Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol
研究概览
简要总结
The prevalence of vitamin D deficiency increases as kidney function declines. As a result, many hemodialysis patients often have low levels of vitamin D. Recent evidence has shown that vitamin D supplementation may improve many aspects of poor health such as heart disease and inflammatory markers. The objectives of this study are to determine how supplementing dialysis patients with ergocalciferol increases vitamin D levels, how long vitamin D levels can be maintained after a 6 month treatment course, and to examine the effect of ergocalciferol on biomarkers of inflammation and vascular health.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Activated vitamin D administration
- •On chronic hemodialysis for ≥ 6 months
- •Use of a synthetic biocompatible dialysis membrane
- •25-hydroxyvitamin D levels < 30 ng/mL
- •Corrected serum calcium < 10.2 mg/dL
- •Serum phosphate < 7 mg/dL
- •Iron replete (Ferritin > 200 ng/mL and transferrin saturation > 20%)
排除标准
- •Current participation in any other investigational drug trial
- •Vitamin D deficiency due to a heredity disorder
- •Liver disease or failure
- •Current or past treatment with ergocalciferol or cholecalciferol ≥ 2000 IU per day (within the past 6 months)
- •Treatment with calcimimetics or bisphosphonates within the last 3 months
- •Treatment with anti-epileptics or other medications that can effect vitamin D metabolism
- •Malnutrition (serum albumin < 2.5 mg/dL)
- •Pregnancy, positive pregnancy test or breastfeeding
- •Malignancy or other significant inflammatory disease
研究组 & 干预措施
Ergocalciferol
Ergocalciferol 50,000 IU by mouth once weekly for 6 months
干预措施: Ergocalciferol (Drug)
Placebo
Placebo by mouth once weekly for 6 months
干预措施: Placebo (Drug)
结局指标
主要结局
The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol
时间窗: 12 months
次要结局
未报告次要终点
研究者
Darius Mason
PI
Albany College of Pharmacy and Health Sciences