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

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.

Inclusion criteria

• 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.

Exclusion criteria

• Diabetic patients, not on paricalcitol, enrolled in other interventional studies, hospitalized in the past month or treated for an infection in the past month and pregnancy.
• We will conduct a pregnancy test for women in the reproductive age group (18-55 years) during the initial screening process. We will obtain serum β-HCG levels to rule out pregnancy and the test will be paid for by the study. The results will be reviewed by the PI. If β-HCG levels are positive these patients will be withdrawn from the study.