Impact of Vitamin D Therapies on Monocyte Function in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Monocyte Protein Expression
研究概览
简要总结
This investigation will consist of a prospective study utilizing two separate populations of patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one with normal renal function.
详细描述
Vitamin D helps form and strengthens bones by allowing the body to absorb calcium. Vitamin D helps the immune system fight infection as well as helps keep muscles strong. Without enough vitamin D, bones can become weak, thin and brittle.
Vitamin D is useful in people with all different types of health issues. CKD is the slow loss of kidney function over time. The main function of the kidneys is to remove wastes and excess water from the body. This loss of function usually takes months or years to occur Patients with CKD often have low levels of vitamin D in their blood.
This study will have two groups of patients with CKD and one group of patients that have normal kidney function, but all groups will have low levels of vitamin D. The two groups with CKD (group 1 and group 2) will receive either cholecalciferol or calcitriol. The purpose of having a control group (group 3) without CKD will be to evaluate if any changes that are witnessed in response to vitamin D therapy are specific to patients with kidney disease or apply to all patients with vitamin D deficiency who receive vitamin D supplements.
There are two different drugs in this study. One is called Calcitriol and is approved by the Food and Drug Administration (FDA) as a vitamin D supplement. The other drug is called cholecalciferol and it is approved by the FDA. Unlike calcitriol, cholecalciferol is a nutritional form of vitamin D that can often be found in various types of foods and its chemical structure must be changed by the body to become the active form of vitamin D. It is believed that cholecalciferol may have different effects in the body compared to calcitriol. It is possible that CKD patients would benefit from receiving both of these drugs, but this is currently unclear. While on this study you will receive either one of these study drugs, depending on which group you are assigned to.
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
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic kidney disease w/GFR<35ml/min
- •Nutritional vitamin D deficiency, defined as 25(OH)D < 25ng/ml
- •Secondary hyperparathyroidism, PTH>75pg/mL
排除标准
- •Active infection
- •Recent hospitalization for acute illness (within last month)
- •Refusal to study participation
- •History of chronic inflammatory disease process (i.e. inflammatory bowel, rheumatoid arthritis, SLE, etc.)
- •Allergy to cholecalciferol or calcitriol
- •History of parathyroidectomy
- •Functional renal transplant within 5 years
- •Current treatment with immunosuppressant medications
- •Noncompliance with prescribed medications
研究组 & 干预措施
Group 1: Cholecalciferol - CKD
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks.
干预措施: Cholecalciferol - CKD (Drug)
Group 2: Calcitriol - CKD
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered calcitriol 0.25mcg daily for 8 weeks.
干预措施: Calcitriol - CKD (Device)
Group 3: Cholecalciferol - non-CKD
Patients in this arm have low vitamin D levels and normal kidney function. They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks.
干预措施: Cholecalciferol - non-CKD (Drug)
结局指标
主要结局
Monocyte Protein Expression
时间窗: 8 weeks of therapy
Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression
Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol
时间窗: 8 weeks of therapy
次要结局
未报告次要终点
研究者
Jason Stubbs, MD
Assistant Professor
University of Kansas Medical Center
