NCT00656032

Vitamin D, Insulin Resistance and Inflammation in ESRD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• End Stage Renal Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-04-10
• Last updated: 2012-01-11

Locations

1 site across 1 country: United States