Vitamin D and the Health of Blood Vessels in Kidney Disease

NCT01247311 | Completed DMC

• 1 other identifier: H10-01689
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease (CKD)

Keywords

Vitamin D; pulse wave velocity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

1.

ACTIVE COMPARATOR

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

2.

ACTIVE COMPARATOR

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

3.

PLACEBO COMPARATOR

Placebo given orally 3xweek for six months

Dietary Supplement: Dietary supplement

Interventions

Dietary supplement DIETARY_SUPPLEMENT

Placebo given orally 3xweek for six months

3.

Vitamin D DIETARY_SUPPLEMENT

5000 IU vitamin D given orally 3xweek for six months

2.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• The Kidney Foundation of Canada: collaborator
• Pfizer: collaborator

Study Sites (1)

St Paul's Hospital & Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Related 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.

  PMID: 25381032 BACKGROUND

• 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.

  PMID: 28550081 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Dietary Supplements; Vitamin D

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Adeera Levin, Dr.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 24, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 15, 2017

Record last verified: 2017-06

Locations

CA (1)