xweek for six months

3.

Placebo given orally 3xweek for six months

Group Type PLACEBO_COMPARATOR

Dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo given orally 3xweek for six months

Interventions

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Dietary supplement

Placebo given orally 3xweek for six months

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

5000 IU vitamin D given orally 3xweek for six months

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

0.5ug 1,25 vitamin D given orally 3xweek for six months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Kidney Foundation of Canada

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Canada

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.

Reference Type BACKGROUND
PMID: 25381032 (View on PubMed)

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.

Reference Type RESULT
PMID: 28550081 (View on PubMed)

Other Identifiers

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H10-01689

Identifier Type: -

Identifier Source: org_study_id

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