Vitamin D and the Health of Blood Vessels in Kidney Disease

Sponsor

University of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT01247311

Collaborator

The Kidney Foundation of Canada (Other), Pfizer (Industry)

129

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease (CKD)	Dietary Supplement: Dietary supplement Dietary Supplement: Vitamin D Dietary Supplement: Vitamin D	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Impact of Vitamin D Supplementation on Vascular Stiffness and Blood Pressure in Chronic Kidney Disease Patients

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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	Dietary Supplement: Vitamin D 0.5ug 1,25 vitamin D given orally 3xweek for six months
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	Dietary Supplement: Vitamin D 5000 IU vitamin D given orally 3xweek for six months
Placebo Comparator: 3. Placebo given orally 3xweek for six months	Dietary Supplement: Dietary supplement Placebo given orally 3xweek for six months

Arm

Intervention/Treatment

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

Dietary Supplement: Vitamin D

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

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

Dietary Supplement: Vitamin D

5000 IU vitamin D given orally 3xweek for six months

Placebo Comparator: 3.

Placebo given orally 3xweek for six months

Dietary Supplement: Dietary supplement

Placebo given orally 3xweek for six months

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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