Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Indiana University School of Medicine
Treatments:
1 alpha-hydroxyergocalciferol Cholecalciferol Ergocalciferols Vitamin D Vitamins