Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

This study is currently recruiting participants.

Verified December 2012 by University of Colorado, Denver

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by (Responsible Party):

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT01384539

First received: June 27, 2011

Last updated: December 6, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 27, 2011

Last Updated Date

December 6, 2012

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Difference between the calcitriol and cholecalciferol groups in conduit artery endothelium-dependent dilation (EDD) in response to treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

EDD measured by brachial artery flow-mediated dilation (FMD)

Original Primary Outcome Measures ^ICMJE

Difference between the calcitriol and cholecalciferol groups in conduit artery endothelium-dependent dilation (EDD) in response to treatment. [ Designated as safety issue: No ]

EDD measured by brachial artery flow-mediated dilation (FMD)

Change History

Complete list of historical versions of study NCT01384539 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare the efficacy of calcitriol and cholecalciferol supplementation on plasma concentrations of C-reactive protein [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation
To compare the effect of calcitriol and cholecalciferol supplementation on vascular endothelial cell expression of Nf-kB [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To compare the efficacy of calcitriol and cholecalciferol on plasma concentrations of C-reactive protein, IL-6 and vascular endothelial cell expression of NF-kB [ Designated as safety issue: No ]

Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

Official Title ^ICMJE

Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Arterial Dysfunction
Chronic Kidney Disease

Intervention ^ICMJE

Drug: Cholecalciferol
Drug: Calcitriol

Study Arm (s)

Experimental: Cholecalciferol
Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months

Intervention: Drug: Cholecalciferol
Experimental: Calcitriol
Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months

Intervention: Drug: Calcitriol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

128

Estimated Completion Date

June 2015

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age ≥ 18 years
Chronic kidney disease stage IIIB or IV by 4 parameter Modified Diet in Renal Diseases Formula (Estimated 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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jessica Kendrick, MD

303-436-5905

Jessica.Kendrick@ucdenver.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01384539

Other Study ID Numbers ^ICMJE

11-0521, 5K23DK087859

Has Data Monitoring Committee

Yes

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators ^ICMJE

Principal Investigator:

Jessica Kendrick, MD

University of Colorado, Denver

Information Provided By

University of Colorado, Denver

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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