Pilot Study: Efficacy and Safety of Vitamin D Supplementation in Glomerular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 10
- 主要终点
- To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels.
研究概览
简要总结
This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. .
详细描述
Vitamin D deficiency has been linked to a variety of adverse health outcomes. Nephrotic patients have very low vitamin D levels, and the underlying mechanisms are not known. Furthermore, approaches to safely and effectively supplement vitamin D in these patients have not been established. The purpose of this research study is to learn if vitamin D supplementation is safe and effective in patients with primary glomerular disease and to also help establish the treatment guidelines. About 35 patients with primary glomerular disease, ages 5-30 years old, will take part in this study. Participants will be asked to take vitamin D supplements each day for 12 weeks and will have 3 study visits.
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
- 5 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, age 5-30 years
- •Diagnosis of primary glomerular disease (such as steroid-resistant nephrotic syndrome, minimal change disease, FSGS, membranous nephropathy, membranoprolfierative glomerulonephritis, and Immunoglobulin A [IgA] nephropathy) without systemic inflammatory disorders (i.e. lupus, vasculitis)
- •Serum 25(OH)D level <30 ng/ml and urine protein:creatinine ratio ≥0.5 at Screening Visit.
排除标准
- •Pregnancy
- •estimated Glomerular Filtration Rate (eGFR) <30 ml/min/1.73m2 at Screening Visit
- •Serum phosphorus > 5.5 mg/dl or hypercalcemia
- •Chronic medical conditions or medications unrelated to the renal disease that may impact vitamin D status
- •Known history of kidney stone(s)
研究组 & 干预措施
Vitamin D Supplementation
Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks
干预措施: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks (Dietary Supplement)
结局指标
主要结局
To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels.
时间窗: 12 weeks
To assess the safety of vitamin D supplementation, by serum Ionized calcium (ICal), Pi, and 25(OH)D, and urinary calcium excretion.
时间窗: 12 weeks
次要结局
- To assess the innate immune response, measured by changes in the induction of Human cathelicidin antimicrobial protein (hCAP) in human monocytes.(12 weeks)
- To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1).(12 weeks)
- To assess arterial stiffness, measured by changes in pulse wave velocity.(12 weeks)