Vitamin D, Insulin Resistance and Inflammation in ESRD

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00656032

Enrollment

Registered

2008-04-10

Start date

2008-04-30

Completion date

2010-01-31

Last updated

2012-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

insulin resistance, end stage renal disease

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.

Interventions

OTHERparicalcitol

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

OTHERcinacalcet

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
An improvement in insulin sensitivity	8 weeks

Secondary

Measure	Time frame
A change in insulin signaling	8 weeks
A decrease in concentration of plasma pro-inflammatory cytokines	8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026