Status:
COMPLETED
Vitamin D, Insulin Resistance and Inflammation in ESRD
Lead Sponsor:
Vanderbilt University
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00656032
Start Date
April 1 2008
End Date
January 1 2010
Last Update
January 11 2012
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232