Vitamin D and the Health of Blood Vessels in Kidney Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease (CKD)
• Intervention / Treatment: Dietary supplement: Vitamin D; Dietary supplement: Vitamin D; Dietary supplement: Dietary supplement

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 Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • St Paul's Hospital & Vancouver General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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; 5000 IU vitamin D given orally 3xweek for six months; 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; Dietary supplement: Vitamin D; 0.5ug 1,25 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	15 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Pfizer; The Kidney Foundation of Canada
• Investigators: Principal Investigator: Adeera Levin, Dr., University of British Columbia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: November 12, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Vitamin D; pulse wave velocity
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: H10-01689