At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓CKD stage 3 (GFR 30-59 ml/min) or stage 4 (GFR 15-29 ml/min)
- ✓Elevated intact PTH: >100 pg/ml for stage 3 CKD or >150 pg/ml for stage 4 CKD
- ✓Low calcidiol (25-hydroxyvitamin D) ≤20 ng/ml
- ✕Intact PTH >400 pg/ml
- ✕Corrected serum calcium >9.7 mg/dl
- ✕Serum phosphorous >5.0 mg/dl
- ✕Systolic/diastolic blood pressure >160/100 mmHg
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in CKD
In Brief
A clinical study evaluating doxercalciferol and Cholecalciferol for Renal Osteodystrophy. Completed, enrolled 55 participants across 1 site.
Detailed Summary
The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown. The National Kidney Foundation presented guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients and active vitamin D therapy in patients with sufficient levels. These guidelines are based on opinion since there are no significant trials to determine if vitamin D supplementation is effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol, and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have not been compared with vitamin D supplementation with a calciferol (ergocalciferol or cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood pressure and strength. In this proposed study we wish to directly compare the effectiveness of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary endpoints will be change in blood pressure.
Study Details
Timeline
Interventions
form of vitamin D that is already in active form.
from of vitamin D that requires cells in the body to make active