COMPARISON OF CHOLECALCIFEROL VERSUS DOXERCALCIFEROL IN THE TREATMENT OF SECONDA

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 大多数中到重度慢性肾脏病(CKD)(3期和4期)患者发生继发性甲状旁腺功能亢进症(2？HPT)，但在这一组中控制甲状旁腺功能亢进的最佳治疗方法尚不清楚。国家肾脏基金会在2003年提出了指南，建议对维生素D不足的患者补充维生素D，对维生素D水平足够的患者进行积极的维生素D治疗。这些指南是基于意见的，因为没有重大试验来确定维生素D补充剂在这一人群中是否有效。维生素D的活性代谢物doxercalciferol、paricalcitol和calciriol已被证明能有效地抑制甲状旁腺激素(PTH)，但尚未与补充维生素D的钙化醇(麦角钙化醇或胆钙化醇)进行比较。除了甲状旁腺机能亢进症，小型研究表明，在维生素D不足的非慢性肾脏病患者中补充维生素D会改善疼痛、幸福感、血压和力量。在这项拟议的研究中，我们希望在一项为期三个月的研究中，直接比较胆钙化醇和多塞骨化醇在抑制维生素D缺乏的慢性肾脏病非透析受试者甲状旁腺素水平升高方面的有效性。次要终点将是肌肉力量、血压、肾功能和生活质量指标的变化。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 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 muscle strength, blood pressure, renal function, and quality of life measures..