Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384539
• Other study ID #: 11-0521
• Secondary ID: 5K23DK087859
• Status: Completed
• Phase: Phase 3
• Start date: July 2011
• Est. completion date: September 2015

Study information

• Verified date: August 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether nutritional (cholecalciferol) or active vitamin D (calcitriol) supplementation improves vascular endothelial function in patients with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The investigators hypothesize that the use of calcitriol supplementation will result in improved vascular endothelial function as compared to cholecalciferol supplementation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age = 18 years

• Chronic kidney disease stage IIIB or IV by 4 parameter Modified Diet in Renal Diseases Formula (Estimated Glomerular Filtration Rate [GFR] 44-15 ml/min/1.73m2)

• Vitamin D (D2 + D3) deficient, defined as serum 25(OH)D level < 30 ng/mL

• Corrected serum calcium < 10.2 mg/dL

• Serum phosphate < 4.6 mg/dL

• Serum albumin > 3.0 g/dL

• Body mass index < 40 kg/m2

• Ability to give informed consent

Exclusion Criteria:

• Significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year

• Expected to undergo living related kidney transplant in next 6 months

• Pregnant, breastfeeding, or unwilling to use adequate birth control

• History of severe liver disease

• Nephrotic range proteinuria (> 3.5 gm/day)

• Use of active vitamin D analogs within 30 days of randomization

Related Conditions & MeSH terms

• Arterial Dysfunction
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Cholecalciferol

• Calcitriol

Locations

Country	Name	City	State
United States	University of Colorado Denver Clinical Translational Research Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.	EDD will be measured by brachial artery flow-mediated dilation (FMD). The mean change in percent FMD from baseline will be documented.	6 months
Secondary	Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein	Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation	6 months
Secondary	Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB	The effect of calcitriol and cholecalciferol supplementation will be evaluated calculating the mean change in total vascular endothelial cell NFkB expression. NFkB expression is given as arbitrary units and represent ratios of endothelial cell protein expression to human umbilical vein endothelial cell (HUVEC) expression in order to account for any variation in the staining procedure.	6 months