Vitamin D, Insulin Resistance and Inflammation in ESRD - Tabular View

Tracking Information

First Received Date ^ICMJE

April 4, 2008

Last Updated Date

June 17, 2009

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

An improvement in insulin sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00656032 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

A change in insulin signaling [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
A decrease in concentration of plasma pro-inflammatory cytokines [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Vitamin D, Insulin Resistance and Inflammation in ESRD

Official Title ^ICMJE

Vitamin D, Insulin Resistance and Inflammation in ESRD

Brief Summary

The broad goal of this study is to understand the mechanisms by which Vitamin D receptor activation leads to changes in insulin signaling in advanced uremia. We hypothesize that 1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin resistance and that administration of a vitamin D3 analog will restore insulin sensitivity in End Stage Renal Disease patients.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

End Stage Renal Disease

Intervention ^ICMJE

Drug: paricalcitol
Drug: cinacalcet

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

CKD and receiving hemodialysis for ≥ 3months
Kt/V ≥ 1.2
≥ 18 years of age
Medically stable
AVF or PTFE dialysis access
No acute inflammatory disease within 4 weeks prior to the study
On stable dose of Paricalcitol for 4 weeks prior to the study
iPTH value between 150 - 1500 within the past 3 months
Ca < 10.5
PO4 < 10

Exclusion Criteria:

Pregnancy
Intolerance to the study medication
Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease)
Type 1 Diabetes mellitus
Uncontrolled Type 2 Diabetes mellitus (HbA1c > 10)
Hospitalization within 1 month prior to the study
Malfunctioning arterial-venous vascular access (recirculation and/or blood flow < 250 ml/min)
Presence of hemodialysis catheter
Patients receiving steroids and/or other immunosuppressive agents (> 10 mg prednisone qd)
BMI < 25 and > 45

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mary Sundell

615-322-4698

mary.b.sundell@vanderbilt.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00656032

Responsible Party

T. Alp Ikizler, MD, Vanderbilt University Medical Center

Study ID Numbers ^ICMJE

080074

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Alp Ikizler, MD

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

June 2009

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