Ergocalciferol Therapy in Calcidiol Deficient, Hemodialysis Patients on Therapeutic Doses of Paricalcitol

Inclusion Criteria

• •Non-diabetic in-center HD patients on stable doses of paricalcitol over past three months with intact parathyroid hormone (iPTH) in the therapeutic range (150-300 pg/ml) will be identified from review of the dialysis program electronic medical records. Woman in the reproductive age group (ages 18-55), excluding those women who have undergone hysterectomy, oopherectomy will undergo a serum β-HCG levels during the selection process. If β-HCG levels are positive these patients will be excluded from the study.
• •Non diabetic patients on HD, on stable dose of paricalcitol supplements for at least 3 months with iPTH in target range. Of the 60 patients enrolled in the observational component, those with high CRP (\> 3 mg/dl) and calcidiol deficiency (\< 15 ng/ml) will be eligible to participate in the interventional study.
• •As the median CRP in the HEMO Study was 11 mg/L and \> 80% of HD patients are calcidiol deficient \[10\], most of the screened patients will be eligible. In each year, the first 12 patients who meet the above criteria and consent for the interventional component, a randomized cross-over trial of cholecalciferol 50,000 IU/ week vs. matching placebo will be conducted.