This is an open label, single center, randomized, active comparator controlled study, comparing the effects of vitamin D replacement using oral ergocalciferol versus paricalcitol on parathyroid hormone (PTH) levels in patients with stage 3 and 4 CKD and vitamin D deficiency or insufficiency. The purpose of this study is to determine which of these two approaches is more successful.
This study will enroll chronic kidney disease patients, stage 3 and 4, who have low serum vitamin D levels as defined by K DOQI Guidelines. Patients will be randomized to receive oral daily ergocalciferol or paricalcitol. A total of 80 patients will be enrolled, 40 in the cholecalciferol group and 40 in the paricalcitol group. Outcomes will be assessed as proportion of patients achieving pre-defined changes from baseline and as absolute changes from baseline values. Baseline values will be determined from averaging two consecutive measurements of the variables of interest prior to randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
1. Patients will receive 1mcg once daily orally if iPTH is less than 500pg/ml; 2. Patients will receive 2mcg once daily orally if iPTH is more than 500pg/ml. Duration of administration will be 16 weeks.
1. If baseline 25 OHD level is less than 5ng/mml: ergocalciferol 50,000 units once a week orally for 12 weeks, then 50,000 units monthly for total duration of 16 weeks. 2. If baseline 25 OHD is between 5 and 15mg/ml: Ergocalciferol 50,000 units once a week orally for 4 weeks, then 50,000 units once a month for total duration of 16 weeks. 3. If baseline 25 OHD level is between 16 and 30ng/ml: Ergocalciferol 50,000 units orally once every 4 weeks for 16 weeks.
VA Medical Center
Salem, Virginia, United States
To achieve 2 consecutive iPTH measurements with 30% or greater decrease from baseline
Time frame: 2 years
To achieve 25OHD level above 30 ng/ml and change cardiovascular markers
Time frame: 2 years
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