Vitamin D and the Health of Blood Vessels in Kidney Disease

University of British Columbia

Status: Completed

Conditions: Chronic Kidney Disease (CKD)

Treatments: Dietary Supplement: Dietary supplement; Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01247311

H10-01689

Details and patient eligibility

About

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.

Full 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).

Enrollment: 129 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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129 participants in 3 patient groups, including a placebo group

1.

Active Comparator group

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

Treatment:

Dietary Supplement: Vitamin D

Dietary Supplement: Vitamin D

2.

Active Comparator group

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

Treatment:

Dietary Supplement: Vitamin D

Dietary Supplement: Vitamin D

3.

Placebo Comparator group

Description:

Placebo given orally 3xweek for six months

Treatment:

Dietary Supplement: Dietary supplement