Vitamin D and the Health of Blood Vessels in Kidney Disease

Chronic Kidney Disease (CKD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247311
• Other study ID #: H10-01689
• Status: Completed
• Phase: N/A
• First received: November 12, 2010
• Last updated: June 13, 2017
• Start date: November 2010
• Est. completion date: August 2014

Study information

• Verified date: June 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Dietary supplement
Placebo given orally 3xweek for six months
• Vitamin D
5000 IU vitamin D given orally 3xweek for six months
• Vitamin D
0.5ug 1,25 vitamin D given orally 3xweek for six months

Locations

Country	Name	City	State
Canada	St Paul's Hospital & Vancouver General Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Pfizer, The Kidney Foundation of Canada

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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 May 26. pii: CJN.10791016. doi: 10.2215/CJ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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