Vitamin D and the Health of Blood Vessels in Kidney Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of British Columbia
Sponsor:
Collaborators:
The Kidney Foundation of Canada
Pfizer
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01247311
First received: November 12, 2010
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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 Intervention
Chronic Kidney Disease (CKD)
Dietary Supplement: Dietary supplement
Dietary Supplement: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Vitamin D Supplementation on Vascular Stiffness and Blood Pressure in Chronic Kidney Disease Patients

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Help both physicians and dietitians decide whether vitamin D therapy is beneficial to patients with kidney disease [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 125
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247311

Contacts
Contact: Katy Vela 604-806-9460 kvela@providencehealth.bc.ca

Locations
Canada, British Columbia
St Paul's Hospital & Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Katy Vela    604-806-9460    kvela@providencehealth.bc.ca   
Sponsors and Collaborators
University of British Columbia
The Kidney Foundation of Canada
Pfizer
Investigators
Principal Investigator: Adeera Levin, Dr. University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01247311     History of Changes
Other Study ID Numbers: H10-01689
Study First Received: November 12, 2010
Last Updated: January 16, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Vitamin D
pulse wave velocity

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 25, 2014