Impact of Vitamin D Therapies on Chronic Kidney Disease

Chronic Kidney Disease (CKD) Clinical Trial

Official title:

Impact of Vitamin D Therapies on Monocyte Function in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222234
• Other study ID #: 11936
• Status: Completed
• Phase: N/A
• First received: October 13, 2010
• Last updated: September 24, 2012
• Start date: October 2010
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This investigation will consist of a prospective study utilizing two separate populations of patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one with normal renal function.

Description:

Vitamin D helps form and strengthens bones by allowing the body to absorb calcium. Vitamin D helps the immune system fight infection as well as helps keep muscles strong. Without enough vitamin D, bones can become weak, thin and brittle.

Vitamin D is useful in people with all different types of health issues. CKD is the slow loss of kidney function over time. The main function of the kidneys is to remove wastes and excess water from the body. This loss of function usually takes months or years to occur Patients with CKD often have low levels of vitamin D in their blood.

This study will have two groups of patients with CKD and one group of patients that have normal kidney function, but all groups will have low levels of vitamin D. The two groups with CKD (group 1 and group 2) will receive either cholecalciferol or calcitriol. The purpose of having a control group (group 3) without CKD will be to evaluate if any changes that are witnessed in response to vitamin D therapy are specific to patients with kidney disease or apply to all patients with vitamin D deficiency who receive vitamin D supplements.

There are two different drugs in this study. One is called Calcitriol and is approved by the Food and Drug Administration (FDA) as a vitamin D supplement. The other drug is called cholecalciferol and it is approved by the FDA. Unlike calcitriol, cholecalciferol is a nutritional form of vitamin D that can often be found in various types of foods and its chemical structure must be changed by the body to become the active form of vitamin D. It is believed that cholecalciferol may have different effects in the body compared to calcitriol. It is possible that CKD patients would benefit from receiving both of these drugs, but this is currently unclear. While on this study you will receive either one of these study drugs, depending on which group you are assigned to.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• Chronic kidney disease w/GFR<35ml/min

• Nutritional vitamin D deficiency, defined as 25(OH)D < 25ng/ml

• Secondary hyperparathyroidism, PTH>75pg/mL

Exclusion Criteria:

• Active infection

• Recent hospitalization for acute illness (within last month)

• Refusal to study participation

• History of chronic inflammatory disease process (i.e. inflammatory bowel, rheumatoid arthritis, SLE, etc.)

• Allergy to cholecalciferol or calcitriol

• History of parathyroidectomy

• Functional renal transplant within 5 years

• Current treatment with immunosuppressant medications

• Noncompliance with prescribed medications

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• End-stage Renal Disease (ESRD)
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• Cholecalciferol
Cholecalciferol tablet, 50,000 units twice a week

Device:
• calcitriol
calcitriol 0.25 mcg every day

Drug:
• Cholecalciferol
Cholecalciferol tablet, 50,000 units twice a week

Locations

Country	Name	City	State
United States	University Of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate the effects of cholecalciferol and calcitriol on pathways involved in innate immunity in monocytes of patients with chronic kidney disease.	The preliminary data suggests an upregulation of the VDR in response to cholecalciferol, with a potential additive effect of concurrently administered calcitriol in patients with ESRD. The goal of this aim is to more fully understand the downstream effects of these changes in VDR expression on pathways involved in monocyte immune responses and to thoroughly investigate differing responses to cholecalciferol versus calcitriol.	baseline	No
Primary	Investigate the effects of cholecalciferol and calcitriol on pathways involved in innate immunity in monocytes of patients with chronic kidney disease.	The preliminary data suggests an upregulation of the VDR in response to cholecalciferol, with a potential additive effect of concurrently administered calcitriol in patients with ESRD. The goal of this aim is to more fully understand the downstream effects of these changes in VDR expression on pathways involved in monocyte immune responses and to thoroughly investigate differing responses to cholecalciferol versus calcitriol.	week 4	No
Primary	Investigate the effects of cholecalciferol and calcitriol on pathways involved in innate immunity in monocytes of patients with chronic kidney disease.	The preliminary data suggests an upregulation of the VDR in response to cholecalciferol, with a potential additive effect of concurrently administered calcitriol in patients with ESRD. The goal of this aim is to more fully understand the downstream effects of these changes in VDR expression on pathways involved in monocyte immune responses and to thoroughly investigate differing responses to cholecalciferol versus calcitriol.	week 8	No
Primary	Investigate the effects of cholecalciferol and calcitriol on pathways involved in innate immunity in monocytes of patients with chronic kidney disease.	The preliminary data suggests an upregulation of the VDR in response to cholecalciferol, with a potential additive effect of concurrently administered calcitriol in patients with ESRD. The goal of this aim is to more fully understand the downstream effects of these changes in VDR expression on pathways involved in monocyte immune responses and to thoroughly investigate differing responses to cholecalciferol versus calcitriol.	week 10	No
Secondary	extend the analysis to assess the effects cholecalciferol and calcitriol on monocyte inflammatory pathways that have been associated with the pathogenesis of atherosclerosis		week 10	No
Secondary	Confirm the preliminary findings that cholecalciferol has unique effects on "inflammatory" (CD16+) monocytes		week 10	No