Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.
研究概览
简要总结
The purpose of this study is to determine whether nutritional (cholecalciferol) or active vitamin D (calcitriol) supplementation improves vascular endothelial function in patients with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The investigators hypothesize that the use of calcitriol supplementation will result in improved vascular endothelial function as compared to cholecalciferol supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Chronic kidney disease stage IIIB or IV by 4 parameter Modified Diet in Renal Diseases Formula (Estimated Glomerular Filtration Rate [GFR] 44-15 ml/min/1.73m2)
- •Vitamin D (D2 + D3) deficient, defined as serum 25(OH)D level < 30 ng/mL
- •Corrected serum calcium < 10.2 mg/dL
- •Serum phosphate < 4.6 mg/dL
- •Serum albumin > 3.0 g/dL
- •Body mass index < 40 kg/m2
- •Ability to give informed consent
排除标准
- •Significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
- •Expected to undergo living related kidney transplant in next 6 months
- •Pregnant, breastfeeding, or unwilling to use adequate birth control
- •History of severe liver disease
- •Nephrotic range proteinuria (> 3.5 gm/day)
- •Use of active vitamin D analogs within 30 days of randomization
研究组 & 干预措施
Cholecalciferol
Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
干预措施: Cholecalciferol (Drug)
Calcitriol
Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
干预措施: Calcitriol (Drug)
结局指标
主要结局
Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.
时间窗: 6 months
EDD will be measured by brachial artery flow-mediated dilation (FMD). The mean change in percent FMD from baseline will be documented.
次要结局
- Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein(6 months)
- Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB(6 months)