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临床试验/NCT00677534
NCT00677534已完成不适用

Exploring the Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease

University of Kansas0 个研究点目标入组 7 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
7
主要终点
Change in Monocyte VDR Expression With Vitamin D Therapy

研究概览

简要总结

The goal of this study is to evaluate the role of nutritional Vitamin D deficiency as a potential contributor to the morbidity witnessed in patients with end-stage renal disease

详细描述

The goals of this study are to elucidate the function of extrarenal 1 alpha-hydroxylase activity in the setting of renal failure and to evaluate the role of nutritional vitamin D deficiency as a potential contributor to monocyte-associated inflammatory pathways in patients with end-stage renal disease (ESRD). This study will consist of patients on chronic maintenance hemodialysis three times per week who have been identified to have nutritional vitamin D deficiency. After consent for study enrollment, patients will undergo a 4 week washout period of all active vitamin D supplementation. After washout is complete, an blood sample will be obtained for baseline 25(OH)D levels and monocyte isolation for analysis by flow cytometry. Patients will then be started on cholecalciferol 50,000 IU twice weekly for 8 weeks. 25-vitamin D levels will be monitored midway through the treatment phase of the study and dosing adjusted as further described in detail within the protocol section. An additional blood sample will be drawn post-therapy for repeat 25(OH)D levels and monocyte isolation for flow cytometry analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • End-stage renal disease undergoing maintenance hemodialysis at KUMC outpatient hemodialysis unit
  • Dialysis vintage of at least 6 months duration
  • Nutritional vitamin D deficiency, defined as 25(OH)D <25 ng/ml
  • Age 21 to 88 years

排除标准

  • Active infection
  • Recent hospitalization for acute illness (within last 1 month)
  • Refusal to study participation
  • Poorly controlled secondary hyperparathyroidism (iPTH>500)
  • History of chronic inflammatory disease process, such as inflammatory bowel, rheumatoid arthritis, lupus, etc.
  • Cinacalcet therapy
  • Previous allergy to ergocalciferol
  • History of parathyroidectomy
  • Current treatment with immunosuppressant medications
  • Noncompliance with prescribed hemodialysis regimen (i.e. skipping treatments, ending sessions early)
  • Functional renal transplant within the last five years

研究组 & 干预措施

1

Experimental

Cholecalciferol (Vitamin D)

干预措施: Cholecalciferol (Drug)

结局指标

主要结局

Change in Monocyte VDR Expression With Vitamin D Therapy

时间窗: Change from End of Washout to Week 12

Monocytes will be analyzed pre- and post-cholecalciferol by flow cytometry to measure changes in monocyte VDR expression. Unit of measure is represented by mean florescence intensity (MFI), which is a relative measure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason Stubbs, MD

Assistant Professor

University of Kansas

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