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Vitamin D, Insulin Resistance and Inflammation in ESRD

NCT00656032 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-01-11

No results posted yet for this study

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.

Conditions

Interventions

OTHER

paricalcitol

1 to 20 micrograms administered via IV; every other day, 3 days per week, for 8 weeks

OTHER

cinacalcet

0 to 180 mg administered orally every day for either 8 weeks or 16 weeks

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Alp Ikizler, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00656032 on ClinicalTrials.gov