Immune Effects of Vitamin D in Hemodialysis Patients

Inclusion Criteria:

• Patient stable on chronic hemodialysis for more than 3 months.
• PTH level between 150 - 800 pg/ml.
• Ability to give informed consent.
• Serum calcium levels (corrected for albumin level of 4.0 g/dL) less than 10.5 mg/dL for the last three consecutive measurements.
• Serum Phosphorus levels between 2.5 and 7.0 mg/dL for the last three consecutive measurements.
• Ca x P-Product of less than 75 mg2/dL2 in the last three consecutive measurements.

Exclusion Criteria:

• Known active malignancy.
• Liver disease defined as serum aspartate aminotransferase, alanine aminotransferase, or gamma-glutamyltransferase levels more than 2 times the upper limits of normal.
• PTH levels between 150 pg/mL and 800 pg/mL.
• Hypercalcemia or hypercalcemic episodes within the last 4 weeks.
• Ca x P-Product more than 75 mg2/dL2 within the last 4 weeks.
• Any clinical significant infections which are or have been treated with antibiotics within 6 weeks prior to start of the study.
• Chronic viral infection (HIV, Hepatitis B or C).
• Currently on immunosuppressive medication (steroids, cyclosporine, etc…).
• Hematocrit less than 30 %.
• History of blood disorders other than renal anemia.
• Age of less than 18 years or more than 75 years.
• Hypersensitivity to paricalcitol or any ingredient of the product.
• Parathyroidectomy.
• Participation in another study at the same time.