Effect of Paricalcitol on Coagulation Study

Effect of Paricalcitol on Coagulation Study

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PROTOCOL DESCRIPTION

Randomized, placebo-controlled administration of paricalcitol (active viatamin D) vs placebo for short term duration of two weeks. The experimental part of the study is the correlation between the markers of thrombosis and the administration of active vitamin D (paricalcitol).

The study is a pilot trial to determine the effect fo paricalcitol on coagulation parameters compared with spontaneous variability in these measures. Patients will have a complete metabolic profile to assess serum creatinine (and calculate eGFR), serum calcium and other labs. If patient qualifies they will have baseline labs obtained, then be randomized to paricalcitol 2 micrograms per day orally or to a matching placebo.

At one week and at two weeks, a brief history and physical will be obtained with focus on symptoms of potential hypercalcemia, a review of medicines (including OTC meds) and lab work will be done. After two weeks, the study is completed.

The study visit duration should be no more than 1.5 hours (anticipate considerably less, eg. 45 minutes). Data related to this study will be captured on a Data Collection Form.

ELIGIBILITY CRITERIA

  • Age > 21 years old
  • Able and willing to give informed consent
  • Diabetes on either oral agents or insulin
  • Chronic kidney disease with eGFR 15-60
  • CERTAIN EXCLUSION CRITERIA APPLY

Contact Information:

Dawn Bowles, RN, CCRP
Clinical Research Nurse
Phone: 540-224-4658
dmbowles@carilionclinic.org